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What should I discuss with my healthcare provider before I receive certolizumab (Cimzia)?
You should not receive this medication if you have active but untreated tuberculosis. 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.
Some people using certolizumab have developed a rare fast-growing type of lymphoma (cancer). This condition affects the liver, spleen, and bone marrow, and it can be fatal. This has occurred mainly in teenagers and young adults using certolizumab or similar medicines to treat Crohn's disease or ulcerative colitis.
However, people with autoimmune disorders (including rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, and psoriasis) may have a higher risk of lymphoma. Talk to your doctor about your individual risk.
To make sure certolizumab is safe for you, tell your doctor if you have:
FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
It is not known whether certolizumab passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
How is certolizumab given (Cimzia)?
Before you start treatment with certolizumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections. 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.
Certolizumab is given as two injections under the skin of your stomach or thigh. This medication is usually given every 2 to 4 weeks. You may be shown how to use injections at home. Do not self inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes.
Certolizumab comes in a prefilled syringe, or as a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.
Certolizumab can lower blood cells that help your body fight infections and help your blood to clot. This can make it easier for you to bleed from an injury or get sick from being around others who are ill.
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.
While using certolizumab, you may need frequent blood tests at your doctor's office. Your skin may also need to be checked for signs of skin cancer.
Use certolizumab regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
If you need surgery or medical tests, tell the surgeon or doctor ahead of time that you are using certolizumab.
Store in the refrigerator. Protect from light and do not freeze. Take the medication and diluent out of the refrigerator and allow them to reach room temperature before preparing your dose.
After mixing certolizumab powder with a diluent, store in the refrigerator and use within 24 hours. Do not freeze. Take the mixture out of the refrigerator and allow it to reach room temperature for up to 2 hours before giving the injection. Do not heat this medicine before using.
If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function for several months after you stop using certolizumab.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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