Side effects of orencia

Contents

Orencia

SIDE EFFECTS

Because clinical trials are conducted under widely varying and controlled conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not predict the rates observed in a broader patient population in clinical practice.

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to abatacept in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.

Clinical Studies Experience In Adult RA Patients Treated With Intravenous Orencia

The data described herein reflect exposure to ORENCIA administered intravenously in patients with active RA in placebo-controlled studies (1955 patients with ORENCIA, 989 with placebo). The studies had either a double-blind, placebo-controlled period of 6 months (258 patients with ORENCIA, 133 with placebo) or 1 year (1697 patients with ORENCIA, 856 with placebo). A subset of these patients received concomitant biologic DMARD therapy, such as a TNF blocking agent (204 patients with ORENCIA, 134 with placebo).

The majority of patients in RA clinical studies received one or more of the following concomitant medications with ORENCIA: methotrexate, nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, TNF blocking agents, azathioprine, chloroquine, gold, hydroxychloroquine, leflunomide, sulfasalazine, and anakinra.

The most serious adverse reactions were serious infections and malignancies.

The most commonly reported adverse events (occurring in ≥10% of patients treated with ORENCIA) were headache, upper respiratory tract infection, nasopharyngitis, and nausea.

The adverse events most frequently resulting in clinical intervention (interruption or discontinuation of ORENCIA) were due to infection. The most frequently reported infections resulting in dose interruption were upper respiratory tract infection (1.0%), bronchitis (0.7%), and herpes zoster (0.7%). The most frequent infections resulting in discontinuation were pneumonia (0.2%), localized infection (0.2%), and bronchitis (0.1%).

In the placebo-controlled trials, infections were reported in 54% of ORENCIA-treated patients and 48% of placebo-treated patients. The most commonly reported infections (reported in 5%-13% of patients) were upper respiratory tract infection, nasopharyngitis, sinusitis, urinary tract infection, influenza, and bronchitis. Other infections reported in fewer than 5% of patients at a higher frequency (>0.5%) with ORENCIA compared to placebo, were rhinitis, herpes simplex, and pneumonia .

Serious infections were reported in 3.0% of patients treated with ORENCIA and 1.9% of patients treated with placebo. The most common (0.2%-0.5%) serious infections reported with ORENCIA were pneumonia, cellulitis, urinary tract infection, bronchitis, diverticulitis, and acute pyelonephritis .

Malignancies

In the placebo-controlled portions of the clinical trials (1955 patients treated with ORENCIA for a median of 12 months), the overall frequencies of malignancies were similar in the ORENCIA-and placebo-treated patients (1.3% and 1.1%, respectively). However, more cases of lung cancer were observed in ORENCIA-treated patients (4, 0.2%) than placebo-treated patients (0). In the cumulative ORENCIA clinical trials (placebo-controlled and uncontrolled, open-label) a total of 8 cases of lung cancer (0.21 cases per 100 patient-years) and 4 lymphomas (0.10 cases per 100 patient-years) were observed in 2688 patients (3827 patient-years). The rate observed for lymphoma is approximately 3.5-fold higher than expected in an age-and gender-matched general population based on the National Cancer Institute’s Surveillance, Epidemiology, and End Results Database. Patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma. Other malignancies included skin, breast, bile duct, bladder, cervical, endometrial, lymphoma, melanoma, myelodysplastic syndrome, ovarian, prostate, renal, thyroid, and uterine cancers . The potential role of ORENCIA in the development of malignancies in humans is unknown.

Infusion-Related Reactions And Hypersensitivity Reactions

Acute infusion-related events (adverse reactions occurring within 1 hour of the start of the infusion) in Studies III, IV, and V were more common in the ORENCIA-treated patients than the placebo patients (9% for ORENCIA, 6% for placebo). The most frequently reported events (1%-2%) were dizziness, headache, and hypertension.

Acute infusion-related events that were reported in >0.1% and ≤1% of patients treated with ORENCIA included cardiopulmonary symptoms, such as hypotension, increased blood pressure, and dyspnea; other symptoms included nausea, flushing, urticaria, cough, hypersensitivity, pruritus, rash, and wheezing. Most of these reactions were mild (68%) to moderate (28%). Fewer than 1% of ORENCIA-treated patients discontinued due to an acute infusion-related event. In controlled trials, 6 ORENCIA-treated patients compared to 2 placebo-treated patients discontinued study treatment due to acute infusion-related events.

In clinical trials of 2688 adult RA patients treated with intravenous ORENCIA, there were two cases (<0.1%) of anaphylaxis or anaphylactoid reactions. Other reactions potentially associated with drug hypersensitivity, such as hypotension, urticaria, and dyspnea, each occurred in less than 0.9% of ORENCIA-treated patients and generally occurred within 24 hours of ORENCIA infusion. Appropriate medical support measures for the treatment of hypersensitivity reactions should be available for immediate use in the event of a reaction .

Adverse Reactions In Patients With COPD

In Study V , there were 37 patients with chronic obstructive pulmonary disease (COPD) who were treated with ORENCIA and 17 COPD patients who were treated with placebo. The COPD patients treated with ORENCIA developed adverse events more frequently than those treated with placebo (97% vs 88%, respectively). Respiratory disorders occurred more frequently in ORENCIA-treated patients compared to placebo-treated patients (43% vs 24%, respectively) including COPD exacerbation, cough, rhonchi, and dyspnea. A greater percentage of ORENCIA-treated patients developed a serious adverse event compared to placebo-treated patients (27% vs 6%), including COPD exacerbation (3 of 37 patients ) and pneumonia (1 of 37 patients ) .

Other Adverse Reactions

Adverse events occurring in 3% or more of patients and at least 1% more frequently in ORENCIA-treated patients during placebo-controlled RA studies are summarized in Table 3.

Table 3: Adverse Events Occurring in 3% or More of Patients and at Least 1% More Frequently in ORENCIA-Treated Patients During Placebo-Controlled RA Studies

Adverse Event (Preferred Term) ORENCIA
(n=1955)a
Percentage
Placebo
(n=989)b
Percentage
Headache 18 13
Nasopharyngitis 12 9
Dizziness 9 7
Cough 8 7
Back pain 7 6
Hypertension 7 4
Dyspepsia 6 4
Urinary tract infection 6 5
Rash 4 3
Pain in extremit 3 2
a Includes 204 patients on concomitant biologic DMARDs (adalimumab, anakinra, etanercept, or infliximab).
b Includes 134 patients on concomitant biologic DMARDs (adalimumab, anakinra, etanercept, or infliximab).

Immunogenicity

Antibodies directed against the entire abatacept molecule or to the CTLA-4 portion of abatacept were assessed by ELISA assays in RA patients for up to 2 years following repeated treatment with ORENCIA. Thirty-four of 1993 (1.7%) patients developed binding antibodies to the entire abatacept molecule or to the CTLA-4 portion of abatacept. Because trough levels of abatacept can interfere with assay results, a subset analysis was performed. In this analysis it was observed that 9 of 154 (5.8%) patients that had discontinued treatment with ORENCIA for over 56 days developed antibodies.

Samples with confirmed binding activity to CTLA-4 were assessed for the presence of neutralizing antibodies in a cell-based luciferase reporter assay. Six of 9 (67%) evaluable patients were shown to possess neutralizing antibodies. However, the development of neutralizing antibodies may be underreported due to lack of assay sensitivity.

No correlation of antibody development to clinical response or adverse events was observed.

The data reflect the percentage of patients whose test results were positive for antibodies to abatacept in specific assays. The observed incidence of antibody (including neutralizing antibody) positivity in an assay is highly dependent on several factors, including assay sensitivity and specificity, assay methodology, sample handling, timing of sample collection, concomitant medication, and underlying disease. For these reasons, comparison of the incidence of antibodies to abatacept with the incidence of antibodies to other products may be misleading.

