- Cimzia Warnings
- Pregnancy and Cimzia
- SIDE EFFECTS
- Clinical Trials Experience
- Adverse Reactions Most Commonly Leading To Discontinuation Of Treatment In Premarketing Controlled Trials
- Controlled Studies With Crohn’s Disease
- Other Adverse Reactions
- Controlled Studies with Rheumatoid Arthritis
- Psoriatic Arthritis Clinical Study
- Ankylosing Spondylitis Clinical Study
- Plaque Psoriasis Clinical Studies
- Adverse Reactions Of Special Interest Across Indications
- Tuberculosis And Opportunistic Infections
- Heart Failure
- Hypersensitivity Reactions
- Postmarketing Experience
- Clinical Trials Experience
- certolizumab (Cimzia, Cimzia Starter)
- Cimzia Side Effects
- In Summary
- For the Consumer
- For Healthcare Professionals
- Further information
- More about Cimzia (certolizumab)
- Taking CIMZIA: A Quick Reference Guide
Cimzia is the brand name of the prescription drug certolizumab. It’s used to treat certain autoimmune disorders, including:
- Rheumatoid arthritis (a condition in which the body attacks its own joints)
- Psoriatic arthritis (a condition that causes joint pain and scaly skin)
- Ankylosing spondylitis (a condition in which the body attacks the joints of the spine and other areas)
- Crohn’s disease (a condition in which the body attacks the lining of the digestive tract)
Cimzia belongs to a class of drugs called tumor necrosis factor (TNF) inhibitors. It works by blocking TNF, a substance that causes inflammation in the body.
The U.S. Food and Drug Administration (FDA) approved Cimzia in 2008. It’s manufactured by UCB, Inc.
Cimzia contains a black box warning because it could increase your risk of developing a severe or life-threatening infection, and lower your body’s ability to fight infections.
Tell your doctor if you’re prone to getting infections, or if you currently have an infection, including a minor one, such as a cut or sore.
Tell your healthcare provider if you live in, have lived in, or have traveled to the Mississippi or Ohio River valleys. Severe fungal infections are more common in these regions.
Before starting on Cimzia, let your doctor know if you’re taking any medication that affects the immune system, such as:
Avoid being around people who are sick or have infections while you’re taking Cimzia.
Call your doctor right away if you experience any symptoms of infection while using this medicine, which may include:
- Fever, sweating, or chills
- Sore throat
- Difficulty breathing
- Weight loss
- Stomach pain
- Blood in phlegm
- Extreme tiredness or fatigue
- Muscle aches
- Red, warm, or painful skin
- Frequent urination, or burning during urination
- Sores on the skin or around the mouth
Before taking this drug, let your doctor know if you have, or have ever had:
- Any other condition that affects your immune system
If you have active tuberculosis (TB) or hepatitis B (a type of liver disease), Cimzia may raise the risk of the infection becoming worse, since it can impair your body’s ability to contain these infections.
You could have TB or hepatitis B and not know it since you may not have symptoms.
Your doctor will order tests to determine whether you have inactive forms of these conditions, so that they can be treated before you start on Cimzia.
Tell your doctor if you have or have ever tested positive for TB (by a blood or skin test), had TB, have been around someone with TB, or have traveled to areas where TB is common.
During your treatment with Cimzia, let your healthcare provider know right away if you experience any symptoms of TB, which may include:
- Chest pain
- Coughing up blood or mucus
- Weight loss
- Loss of appetite
- Loss of muscle tone
- Night sweats
Also, tell your doctor if you’ve ever had hepatitis B or if you experience any symptoms of the disease during or after your use of Cimzia.
Common symptoms of hepatitis B include:
- Yellowing of the skin or eyes (jaundice)
- Loss of appetite
- Nausea or vomiting
- Dark-colored urine
- Clay-colored stools
- Muscle aches
- Stomach pain
- Excessive tiredness
This drug also contains a black box warning because some children, teenagers, and young adults who took medicines similar to Cimzia developed serious or life-threatening cancers, including lymphoma, a type of cancer that begins in the blood cells that fight infection.
Usually, children and teenagers shouldn’t take Cimzia. But your doctor may decide that the benefits of the treatment outweigh the risks in a given situation.
Tell your doctor right away if you or your child develops any of the following symptoms during treatment with Cimzia:
- Swollen glands in the neck, groin, or underarms
- Unexplained weight loss
- Easy bruising or bleeding
Let your healthcare provider know you’re taking this medicine before having any type of medical test or surgery, including a dental procedure.
Don’t receive any vaccines while taking Cimzia without first discussing it with your doctor.
