Certolizumab pegol Subcutaneous

Subcutaneous routePowder for SolutionSolution

Risk of 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.

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 .

Tuberculosis, invasive fungal infections, bacterial, viral, and other opportunistic infections, some fatal, have been observed in patients receiving certolizumab pegol. Patients should be evaluated for tuberculosis risk factors and be tested for latent tuberculosis infection prior to initiating certolizumab pegol and during therapy. Treatment of latent tuberculosis infection should be initiated prior to therapy with certolizumab pegol. Monitor patients receiving certolizumab pegol for signs and symptoms of infection including tuberculosis in patients who tested negative for latent tuberculosis infection .

Commonly used brand name(s):

In the U.S.

  • Cimzia

Available Dosage Forms:

  • Solution
  • Powder for Solution

Therapeutic Class: Immune Suppressant

Pharmacologic Class: Monoclonal Antibody

Uses For certolizumab pegol

Certolizumab pegol is used to decrease signs and symptoms of moderately to severely active Crohn's disease in adult patients who have not been helped by other medicines. It is also used to treat the symptoms of moderately to severely active rheumatoid arthritis.

certolizumab pegol is available only with your doctor's prescription.

Before Using certolizumab pegol

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For certolizumab pegol, the following should be considered:


Tell your doctor if you have ever had any unusual or allergic reaction to certolizumab pegol or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Appropriate studies have not been performed on the relationship of age to the effects of certolizumab pegol in the pediatric population. Safety and efficacy have not been established.


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of certolizumab pegol in the elderly. However, certolizumab pegol may cause more serious infections in the elderly, which may require caution in patients receiving certolizumab pegol.


Pregnancy CategoryExplanation
All TrimestersBAnimal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using certolizumab pegol 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.

  • Anakinra
  • Bacillus of Calmette and Guerin Vaccine, Live
  • Influenza Virus Vaccine, Live
  • Measles Virus Vaccine, Live
  • Mumps Virus Vaccine, Live
  • Poliovirus Vaccine, Live
  • Rotavirus Vaccine, Live
  • Rubella Virus Vaccine, Live
  • Smallpox Vaccine
  • Typhoid Vaccine
  • Varicella Virus Vaccine
  • Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of certolizumab pegol. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bleeding problems or
  • Congestive heart failure or
  • Diabetes or
  • Lupus-like syndrome or
  • Nervous system problems (e.g., seizures, multiple sclerosis, optic neuritis, peripheral neuropathy) or
  • Psoriasis (skin disease)—Use with caution. May make these conditions worse.
  • Cancer or
  • Hepatitis B, history of or
  • Tuberculosis, history of—Patients with these conditions may have an increased chance for side effects.
  • Infection, active or recurring—Should not be used in patients with this condition.
  • Tuberculosis infection, inactive—Should be treated before starting therapy with certolizumab pegol.

Proper Use of certolizumab pegol

A nurse or other trained health professional will give you certolizumab pegol. certolizumab pegol is given as a shot under your skin, usually on the abdomen or thigh.

Certolizumab pegol may sometimes be given at home to patients who do not need to be in the hospital or clinic. If you are using certolizumab pegol at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use the medicine.

certolizumab pegol comes with a Medication Guide and patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

If you use certolizumab pegol at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems.

To use the prefilled syringe:

  • First, gather the items you will need on a clean, flat surface using a cloth or towel in a well-lighted area.
  • Remove the carton with the syringe from the refrigerator and place it on the clean cloth.
  • Allow 30 minutes for the syringe to warm up to room temperature. Do not warm certolizumab pegol in any other way.
  • Wash your hands with soap and water.
  • Choose an injection site on your body (e.g., abdomen or stomach area, or thigh). Clean the injection site with an alcohol swab, and do not touch the area until you are ready for injection.
  • Remove the needle cover when you are ready to inject.
  • Hold the syringe with one hand between the thumb and index fingers. Do not to touch the needle or let it touch any surface.
  • Use your free hand to pinch and hold the skin at the injection site.
  • Inject the medicine in a dart-like motion into the pinched skin at a 45-degree angle.
  • Use your thumb to push the plunger and inject the full dose of the medicine. Pull the needle out of the skin.

Do not inject certolizumab pegol if blood enters the syringe. If you notice blood inside the syringe, pull the needle out and throw away the syringe and needle in a hard-closed container.