Clinical Experience In Methotrexate-Naive Patients

Study VI was an active-controlled clinical trial in methotrexate-naive patients . The safety experience in these patients was consistent with Studies I-V.

Clinical Studies Experience In Adult RA Patients Treated With Subcutaneous Orencia

Study SC-1 was a randomized, double-blind, double-dummy, non-inferiority study that compared the efficacy and safety of abatacept administered subcutaneously (SC) and intravenously (IV) in 1457 subjects with rheumatoid arthritis, receiving background methotrexate, and experiencing an inadequate response to methotrexate (MTX-IR) . The safety experience and immunogenicity for ORENCIA administered subcutaneously was consistent with intravenous Studies I-VI. Due to the route of administration, injection site reactions and immunogenicity were evaluated in Study SC-1 and two other smaller studies discussed in the sections below.

Injection Site Reactions In Adult RA Patients Treated With Subcutaneous Orencia

Study SC-1 compared the safety of abatacept including injection site reactions following subcutaneous or intravenous administration. The overall frequency of injection site reactions was 2.6% (19/736) and 2.5% (18/721) for the subcutaneous abatacept group and the intravenous abatacept group (subcutaneous placebo), respectively. All these injection site reactions (including hematoma, pruritus, and erythema) were mild (83%) to moderate (17%) in severity, and none necessitated drug discontinuation.

Immunogenicity In Adult RA Patients Treated With Subcutaneous Orencia

Study SC-1 compared the immunogenicity to abatacept following subcutaneous or intravenous administration. The overall immunogenicity frequency to abatacept was 1.1% (8/725) and 2.3% (16/710) for the subcutaneous and intravenous groups, respectively. The rate is consistent with previous experience, and there was no correlation of immunogenicity with effects on pharmacokinetics, safety, or efficacy.

Immunogenicity And Safety Of Subcutaneous Orencia Administration As Monotherapy Without An Intravenous Loading Dose

Study SC-2 was conducted to determine the effect of monotherapy use of ORENCIA on immunogenicity following subcutaneous administration without an intravenous load in 100 RA patients, who had not previously received abatacept or other CTLA4Ig, who received either subcutaneous ORENCIA plus methotrexate (n=51) or subcutaneous ORENCIA monotherapy (n=49). No patients in either group developed anti-product antibodies after 4 months of treatment. The safety observed in this study was consistent with that observed in the other subcutaneous studies.

Immunogenicity And Safety Of Subcutaneous Orencia Upon Withdrawal (Three Months) And Restart Of Treatment

Study SC-3 in the subcutaneous program was conducted to investigate the effect of withdrawal (three months) and restart of ORENCIA subcutaneous treatment on immunogenicity in RA patients treated concomitantly with methotrexate. One hundred sixty-seven patients were enrolled in the first 3-month treatment period and responders (n=120) were randomized to either subcutaneous ORENCIA or placebo for the second 3-month period (withdrawal period). Patients from this period then received open-label ORENCIA treatment in the final 3-month period of the study (period 3). At the end of the withdrawal period, 0/38 patients who continued to receive subcutaneous ORENCIA developed anti-product antibodies compared to 7/73 (9.6%) of patients who had subcutaneous ORENCIA withdrawn during this period. Half of the patients receiving subcutaneous placebo during the withdrawal period received a single intravenous infusion of ORENCIA at the start of period 3 and half received intravenous placebo. At the end of period 3, when all patients again received subcutaneous ORENCIA, the immunogenicity rates were 1/38 (2.6%) in the group receiving subcutaneous ORENCIA throughout, and 2/73 (2.7%) in the group that had received placebo during the withdrawal period. Upon reinitiating therapy, there were no injection reactions and no differences in response to therapy in patients who were withdrawn from subcutaneous therapy for up to 3 months relative to those who remained on subcutaneous therapy, whether therapy was reintroduced with or without an intravenous loading dose. The safety observed in this study was consistent with that observed in the other studies.

Clinical Studies Experience In Juvenile Idiopathic Arthritis Patients Treated With Intravenous Orencia

In general, the adverse events in pediatric patients were similar in frequency and type to those seen in adult patients .

Study JIA-1 was a three-part study including an open-label extension that assessed the safety and efficacy of intravenous ORENCIA in 190 pediatric patients, 6 to 17 years of age, with polyarticular juvenile idiopathic arthritis. Overall frequency of adverse events in the 4-month, lead-in, open-label period of the study was 70%; infections occurred at a frequency of 36% . The most common infections were upper respiratory tract infection and nasopharyngitis. The infections resolved without sequelae, and the types of infections were consistent with those commonly seen in outpatient pediatric populations. Other events that occurred at a prevalence of at least 5% were headache, nausea, diarrhea, cough, pyrexia, and abdominal pain.

A total of 6 serious adverse events (acute lymphocytic leukemia, ovarian cyst, varicella infection, disease flare , and joint wear) were reported during the initial 4 months of treatment with ORENCIA.

Of the 190 patients with juvenile idiopathic arthritis treated with ORENCIA in clinical trials, there was one case of a hypersensitivity reaction (0.5%). During Periods A, B, and C, acute infusion-related reactions occurred at a frequency of 4%, 2%, and 3%, respectively, and were consistent with the types of events reported in adults.

Upon continued treatment in the open-label extension period, the types of adverse events were similar in frequency and type to those seen in adult patients, except for a single patient diagnosed with multiple sclerosis while on open-label treatment.

Antibodies directed against the entire abatacept molecule or to the CTLA-4 portion of abatacept were assessed by ELISA assays in patients with juvenile idiopathic arthritis following repeated treatment with ORENCIA throughout the open-label period. For patients who were withdrawn from therapy for up to 6 months during the double-blind period, the rate of antibody formation to the CTLA-4 portion of the molecule was 41% (22/54), while for those who remained on therapy the rate was 13% (7/54). Twenty of these patients had samples that could be tested for antibodies with neutralizing activity; of these, 8 (40%) patients were shown to possess neutralizing antibodies.

The presence of antibodies was generally transient and titers were low. The presence of antibodies was not associated with adverse events, changes in efficacy, or an effect on serum concentrations of abatacept. For patients who were withdrawn from ORENCIA during the double-blind period for up to 6 months, no serious acute infusion-related events were observed upon re-initiation of ORENCIA therapy.

Clinical Studies Experience In Juvenile Idiopathic Arthritis Patients Treated With Subcutaneous Orencia

Study JIA-2 was an open-label study with a 4-month short-term period and a long-term extension period that assessed the pharmacokinetics (PK), safety, and efficacy of subcutaneous ORENCIA in 205 pediatric patients, 2 to 17 years of age with juvenile idiopathic arthritis. The safety experience and immunogenicity for ORENCIA administered subcutaneously were consistent with the intravenous Study JIA-1.

There were no reported cases of hypersensitivity reactions. Local injection-site reactions occurred at a frequency of 4.4%.

Clinical Studies Experience In Adult PsA Patients

The safety of ORENCIA was evaluated in 594 patients with psoriatic arthritis (341 patients on ORENCIA and 253 patients on placebo), in two randomized, double-blind, placebo-controlled trials. Of the 341 patients who received ORENCIA, 128 patients received intravenous ORENCIA (PsA-I) and 213 patients received subcutaneous ORENCIA (PsA-II). The safety profile was comparable between studies PsA-I and PsA-II and consistent with the safety profile in rheumatoid arthritis .

Postmarketing Experience

Adverse reactions have been reported during the postapproval use of ORENCIA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to ORENCIA. Based on the postmarketing experience in adult RA patients, the following adverse reaction has been identified during postapproval use with ORENCIA.