Before using Cimzia, tell your doctor if you have, or have ever had:
- Any condition that affects your nervous system, such as multiple sclerosis (MS)
- Guillain-Barré syndrome (a condition that causes weakness, tingling, and sometimes paralysis)
- Blood disorders or any type of bleeding problem
- Optic neuritis (inflammation of the nerve that sends messages from the eye to the brain)
- Tingling in any part of your body
- Heart failure
- Abnormal blood cell counts
Keep all appointments with your doctor and laboratory while taking Cimzia. You’ll need to undergo frequent tests to check your body’s response to the medicine.
Pregnancy and Cimzia
It’s not known whether Cimzia could harm an unborn baby.
Tell your doctor if you’re pregnant or might become pregnant while using this medicine.
It’s also not known whether Cimzia could pass into breast milk or hurt a breastfeeding baby. Don’t breastfeed while using this drug.
The most serious adverse reactions were:
- Serious Infections
- Heart Failure
Clinical Trials Experience
Because clinical studies are conducted under widely varying and controlled conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug, and may not predict the rates observed in a broader patient population in clinical practice.
In premarketing controlled trials of all patient populations combined the most common adverse reactions (≥ 8%) were upper respiratory infections (18%), rash (9%) and urinary tract infections (8%).
The proportion of patients with Crohn’s disease who discontinued treatment due to adverse reactions in the controlled clinical studies was 8% for CIMZIA and 7% for placebo. The most common adverse reactions leading to the discontinuation of CIMZIA (for at least 2 patients and with a higher incidence than placebo) were abdominal pain (0.4% CIMZIA, 0.2% placebo), diarrhea (0.4% CIMZIA, 0% placebo), and intestinal obstruction (0.4% CIMZIA, 0% placebo).
The proportion of patients with rheumatoid arthritis who discontinued treatment due to adverse reactions in the controlled clinical studies was 5% for CIMZIA and 2.5% for placebo. The most common adverse reactions leading to discontinuation of CIMZIA were tuberculosis infections (0.5%); and pyrexia, urticaria, pneumonia, and rash (0.3%).
Controlled Studies With Crohn’s Disease
The data described below reflect exposure to CIMZIA at 400 mg subcutaneous dosing in studies of patients with Crohn’s disease. In the safety population in controlled studies, a total of 620 patients with Crohn’s disease received CIMZIA at a dose of 400 mg, and 614 subjects received placebo (including subjects randomized to placebo in Study CD2 following open label dosing of CIMZIA at Weeks 0, 2, 4). In controlled and uncontrolled studies, 1,564 patients received CIMZIA at some dose level, of whom 1,350 patients received 400 mg CIMZIA. Approximately 55% of subjects were female, 45% were male, and 94% were Caucasian. The majority of patients in the active group were between the ages of 18 and 64.
During controlled clinical studies, the proportion of patients with serious adverse reactions was 10% for CIMZIA and 9% for placebo. The most common adverse reactions (occurring in ≥ 5% of CIMZIA-treated patients, and with a higher incidence compared to placebo) in controlled clinical studies with CIMZIA were upper respiratory infections (e.g. nasopharyngitis, laryngitis, viral infection) in 20% of CIMZIA-treated patients and 13% of placebo-treated patients, urinary tract infections (e.g. bladder infection, bacteriuria, cystitis) in 7% of CIMZIA-treated patients and in 6% of placebo-treated patients, and arthralgia (6% CIMZIA, 4% placebo).
Other Adverse Reactions
The most commonly occurring adverse reactions in controlled trials of Crohn’s disease were described above. Other serious or significant adverse reactions reported in controlled and uncontrolled studies in Crohn’s disease and other diseases, occurring in patients receiving CIMZIA at doses of 400 mg or other doses include:
Blood and lymphatic system disorders: Anemia, leukopenia, lymphadenopathy, pancytopenia, and thrombophilia.
Cardiac disorders: Angina pectoris, arrhythmias, atrial fibrillation, cardiac failure, hypertensive heart disease, myocardial infarction, myocardial ischemia, pericardial effusion, pericarditis, stroke and transient ischemic attack.
Eye disorders: Optic neuritis, retinal hemorrhage, and uveitis.
General disorders and administration site conditions: Bleeding and injection site reactions.
Hepatobiliary disorders: Elevated liver enzymes and hepatitis.
Immune system disorders: Alopecia totalis.
Psychiatric disorders: Anxiety, bipolar disorder, and suicide attempt.
Renal and urinary disorders: Nephrotic syndrome and renal failure.
Reproductive system and breast disorders: Menstrual disorder.
Skin and subcutaneous tissue disorders: Dermatitis, erythema nodosum, and urticaria.
Vascular disorders: Thrombophlebitis, vasculitis.
