- Orencia Side Effects
- In Summary
- For the Consumer
- For Healthcare Professionals
- Further information
- More about Orencia (abatacept)
- Use with caution in
- Not to be used in
- Pregnancy and breastfeeding
- Side effects
- How can this medicine affect other medicines?
- Other medicines containing the same active ingredient
- Methotrexate for Hair Loss:
Orencia Side Effects
Generic Name: abatacept
Medically reviewed by Drugs.com. Last updated on Dec 24, 2018.
- Side Effects
Note: This document contains side effect information about abatacept. Some of the dosage forms listed on this page may not apply to the brand name Orencia.
Common side effects of Orencia include: headache and nasopharyngitis. Other side effects include: dyspepsia and hypertension. See below for a comprehensive list of adverse effects.
For the Consumer
Applies to abatacept: powder for solution, solution
Along with its needed effects, abatacept (the active ingredient contained in Orencia) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking abatacept:
- Back pain
- bladder pain
- bloody or cloudy urine
- body aches or pain
- cough producing mucus
- difficult or labored breathing
- difficult, burning, or painful urination
- ear congestion
- frequent urge to urinate
- loss of voice
- lower back or side pain
- nausea or vomiting
- noisy breathing
- pain or tenderness around the eyes and cheekbones
- sore throat
- stuffy or runny nose
- tightness of the chest
- troubled breathing
- unusual tiredness or weakness
- Blurred vision
- burning or stinging of the skin
- chest pain
- painful cold sores or blisters on the lips, nose, eyes, or genitals
- pounding in the ears
- skin rash
- slow or fast heartbeat
- difficulty with swallowing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- hives or welts
- itching, pain, redness, swelling, tenderness, or warmth on the skin
- stomach pain or tenderness
- swelling of the face, throat, or tongue
Incidence not known
- Redness, soreness, or itching of the skin
- sores, welts, blisters
Some side effects of abatacept may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
- bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- stomach discomfort or upset
- pain in the arms or legs
For Healthcare Professionals
Applies to abatacept: intravenous powder for injection, subcutaneous solution
Very common (10% or more): Upper respiratory tract infection (including tracheitis, nasopharyngitis)
Common (1% to 10%): Lower respiratory tract infection (including bronchitis), rhinitis, pneumonia, cough, sinusitis
Uncommon (0.1% to 1%): Bronchospasm, wheezing, dyspnea
Rare (less than 0.1%): Throat tightness, bacterial pneumonia, influenza pneumonia
Frequency not reported: Tracheitis
Uncommon (0.1% to 1%): Hypersensitivity
Common (1% to 10%): Herpes infections (including herpes simplex, oral herpes, and herpes zoster), influenza
Uncommon (0.1% to 1%): Streptococcal sepsis
Rare (less than 0.1%): Tuberculosis, bacteremia
Common (1% to 10%): Abdominal pain, diarrhea, nausea, dyspepsia, mouth ulceration, aphthous stomatitis, vomiting
Uncommon (0.1% to 1%): Tooth infection, gastritis, weight increased
Rare (less than 0.1%): Gastrointestinal infection, diverticulitis, peridiverticular abscess
Common (1% to 10%): Urinary tract infection
Uncommon (0.1% to 1%): Pelvic inflammatory disease, amenorrhea, menorrhagia
Common (1% to 10%): Rash (including dermatitis), alopecia, pruritus
Uncommon (0.1% to 1%): Onychomycosis, skin abscess
Frequency not reported: Dry skin, cellulitis, increased tendency to bruise, infected skin ulcers
Very common (10% or more): Headache (12%)
Common (1% to 10%): Dizziness, paresthesia
Uncommon (0.1% to 1%): Migraine
Frequency not reported: Vertigo
Common (1% to 10%): Local injection site reactions
Common (1% to 10%): Hypertension, flushing
Uncommon (0.1% to 1%): Palpitations, tachycardia, bradycardia, hypotension, hot flush, vasculitis, hypotension
Common (1% to 10%): Liver function test abnormal (including transaminases increased)
Frequency not reported: abnormal liver function tests and increased transaminases
Common (1% to 10%): Leukopenia
Uncommon (0.1% to 1%): Thrombocytopenia
Frequency not reported: Weight gain
Common (1% to 10%): Pain in extremity
Uncommon (0.1% to 1%): Musculoskeletal infections, arthralgia
Common (1% to 10%): Conjunctivitis
Uncommon (0.1% to 1%): Dry eye, visual acuity reduced
Uncommon (0.1% to 1%): Depression, anxiety, sleep disorder (including insomnia)
Uncommon (0.1% to 1%): Pyelonephritis
1. Gartlehner G, Hansen RA, Jonas BL, Thieda P, Lohr KN “The comparative efficacy and safety of biologics for the treatment of rheumatoid arthritis: a systematic review and metaanalysis.” J Rheumatol 33 (2006): 2398-408
2. Genovese MC, Becker JC, Schiff M, et al. “Abatacept for rheumatoid arthritis refractory to tumor necrosis factor alpha inhibition.” N Engl J Med 353 (2005): 1114-23
3. Nogid A, Pham DQ “Role of abatacept in the management of rheumatoid arthritis.” Clin Ther 28 (2006): 1764-78
4. “Product Information. Orencia (abatacept).” Bristol-Myers Squibb, Princeton, NJ.
