Cimzia (certolizumab) is a prescription biologic used to treat several autoimmune conditions, like rheumatoid arthritis, psoriatic arthritis, and Crohn's disease. It works by blocking a protein called tumor necrosis factor (TNF), which helps reduce inflammation in your body. The medication is given as an injection under the skin every 2 to 4 weeks, depending on your condition. Common side effects include upper respiratory infections, urinary tract infections (UTIs), and skin rash.
Moderate-to-severe Crohn's disease when other treatments haven't worked - adults only
Moderate-to-severe rheumatoid arthritis (RA) - adults only
Polyarticular juvenile idiopathic arthritis (pJIA) - adults children 2 years and older
Psoriatic arthritis (PsA) - adults only
Ankylosing spondylitis (AS) - adults only
Non-radiographic axial spondyloarthritis (nr-axSpA) - adults only
Moderate-to-severe plaque psoriasis (PsO) - adults only
Cimzia (certolizumab) is a type of biologic disease-modifying antirheumatic drug (DMARD). More specifically, it's a tumor necrosis factor (TNF) blocker. TNF is a protein in the body that plays a key role in inflammation. By blocking TNF, Cimzia (certolizumab) helps lower inflammation and relieve symptoms like pain, swelling, and tissue damage.
Source: DailyMed
Along with its needed effects, a medicine 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:
More common
Bladder pain
bloody or cloudy urine
body aches or pain
chills
difficult, burning, or painful urination
difficulty with breathing
ear congestion
frequent urge to urinate
headache
hoarseness
loss of voice
lower back or side pain
unusual tiredness or weakness
Less common
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
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
Rare
Blurred vision
confusion
coughing or spitting up blood
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
fainting
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
sweating
swelling of the lymph glands
weakness
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 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:
Less common
Vomiting
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Treats a variety of autoimmune conditions
Only need to inject every 2 to 4 weeks
Available as a prefilled syringe for at-home administration
Can raise your risk for infections
Some people might have difficulty injecting it properly
Might have a higher risk for certain cancers
Cimzia (certolizumab) comes as two 200 mg prefilled syringes in each carton. If your dose is 400 mg, you'll need to give yourself two 200 mg injections.
Inject Cimzia (certolizumab) under the skin of your upper thighs or stomach. If using your stomach, stay at least 2 inches away from your belly button.
To help prevent bruising or skin irritation from Cimzia (certolizumab), change the injection spot each time. Make sure each injection is at least 1 inch away from where you last injected. Avoid skin that is sore, red, bruised, hard, scarred, or has stretch marks.
Cimzia (certolizumab) can raise your risk of serious or life-threatening infections. If you get symptoms like fever, cough, trouble breathing, or chills, let your prescriber know right away. You might have to stop taking the medication so your body can fight the infection.
Don't use Cimzia (certolizumab) with other TNF blockers or other DMARDs. Doing so can further raise your risk of infection and might not control your symptoms any better.
Call your prescriber right away if you notice signs of low blood cells while using Cimzia (certolizumab), like easy bruising, bleeding, or fever that won’t go away.
Cimzia (certolizumab) can cause serious allergic reactions. Get medical help right away if you have symptoms like rash, swelling, or trouble breathing. If you're sensitive to latex, tell your care team since parts of the prefilled syringe contain latex.
Store Cimzia (certolizumab) in the refrigerator. The prefilled syringes can also be kept and at room temperature for up to 7 days, and unopened vials can stay at room temperature for up to 6 months. Once the medication has been stored at room temperature, don’t put it back in the fridge. Be sure to label the box with the date you took it out so you know when to throw it away if unused.
How to use Cimzia (certolizumab):
Your care team will teach you on how to inject the medication. You can also read the instructions for use or watch the training video. Contact your prescriber or pharmacist if you have any questions.
Before injecting, take the prefilled syringe out of the refrigerator and let it sit flat at room temperature for about 30 minutes. Don’t heat it any other way.
Clean the injection site with an alcohol swab and let the area dry completely.