Controlled Studies with Rheumatoid Arthritis
CIMZIA was studied primarily in placebo-controlled trials and in long-term follow-up studies. The data described below reflect the exposure to CIMZIA in 2,367 RA patients, including 2,030 exposed for at least 6 months, 1,663 exposed for at least one year and 282 for at least 2 years; and 1,774 in adequate and well-controlled studies. In placebo-controlled studies, the population had a median age of 53 years at entry; approximately 80% were females, 93% were Caucasian and all patients were suffering from active rheumatoid arthritis, with a median disease duration of 6.2 years. Most patients received the recommended dose of CIMZIA or higher.
Table 1 summarizes the reactions reported at a rate of at least 3% in patients treated with CIMZIA 200 mg every other week compared to placebo (saline formulation), given concomitantly with methotrexate.
Table 1: Adverse Reactions Reported by ≥3% of Patients Treated with CIMZIA Dosed Every Other Week during Placebo-Controlled Period of Rheumatoid Arthritis Studies, with Concomitant Methotrexate.
|Placebo+ MTX# (%)
|CIMZIA 200 mg EOW + MTX(%)
|Upper respiratory tract||2||6|
|#EOW = Every other Week, MTX = Methotrexate.|
Hypertensive adverse reactions were observed more frequently in patients receiving CIMZIA than in controls. These adverse reactions occurred more frequently among patients with a baseline history of hypertension and among patients receiving concomitant corticosteroids and non-steroidal anti-inflammatory drugs.
Patients receiving CIMZIA 400 mg as monotherapy every 4 weeks in rheumatoid arthritis controlled clinical trials had similar adverse reactions to those patients receiving CIMZIA 200 mg every other week.
Other infrequent adverse reactions (occurring in less than 3% of RA patients) were similar to those seen in Crohn’s disease patients.
Psoriatic Arthritis Clinical Study
CIMZIA has been studied in 409 patients with psoriatic arthritis (PsA) in a placebo-controlled trial. The safety profile for patients with PsA treated with CIMZIA was similar to the safety profile seen in patients with RA and previous experience with CIMZIA.
Ankylosing Spondylitis Clinical Study
CIMZIA has been studied in 325 patients with axial spondyloarthritis of whom the majority had ankylosing spondylitis (AS) in a placebo-controlled study (AS-1). The safety profile for patients in study AS-1 treated with CIMZIA was similar to the safety profile seen in patients with RA.
Plaque Psoriasis Clinical Studies
In clinical studies, a total of 1112 subjects with plaque psoriasis were treated with CIMZIA. Of these, 779 subjects were exposed for at least 12 months, 551 for 18 months, and 66 for 24 months.
Placebo-Controlled Period (Week 0-16)
In the placebo-controlled period of Studies PS-1, PS-2 and PS-3 in the 400 mg group, adverse events occurred in 63.5% of subjects in the CIMZIA group compared to 61.8% of subjects in the placebo group. The rates of serious adverse events were 4.7% in the CIMZIA group and 4.5% in the placebo group. Table 2 summarizes the adverse reactions that occurred at a rate of at least 1% and at a higher rate in the CIMZIA group than in the placebo group.
Table 2: Adverse Reactions Occurring in ≥1% of Subjects in the CIMZIA Group and More Frequently than in the Placebo Group in the Plaque Psoriasis Studies PS-1, PS-2, and PS-3.
Elevated Liver Enzymes
Elevated liver enzymes were reported more frequently in the CIMZIA-treated subjects (4.3% in the 200 mg group and 2.3% in the 400 mg group) than in the placebo-treated subjects (2.5%). Of CIMZIA-treated subjects who had elevation of liver enzymes, two subjects were discontinued from the trial. In controlled Phase 3 studies of CIMZIA in adults with PsO with a controlled period duration ranging from 0 to 16 weeks, AST and/or ALT elevations ≥5 x ULN occurred in 0.9% of CIMZIA 200 mg or CIMZIA 400 mg arms and none in placebo arm.
Psoriasis-Related Adverse Events
In controlled clinical studies in psoriasis, change of plaque psoriasis into a different psoriasis sub-types (including erythrodermic, pustular and guttate), was observed in <1% of Cimzia treated subjects.
Adverse Reactions Of Special Interest Across Indications
The incidence of infections in controlled studies in Crohn’s disease was 38% for CIMZIA-treated patients and 30% for placebo-treated patients. The infections consisted primarily of upper respiratory infections (20% for CIMZIA, 13% for placebo). The incidence of serious infections during the controlled clinical studies was 3% per patient-year for CIMZIA-treated patients and 1% for placebo-treated patients. Serious infections observed included bacterial and viral infections, pneumonia, and pyelonephritis.