  • Vasculitis (including cutaneous vasculitis and leukocytoclastic vasculitis)
  • New or worsening psoriasis

Read the entire FDA prescribing information for Orencia (Abatacept)

Abatacept

What is abatacept?

Abatacept (brand name Orencia) belongs to a new class of medicines called biological disease modifying antirheumatic drugs (biological DMARDs or bDMARDs). bDMARDs have now been given to over a million people worldwide since their initial use in the late 1990s. These medicines block natural substances called cytokines. These are substances found in excessive amounts in the blood and joints of people with rheumatoid arthritis and juvenile arthritis. The increased levels of cytokines cause inflammation, which results in symptoms of pain, joint swelling and stiffness, and can lead to joint damage. By blocking T cell (a type of white blood cell) responses, abatacept reduces inflammation, lessens the symptoms and helps stop further joint damage.

What benefit can you expect from your treatment?

Unlike standard antirheumatic drugs (DMARDs), abatacept works relatively quickly. You may notice some relief of joint swelling, pain and stiffness within the first 4-8 weeks of treatment.

Stopping abatacept

If abatacept treatment is stopped for more than a few weeks there is a risk that your condition may worsen. Continue with your treatment unless advised by your doctor or unless side effects develop (see Side effects). If you stop abatacept for any reason you must contact your doctor. Failure to do so may mean that your continued treatment may no longer be subsidised.

How will your condition be monitored?

In view of the current prescribing restrictions for all bDMARDs:

  • Abatacept will only be started if your disease is active and if standard treatments have been unsuccessful.
  • It will not be continued unless it helps your condition. This will be assessed at least 12 weeks after the start of treatment.
  • Blood tests will be required during your treatment to monitor your condition and to determine the effectiveness of treatment.
  • The frequency of blood tests will depend on what other medicines you are taking and what other illnesses you might have. Your rheumatologist will determine the frequency of tests required.

How is abatacept given?

Abatacept is given as a drip (infusion) into the vein, or as an injection under the skin of the abdomen or thigh. The infusion normally takes thirty minutes. This is followed by a one hour period of observation to make sure you don’t have any side effects. Additional doses are usually given at 2 and 4 weeks after the first dose. Subsequent doses are usually given every 4 weeks. When given as an injection under the skin (subcutaneous injection), doses are given weekly.The treatment may still begin with a single dose given as an infusion (loading dose).

Abatacept is given in combination with the DMARD methotrexate.

What is the dosage?

For infusions the dose is based on the person’s weight, so each person’s dose may be different. The subcutaneous dose is a standard 125mg weekly injection.

Can other medicines be taken with abatacept?

Abatacept may be used with other arthritis medicines including:

  • other DMARDs such as methotrexate
  • steroid medicines such as prednisolone or cortisone injections into the joint
  • anti-inflammatory medicines (NSAIDs) such as naproxen (Naprosyn) or ibuprofen (Brufen, Nurofen)
  • simple pain medicines such as paracetamol.

Abatacept cannot be used with other bDMARDs. There are separate information sheets for the medicines mentioned above.

Are there any side effects?

You might experience side effects with your treatment. Contact your doctor if you have any concerns about possible side effects. Many side effects disappear when abatacept treatment is stopped.

Most common possible side effects

  • Common possible side effects include:
    • headaches, runny nose, dizziness or cough
    • sore throat, heartburn or nausea
    • back, arm or leg pain
    • urine infections
    • rash.
  • Stomach and bowel discomfort may also occur.
  • As abatacept affects the immune system, mild infections, particularly of the upper respiratory tract (e.g. colds, sinusitis) may occur more frequently than usual. Treatment with abatacept may need to be temporarily stopped so contact your doctor for advice.

Less common or rare possible side effects

  • Side effects can occur during the infusion itself. These may include fever or chills, itch, chest pain, shortness of breath or changes in blood pressure. These effects are more likely to occur during the first or second infusion.
  • Mild pain, swelling, bruising or itching may occur at the injection site (for subcutaneous doses). It is therefore important to rotate the injection site.
  • Serious infections such as tuberculosis (TB) are seen rarely, and screening for TB is needed before treatment begins (see Precautions).
  • Rarely abatacept may cause an allergic reaction with itchy, red skin or a rash.
  • It is still unclear from research if there is an increased risk of cancer due to abatacept treatment but registry data has been reassuring. (see Precautions).

What precautions are necessary?

Infections

  • If you have an active infection of any kind, treatment with abatacept will not be given until the infection is treated successfully.
  • Abatacept will not be given if you have active untreated tuberculosis (TB) or HIV (AIDS) infection as it is likely to make these conditions worse.
  • If you have latent (inactive) TB preventative anti-TB treatment will be started at least 4 weeks before abatacept. The anti-TB treatment will usually need to be taken for 9 months.
  • Hepatitis B or C infection may not necessarily exclude treatment.
  • Because of the risks associated with infection the following tests may be conducted before commencing treatment with abatacept:
    • blood tests for hepatitis B and C
    • chest x-ray and two step Tuberculin Skin Test (Mantoux) or QuantiFERON blood test for tuberculosis (TB)
    • HIV tests are required for those who are at risk of this infection.

Precautions with other diseases

  • People with chronic lung disease (COPD) are not usually given abatacept but each case will be assessed individually.

Use with other medicines

  • Abatacept can interact with other medicines. You should tell your doctor (including your general practitioner, rheumatologist and others) about all medicines you are taking or plan to take. This includes over the counter or herbal/naturopathic medicines.
  • You should also mention your treatment when you see other health professionals.
  • Abatacept does not increase the risk of side effects from low dose aspirin (taken for prevention of heart attack and strokes).
  • The simple pain reliever paracetamol and combined pain medicines such as Panadeine and Panadeine Forte can be used while you are receiving abatacept treatment provided you take them as directed.

Vaccines

  • If you are on abatacept it is recommended you should not be immunised with ‘live’ vaccines such as MMR (measles, mumps and rubella), OPV (oral polio virus), BCG (Bacillus Calmette Guerin), Herpes Zoster (Zostavax) or yellow fever. Talk with your rheumatologist before receiving any vaccines.
  • Pneumovax and the combined yearly seasonal flu/swine flu vaccinations are safe and recommende

Surgery

  • If you require surgery for any reason, treatment with abatacept will be stopped before surgery. It will be restarted again after the operation at a time determined by your surgeon and rheumatologist. Treatment will be restarted once the wound is healed and if there is no infection present.

Use with alcohol

  • You may drink alcohol while taking abatacept. However, if you are also taking methotrexate you should be particularly cautious about your alcohol intake.
  • It is not known precisely what level of drinking is safe when on methotrexate, however there is general agreement that 1 to 2 standard drinks taken once or twice a week is unlikely to cause a problem.
  • Drinking more than 4 standard drinks on one occasion, even if infrequently, is strongly discouraged.

Cancer risk

  • Lymphoma, a cancer of lymph glands, is found more commonly in patients with severe active rheumatoid arthritis than in the general population. Studies are in progress to see if treatment with abatacept changes this. To date there is no evidence to suggest that this medicine increases lymphoma.
  • If cancer has been previously treated and cured it is unclear whether abatacept can be used safely. An interval of 5 years is normally recommended between cure of a cancer and starting TNF-bDMARDs.
  • For general cancer prevention, stopping smoking and taking skin cancer prevention measures are recommended. It is important to use sunscreen and avoid prolonged sun exposure. A yearly skin check is recommended.
  • Talk to your doctor if you have any concerns about issues relating to cancer risk.

Use in pregnancy and when breastfeeding

How to store abatacept

  • Keep the medicine refrigerated, even when travelling.
  • Keep all medicines out of reach of children.