When you're ready to inject, take off the needle cover from the syringe. Then hold the syringe with one hand and pinch the cleaned skin with the other.
Insert the needle into the pinched skin at about a 45-degree angle and push the plunger down with your thumb until all the medication is injected. Then take out the needle and let go of your skin.
After injecting, throw the needle and syringe in a sharps container or use a strong plastic container like an empty laundry detergent bottle. This helps lower the risk of needle-stick injuries. Don't throw away needles or syringes in your trash.
Cimzia (certolizumab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk factors: Active, chronic, or recurrent infection | Age 65 years and older | Having other conditions that raise your risk of infection | Taking other medications that weaken your immune system
Cimzia (certolizumab) can make it harder for your body to fight off infections. This means you have a higher risk of getting serious or even life-threatening infections caused by bacteria, viruses, or fungi. Your risk is even higher if you're 65 or older, already have an infection, have certain health conditions, or take other medications that weaken your immune system.
Cimzia (certolizumab) can also cause tuberculosis (TB) infections or hepatitis B virus (HBV) to come back if you've had them in the past or are a carrier. That’s why you’ll need to get tested for both TB and HBV before starting this medication. If you test positive, you’ll need treatment before it’s safe to begin Cimzia (certolizumab).
Call your care team or go to the hospital right away if you get signs of an infection like fever, cough, trouble breathing, diarrhea, chills, sweating, or weakness. You might need to stop Cimzia (certolizumab) for a while so your body can fight the infection.
Risk factors: Age 18 years old and younger | Taking medications that weaken your immune system | History of cancer | Rheumatoid arthritis
Cimzia (certolizumab) might raise your risk of getting certain types of cancers, like leukemia, lymphoma, or skin cancer. The risk is higher in people ages 18 and younger, those with rheumatoid arthritis, or if you're taking other medications that weaken your immune system. You'll probably need certain blood tests and occasional physical exams to check for signs of cancer while you're taking this medication. Contact your care team if you notice any warning signs like swollen lymph nodes (in your neck, armpits, or groin), tiredness, weight loss, reduced appetite, frequent nosebleeds, or lumps on your skin.
Some people have had new or worsening heart failure while taking TNF blockers like Cimzia (certolizumab). Contact your prescriber if you notice signs like shortness of breath, swelling in your legs or feet, an irregular heartbeat, feeling very tired, or weakness while taking this medication. These could be signs of a serious heart problem that needs medical attention.
Risk factors: Latex allergy
Though rare, some people taking Cimzia (certolizumab) have had allergic reactions to the medication. These can include rash, hives, trouble breathing, swelling of the face or lips, and serious reactions like anaphylaxis. Get medical help right away if you have any of these symptoms while taking this medication.
Also, the needle shield inside the cap of the Cimzia (certolizumab) prefilled syringe contains a material similar to natural rubber latex. If you’re sensitive to latex, this might cause a reaction. Be sure to tell your prescriber if you have a latex allergy and what kind of reaction you’ve had in the past.
In rare cases, TNF blockers like Cimzia (certolizumab) have been linked to new or worsening nervous system problems, including conditions like multiple sclerosis or Guillain-Barré syndrome. Let your care team know if you experience dizziness, numbness or tingling, weakness in your arms or legs, or vision changes while taking this medication.
Although rare, people taking TNF blockers like Cimzia (certolizumab) have had low blood cell counts. This can raise your risk of serious infections, bleeding, and anemia. Call your care team right away if you notice signs like fever that won’t go away, easy bruising, unusual bleeding, or pale skin. If your blood counts drop too low, you'll probably need to stop taking the medication.
Cimzia (certolizumab) can sometimes lead to a rare condition called drug-induced lupus erythematosus (DILE). Symptoms can include shortness of breath, joint pain, or a rash on your cheeks or arms that gets worse in sunlight. If you have any of these symptoms, your prescriber might stop the medication to keep you safe. Let your care team know right away if you notice any unusual symptoms.