The incidence of new cases of infections in controlled clinical studies in rheumatoid arthritis was 0.91 per patient-year for all CIMZIA-treated patients and 0.72 per patient-year for placebo-treated patients. The infections consisted primarily of upper respiratory tract infections, herpes infections, urinary tract infections, and lower respiratory tract infections. In the controlled rheumatoid arthritis studies, there were more new cases of serious infection adverse reactions in the CIMZIA treatment groups, compared to the placebo groups (0.06 per patient-year for all CIMZIA doses vs. 0.02 per patient-year for placebo). Rates of serious infections in the 200 mg every other week dose group were 0.06 per patient-year and in the 400 mg every 4 weeks dose group were 0.04 per patient-year. Serious infections included tuberculosis, pneumonia, cellulitis, and pyelonephritis. In the placebo group, no serious infection occurred in more than one subject. There is no evidence of increased risk of infections with continued exposure over time .
In controlled clinical studies in psoriasis, the incidence rates of infections were similar in the CIMZIA and placebo groups. The infections consisted primarily of upper respiratory tract infections and viral infections (including herpes infections). Serious adverse events of infection occurred in CIMZIA-treated patients during the placebo-controlled periods of the pivotal studies (pneumonia, abdominal abscess, and hematoma infection) and Phase 2 study (urinary tract infection, gastroenteritis, and disseminated tuberculosis).
Tuberculosis And Opportunistic Infections
In completed and ongoing global clinical studies in all indications including 5,118 CIMZIA-treated patients, the overall rate of tuberculosis is approximately 0.61 per 100 patient-years across all indications.
The majority of cases occurred in countries with high endemic rates of TB. Reports include cases of disseminated (miliary, lymphatic, and peritoneal) as well as pulmonary TB. The median time to onset of TB for all patients exposed to CIMZIA across all indications was 345 days. In the studies with CIMZIA in RA, there were 36 cases of TB among 2,367 exposed patients, including some fatal cases. Rare cases of opportunistic infections have also been reported in these clinical trials. In Phase 2 and Phase 3 studies with CIMZIA in plaque psoriasis, there were 2 cases of TB among 1112 exposed patients .
In clinical studies of CIMZIA, the overall incidence rate of malignancies was similar for CIMZIA-treated and control patients. For some TNF blockers, more cases of malignancies have been observed among patients receiving those TNF blockers compared to control patients .
In placebo-controlled and open-label studies, cases of new or worsening heart failure have been reported for CIMZIA-treated patients. The majority of these cases were mild to moderate and occurred during the first year of exposure .
The following symptoms that could be compatible with hypersensitivity reactions have been reported rarely following CIMZIA administration to patients: angioedema, allergic dermatitis, dizziness (postural), dyspnea, hot flush, hypotension, injection site reactions, malaise, pyrexia, rash, serum sickness, and (vasovagal) syncope .
In clinical studies in Crohn’s disease, 4% of patients treated with CIMZIA and 2% of patients treated with placebo that had negative baseline ANA titers developed positive titers during the studies. One of the 1,564 Crohn’s disease patients treated with CIMZIA developed symptoms of a lupus-like syndrome.
In clinical trials of TNF blockers, including CIMZIA, in patients with RA, some patients have developed ANA. Four patients out of 2,367 patients treated with CIMZIA in RA clinical studies developed clinical signs suggestive of a lupus-like syndrome. The impact of long-term treatment with CIMZIA on the development of autoimmune diseases is unknown .
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 certolizumab pegol in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.
Patients with Crohn’s disease were tested at multiple time points for antibodies to certolizumab pegol during Studies CD1 and CD2. In patients continuously exposed to CIMZIA, the overall percentage of patients who were antibody positive to CIMZIA on at least one occasion was 8%; approximately 6% were neutralizing in vitro. No apparent correlation of antibody development to adverse events or efficacy was observed. Patients treated with concomitant immunosuppressants had a lower rate of antibody development than patients not taking immunosuppressants at baseline (3% and 11%, respectively). The following adverse events were reported in Crohn’s disease patients who were antibody-positive (N = 100) at an incidence at least 3% higher compared to antibody-negative patients (N = 1,242): abdominal pain, arthralgia, edema peripheral, erythema nodosum, injection site erythema, injection site pain, pain in extremity, and upper respiratory tract infection.
In two long-term (up to 7 years of exposure), open-label Crohn’s disease studies, overall 23% (207/903) of patients developed antibodies against certolizumab pegol on at least one occasion. Of the 207 patients who were antibody positive, 152 (73%) had a persistent reduction of drug plasma concentration, which represents 17% (152/903) of the study population. The data from these two studies do not suggest an association between the development of antibodies and adverse events.
