What is the most important information I should know about certolizumab?
Certolizumab affects your immune system. Serious and sometimes fatal infections may occur.
Your risk of infection may be higher if you have diabetes, HIV, a weak immune system, hepatitis B, chronic infections, if you use certain medications, or if you live in or travel to certain areas.
Call your doctor at once if you have symptoms such as fever, chills, cough, diarrhea, night sweats, flu symptoms, or skin sores.
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 is certolizumab?
Certolizumab is used to treat the symptoms of Crohn's disease after other treatments have failed.
Certolizumab is also used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.
Certolizumab may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before using certolizumab?
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?
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 happens if I miss a dose?
Call your doctor for instructions if you miss a dose of certolizumab.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while receiving certolizumab?
Avoid injecting certolizumab into scars or stretch marks, or into skin that is red, bruised, swollen, hard, or tender.
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.
What are the possible side effects of certolizumab?
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, and a skin rash on your cheeks or arms that 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 other drugs will affect certolizumab?
Tell your doctor about all your other medicines, especially:
- abatacept;
- adalimumab;
- anakinra;
- etanercept;
- golimumab;
- infliximab;
- natalizumab; or
- rituximab.
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?
Your doctor or pharmacist can provide more information about certolizumab.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2020 Cerner Multum, Inc. Version: 17.01. Revision date: 4/8/2019.
