Cimzia

DRUG DESCRIPTION

CIMZIA (certolizumab pegol) is a TNF blocker. CIMZIA (certolizumab pegol) is a recombinant, humanized antibody Fab' fragment, with specificity for human tumor necrosis factor alpha (TNF?), conjugated to an approximately 40kDa polyethylene glycol (PEG2MAL40K). The Fab' fragment is manufactured in E. coli and is subsequently subjected to purification and conjugation to PEG2MAL40K, to generate certolizumab pegol. The Fab' fragment is composed of a light chain with 214 amino acids and a heavy chain with 229 amino acids. The molecular weight of certolizumab pegol is approximately 91 kiloDaltons.

CIMZIA (certolizumab pegol) is supplied as either a sterile, white, lyophilized powder for solution or as a sterile, solution in a single-use prefilled 1 mL glass syringe for subcutaneous injection. After reconstitution of the lyophilized powder with 1 mL sterile Water for Injection, USP, the resulting pH is approximately 5.2.

Each single-use vial provides approximately 200 mg certolizumab pegol, 100 mg sucrose, 0.9 mg lactic acid, and 0.1 mg polysorbate. Each prefilled syringe delivers 1 mL (200 mg) of drug product with a pH of approximately 4.7. Each 1 mL syringe of CIMZIA contains 200 mg of certolizumab pegol, 1.36 mg of sodium acetate, 7.31 mg sodium chloride, and Water for Injection, USP.

CIMZIA (certolizumab pegol) is a clear to opalescent solution that is colorless to pale yellow and essentially free from particulates. No preservatives are present.

What are the possible side effects of certolizumab (Cimzia)?

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

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

  • fever, sweating, chills, tired feeling;
  • feeling short of breath;
  • cough, sore throat; or
  • flu symptoms, weight loss.

Call your doctor at once...

Read All Potential Side Effects and See Pictures of Cimzia

What are the precautions when taking certolizumab pegol (Cimzia)?

Before using certolizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: any current infection.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: any infection that keeps coming back, hepatitis B infection, HIV infection, tuberculosis (TB), cuts or open sores, cancer, diabetes, heart failure, blood/bone marrow disorders, history of cancer (such as lymphoma), brain/nervous system disorders...

Read All Potential Precautions of Cimzia


Cimzia Consumer (continued)

SIDE EFFECTS: See also Warning section.

Fever, cough, sore throat, stuffy/runny nose, burning/painful/frequent urination, or joint pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if you develop signs of infection while using this drug, such as: fever, chills, persistent sore throat, persistent cough, night sweats, trouble breathing, painful/frequent urination, unusual vaginal discharge, white patches in the mouth (oral thrush).

Tell your doctor right away if you have any serious side effects, including: shortness of breath, swelling ankles/feet, severe/unusual tiredness, easy bruising/bleeding, swollen joints, rash on nose and cheeks, eye pain, vision changes, dizziness, numbness/tingling of arms/legs, seizures.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using certolizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: any current infection.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: any infection that keeps coming back, hepatitis B infection, HIV infection, tuberculosis (TB), cuts or open sores, cancer, diabetes, heart failure, blood/bone marrow disorders, history of cancer (such as lymphoma), brain/nervous system disorders (such as multiple sclerosis, seizures).

Because certolizumab can make you more likely to get infections or may worsen any current infections, do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received the polio vaccine taken by mouth or flu vaccine inhaled through the nose. Also avoid contact with people who have infections that may spread to others (such as chickenpox, flu). Wash your hands well to prevent the spread of infections.

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Older adults are more sensitive to the effects of this drug, especially the risk of infections.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Cimzia Patient Information Including Side Effects

Brand Names: Cimzia

Generic Name: certolizumab (Pronunciation: SER toe LIZ oo mab)

  • What is certolizumab (Cimzia)?
  • What are the possible side effects of certolizumab (Cimzia)?
  • What is the most important information I should know about certolizumab (Cimzia)?
  • What should I discuss with my healthcare provider before I receive certolizumab (Cimzia)?
  • How is certolizumab given (Cimzia)?
  • What happens if I miss a dose (Cimzia)?
  • What happens if I overdose (Cimzia)?
  • What should I avoid while receiving certolizumab (Cimzia)?
  • What other drugs will affect certolizumab (Cimzia)?
  • Where can I get more information?

What is certolizumab (Cimzia)?

Certolizumab reduces the effects of a substance in the body that can cause inflammation.

Certolizumab is used to treat the symptoms of Crohn's disease after other drugs have been tried without successful treatment of symptoms. Certolizumab is also used to treat moderate to severe rheumatoid arthritis in adults.

Certolizumab may also be used for other purposes not listed in this medication guide.

What are the possible side effects of certolizumab (Cimzia)?

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

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

  • fever, sweating, chills, tired feeling;
  • feeling short of breath;
  • cough, sore throat; or
  • flu symptoms, weight loss.

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

  • shortness of breath with swelling of your ankles or feet;
  • chest pain, ongoing cough, coughing up blood or mucus;
  • swollen glands in your neck, armpits, or groin;
  • easy bruising or bleeding, pale skin, unusual weakness;
  • fast or slow heart rate;
  • pain or burning when you urinate;
  • seizure (convulsions);
  • jaundice (yellowing of the skin or eyes);
  • severe blistering, peeling, and red skin rash;
  • vision problems, dizziness, numbness or tingly feeling, muscle weakness in your arms or legs;
  • joint pain or swelling with fever, muscle aches, nausea, vomiting, unusual thoughts or behavior, and/or seizure (convulsions); or
  • patchy skin color, red spots, or a butterfly-shaped skin rash over your cheeks and nose (worsens in sunlight).

Less serious side effects may include:

  • stuffy nose, sinus pain;
  • stomach pain, diarrhea, constipation; or
  • pain, redness, itching, swelling, or bleeding where the medicine was injected.

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

What is the most important information I should know about certolizumab (Cimzia)?

Before you start treatment with certolizumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections. Tell your doctor if you have any signs of infection or if you have recently received any vaccines.

Tell your doctor if you are allergic to any drugs, or if you have lupus, diabetes, HIV/AIDS, hepatitis B, a seizure disorder, congestive heart failure, a history of cancer, or a disease that affects the nerves or muscles (such as multiple sclerosis or myasthenia gravis).

Certolizumab can lower the blood cells that help your body fight infections. Avoid contact with people who have colds, the flu, or other contagious illnesses.

Serious and sometimes fatal infections may occur during treatment with certolizumab. Contact your doctor right away if you have signs of infection such as: fever, cough, sweating, tired feeling, or if you feel short of breath.

Some infections are more likely to occur in certain areas of the world. Tell your doctor where you live and where you have recently traveled or plan to travel to during treatment.

Do not receive a "live" vaccine while you are being treated with certolizumab.

Treatment with certolizumab may increase your risk of developing certain types of cancer such as lymphoma (cancer of the lymph nodes) or autoimmune disorders (such as a lupus-like syndrome). This risk may be greater in children and young adults. Talk to your doctor about your specific risk.

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