The overall percentage of patients with antibodies to certolizumab pegol detectable on at least one occasion was 7% (105 of 1,509) in the rheumatoid arthritis placebo-controlled trials. Approximately one third (3%, 39 of 1,509) of these patients had antibodies with neutralizing activity in vitro. Patients treated with concomitant immunosuppressants (MTX) had a lower rate of antibody development than patients not taking immunosuppressants at baseline. Patients treated with concomitant immunosuppressant therapy (MTX) in RA-I, RA-II, RA-III had a lower rate of neutralizing antibody formation overall than patients treated with CIMZIA monotherapy in RA-IV (2% vs. 8%). Both the loading dose of 400 mg every other week at Weeks 0, 2 and 4 and concomitant use of MTX were associated with reduced immunogenicity.
Antibody formation was associated with lowered drug plasma concentration and reduced efficacy. In patients receiving the recommended CIMZIA dosage of 200 mg every other week with concomitant MTX, the ACR20 response was lower among antibody positive patients than among antibody-negative patients (Study RA-I, 48% versus 60%; Study RA-II 35% versus 59%, respectively). In Study RA-III, too few patients developed antibodies to allow for meaningful analysis of ACR20 response by antibody status. In Study RA-IV (monotherapy), the ACR20 response was 33% versus 56%, antibody-positive versus antibody-negative status, respectively . No association was seen between antibody development and the development of adverse events.
Approximately 8 % (22/265) and 19% (54/281) of subjects with psoriasis who received CIMZIA 400 mg every 2 weeks and CIMZIA 200 mg every 2 weeks for 48 weeks, respectively, developed antibodies to certolizumab pegol. Of the subjects who developed antibodies to certolizumab pegol, 45% (27/60) had antibodies that were classified as neutralizing. Antibody formation was associated with lowered drug plasma concentration and reduced efficacy.
The data reflect the percentage of patients whose test results were considered positive for antibodies to certolizumab pegol in an ELISA, and are highly dependent on the sensitivity and specificity of the assay.
The following adverse reactions have been identified during post-approval use of CIMZIA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure.
Vascular disorder: systemic vasculitis has been identified during post-approval use of TNF blockers.
Skin: case of severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, and new or worsening psoriasis (all sub-types including pustular and palmoplantar) have been identified during post-approval use of TNF blockers.
Immune System Disorders: sarcoidosis
Neoplasms benign, malignant and unspecified (including cysts and polyps): Melanoma, Merkel cell carcinoma (neuroendocrine carcinoma of the skin) .
Read the entire FDA prescribing information for Cimzia (Certolizumab Pegol Injection)
certolizumab (Cimzia, Cimzia Starter)
What should I discuss with my healthcare provider before using certolizumab (Cimzia, Cimzia Starter)?
You should not use certolizumab if you are allergic to it. You may not be able to use certolizumab if you have symptoms of an infection such as fever, chills, cough, skin sores, shortness of breath, weight loss, diarrhea, or painful urination.
Tell your doctor if you have ever had tuberculosis or if anyone in your household has tuberculosis. Also tell your doctor if you have recently traveled. Tuberculosis and some fungal infections are more common in certain parts of the world, and you may have been exposed during travel.
Certolizumab may cause a rare type of lymphoma (cancer) of the liver, spleen, and bone marrow that can be fatal. This has occurred mainly in teenagers and young men with Crohn’s disease or ulcerative colitis. However, anyone with an inflammatory autoimmune disorder may have a higher risk of lymphoma. Talk with your doctor about your own risk.
Tell your doctor if you have ever had:
- a chronic infection;
- hepatitis B (or if you are a carrier of the virus);
- lymphoma or other types of cancer;
- a blood cell disorder;
- congestive heart failure;
- a seizure;
- an allergy to latex;
- numbness or tingling, or a nervous system disorder such as multiple sclerosis or Guillain-Barré syndrome; or
- if you are scheduled to receive any vaccines, or have recently been vaccinated with BCG (Bacille Calmette-Guerin).
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant. Your name may be listed on a pregnancy registry to track the effects of certolizumab on the baby.
It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.
Certolizumab is not approved for use by anyone younger than 18 years old.
How is certolizumab given (Cimzia, Cimzia Starter)?
Your doctor may perform tests to make sure you do not have tuberculosis or other infections.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Certolizumab is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.
Certolizumab is usually given every 2 to 4 weeks. You may need to use more than 1 injection to get a full dose. Follow your doctor’s dosing instructions very carefully.
Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you have questions.
Prepare your injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.
Certolizumab can increase your risk of bleeding or infection. You will need frequent medical tests.
