Certolizumab (SER-toe-LIZ-oo-mab)Brand Name:
Patients who use Certolizumab have an increased risk of infection. Severe and sometimes fatal infections, including tuberculosis (TB), fungal infections, and sepsis, have occurred in patients who use Certolizumab . Most patients who developed these infections were taking medicines that suppressed their immune systems (eg, methotrexate, corticosteroids).
You should be tested for TB infection before you start Certolizumab . If you have a TB infection, treatment for TB should be started before you begin Certolizumab . Tell your doctor right away if you develop symptoms of infection, such as fever, chills, persistent cough or sore throat, unusual vaginal discharge, painful or frequent urination, or persistent feeling of being unwell. Tell your doctor if you have a history of chronic or recurrent infections.
Certolizumab is a tumor necrosis factor (TNF) blocker. Lymphoma and other types of cancer have been reported in children and teenagers treated with TNF blockers. This has been fatal in some cases. Certolizumab is not approved for use in children or teenagers. Talk with your doctor for more information.
Certolizumab is used for:
Reducing signs and symptoms of Crohn disease in certain patients. It is also used to treat moderately to severely active rheumatoid arthritis. It may be used alone or in combination with other medicine.
Certolizumab is a TNF blocker. It works by blocking a protein (TNF-alpha) found in the body's immune system that causes inflammation.
Do NOT use Certolizumab if:
- you are allergic to any ingredient in Certolizumab
- you also use a costimulation modulator (eg, abatacept), an interleukin-1-blocker (eg, anakinra), a monoclonal antibody (eg, rituximab, natalizumab), or another TNF blocker (eg, infliximab, adalimumab)
Contact your doctor or health care provider right away if any of these apply to you.
Before using Certolizumab :
Some medical conditions may interact with Certolizumab . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have any type of infection, including bacterial, viral, or protozoal infection; fungal infection (eg, coccidiomycosis, histoplasmosis); HIV infection; TB infection; skin infection; or open cuts or sores on your body
- if you have a history of chronic or recurring infections, a positive TB skin test, or if you have recently been around someone who might have TB
- if you have ever lived in or traveled to an area where TB is common
- if you live, have lived in, or traveled to certain parts of the country (eg, Ohio or Mississippi river valleys) where certain types of fungal infections (eg, histoplasmosis, coccidioidomycosis, blastomycosis) are common. Check with your doctor if you are not sure if you have lived in an area where these infections are common
- if you have a history of hepatitis B, other liver problems, diabetes, heart problems (eg, heart failure), or nervous system problems (eg, CNS demyelinating disease, Guillain-BarrÃ© syndrome, multiple sclerosis, seizures)
- if you have a weakened immune system, HIV, or autoimmune problems (eg, lupus); a blood problem (eg, anemia); bone marrow problems; lymphoma; or cancer
- if you have recently received or are scheduled to receive a vaccine
Some MEDICINES MAY INTERACT with Certolizumab . Tell your health care provider if you are taking any other medicines, especially any of the following:
- Costimulation modulators (eg, abatacept), interleukin-1-blockers (eg, anakinra), natalizumab, rituximab, other TNF blockers (eg, adalimumab, infliximab), or another medicine that may weaken the immune system because the risk of severe infection may be increased
This may not be a complete list of all interactions that may occur. Ask your health care provider if Certolizumab may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Certolizumab :
Use Certolizumab as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Certolizumab comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Certolizumab refilled.
- Certolizumab is usually given as an injection under the skin at your doctor's office, hospital, or clinic. If you will be using it at home, a health care provider will teach you how to use it. Be sure you understand how to use Certolizumab . Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Do not use Certolizumab if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- Let Certolizumab come to room temperature before you inject it.
- Certolizumab may be injected under the skin in your stomach or thigh area. Rotate injection sites.
- Do not inject into areas of the skin that are sore, bruised, red, or hard.
- Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- If you miss a dose of Certolizumab , use it as soon as possible. Then go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Certolizumab .
Important safety information:
- Certolizumab may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- Certolizumab may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
- Certolizumab may increase the risk of developing blood cancer (eg, leukemia, lymphoma) and other types of cancer. This may be fatal in some cases. Discuss any questions or concerns with your doctor. Tell your doctor if you have ever had cancer. Contact your doctor right away if you develop symptoms of leukemia or lymphoma such as unusual bruising, unusual lumps or swelling (eg, in your neck, armpit, or groin), night sweats, recurring fever, unusual tiredness or weakness, persistent unexplained itching, or unexplained weight loss.
- Some patients who use Certolizumab have developed new or worsening psoriasis. Tell your doctor right away if you notice any new or worsening skin problems (eg, red, flaky, or itchy skin patches).
- Tell your doctor or dentist that you take Certolizumab before you receive any medical or dental care, emergency care, or surgery.
- Do not receive a live vaccine (eg, measles, mumps) while you are taking Certolizumab . Talk with your doctor before you receive any vaccine.
- Certolizumab may interfere with certain lab tests, including blood clotting tests and TB tests. Be sure your doctor and lab personnel know you are using Certolizumab .
- Lab tests, including TB tests, complete blood cell counts and liver function, may be performed while you use Certolizumab . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Certolizumab with caution in the ELDERLY; they may be more sensitive to its side effects, especially infection.
- Certolizumab should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in children have not been confirmed. Certolizumab is not approved for use in children. Children and teenagers may be at increased risk for developing certain types of cancer with Certolizumab , which may be fatal.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Certolizumab while you are pregnant. It is not known if Certolizumab is found in breast milk. Do not breast-feed while taking Certolizumab .
Possible side effects of Certolizumab :
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Minor pain, redness, or swelling at the injection site.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); butterfly-shaped rash on the nose and cheeks; chest pain; dark urine; dizziness; fainting; irregular heartbeat; joint pain; loss of appetite; mental or mood changes (eg, anxiety, depression, suicidal thoughts or actions); muscle weakness; numbness, tingling, or pain in the hands or feet; red, swollen, blistered, or peeling skin; seizure; severe or persistent pain, swelling, or redness at the injection site; shortness of breath; sudden, unusual weight gain; swelling of the hands, ankles, or feet; symptoms of infection (eg, chills, fever, painful or frequent urination, persistent cough or sore throat, persistent feeling of being unwell, unusual vaginal discharge or odor, unusual weight loss, white patches in the mouth); unusual bruising or bleeding; unusual lumps (eg, in the armpits, groin, neck); unusual sweating; unusual tiredness or weakness; unusually pale skin; vision changes; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.Proper storage of Certolizumab :
Store Certolizumab in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Store away from heat, moisture, and light. Do not use Certolizumab past the expiration date on the label. Keep Certolizumab out of the reach of children and away from pets.
- If you have any questions about Certolizumab , please talk with your doctor, pharmacist, or other health care provider.
- Certolizumab is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Certolizumab . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
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