Important things to remember:

  • While taking abatacept you must see your rheumatologist regularly to ensure the treatment is working and to minimise any possible side effects.
  • If you stop abatacept for any reason you must contact your doctor. Failure to do so may mean that your continued treatment may no longer be subsidised.
  • If you are worried about any side effects you should contact your rheumatologist as soon as possible.
  • If you are injecting abatacept under the skin (subcutaneously) remember to change the injection site each time.
  • It is important to tell your doctor if you have had cancer or if you develop cancer.
  • If you are taking abatacept and plan to become pregnant you must discuss the timing with your doctor.

This information has been produced by the Australian Rheumatology Association (ARA) to help you understand the medicine that has been prescribed for you. Please read it carefully and discuss it with your doctor. The information in this sheet has been obtained from various sources and has been reviewed by the ARA. It is intended as an educational aid and does not cover all possible uses, actions, precautions, side effects, or interactions of the medicines mentioned. This information is not intended as medical advice for individual problems nor for making an individual assessment of the risks and benefits of taking a particular medicine. It can be reproduced in its entirety but cannot be altered without permission from the ARA. The NHMRC publication: How to present the evidence for consumers: preparation of consumer publications (2000) was used as a guide in developing this publication.

Five-Year Data Demonstrate Long-Term Efficacy and Safety with ORENCIA® (abatacept) in Adults with Rheumatoid Arthritis Who had an Inadequate Response to Methotrexate

BOSTON–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced that cumulative five-year data from an open-label long-term extension of a Phase IIb trial demonstrate the long-term efficacy and safety of ORENCIA® (abatacept) in adult rheumatoid arthritis (RA) patients who had an inadequate response to methotrexate (MTX). The data show that, in these patients, ORENCIA provided sustained improvements in ACR responses, physical function and health-related quality of life. These data, combined with the retention rates observed in this study, demonstrate that ORENCIA provides durable long-term clinical benefits in patients with active RA who had an inadequate response to MTX. Results of this study were presented at the 2007 American College of Rheumatology (ACR) Annual Scientific Meeting.

“Studying the long-term efficacy of a treatment is important because RA is a chronic disease,” said Joel Kremer, M.D., Chief of Rheumatology, Albany Medical College. “These data are important because they show that ORENCIA is efficacious and has an acceptable safety profile over an extended period of time in patients with an inadequate response to methotrexate.”

Details of the Study

Patients in the initial one-year, double-blind, placebo-controlled randomized trial received MTX and either ORENCIA (10 mg/kg or 2 mg/kg) or placebo administered as a 30-minute intravenous infusion on Days 1, 15 and 30, and every four weeks thereafter, in addition to MTX. The primary endpoint of the double-blind portion of the study was ACR 20 at 6 months (60 percent for ORENCIA® (abatacept) vs. 35.5 percent for placebo). All patients completing the double-blind period were eligible to continue in the open-label long-term extension, in which all participants received a fixed dose of ORENCIA approximating 10 mg/kg every four weeks, in addition to MTX. Efficacy, health- related quality of life and safety were assessed.

Of the 235 patients completing the double-blind period, 219 entered the long-term extension (ORENCIA 10 mg/kg=84; ORENCIA 2 mg/kg=68; placebo=67), and 130 (59.4 percent) continued in the trial for five years. Baseline RA characteristics for long-term extension patients were similar between groups at initial randomization (mean disease duration: 8.2 – 9.9 years).

Data included in this as-observed analysis were from the original group receiving a dose approximating 10 mg/kg of ORENCIA in the one-year double blind phase (n=115) through five years’ total treatment (n=56). At Year 1, improvements in ACR 20, 50 and 70 responses* observed in this group were 77 percent, 53 percent and 29 percent, respectively. At Year 5, improvements in ACR 20, 50 and 70 responses were sustained (83 percent, 65 percent and 40 percent, respectively). More than one-third of these patients achieved an ACR 70 response at Year 5.

Physical function and health-related quality of life were assessed using the modified Health Assessment Questionnaire Disability Index (mHAQ-DI) and Short-Form 36 (SF-36), respectively. Clinically meaningful improvement in physical function was observed in 54.8 percent of patients at Year 1 and 52.8 percent of patients at Year 5 (n=53). Improvements in health-related quality of life were also maintained at Year 5. The mean improvement from baseline in the physical component summary was 9.7 at Year 1 (mean score 40.6) and was stable at 9.7 at Year 5 (mean score 41.7). The mean improvement in the mental component was 6.1 at Year 1 (mean score 52.3) and 5.4 at Year 5 (mean score 50.8). Improvements in all individual component scores of the SF-36 were also observed at Year 1 and maintained at Year 5.

The safety analysis represents five years of cumulative data. This includes all patients who received at least one dose of ORENCIA during the one-year double-blind period and all patients who entered the open-label period who received at least one dose of ORENCIA plus all patients randomized to receive placebo (n=287). The incidence rates observed during the five-year cumulative period for serious adverse events (SAEs), infections, serious infections, malignancies and autoimmune events were consistent with both the double-blind period and the integrated safety summary, which is comprised of seven core RA studies representing approximately 8,400 patient years of exposure. The incidence rates for SAEs in the double-blind period, five-year cumulative period and the integrated safety summary were 20/100 pt-years, 18.9/100 pt-yrs and 15.4/100 pt-yrs, respectively. The incidence rates for infections in the double-blind period, five-year cumulative period and the integrated safety summary were 94.2/100 pt-years, 77.3/100 pt-yrs and 79.2/100 pt-yrs, respectively. The incidence rates for serious infections in the double-blind period, five-year cumulative period and the integrated safety summary were 2.1/100 pt-years, 3.0/100 pt-yrs and 3.0/100 pt-yrs, respectively. The incidence rates for malignancies in the double-blind period, five-year cumulative period and the integrated safety summary were 2.1/100 pt- years, 1.5/100 pt-yrs and 1.3/100 pt-yrs, respectively. A total of 12 autoimmune disorders, the most frequent of which were psoriasis and cutaneous vasculitis, were reported in 12 patients in the cumulative study period.

During the five-year cumulative period, 32 patients (11.1 percent) discontinued due to SAEs. A total of five deaths occurred through five years of the study; all were considered to be unlikely related or unrelated to study medication.

About ORENCIA® (abatacept)

ORENCIA is indicated in the United States for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs, such as methotrexate or TNF antagonists. ORENCIA may be used as monotherapy or concomitantly with DMARDs other than TNF antagonists. ORENCIA should not be administered concomitantly with TNF antagonists and is not recommended for use concomitantly with anakinra.

Dosing and Administration

ORENCIA is administered by a healthcare professional as a 30-minute intravenous infusion at a fixed dose based on body weight range approximating 10 mg/kg at day 0, 2 weeks, 4 weeks, and every 4 weeks thereafter. Acute infusion-related reactions were experienced in nine percent of people treated with ORENCIA and in six percent of people treated with placebo. According to the full prescribing information, the most frequently reported infusion- related adverse events (1 percent to 2 percent) were dizziness, headache, and hypertension. In pivotal studies, premedications were not required. However, appropriate medical support measures for the treatment of hypersensitivity reactions should be available for immediate use in the event of a reaction.

Important Safety Information about ORENCIA® (abatacept)

Before receiving treatment with ORENCIA individuals should tell their doctor if they are taking a TNF blocker (e.g., Enbrel®, Humira®, Remicade®) to treat rheumatoid arthritis (RA). ORENCIA should not be taken with these medications because of a higher chance of getting a serious infection. Individuals should also tell their doctor if they are taking Kineret® to treat RA. ORENCIA should not be taken with Kineret. People taking ORENCIA should notify their doctor if they are taking any other medications including hormones, over-the-counter medicines, vitamins, supplements or herbal products.