Store this medicine in its original carton in the refrigerator. Protect from light and do not freeze.
Take the syringe out of the refrigerator and let it reach room temperature before injecting your dose.
Unopened prefilled syringes may also be stored at room temperature for up to 7 days, away from heat and light. Throw away any prefilled syringe not used within 7 days. Do not put it back in the refrigerator.
Each prefilled syringe is for one use only. Throw away after one use, even if there is still medicine left inside.
Use a needle and syringe only once and then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.
If you’ve ever had hepatitis B, using certolizumab can cause this virus to become active or get worse. You may need frequent liver function tests while using this medicine and for several months after you stop.
What is Crohn’s disease? See Answer
Cimzia Side Effects
Generic Name: certolizumab
Medically reviewed by Drugs.com. Last updated on Nov 27, 2018.
- Side Effects
Note: This document contains side effect information about certolizumab. Some of the dosage forms listed on this page may not apply to the brand name Cimzia.
Common side effects of Cimzia include: infection and viral infection. Other side effects include: skin rash. See below for a comprehensive list of adverse effects.
For the Consumer
Applies to certolizumab: subcutaneous powder for solution, subcutaneous solution
Subcutaneous route (Powder for Solution; Solution)
Serious Infections-Patients treated with certolizumab pegol are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.Certolizumab pegol should be discontinued if a patient develops a serious infection or sepsis.Reported infections include:Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before certolizumab pegol use and during therapy. Treatment for latent infection should be initiated prior to certolizumab pegol use.Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.The risks and benefits of treatment with certolizumab pegol should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with certolizumab pegol, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.Malignancy-Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which certolizumab pegol is a member. certolizumab pegol is not indicated for use in pediatric patients.
Along with its needed effects, certolizumab (the active ingredient contained in Cimzia) 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 immediately if any of the following side effects occur while taking certolizumab:
- Bladder pain
- bloody or cloudy urine
- body aches or pain
- difficult, burning, or painful urination
- difficulty with breathing
- ear congestion
- frequent urge to urinate
- loss of voice
- lower back or side pain
- nasal congestion
- runny nose
- sore throat
- unusual tiredness or weakness
- 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
- bloating or swelling of the face, arms, hands, lower legs, or feet
- chest pain
- frequent urination
- pain in the arms, ankles, knees, or legs
- painful, red lumps under the skin, mostly on the legs
- rapid weight gain
- stomach pain
- tingling of the hands or feet
- tightness in the chest
- unusual weight gain or loss
- Blurred vision
- coughing or spitting up blood
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- feeling of warmth
- general feeling of discomfort, illness, or weakness
- itching, skin rash
- joint pain or swelling
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- loss of appetite
- muscle aches
- night sweats
- redness of the face, neck, arms, and occasionally, upper chest
- sudden high fever or low-grade fever for months
- swelling of the lymph glands
Incidence not known
- Blistering, peeling, or loosening of the skin
- red skin lesions, often with a purple center
- red, irritated eyes
- red, scaling, or crusted skin
- sores, ulcers, or white spots in the mouth or on the lips
Some side effects of certolizumab 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:
- Difficulty with moving
- muscle pain or stiffness
For Healthcare Professionals
Applies to certolizumab: subcutaneous kit
Uncommon (0.1% to 1%): Vasculitides, lupus erythematosus
Rare (less than 0.1%): Angioneurotic edema, sarcoidosis, serum sickness, panniculitis (including erythema nodosum)
Frequency not reported: Viral infections (herpes, papillomavirus, influenza), pneumonia, tuberculosis, cellulitis, pyelonephritis bacterial and viral infections, positive ANA titers
Common (1% to 10%): Hypertension
Uncommon (0.1% to 1%): Cardiomyopathies (including heart failure), ischemic coronary artery disorders, arrhythmias (including atrial fibrillation), palpitations, hypercoagulation (including thrombophlebitis, pulmonary embolism), edema (including peripheral, facial), ecchymoses (including hematoma, petechiae)