It’s not clear if Cimzia (certolizumab) makes the vaccines work less well. To be safe, you should avoid live vaccines while taking this medication and right before starting it. It’s a good idea to get caught up on your vaccines before beginning treatment. Talk to your prescriber about which ones you might need.
Crohn's disease: The typical starting dose is 400 mg injected under the skin at the beginning, then again at week 2 and week 4. If the medication works well for you, you'll switch to a maintenance dose of 400 mg every 4 weeks to keep your symptoms under control.
Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis: The typical starting dose is 400 mg injected under the skin at the beginning, and again at week 2 and week 4. After that, you'll switch to a maintenance dose of 200 mg every 2 weeks or 400 mg every 4 weeks.
Polyarticular juvenile idiopathic arthritis: The dose is based on weight.
10 kg to less than 20 kg: The typical starting dose is 100 mg injected under the skin at the beginning, and again at week 2 and week 4. After that, you'll switch to a maintenance dose of 50 mg every 2 weeks.
20 kg to less than 40 kg: The typical starting dose is 200 mg injected under the skin at the beginning, and again at week 2 and week 4. After that, you'll switch to a maintenance dose of 100 mg every 2 weeks.
40 kg and more: The typical starting dose is 400 mg injected under the skin at the beginning, and again at week 2 and week 4. After that, you'll switch to a maintenance dose of 200 mg every 2 weeks.
Plaque psoriasis: The typical dose is 400 mg injected under the skin every 2 weeks.
If you weigh 90 kg or less, your prescriber might recommend a different dosing schedule of 400 mg injected under the skin at the beginning, and again at week 2 and week 4. After that, you'll switch to a maintenance dose of 200 mg every 2 weeks.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Moderate-to-severe Crohn's disease when other treatments haven't worked - adults only
Moderate-to-severe rheumatoid arthritis (RA) - adults only
Polyarticular juvenile idiopathic arthritis (pJIA) - adults children 2 years and older
Psoriatic arthritis (PsA) - adults only
Ankylosing spondylitis (AS) - adults only
Non-radiographic axial spondyloarthritis (nr-axSpA) - adults only
Moderate-to-severe plaque psoriasis (PsO) - adults only
Rheumatoid arthritis (RA)
Plaque psoriasis (PsO) and psoriatic arthritis (PsA)
Ankylosing spondylitis (AS)
Childhood arthritis (polyarticular juvenile idiopathic arthritis, JIA)
Rheumatoid arthritis (RA) - adults only
Juvenile idiopathic arthritis (JIA) - people age 2 and older
Psoriatic arthritis (PsA) - adults only
Ankylosing spondylitis (AS) - adults only
Crohn's disease (CD) - people age 6 and older
Ulcerative colitis (UC) - people age 5 and older
Plaque psoriasis - adults only
Hidradenitis suppurativa (HS) - people age 12 and older
Uveitis - people age 2 and older
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CIMZIA. (n.d.). Dosing Injections at Home.
CIMZIA. (n.d.). PREFILLED SYRINGE— STEP-BY-STEP INSTRUCTIONS FOR USE.
Fleischmann, R., et al. (2009). Efficacy and safety of certolizumab pegol monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease-modifying antirheumatic therapy: The FAST4WARD study. Annals of the Rheumatic Diseases.
Landewé, R., et al. (2014). Efficacy of certolizumab pegol on signs and symptoms of axial spondyloarthritis including ankylosing spondylitis: 24-week results of a double-blind randomised placebo-controlled Phase 3 study. Annals of the Rheumatic Diseases.
Mease, P. J., et al. (2014). Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24-week results of a Phase 3 double-blind randomised placebo-controlled study (RAPID-PsA). Annals of the Rheumatic Diseases.
MotherToBaby. (n.d.). MotherToBaby pregnancy studies.
Solhjoo, M., et al. (2023). Drug-Induced Lupus Erythematosus. StatPearls.
UCB, Inc. (2024). CIMZIA- certolizumab pegol kit. CIMZIA- certolizumab pegol injection, solution [package insert]. DailyMed.
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