Individuals should let their doctor know if they have any kind of infection including an infection that is in only one place of the body (such as an open cut or sore) or an infection that is in the whole body (such as the flu). Having an infection could increase the risk for serious side effects from ORENCIA. It is also important for individuals to let their doctor know if they have an infection that won’t go away or a history of infections that keep coming back.

People who have had tuberculosis (TB), a positive skin test for TB, recent close contact with someone who has had TB or develop any of the symptoms of TB (a dry cough that doesn’t go away, weight loss, fever, night sweats) should call their doctor right away. Before starting treatment with ORENCIA, a doctor may examine the individual for TB or perform a skin test.

In addition, individuals should let their doctor know if they are scheduled to have surgery or any vaccination or have recently received a vaccination. People should inform their doctor if they have a history of chronic obstructive pulmonary (lung) disease (COPD). Taking ORENCIA® (abatacept) may cause COPD symptoms to get worse.

People who have diabetes and use a blood glucose monitor to check their sugar levels should tell their doctor. The infusion of ORENCIA contains maltose, a sugar that can give falsely high blood glucose readings with some monitors on the day the infusion is received. The doctor may recommend a different monitor.

Women who are pregnant, planning to become pregnant or are thinking about becoming pregnant should tell their doctor. It is not known if ORENCIA can harm an unborn baby. Women who are breast-feeding should also inform their doctor. They will need to decide to either breast-feed or receive treatment with ORENCIA® (abatacept), but not both.

Like all medicines that affect your immune system, ORENCIA can cause serious side effects. The possible serious side effects include serious infections and allergic reactions. Also, rare cases of certain kinds of cancers have been reported.

People taking ORENCIA are at increased risk for developing infections including pneumonia, and other infections caused by viruses, bacteria, or fungi. Individuals should call their doctor immediately if they feel sick or get any infection during treatment with ORENCIA.

Allergic reactions are usually mild or moderate, generally occur within the first 24 hours of an infusion, and include hives, swollen face, eyelids, lips, tongue, throat, or trouble breathing. There have been some serious allergic reactions reported in people that received an infusion of ORENCIA.

There have been rare cases of certain kinds of cancer in people receiving ORENCIA. The role of ORENCIA in the development of cancer is not known.

The more common side effects with ORENCIA are headache, upper respiratory tract infection, sore throat, and nausea.

For Full Prescribing Information, please visit http://www.orencia.com/ or

Bristol-Myers Squibb Company is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.

* Based on the percentages of patients achieving ACR 20, 50 and 70 responses, indicating 20 percent, 50 percent and 70 percent improvements in ACR criteria, respectively.

SOURCE: Bristol-Myers Squibb Company

CONTACT: Media: Sarah Koenig, +1-609-252-4145, or cell, +1-908-397-5379,

[email protected], or Investors: John Elicker, +1-212-546-3775,

[email protected], both of Bristol-Myers Squibb Company

Web site: http://www.bms.com/

http://www.orencia.com/

ORENCIA® (abatacept) Side Effects

Important Facts About
ORENCIA® (abatacept)

This is a summary of important information that you need to know in order to take ORENCIA safely. Work with the rheumatologist to make the treatment suitable and safe for you or your loved one.

  • Look out for the following
    icons as you read:

  • Talk to your
    rheumatologist

  • Call a healthcare
    provider right away

  • Helpful information
    to remember

What is ORENCIA?

ORENCIA (abatacept) is a prescription biologic medicine for:

Adult Rheumatoid Arthritis (RA)

ORENCIA is used to reduce signs and symptoms of moderate to severe Rheumatoid Arthritis (RA) in adults 18 years and older. Taking ORENCIA may prevent further damage to your bones and joints, and may help your ability to perform daily activities. ORENCIA may help those who are not getting the results they need with other medicines for RA.

In adults, ORENCIA may be used alone or with other RA treatments, but should not be used with TNF-blockers (also called Tumor Necrosis Factor antagonists). TNF-blockers are a type of RA medication, and include such treatments as Enbrel® (etanercept), Humira® (adalimumab), and
Remicade® (infliximab).

Juvenile Idiopathic Arthritis (JIA)

ORENCIA is used to reduce signs and symptoms of moderate to severe polyarticular JIA in patients 2 years of age and older. ORENCIA may be used alone or with methotrexate (MTX).

Adult Psoriatic Arthritis (PsA)

ORENCIA is used to reduce signs and symptoms of active Psoriatic Arthritis (PsA) in adults 18 years and older. In adults, ORENCIA may be used alone or with other PsA treatments.

  • ORENCIA is for adults 18 years and older with moderate to severe RA.
  • ORENCIA is for patients 2 years of age and older with moderate to severe polyarticular JIA.
  • ORENCIA is for adults 18 years and older with active PsA.
  • ORENCIA should not be used with TNF-blockers.
  • ORENCIA has not been studied in children under 2 years of age.
  • ORENCIA has not been studied in children for uses other than JIA.

ORENCIA is available in two forms:

ORENCIA intravenous (IV) infusion is given by your healthcare provider through a vein in your arm.

  • ORENCIA IV is approved for patients 6 years and older.
  • ORENCIA IV has not been studied in children under the age of 6.

OR

ORENCIA subcutaneous (SC) injection is a shot that is given just under your skin. It is available as a prefilled syringe or a ClickJect™ Autoinjector.

  • ORENCIA SC prefilled syringe is available for patients 2 years and older.
  • ORENCIA ClickJect™ Autoinjector has not been studied in children under 18 years of age.
  • Talk to your rheumatologist about the best way for you or your child to receive ORENCIA.

What should I discuss with my rheumatologist before starting ORENCIA?

  • Talk to your rheumatologist about all of your medical conditions, including if:
    • You have any kind of infection, as you may have a higher chance of getting serious side effects from an infection while taking ORENCIA. Infections include:
      • Small infections (such as an open cut or sore) to whole body infections (such as the flu).
      • Any infection that will not go away or a history of infections that keep coming back.
      • Viral hepatitis, a viral infection that affects the liver. Tell your rheumatologist if you have or have ever had viral hepatitis. Before starting ORENCIA, your rheumatologist may examine you for hepatitis.
      • Tuberculosis (TB), a type of lung infection. Tell your rheumatologist if you have ever had TB or a positive skin test for TB, or have recently been in close contact with someone who has ever had TB. Before starting ORENCIA, your rheumatologist may check you for TB or do a skin test. Call your rheumatologist if you notice any symptoms of TB, including: a cough that does not go away, weight loss, fever, or night sweats.
    • You have allergies to the ingredients of ORENCIA. For a list of ingredients, see What are the ingredients in ORENCIA? in the Patient Information section of the Full Prescribing Information.
    • You have Chronic Obstructive Pulmonary Disease (COPD), a type of lung disease.
    • You have diabetes. Your healthcare provider may tell you to use a different way to monitor your blood sugar levels on the day that you receive ORENCIA IV infusion. ORENCIA IV contains maltose, which can alter the blood sugar readings with certain types of blood glucose monitors.
  • Tell your rheumatologist about all of your medical treatments, including if:
    • You are scheduled to have surgery.
    • You recently received or are scheduled to receive vaccinations.
    • You are taking:
      • Other medications for RA, JIA, or PsA.
      • Prescription medications or over-the-counter medications.
      • Vitamins or herbal supplements.
  • Let your rheumatologist know if you are a woman who is:
    • Pregnant or considering pregnancy. It is not known if ORENCIA can harm an unborn baby. If ORENCIA is taken during pregnancy, talk to your healthcare provider before your baby receives any vaccines.
    • Breastfeeding or planning to breastfeed. It is not known if ORENCIA passes into breast milk. Talk to your healthcare provider about the best way to feed your baby if you use ORENCIA.

What should I avoid while I am on ORENCIA?

ORENCIA and other medicines may affect each other, which could cause serious side effects. You should avoid taking ORENCIA with other biologics that may affect your immune system. Doing so may increase your chances of getting a serious infection.

