Brand Names: Cimzia, Cimzia Starter
Generic Name: certolizumab
- What is certolizumab (Cimzia, Cimzia Starter)?
- What are the possible side effects of certolizumab (Cimzia, Cimzia Starter)?
- What is the most important information I should know about certolizumab (Cimzia, Cimzia Starter)?
- What should I discuss with my healthcare provider before using certolizumab (Cimzia, Cimzia Starter)?
- How is certolizumab given (Cimzia, Cimzia Starter)?
- What happens if I miss a dose (Cimzia, Cimzia Starter)?
- What happens if I overdose (Cimzia, Cimzia Starter)?
- What should I avoid while receiving certolizumab (Cimzia, Cimzia Starter)?
- What other drugs will affect certolizumab (Cimzia, Cimzia Starter)?
- Where can I get more information (Cimzia, Cimzia Starter)?
What is certolizumab (Cimzia, Cimzia Starter)?
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 treatments have failed.
Certolizumab may also be used for purposes not listed in this medication guide.
What are the possible side effects of certolizumab (Cimzia, Cimzia Starter)?
Get emergency medical help if you have 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. Tell your doctor if you have signs of infection, such as: fever, chills, cough, sweating, muscle pain, open sores or skin wounds, unusual tiredness, feeling short of breath, painful urination, diarrhea, or weight loss.
Call your doctor right away if you have any of these symptoms of lymphoma:
- chest pain, cough, feeling short of breath;
- swelling in your neck, underarm, or groin (this swelling may come and go);
- fever, night sweats, itching, weight loss, feeling tired;
- feeling full after eating only a small amount; or
- pain in your upper stomach that may spread to your back or shoulder.
Stop using certolizumab and call your doctor at once if you have:
- shortness of breath (even with mild exertion), swelling, rapid weight gain;
- pale skin, easy bruising or bleeding;
- a new growth on your skin (may be red or purple), or any change in the size or color of a mole, freckle, or bump on your skin;
- nerve problems--vision problems, dizziness, numbness or tingly feeling, muscle weakness in your arms or legs;
- liver problems--loss of appetite, right-sided stomach pain, tiredness, jaundice (yellowing of the skin or eyes); or
- new or worsening symptoms of lupus--joint pain or swelling with a skin rash on your cheeks or arms (worsens in sunlight).
Common side effects may include:
- pain or burning when you urinate;
- rash; or
- cold symptoms such as stuffy nose, sneezing, sore throat.
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, Cimzia Starter)?
Certolizumab affects your immune system. Serious and sometimes fatal infections may occur.
Using certolizumab may also increase your risk of developing certain types of cancer, including a rare fast-growing type of lymphoma that can be fatal.
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, diarrhea, or painful urination.
Tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common (Ohio River Valley, Mississippi River Valley, and the Southwest).
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;
- congestive heart failure;
- a seizure;
- 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 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.
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. Follow your doctor's dosing instructions very carefully.
Read and carefully follow any Instructions for Use provided with your medicine. Do not use certolizumab if you don't understand all instructions for proper use. 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 by changing the way your immune system works. You will need frequent medical tests.
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.
Store this medicine in its original carton in the refrigerator. Protect from light and do not freeze.
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.
What happens if I miss a dose (Cimzia, Cimzia Starter)?
Call your doctor for instructions if you miss a dose of certolizumab.
What happens if I overdose (Cimzia, Cimzia Starter)?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while receiving certolizumab (Cimzia, Cimzia Starter)?
Ask your doctor before receiving any vaccine while you are being treated with certolizumab.
Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.
What other drugs will affect certolizumab (Cimzia, Cimzia Starter)?
Tell your doctor about all your other medicines, especially:
This list is not complete. Other drugs may affect certolizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Where can I get more information (Cimzia, Cimzia Starter)?
Your doctor or pharmacist can provide more information about certolizumab.
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