Frequency not reported: Angina pectoris, myocardial infarction, pericardial effusion, stroke
Rare (less than 0.1%): Pericarditis, atrioventricular block, cerebrovascular accident, arteriosclerosis, Raynaud’s phenomenon, livedo reticularis, telangiectasia
Postmarketing reports: Systemic vasculitis
Common (1% to 10%): Upper respiratory tract infection, nasopharyngitis, pharyngitis, acute bronchitis, pneumonia, inflammation
Uncommon (0.1% to 1%): Asthma, pleural effusion, respiratory tract congestion, lower respiratory tract infection, oropharyngeal dryness, cough
Rare (less than 0.1%): Interstitial lung disease, pneumonitis
Common (1% to 10%): Rash
Uncommon (0.1% to 1%): Alopecia, new onset or worsening of psoriasis (including palmoplantar pustular psoriasis) and related conditions, dermatitis and eczema, sweat gland disorder, skin ulcer, photosensitivity, acne, skin discoloration, dry skin, nail and nail bed disorders skin injuries
Rare (less than 0.1%): Skin exfoliation and desquamation, bullous conditions, hair texture disorder
Frequency not reported: Cellulitis, erythema nodosum, urticaria, pruritus
Postmarketing reports: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme
Common (1% to 10%): Urinary tract infections, pyelonephritis
Uncommon (0.1% to 1%): Menstrual cycle and uterine bleeding disorders (including amenorrhea), breast disorders, hematuria, bladder symptoms, urethral symptoms
Rare (less than 0.1%): Sexual dysfunction
Common (1% to 10%): Eosinophilic disorders, leukopenia (including neutropenia, lymphopenia)
Uncommon (0.1% to 1%): Anemia, lymphadenopathy, thrombocytopenia, thrombocytosis, blood alkaline phosphatase increased, coagulation time prolonged
Rare (less than 0.1%): Pancytopenia, splenomegaly, erythrocytosis, white blood cell morphology abnormal, ancytopenia (including aplastic anemia), erythrocytosis
Frequency not reported: Thrombophilia, hemorrhage, hypercoagulation, hematoma, blood uric acid increased, blood bilirubin increased
Common (1% to 10%): Hepatitis (including hepatic enzyme increased)
Uncommon (0.1% to 1%): Hepatopathy (including cirrhosis), cholestasis
Rare (less than 0.1%): Reactivation of hepatitis B virus (HBV), including fatalities
Frequency not reported: Elevated liver enzymes
Common (1% to 10%): Conjunctivitis
Frequency not reported: Retinal hemorrhage, uveitis
Uncommon (0.1% to 1%): Blood and lymphatic system malignancies (including lymphoma and leukemia), solid organ tumors, non-melanoma skin cancers, pre-cancerous lesions (including oral leukoplakia, melanocytic nevus), benign tumors, cysts (including skin papilloma)
Rare (less than 0.1%): Gastrointestinal tumors, melanoma
Frequency not reported: Merkel cell carcinoma
Uncommon (0.1% to 1%): Anxiety, mood disorders (including associated symptoms), restlessness
Rare (less than 0.1%): Suicide attempt, delirium, mental impairment, bipolar disorder
Uncommon (0.1% to 1%): Renal impairment
Rare (less than 0.1%): Nephropathy (including nephritis)
Common (1% to 10%): Back pain, arthralgia, muscle spasms, pain in extremity
Uncommon (0.1% to 1%): Muscle disorders, blood creatine phosphokinase increased
Common (1% to 10%): Abdominal pain (including upper abdominal pain), diarrhea, dyspepsia, gastritis, nausea
Uncommon (0.1% to 1%): Ascites, gastrointestinal infections, abdominal distension, gastrointestinal fistula, odynophagia, oropharyngeal dryness, hypermotility, splenomegaly, pancreatitis, dental infections, gastrointestinal ulceration and perforation, gastrointestinal tract inflammation (any site), stomatitis
Rare (less than 0.1%): Gastrointestinal stenosis, gastrointestinal obstruction
Common (1% to 10%): Headaches (including migraine), sensory abnormalities
Uncommon (0.1% to 1%): Peripheral neuropathies, dizziness, tremor, vertigo, acoustic neuritis, trigeminal neuralgia, Raynaud’s phenomenon, cranial nerve inflammation, cranial nerve impairment, dysesthesia, paresthesia
Rare (less than 0.1%): Seizure, exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis, and with peripheral demyelinating disease, including Guillain-Barre syndrome
Common (1% to 10%): Pyrexia, fatigue, pain (any site), asthenia, pruritus (any site)
Rare (less than 0.1%): Fistula (any site)
Uncommon (0.1% to 1%): Injection site reactions (erythema, itching, hematoma, pain, swelling, bruising)
Uncommon (0.1% to 1%): Electrolyte imbalance, dyslipidemia, appetite disorders, weight change, electrolyte imbalance, increased alkaline phosphatase levels
Rare (less than 0.1%): Hemosiderosis
Rare (less than 0.1%): Thyroid disorders
The most commonly reported side effects were upper respiratory infection (18%), urinary tract infection (18%), and rash (9%)
1. “Product Information. Cimzia (certolizumab).” UCB Pharma Inc, Smyrna, GA.