  • Tell your rheumatologist if you are taking other biologic medicines, such as:
  • Talk to your rheumatologist and your other healthcare providers before you begin to take anything new or if you have any changes to your medications during your treatment with ORENCIA. It is a good idea to keep an up-to-date list of all of your medicines, vitamins, and herbal supplements on hand to show your doctors and pharmacists.

What are the possible side effects of ORENCIA?

This is a list of some of the possible side effects of ORENCIA for your reference.

  • Talk to your rheumatologist about any side effect that may be bothering you. Your rheumatologist can work with you to manage side effects throughout your treatment.

Serious side effects
Serious side effects are those that may require medical treatment or hospitalization, cause permanent damage, or be life-threatening or sometimes even fatal. Talk to your healthcare provider about any concerns you may have.

  • Infections. ORENCIA can make you more likely to get infections or make the infections that you have worse. In some cases, these infections have been fatal. Symptoms of an infection include:
    • Fever
    • Cough
    • Warm, red, or painful skin
    • Feeling very tired
    • Flu-like symptoms
  • Call your healthcare provider right away if you feel sick or have any of the symptoms of an infection.
  • Allergic reactions. Allergic reactions can happen with ORENCIA. Symptoms of an allergic reaction may include:
    • Hives
    • Swollen face, eyelids, lips, or tongue
    • Trouble breathing
  • Seek urgent medical attention if you have any of the symptoms of an allergic reaction.
  • If you have the hepatitis B virus, talk to your healthcare provider as hepatitis B can become an active infection while you use ORENCIA. Your rheumatologist may do blood tests before treatment with ORENCIA to check if you have hepatitis B.
  • If you are receiving or are scheduled to receive vaccinations, it is important to know that:
    • You should not receive live vaccines while taking ORENCIA and for 3 months after ending treatment, as it may cause serious side effects.
    • ORENCIA may also cause some other vaccinations to be less effective.
  • Talk to your rheumatologist about your vaccination plans.
  • If you have Chronic Obstructive Pulmonary Disease (COPD), you may experience breathing problems more often while taking ORENCIA. Call your healthcare provider if you experience any of the following:
    • Worsened COPD
    • Cough
    • Trouble breathing
  • Certain kinds of cancer (malignancies) have been reported in people using ORENCIA. It is not known if ORENCIA increases your chances of developing certain kinds of cancer.

Most common side effects
The most common side effects of ORENCIA include:

    • Headache
    • Upper respiratory tract infection
    • Sore throat
    • Nausea

In children and adolescents, other side effects may include:

    • Diarrhea
    • Cough
    • Fever
    • Abdominal pain

These are not all of the possible side effects of ORENCIA. If you have any questions or want more information about side effects, ask your rheumatologist or healthcare provider.

If you experience any side effects and would like to report them to the FDA, you can call 1-800-FDA-1088.

How will I receive ORENCIA?

ORENCIA is available in two forms, as intravenous (IV) infusions and as subcutaneous (SC) injections. Work with your rheumatologist to determine the right treatment plan for you or your child.

ORENCIA IV infusion is given by a healthcare provider through a vein in your arm.

  • ORENCIA IV is approved for children 6 years and older.
  • ORENCIA IV has not been studied in children under the age of 6.
    • You will receive your first three infusions 2 weeks apart from each other (Weeks 0, 2,
      and 4). After that, you will receive an infusion every 4 weeks.
    • Each infusion takes about 30 minutes, though actual time in the clinic will be longer.

ORENCIA SC injection is a shot that is given just under your skin. It is available as a prefilled syringe or ClickJect™ Autoinjector.

  • ORENCIA SC prefilled syringe is available for patients 2 years and older.
  • ORENCIA ClickJect™ Autoinjector has not been studied in children under 18 years of age.

If your rheumatologist decides that your injections can be given at home, you or your caregiver will receive training on how to prepare and inject ORENCIA. Do not try to inject ORENCIA until you have been shown the right way by your rheumatologist or healthcare provider.

  • You will use ORENCIA SC injection once weekly.
  • For more information about preparing and giving ORENCIA SC injections at home, see Instructions for Use in the Patient Information section of the Full Prescribing Information.
    Please talk to your healthcare provider about the best way to receive ORENCIA.

Please click here to read the Patient Information in the Full Prescribing Information.

Orencia and Weight gain – from FDA reports

Summary:

Weight gain is found among people who take Orencia, especially for people who are female, 60+ old , have been taking the drug for 6 – 12 months, also take medication Enbrel, and have Pain. This study is created by eHealthMe based on reports of 45,258 people who have side effects when taking Orencia from Food and Drug Administration (FDA), and is updated regularly.

You are not alone. eHealthMe can help you improve drug uses, prevent side effects, and save money when you take medications. We have been monitoring drugs since 2008. Our original studies have been referenced on 600+ peer-reviewed medical publications. Join us now or use our public tools.

On Jan, 08, 2020

45,258 people reported to have side effects when taking Orencia.
Among them, 417 people (0.92%) have Weight gain

Number of reports submitted per year:

Time on Orencia when people have Weight gain *:

  • < 1 month: 14.29 %
  • 1 – 6 months: 20.0 %
  • 6 – 12 months: 45.71 %
  • 1 – 2 years: 5.71 %
  • 2 – 5 years: 14.29 %
  • 5 – 10 years: 0.0 %
  • 10+ years: 0.0 %

Gender of people who have Weight gain when taking Orencia *:

  • female: 81.93 %
  • male: 18.07 %

Age of people who have Weight gain when taking Orencia *:

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 0.38 %
  • 20-29: 1.91 %
  • 30-39: 8.4 %
  • 40-49: 19.08 %
  • 50-59: 22.9 %
  • 60+: 47.33 %

Conditions people have *:

Other drugs people take besides Orencia *:

  1. Enbrel: 118 people, 28.30%
  2. Humira: 113 people, 27.10%
  3. Arava: 91 people, 21.82%
  4. Xeljanz: 74 people, 17.75%
  5. Actemra: 71 people, 17.03%

Other side effects people have besides Weight gain *:

* Approximation only. Some reports may have incomplete information.

If you find the study useful, join us!

eHealthMe can help you improve drug uses, prevent side effects, and save money when you take medications. Learn more.

Related publications that referenced our studies:

  • Eslami Shahrbabaki M, Nasirian M, Eslami Shahrbabaki P, “Extreme Weight Gain due to Short-term Use of Low-dose Propranolol”, Journal of Mazandaran University of Medical Sciences, 2015 Jan .

How the study uses the data?

The study is based on abatacept (the active ingredients of Orencia) and Orencia (the brand name). Other drugs that have the same active ingredients (e.g. generic drugs) are not considered. Dosage of drugs is not considered in the study.

To check all the drugs that have ingredients of abatacept and Weight gain:

  • Weight gain and drugs with ingredients of abatacept (574 reports)

How severe was Weight gain and when was it recovered:

  • Weight gain in Orencia

What’s eHealthMe?

eHealthMe is a health data analysis company based in Mountain View, California. We monitor and analyze the outcomes of drugs and supplements that are currently on the market since 2008. Original studies of eHealthMe have been referenced on 600+ peer-reviewed medical publications. On eHealthMe, health care professionals and consumers can study drugs with our free tools. Reports generated by our tools are personalized to gender and age. Choose a tool now.

Orencia has active ingredients of abatacept. It is often used in rheumatoid arthritis. Check the latest outcomes from 45,499 Orencia users, or browse all drugs.

What is Weight gain?

Weight gain has been reported by people with depression, rheumatoid arthritis, high blood pressure, birth control, pain. Check the latest reports from 166,164 Weight gain patients, or browse all conditions.