The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For injection dosage form (prefilled syringe):
    • For Crohn's disease:
      • Adults—At first, 400 milligrams (mg) (given as two 200 mg) injected under the skin and at weeks 2 and 4. The recommended maintenance dose is 400 mg every four weeks.
      • Children—Use and dose must be determined by your doctor.
    • For rheumatoid arthritis:
      • Adults—At first, 400 milligrams (mg) (given as two 200 mg) injected under the skin and at weeks 2 and 4, followed by 200 mg every other week. The recommended maintenance dose is 400 mg every four weeks.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of certolizumab pegol, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Protect the medicine from direct light. Keep your medicine in the original package until you are ready to use it.

Throw away used syringes in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using certolizumab pegol

It is very important that your doctor check your progress at regular visits to make sure that certolizumab pegol is working properly. Blood tests may be needed to check for unwanted effects.

Certolizumab pegol can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

  • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
  • Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.
  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
  • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
  • Avoid contact sports or other situations where bruising or injury could occur.

You will need to have a skin test for tuberculosis before you start using certolizumab pegol. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis test.

Do not have any live vaccines (immunizations) while you are being treated with certolizumab pegol. Check with your doctor before having any vaccines.

Check with your doctor right away if you have any symptoms of liver problems including skin and eyes turning yellow, dark brown-colored urine, right sided abdominal pain, fever, or severe tiredness.

certolizumab pegol may cause other unwanted effects that may not occur until months or years after certolizumab pegol is used. A small number of people (including children and teenagers) who have used certolizumab pegol have developed certain types of cancer. Some patients developed a rare type of cancer called lymphoma. Talk with your doctor if you have unusual bleeding, bruising, or weakness; swollen lymph nodes in the neck, underarms, or groin; or unexplained weight loss. Also, check with your doctor right away if your skin has red, scaly patches, or raised bumps that are filled with pus.

Check with your doctor right away if you have more than one of these symptoms: chest pain; decreased urine output; dilated neck veins; extreme fatigue; irregular breathing; irregular heartbeat; shortness of breath; swelling of the face, fingers, feet, or lower legs; tightness in the chest; trouble with breathing; weight gain; or wheezing. These may be signs of a heart condition called congestive heart failure (CHF).

Certolizumab pegol may cause serious allergic reactions. Check with your doctor right away if you have a rash; itching; swelling of the face, throat, legs, or feet; or troubled breathing after you receive the injection.

Some people who have used certolizumab pegol developed lupus-like symptoms during treatment and got better after certolizumab pegol was stopped. Make sure your doctor knows if you start having chest pains, shortness of breath, joint pain, or a rash on your cheeks or arms that is sensitive to the sun.

Do not change or stop using certolizumab pegol without checking with your doctor first. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.

Do not take other medicines unless they have been discussed with your doctor. Your doctor will discuss with you any changes in your medicine.

certolizumab pegol Side Effects

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 or nurse immediately if any of the following side effects occur:

More common
  • Bladder pain
  • bloody or cloudy urine
  • body aches or pain
  • chills
  • cough or hoarseness
  • difficult, burning, or painful urination
  • difficulty with breathing
  • ear congestion
  • fever
  • frequent urge to urinate
  • headache
  • loss of voice
  • lower back or side pain
  • nasal congestion
  • runny nose
  • sneezing
  • sore throat
  • 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
  • chest pain
  • colds or flu-like symptoms
  • frequent urination
  • pain in the ankles or knees
  • pain in the arms or legs
  • painful, red lumps under the skin, mostly on the legs
  • rapid weight gain
  • shortness of breath
  • stomach pain
  • tingling of the hands or feet
  • tightness in the chest
  • troubled breathing
  • unusual weight gain or loss
  • wheezing
  • Blurred vision
  • confusion
  • coughing or spitting up blood
  • diarrhea
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • fainting
  • feeling of warmth
  • general feeling of discomfort, illness, or weakness
  • inflammation of the joints
  • itching
  • joint pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • muscle aches
  • nausea
  • night sweats
  • redness of the face, neck, arms and occasionally, upper chest
  • skin rash
  • 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:

More common
  • Difficulty with moving
  • muscle pain or stiffness
  • stuffy or runny nose
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.

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