5. Cerner Multum, Inc. “UK Summary of Product Characteristics.” O 0
6. Cerner Multum, Inc. “Australian Product Information.” O 0
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.
- What are the new drugs for the treatment of rheumatoid arthritis (RA)?
More about Orencia (abatacept)
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
- Support Group
- Pricing & Coupons
- En Español
- 41 Reviews
- Drug class: antirheumatics
- FDA Approval History
- Orencia (Abatacept Auto-Injectors)
- Orencia (Abatacept Infusion)
- Orencia (Abatacept Prefilled Syringes)
- Orencia (Advanced Reading)
- Orencia (AHFS Monograph)
- … +1 more
Related treatment guides
- Juvenile Idiopathic Arthritis
- Psoriatic Arthritis
- Rheumatoid Arthritis
A: Orencia (abatacept) is a selective T cell costimulation modulator. Orencia is approved for the treatment of moderate to severe rheumatoid arthritis in adult patients. The medication can be used alone or in combination with DMARDS (disease modifying anti-rheumatic drugs) but not with TNF antagonists. According to Orencia’s web site, the medication is different from other rheumatoid arthritis treatment due to the fact that Orencia works early in the inflammatory process at the T-cell level. This results in a reduction of the activation of T cells thereby reducing the activation of other cells involved in the inflammatory process. Orencia is given by IV infusion over 30 minutes. After the initial dose, patients generally receive infusions at 2 and 4 weeks then every 4 weeks. Remicade (infliximab) is classified as a disease modifying anti-rheumatic, a miscellaneous gastrointestinal agent, an immunosuppressant agent, a monoclonal antibody, and a tumor necrosis factor (TNF) blocking agent. Remicade is approved for the treatment of moderate to severe rheumatoid arthritis, moderate to severe Crohn’s disease, psoriatic arthritis, chronic severe plaque psoriasis, ankylosing spondylitis and ulcerative colitis. According to Remicade’s web site, the medication works in the body because it is a type of protein that will recognize, then attach to and finally block the action of TNF (tumor necrosis factor). By blocking the action of TNF, Remicade may decrease the inflammation that was caused by TNF. Remicade is given by IV infusion over approximately two hours. After the initial dosage, patients usually receive following doses at two and six weeks afterwards. Patients then generally receive infusions every eight weeks unless you are being treated for ankylosing spondylitis which is every six weeks. Enbrel (etanercept) is classified as a disease modifying antirheumatic and as a TNF (tumor necrosis factor) blocking agent. Enbrel is approved for the treatment of moderate to severe active rheumatoid arthritis, moderate to severe juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis and moderate to severe plaque psoriasis. According to Enbrel’s web site, the medication works by reducing the levels of the active form of TNF. This helps to reduce inflammation. Enbrel is given by subcutaneous injection. For rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis the usual dose is 50 mg once weekly or 25 mg given twice weekly. For patients with plaque psoriasis, the dosage can vary. One of the differences between the three medications is the administration. Two require IV infusion and one can be given subcutaneous. How frequently the medication is used can also vary between the medications. Some physicians reserve using Orencia for patients who did not have an adequate response to the disease modifying drugs (DMARDS) or the TNF antagonists. There are differences in the medications on what they can or cannot be combined with. There are cost differences between the three. As with any medication, there are risks, warnings and side effects associated with the medications. These medications carry some serious warnings and side effects. Therefore physicians need to carefully evaluate which treatment is best for each individual patient. Medication selection involves many factors. These factors include: your diagnosis, other treatment options you have tried in the past, other medical conditions you have, other medications that you are taking, any drug allergies you may have and any other pertinent medical information. Due to the complexity of the process of selecting a medication, your physician is best able to tell you which medications would be appropriate for you and which medication would likely be your best treatment option. Jen Marsico, RPh
- This medicine can compromise the body’s ability to fight infections. Cases of other serious infections, including tuberculosis (TB), have been seen in people treated with this medicine. You should be tested for TB and viral hepatitis before treatment is started. Tell your doctor immediately if you experience weight loss, fever or persistent coughing during treatment, as these can be symptoms of TB.