Browse side effects by gender and age:

Female: 0-1 2-9 10-19 20-29 30-39 40-49 50-59 60+

Male: 0-1 2-9 10-19 20-29 30-39 40-49 50-59 60+

How to use the study?

Patients can bring a copy of the report to their healthcare provider to ensure that all drug risks and benefits are fully discussed and understood. It is recommended that patients use the information presented as a part of a broader decision-making process.

Please DO NOT STOP MEDICATIONS without first consulting a physician since doing so could be hazardous to your health.

Take a Pill, Gain a Pound

There is a lot of discussion of obesity and rheumatoid arthritis (including many great articles on this site). But I am given to wonder, which came first – the RA or the weight? Or specifically, how much are the medications I’m taking for my RA contributing to my weight gain and/or preventing me from losing the excess pounds?

While I am a decade older now than I was when I was diagnosed, I am also at least 25 pounds heavier – in spite of ongoing efforts to get to a healthier weight and maintain it. This resistance to shedding excess bulk seems to have solidified the past year. As I tried to figure out what has been going on, I noticed a direct link with my RA treatment. There are three main culprits in my life.

Steroids

I’ve written before about my love/hate relationship with prednisone and related steroids. My rheumatologist trusts me with a prednisone prescription that she knows that I will use sparingly when needed to calm (or ward off) a flare, or when I get close to my next infusion and the last treatment is obviously wearing off. One of the reasons for the “hate” in the love/hate relationship is that prednisone puts on the pounds. Prednisone is in a class of drugs called glucocorticoids. Among the many effects of these medications is they affect the levels of glucose in the body which, in turn, has a direct impact on weight. If I take 5 mg. of prednisone a day for five days, I will literally gain five pounds. And the pounds don’t disappear when I stop taking the drug.

Lyrica and Gabapentin

I first took Lyrica to help treat nerve pain while I was recovering from spinal fusion surgery. I switched to gabapentin, a similar but generic drug when my insurance would no longer cover Lyrica. One of the things I discovered is that I slept really, really well when I was taking either of these medications. Since sleep disturbance is a major issue for me, I talked to my rheumatologist who approved my continued use of gabapentin at night to help me sleep. At first, I took it every night. After the first couple of weeks, I noticed that even though I was walking four miles most days and watching my diet, I was gaining weight. Research revealed that both Lyrica and gabapentin have weight gain as a listed side effect. I stopped taking gabapentin and the pounds started once again to drop. I still take gabapentin once or twice a week – usually after several nights of not getting a decent night’s sleep. If I take it more than that, I see the numbers on my scale rise.

TNF Inhibitors

TNF Inhibitors are the most established biologics for RA. They include Enbrel, Remicade, Humira, Cimzia and Simponi and additionally include the recently approved biosimilars Cyltezo, Amjevita, Renflexis, Inflectra, and Erelzi (some of which are not yet available in the U.S.). While I haven’t been prescribed any of the biosimilars, I’ve been on all of the original “reference” TNF medications and am currently on the infused version of Simponi, Simponi Aria. While I was able to take off 25 pounds the year before I started Simponi (when I was on Actemra, an IL-6 inhibitor), my attempts at weight loss since going back on a TNF inhibitor have been stalled. The National Institute of Health reports a study of psoriasis patients who gained weight being treated with TNF inhibitors as opposed to patients who were treated with other therapies. While RA patients were not specifically studied, it’s not much of a stretch to assume the weight gain effects of the drugs would be similar.

I’m pretty good at overcoming all kinds of obstacles, including those associated with RA (and the related insurance, medical, disability, and other issues). However, I have to admit that this one has me stumped. The implications of not treating RA are substantial (and not good). However, being overweight has its own multitude of health concerns – including the fact that it can contribute to RA symptoms.

The answer? Time to talk to my doctor.

What is Abatacept (Orencia®)?

Abatacept is approved for adults with rheumatoid arthritis (RA), adults with psoriatic arthritis, and children 2 years of age and older with polyarticular juvenile idiopathic arthritis. Abatacept reduces the signs and symptoms of these diseases, such as joint swelling, pain, and fatigue. The brand name for abatacept is Orencia. It is part of a class of drugs called biologics.

How do I take it?

Abatacept may be given as an injection under your skin that you administer yourself, similar to insulin injections. It may also be administered to you as an infusion (intravenous medication).

Subcutaneous injection

The abatacept subcutaneous injections (shots) are available as a 125mg prefilled syringe or auto-injector (pen). It is given once a week. You will be instructed on how to give yourself injections.

If you have RA, your doctor may choose for you to have an intravenous (IV) loading dose before starting the abatacept injections. For these patients, the first subcutaneous injection is given within a day of the intravenous infusion.

Intravenous Infusion

The intravenous (IV) infusion is given to you by a healthcare professional. This procedure usually takes about 30 minutes. After you receive your first dose you will get your second dose two weeks later and the third dose at four weeks from the first infusion. After the third dose, you will then be given infusions every four weeks.

If you are being switched to the subcutaneous injection from the intravenous infusion, the first injection should be given instead of the next scheduled intravenous infusion.

What about side effects?

Some common side effects that patients report are headaches and nausea.

For patients who are using the subcutaneous injections, the medicine can cause slight irritation near the injection site. If this happens, the discomfort should be mild. If you have pain, swelling, warmth, or discoloration near the injection site, you should contact your healthcare provider.

Allergic reactions may happen. Call your healthcare provider or an emergency medical provider if you have any signs of an allergic reaction, such as rashes or hives; swollen face, eyelids, lips, or tongue; and difficulty breathing.

The most common serious side effect is infection. Abatacept can lower the body’s ability to fight infection. Be sure to contact your physician if have any signs of infection, such as fever, fatigue, cough, or red or painful skin. You may have to stop abatacept while being treated for an infection. You may also need to stop abatacept if you are planning a surgery.

You will need to have a negative tuberculosis (TB) skin test before beginning abatacept therapy. Your doctor may also want to check your blood to make sure you do not have Hepatitis B or C.

Make sure your doctor knows if you have chronic obstructive pulmonary disease (COPD), because abatacept may cause you to have more frequent breathing problems if you have COPD.

You should not be given any live vaccines, such as Flu-Mist (the nasal-spray flu vaccine), the chicken pox vaccine, the shingles vaccine or the measles vaccines, while on abatacept or within three months of stopping abatacept. The flu-shot (flu injection vaccine) is not a live virus and all patients should consider having this vaccination yearly.

What about other medications?

Many patients need to continue another oral medication for RA, like methotrexate or plaquenil, while on abatacept, and should continue to take this if advised to do so by their doctor.

Never take Abatacept with any TNF blocker such as Humira®, Enbrel®, or Remicade®, or any other biologic medication used to treat RA.

When you are taking Abatacept, it is very important that your doctors know if you are taking any other medicine. This includes prescription and non-prescription medicines as well as birth control pills, vitamins, and herbal supplements.

What else should I know?

The abatacept syringes should be kept in the refrigerator in the original carton. Do not freeze this medicine.

You must continue your regular visits to the rheumatologist. Your doctor will monitor you for any improvements in your rheumatoid arthritis and for any signs of infections. It may take two months of Abatacept treatment before any improvement in symptoms occurs.

Your doctor will need to monitor your blood to make sure you are not getting any side effects from abatacept or other medications you may be taking.

A Federal Drug Administration patient information guide is available online at:

Generic Name: abatacept (a BAY ta sept)
Brand Names: Orencia

Medically reviewed by Drugs.com. Last updated on Sep 23, 2019.

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Interactions
  • More

What is Orencia?

Orencia (abatacept) a protein that prevents your body’s immune system from attacking healthy tissues such as joints. The immune system helps your body fight infections. In people with autoimmune disorders, the immune system mistakes the body’s own cells for invaders and attacks them.