2. Cerner Multum, Inc. “UK Summary of Product Characteristics.” O 0
3. Cerner Multum, Inc. “Australian Product Information.” O 0
4. “Certolizumab (Cimzia) for Crohn’s disease.” Med Lett Drugs Ther 50 (2008): 81-2
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 Cimzia (certolizumab)
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
- Pricing & Coupons
- En Español
- 41 Reviews
- Drug class: TNF alfa inhibitors
- FDA Alerts (5)
- FDA Approval History
- Cimzia (Certolizumab Prefilled Syringes)
- Cimzia (Certolizumab Vials)
- Cimzia (Advanced Reading)
- Cimzia (AHFS Monograph)
- … +1 more
Related treatment guides
- Ankylosing Spondylitis
- Crohn’s Disease
- Crohn’s Disease, Acute
- Crohn’s Disease, Maintenance
- … +4 more
Taking CIMZIA: A Quick Reference Guide
*The CIMplicity program is provided as a service of UCB and is intended to support the appropriate use of CIMZIA. The CIMplicity program may be amended or canceled at any time without notice. Some program and eligibility restrictions may apply.
†Eligibility: Available to individuals with commercial prescription insurance coverage for CIMZIA. Not valid for prescriptions that are reimbursed, in whole or in part, under Medicare (including Medicare Part D), Medicaid, similar federal- or state-funded programs (including any state prescription drug assistance programs and the Government Health Insurance Plan available in Puerto Rico), or where otherwise prohibited by law. Product dispensed pursuant to program rules and federal and state laws. Claims should not be submitted to any public payor (ie, Medicare, Medicaid, Medigap, TRICARE, VA, and DoD) for reimbursement. The maximum annual benefit amount is $15,000 per calendar year. The parties reserve the right to amend or end this program at any time without notice.
If you are uninsured, other financial assistance may be available. Call ucbCARES™ toll free at 1-844-599-CARE (2273) for more information. The CIMplicity program is provided as a service of UCB, Inc., and is intended to support the appropriate use of CIMZIA. Any CIMplicity program may be amended or canceled at any time without notice. Some program and eligibility restrictions apply. Please consult your doctor if you have any questions about your condition or treatment. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
UCB, Inc., is not liable for unintended or unauthorized use of the CIMplicity Savings Card if it is lost or stolen.
People with autoimmune conditions, such as rheumatoid arthritis (RA) and lupus, can experience hair loss as a troubling symptom of their disease. Other times though, the cause of the shedding locks could be the medications used to treat arthritis.
Fortunately, hair loss from arthritis medications is not a widespread complication. Still, if your hair is an important part of your identity, it’s not a small matter to you.
What Medications Cause Hair Loss?
Methotrexate: The most commonly prescribed disease-modifying antirheumatic drug (DMARD) for rheumatoid arthritis, methotrexate is responsible for hair loss in about 1 to 3 percent of people. The hair loss happens because methotrexate is doing what it’s supposed to do – stop cells from growing. This includes cells causing inflammation and, unfortunately, hair follicles.
Folic acid is commonly prescribed with methotrexate to alleviate some of its side effects. Taking this synthetic form of folate, a B-complex vitamin, can help keep your hair healthy, but it has not been found to promote hair growth.
Leflunomide (Arava): Another widely used DMARD for RA with the potential for hair loss is leflunomide. It often is prescribed in combination with methotrexate, and causes hair loss similar to the way methotrexate does in about 10 percent of users.
Biologics: In rare cases, biologics such as etanercept (Enbrel) or adalimumab (Humira) have hair loss side effects. It’s not known exactly why these drugs affect hair growth, but it’s suspected it’s because they change the balance of messenger molecules known as “cytokines” in the body.
What to Expect from Hair Loss Side Effects
Generally as a drug-related side effect, hair loss is not drastic and the hair does not fall out in patches. And it usually grows back after you stop taking the drug.
But if you have inherited male or female pattern baldness, arthritis medications could trigger or accelerate such permanent hair loss. The most common form of hair loss, male pattern baldness, affects up to 80 million Americans and usually shows as a receding hairline or balding on top. Women tend to thin at the front and top of the scalp.
While your instinct may be to drop the meds at the first sight of hair loss, you should weigh the benefits of the drug for your arthritis against this cost of hair loss.
When to Talk to Your Doctor
If drug-induced hair loss is taking a considerable toll on your appearance and self-confidence, one possible solution may be to lower the dosage. Your rheumatologist might also recommend switching to another drug.
If altering your drug regimen isn’t an option, you may be referred to a dermatologist for hair loss lotions or other re-growth treatments.
Talk to your rheumatologist immediately if you have sudden or patchy hair loss, or if you see excessive amounts of hair falling out when you wash or comb your hair, you regularly find hair in your food, or see lots of it on your pillow. You could have a serious underlying medical condition that needs attention.