- It is important to try and avoid exposure to infections while you are having treatment with this medicine. Let your doctor know as soon as possible if you get any symptoms of any infection, so that it can be treated without delay. If you develop a serious infection, treatment with this medicine should be stopped until the infection is controlled.
- Women who could get pregnant should use an effective method of contraception to prevent pregnancy, both during treatment with this medicine and for at least 14 weeks after their last dose of this medicine. Seek further medical advice from your doctor.
- This medicine contains maltose, which is a type of sugar that can give a falsely high blood glucose reading with certain types of blood glucose monitors. Your doctor or pharmacist will be able to check this for you.
Use with caution in
- Elderly people.
- Carriers of hepatitis B.
- People with dormant (currently inactive) tuberculosis infection.
- People with a history of recurrent infections.
- People who are, or who have recently been, receiving treatment that suppresses the activity of the immune system, eg long-term oral corticosteroids, chemotherapy, radiotherapy, medicines to prevent transplant rejection.
- Multiple sclerosis.
- People with a history of or current cancer.
- Orencia infusion contains sodium, which should be taken into consideration for people on a controlled-sodium diet. Orencia subcutaneous injection is sodium-free.
Not to be used in
- Active tuberculosis.
- Severe and uncontrolled infections.
- Infection of the blood or body tissues with pus-forming or other pathogenic organisms (sepsis).
- Infections due to lowered resistance of the body (opportunistic infections).
- Orencia subcutaneous injection is not recommended for children and adolescents under 18 years of age.
- Orencia infusion is not recommended for children under six years of age.
This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
- The safety of this medicine for use during pregnancy has not been established. The manufacturer states that it should not be used during pregnancy unless considered essential by your doctor.
- Women who could get pregnant should use an effective method of contraception to prevent pregnancy during treatment, and for at least 14 weeks after their last dose of this medicine.
- It is not known if this medicine passes into breast milk. Women should not breastfeed during treatment with this medicine, or for at least 14 weeks after their last dose.
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.
Very common (affect more than 1 in 10 people)
- Upper respiratory tract infections, such as infections of the nose and throat.
Common (affect between 1 in 10 and 1 in 100 people)
- Lower respiratory tract infections, for example chest infections such as bronchitis or pneumonia.
- Urinary tract infections.
- Cold sores.
- Decrease in the number of white blood cells in the blood (leucopenia).
- Pins and needles sensations (paraesthesia).
- Increase in blood pressure.
- Disturbances of the gut such as diarrhoea, indigestion, nausea, vomiting or abdominal pain.
- Mouth ulcers.
- Skin reactions, such as itching, rash or dermatitis.
- Increased hair loss (alopecia).
- Feeling weak or tired.
- Injection site reactions.
- Alteration in results of liver function tests.
Uncommon (affect between 1 in 100 and 1 in 1000 people)
- Infections of the skin, nails, kidneys, blood or teeth.
- Decrease in the number of platelets in the blood (thrombocytopenia).
- Increased tendency to bruise.
- Depression, anxiety.
- Faster or slower than normal heart rate.
- Decrease in blood pressure.
- Wheezing or shortness of breath.
- Sensation of spinning (vertigo).
- Inflammation of the stomach (gastritis).
- Weight gain.
- Flu-like symptoms.
- Heavy menstrual periods or stopping of periods.
- Dry skin or eyes.
- Joint pain (arthralgia).
- Nettle-type rash.
- Basal cell carcinoma.
Rare (affect between 1 in 1000 and 1 in 10,000 people)
- Gut infections.
- Throat tightness.
- Lung cancer.
The side effects listed above may not include all of the side effects reported by the medicine’s manufacturer.
For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
How can this medicine affect other medicines?
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while having treatment with this one, to make sure that the combination is safe.
Abatacept is not recommended for use with the following medicines, as the combination may increase the risk of serious infections, without an increase in effectiveness against arthritis:
There may be an increased risk of infections if this medicine is used to treat people who are or who have recently been receiving treatment that suppresses the activity of the immune system, eg long-term oral corticosteroids, chemotherapy, radiotherapy or medicines to prevent transplant rejection.
