CERTOLIZUMAB

(SER toe LIZ oo mab) Brand: Cimzia

What is the most significant information I must know about certolizumab?

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 malady or ulcerative colitis.

• Call your doctor at once if you have any of the next symptoms: fever, night sweats, itching, loss of appetite, weight loss, tiredness, feeling full after eating only a little amount, pain in your upper stomach that may spread to your shoulder, nausea, light bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart course, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Serious and sometimes fatal infections may occur during treatment with certolizumab. Contact your doctor right away if you have open sores or skin wounds, or signs of infection such as: fever, cough, or flu symptoms.

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

What is certolizumab?

Certolizumab reduces the effects of a stuff in the body that can reason inflammation.

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

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

What must I discuss with my healthcare provider till I receive certolizumab?

• You must not receive this medicine if you have active but untreated tuberculosis. Speak 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 malady or ulcerative colitis.

• However, people with autoimmune disorders (including rheumatoid arthritis, Crohn's malady, ankylosing spondylitis, and psoriasis) may have a higher risk of lymphoma. Conversation to your doctor about your individual risk.

• To create certain certolizumab is safety for you, speak your doctor if you have:

· an active or last infection;

· signs of infection such as fever, cough, or flu symptoms;

· open sores or skin wounds;

· lupus;

· HIV or AIDS;

· hepatitis B (or if you are a carrier of the virus);

· a history of cancer (especially skin cancer);

· epilepsy or seizure disorder;

· congestive heart failure;

· numbness or tingling, or a malady that affects your nerves or muscles (such as multiple sclerosis, myasthenia gravis, Guillain-Barre syndrome); or

· if you are scheduled to receive any vaccines, or have recently been vaccinated with BCG (Bacille Calmette-Guerin).

• FDA pregnancy category B. This medicine is not expected to be deleterious to an unborn child. Speak 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 child. Speak your doctor if you are breast-feeding a baby.

How is certolizumab given?

• Till you start treatment with certolizumab, your doctor may perform trials to create certain you do not have tuberculosis or another infections. Some infections are more likely to occur in determined areas of the world. Speak 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 medicine is generally given each 2 to 4 weeks. You may be shown how to use injections at house. Do not self inject this medication 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 medication that should be mixed with a liquid (diluent) till using it. If you are using the injections at house, be certain you understand how to properly mix and store the medication.

Certolizumab can lower blood cells that help your body fight infections and help your blood to clot. This can create it easier for you to bleed from an injury or get sick from being near 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, weary feeling, or if you feel short of breath.

• While using certolizumab, you may need frequent blood trials 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 till you run out of medication completely.

• If you need surgery or medical trials, speak the surgeon or doctor onward of time that you are using certolizumab.

• Store in the refrigerator. Protect from easy and do not freeze. Take the medicine and diluent out of the refrigerator and let them to reach room temperature till preparing your doze.

• 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 let it to reach room temperature for up to 2 hours till giving the injection. Do not heat this medication till using.

If you have hepatitis B you may develop liver symptoms after you stop taking this medicine, even months after stopping. Your doctor may want to check your liver function for different months after you stop using certolizumab.

What happens if I miss a dose?

• Call your doctor for instructions if you miss a doze of certolizumab.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.

What must I avoid while receiving certolizumab?

• Do not receive a "live" vaccine while using certolizumab, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, yellow fever, varicella (chickenpox), zoster (shingles), oral typhoid vaccine, and nasal flu (influenza) vaccine.

• You may receive "killed-virus" vaccines such as a flu shot, polio vaccine, rabies vaccine, or hepatitis A vaccine. Ask your doctor till receiving any vaccine while you are being treated with certolizumab.

• Avoid being around people who are sick or have infections. Speak your doctor at once if you develop signs of infection.

• Avoid activities that may magnify your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

What are the possible side effects of certolizumab?

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

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 little 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:

· signs of infection (fever, chills, sore throat, vomiting, diarrhea, flu symptoms);

· swelling of your ankles or feet;

· quick or slow heart rate;

· pain or burning when you urinate;

· confusion, neck stiffness, seizure (convulsions);

· 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, 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).

• General side effects may include:

· stuffy nose, sinus pain;

· stomach pain, mild diarrhea, constipation; or

· pain, redness, itching, swelling, or bleeding where the medication 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 message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect certolizumab?

• Speak your doctor about all medicines you use, and those you start or stop using during your treatment with certolizumab, especially:

· abatacept;

· anakinra;

· natalizumab;

· rituximab;

· NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others; or

· another drugs that weaken your immune system (such as cancer medication, methotrexate, or steroids).

• This list is not complete. Another drugs may interact with certolizumab, including prescription and over-the-counter medicines, vitamins, and herbal commodity. Not all possible interactions are listed in this medicine manual.

Where can I get more information?

• Your doctor or pharmacist can provide more information about certolizumab.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each 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 external 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 must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help 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.

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