Orencia is a prescription medicine used to treat the symptoms of rheumatoid arthritis, and to prevent joint damage caused by these conditions. This medicine is for adults and children who are at least 2 years old.

Orencia is not a cure for any autoimmune disorder and will only treat the symptoms of your condition.

Orencia is also used to treat active Psoriatic Arthritis (PsA) in adults.

Important information

Before using Orencia, tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.

Also tell your doctor if you have a weak immune system, any type of infection (including skin infection or open sores), COPD, diabetes, a history of hepatitis, or if you have scheduled to receive any vaccinations.

Children using this medication should be current on all childhood immunizations before starting treatment with Orencia. Serious infections may occur during treatment with Orencia. Contact your doctor right away if you have signs of infection such as: fever, chills, dry cough, sore throat, night sweats, tired feeling, weight loss, or painful warmth or redness of your skin.

Before taking this medicine

You should not use Orencia if you are allergic to abatacept.

Before using Orencia, tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.

To make sure Orencia is safe for you, tell your doctor if you have ever had:

  • a weak immune system;

  • any type of infection including a skin infection or open sores;

  • infections that go away and come back;

  • COPD (chronic obstructive pulmonary disease);

  • diabetes;

  • hepatitis; or

  • if you are scheduled to receive any vaccines.

Using Orencia may increase your risk of developing certain types of cancer such as lymphoma (cancer of the lymph nodes). This risk may be greater in older adults. Talk to your doctor about your specific risk.

It is not known whether Orencia will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Orencia on the baby.

It is not known whether abatacept passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Children using Orencia should be current on all childhood immunizations before starting treatment.

How should I use Orencia?

Before you start treatment with Orencia, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Orencia is injected under the skin, or into a vein through an IV. You may be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.

Orencia is injected under the skin when given to a child between 2 and 6 years old.

Orencia must be given slowly when infected into a vein, and the IV infusion can take at least 30 minutes to complete.

This medicine is usually given every 1 to 4 weeks. Follow your doctor’s instructions.

You may need to mix Orencia with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication.

Do not shake the medication bottle or you may ruin the medicine. Prepare your dose only when you are ready to give an injection. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

Each single-use vial (bottle) or prefilled syringe of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof “sharps” disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

If you need surgery, tell the surgeon ahead of time that you are using Orencia.

If you have ever had hepatitis B, Orencia can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function during treatment and for several months after you stop using this medicine.

This medicine can cause false results with certain blood glucose tests, showing high blood sugar readings. If you have diabetes, talk to your doctor about the best way to check your blood sugar while you are using Orencia.

Autoimmune disorders are often treated with a combination of different drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor’s advice.

Store Orencia in the refrigerator. Do not freeze. Keep the medicine in original carton to protect it from light. Do not use Orencia if the expiration date on the medicine label has passed.

If you need to transport the medicine, place the syringes in a cooler with ice packs.

Orencia that has been mixed with a diluent may be stored in a refrigerator or at room temperature and used within 24 hours.

Orencia dosing information

Usual Adult Dose of Orencia for Rheumatoid Arthritis:

IV:
-Less than 60 kg, give 500 mg
-If 60 to 100 kg, give 750 mg
-If greater than 100 kg, give 1000 mg
Administer once as a 30-minute IV infusion. The dose is repeated 2 and 4 weeks after the initial dose, then every 4 weeks thereafter. It may be administered alone or with disease-modifying antirheumatic drugs other than TNF antagonists.
SUBCUTANEOUS:
-After a single IV infusion as a loading dose (as per body weight categories above), 125 mg administered by subcutaneous injection should be given within a day, followed by 125 mg subcutaneously once a week.
-Patients who are unable to receive an infusion may initiate weekly injections subcutaneously without an IV loading dose.
-Patients transitioning from IV therapy to subcutaneous administration should administer the first subcutaneous dose instead of the next scheduled IV dose.

-This drug should not be administered concomitantly with TNF antagonists or used concomitantly with other biologic rheumatoid arthritis (RA) therapy, such as anakinra.
Use: For reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. This drug may be used as monotherapy or concomitantly with disease-modifying antirheumatic drugs (DMARDs) other than tumor necrosis factor (TNF) antagonists.

Usual Pediatric Dose of Orencia for Juvenile Idiopathic Arthritis:

IV:
6 to 17 years:
If less than 75 kg, give 10 mg/kg IV
75 kg to 100 kg, give 750 mg IV
If greater than 100 kg, give 1000 mg IV
-The maximum dose per intravenous administration should not exceed 1000 mg.
-Administer once as a 30-minute IV infusion. The dose is repeated 2 and 4 weeks after the initial dose, then every 4 weeks thereafter. It may be administered alone or concomitantly with methotrexate.
SUBCUTANEOUS:
2 years and older:
The subcutaneous injection should be given without an IV loading dose:
10 kg to less than 25 kg: 50 mg subcutaneously once a week
25 kg to less than 50 kg: 87.5 mg subcutaneously once a week
50 kg or more: 125 mg subcutaneously once a week

-This drug should not be administered concomitantly with TNF antagonists or used concomitantly with other biologic rheumatoid arthritis (RA) therapy, such as anakinra.
-The safety and efficacy of the auto-injector for subcutaneous injection has not been studied in patients under 18 years of age.
Use: For reducing signs and symptoms in pediatric patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis. This drug may be used as monotherapy or concomitantly with methotrexate (MTX).

What happens if I miss a dose?

Call your doctor for instructions if you miss your Orencia dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Orencia?

Do not receive a “live” vaccine while using Orencia, and for at least 3 months after your treatment ends. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Orencia side effects

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, light-headed, itchy, or have a severe headache or trouble breathing within 1 hour after receiving the injection.

Get emergency medical help if you have signs of an allergic reaction to Orencia: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with Orencia. Stop using this medicine and call your doctor right away if you have signs of infection such as:

Call your doctor at once if you have any of these other serious side effects:

  • trouble breathing;

  • stabbing chest pain, wheezing, cough with yellow or green mucus;

  • pain or burning when you urinate; or

  • signs of skin infection such as itching, swelling, warmth, redness, or oozing.

Common Orencia side effects may include:

  • fever;

  • nausea, diarrhea, stomach pain;

  • headache; or

  • cold symptoms such as stuffy nose, sneezing, sore throat, cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Orencia?

Tell your doctor about all your current medicines and any you start or stop using, especially:

This list is not complete. Other drugs may interact with abatacept, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Orencia only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2020 Cerner Multum, Inc. Version: 7.03.

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Medical Disclaimer

Abatacept Injection

Before using abatacept,

  • tell your doctor and pharmacist if you are allergic to abatacept or any other medications.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anakinra (Kineret), adalimumab (Humira), etanercept (Enbrel),and infliximab (Remicade). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have an infection anywhere in the body, including infections that come and go, such as cold sores, and chronic infections that do not go away, or if you often get any type of infection such as bladder infections. Also tell your doctor if you have or have ever had chronic obstructive pulmonary disease (COPD; a group of lung diseases that includes chronic bronchitis and emphysema); any disease that affects your nervous system, such as multiple sclerosis; any disease that affects your immune system, such as cancer, human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), or severe combined immunodeficiency syndrome (SCID). Also tell your doctor if you have or have ever had tuberculosis (TB; a lung infection that may not cause symptoms for many years and that may spread to other parts of the body) or if you have been around someone who has or has had tuberculosis. Your doctor may give you a skin test to see whether you are infected with tuberculosis. Tell your doctor if you have ever had a positive skin test for tuberculosis in the past.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using abatacept, call your doctor.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are using abatacept.
  • tell your doctor if you have recently received or are scheduled to receive any vaccines. You should not have any vaccinations while you are using abatacept or for 3 months after you stop using abatacept without talking to your doctor.

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