This medicine suppresses part of the immune system. This means that vaccines may potentially be less effective if given during treatment, and live vaccines may cause serious infections. Live vaccines include: measles, mumps, rubella, MMR, oral polio, oral typhoid and yellow fever. It is recommended that live vaccines are not given to people being treated with this medicine or within three months of stopping this medicine. Children having this treatment should be brought up to date with the current childhood immunisation schedule before treatment is started.
Other medicines containing the same active ingredient
There are currently no other medicines available in the UK that contain abatacept as the active ingredient.
Last updated 28.02.2013
Two drugs—one used to treat rheumatoid arthritis and another for different types of blood cancers—have shown promise in reversing hair loss characteristic of alopecia areata and related disorders, according to a study in mice funded in part by the NIH’s National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The study was published in Science Advances.
Alopecia areata is an autoimmune disease in which the immune system, designed to protect the body from foreign invaders such as viruses and bacteria, mistakenly attacks hair follicles, leading to hair loss on the scalp and elsewhere. There is neither a cure for alopecia areata nor drugs approved for its treatment, though some steroid-based medications may help promote new hair growth without treating the underlying disease.
Previous research led by Angela Christiano, Ph.D., of Columbia University, tested the effects of tofacitinib and ruxolitinib on hair regrowth in a mouse model of alopecia areata. Tofacitinib and ruxolitinib inhibit the Janus kinase–signal transducer and activator of transcription (JAK-STAT) pathway, which classifies them as JAK inhibitors. The researchers found these drugs promoted rapid hair regrowth in both mice and humans with alopecia areata when given orally. Even more robust hair growth resulted when the drugs were applied topically to the mice, suggesting an effect on the hair follicle itself.
“The results of our previous study were intriguing and unexpected,” said Dr. Christiano. “We knew the drugs could stop the autoimmune reaction that caused the hair loss, but we wanted to further investigate how the drugs affected the hair follicle directly.”
In this new study, Christiano and colleagues shaved the backs of mice with normal hair follicles that were in the resting stage of the hair cycle. Mice were then treated topically on one side daily with either an inactive substance, a sonic hedgehog agonist (a compound already known to stimulate hair growth), tofacitinib, or ruxolitinib. The researchers found the JAK inhibitors accelerated the hair cycle similarly to the sonic hedgehog agonist. In fact, approximately 90 percent of mice treated with the JAK inhibitors for five days showed growth within 10 days of starting treatment. No hair growth was evident in the mice treated with the inactive substance.
The experiment was later extended by Christiano and colleagues to examine the effects of JAK inhibition on hair growth in human tissues. Researchers grafted human scalp skin onto mice, followed by six weeks of recovery. Similar to before, JAK inhibitor treatments were then applied topically to the grafts to examine density of hair follicle growth. Ultimately, the JAK inhibitors significantly increased growth and length of hair shafts within days of treatment.
“Hair loss associated with alopecia areata can have significant psychosocial effects on an individual, and we have had few real treatments for the disease. Being able to use existing drugs for this purpose is a promising treatment approach,” said Christiano. More studies are underway to determine how the compounds affect follicles damaged by alopecia areata and other disorders.
This work was supported by NIAMS (grant numbers P30-AR044535, R01-AR056016, R21-AR061881) and the National Institute of General Medical Sciences (T32-GM082771). Locks of Love, the Alopecia Areata Initiative, and the Dermatology Foundation provided additional support.
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Methotrexate for Hair Loss:
When treating hair loss, MTX has a role in treating both scarring and non scarring conditions. Evidence supports a role of weekly oral methotrexate in treatment of lichen planopilaris, frontal fibrosing alopecia, discoid lupus and alopecia areata. In the treatment of alopecia areata, methotrexate has been used in both children and adults, often in combination with systemic corticosteroids (like dexamethasone and prednisone).
Hair Loss as a side effect of MTX
In addition to its use in treating hair loss, methotrexate can sometimes also cause hair loss. About 2-4 % of users experience hair loss and the type of hair loss includes both increased hair breakage as well as increased shedding. Hair color changes can also occur.
MTX side effects
Anyone considering MTX needs to speak to their physician about the risks and benefits. Side effects from methotrexate include reduced blood counts, liver damage, ulcers, cough, lung irritation (rarely fibrosis or scarring in the lung), nausea and abdominal pain, fatigue, kidney damage and memory problems. Methotrexate can not be used by women trying to become pregnant or who are pregnant.
Because methotrexate interferes with how folic acid is metabolized, the drug needs to be taken with folic acid supplements. Generally methotrexate is given only one day per week and folic acid is given the other 6 days of the week (on the days methotrexate is not taken).