INFLIXIMAB - INJECTION - side effects

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GENERIC NAME: INFLIXIMAB - INJECTION (in-FLICKS-ih-mab)

BRAND NAME(S): Remicade

Warning | Medication Uses | How To Use | Side Effects | Precautions | Drug Interactions | Overdose | Notes | Missed Dose | Storage

WARNING: Infliximab decreases immune system function (immunosuppression), which can result in serious infections (e.g., tuberculosisor fungal infections), or a worsening of an existing infection. Beforestarting treatment with infliximab, you should have a TB skin test doneto check for tuberculosis that may not be causing any symptoms (latentTB). If you are diagnosed with TB, anti-tuberculosis medicines must bestarted before you start infliximab therapy. This will prevent aserious TB infection. Tell your doctor immediately if you develop signsof infection while using this drug, such as: fever, persistent sore throat, unusual vaginal discharge, painful or frequent urination.

USES: Infliximab inhibits a protein calledTNF. This action results in decreased swelling (inflammation) anddecreased immune system function (immunosuppression). Infliximab iseffective in treating rheumatoid arthritis and certain bowel diseases (Crohn's disease), since swelling and an overactive immune system likely play a role in these diseases.

HOW TO USE: This medication is givenby vein (IV) over at least 2 hours. Follow all instructions for propermixing and dilution with the correct IV fluids. Consult yourpharmacist. This medication should be checked visually for particles ordiscoloration before use. The liquid should be colorless to lightyellow and translucent particles may be present (this is normal). Donot use the liquid if whitish/opaque particles or discoloration arepresent.

SIDE EFFECTS: Nausea or pain at theinjection site may occur. If these effects persist or worsen, notifyyour doctor. Report promptly: signs of infection (e.g., persistent sorethroat, fever), chills, severe headache,chest pain, cough, extreme fatigue, stomach pain, unusual vaginaldischarge, white patches in the mouth (fungal infection). Unlikely butreport promptly: diarrhea,joint/muscle pain, mental/mood changes, vision changes, unexplainedmuscle weakness, numbness/tingling, changes in skin appearance, painfulurination, increased urgency/frequency of urination, unusual bruisingor bleeding, sudden weight gain. Very unlikely but report promptly:fast or irregular pulse, unusual lumps/growths, night sweats,unexplained weight loss, swollen glands. In the unlikely event you havean allergic reaction to this medication, seek medical attentionimmediately. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing.

INFLIXIMAB-INJECTION (cont.)

PRECAUTIONS: Tellyour doctor your medical history, especially of: any allergies, currentinfections, seizures, certain brain/spinal cord disorders(demyelinating disorders such as multiple sclerosis), history of cancer(e.g., lymphoma), decreased bone marrow function. This medication isnot recommended for use if you have the following medical condition: congestive heart failure(CHF). Infliximab may worsen CHF; some deaths have occurred in patientswith CHF. Consult your doctor or pharmacist for more details. Use ofthis medication may result in a secondary infection (e.g., oral,bladder or vaginal yeast infection). Caution is advised when this drugis used in the elderly, as this group may be more sensitive to drugside effects. This medication should be used only when clearly neededduring pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug is excreted into breastmilk. Because of the potential risk to the infant, breast-feeding whileusing this medication is not recommended. Consult your doctor beforebreast-feeding.

DRUG INTERACTIONS: Tell yourdoctor of all nonprescription and prescription medication you may use,especially: . immune system suppressing drugs (e.g., prednisone, cyclosporine), anakinra.

OVERDOSE: If overdose is suspected,contact your local poison control center or emergency room immediately.US residents can call the US national poison hotline at 1-8.... Canadian residents should call their local poison control center directly.

NOTES: Do not share this medication withothers. Laboratory and/or medical tests may be performed to monitoryour response to therapy.

MISSED DOSE: If the dose is interrupted, contact your doctor immediately to establish a new dosing schedule.

STORAGE: Store in a refrigeratorbetween 36 and 46 degrees F (2 to 8 degrees C) away from light andmoisture. Do not freeze. After mixing and dilution in correct IV fluids(consult your pharmacist for details), the drug should be usedimmediately. Discard any unused liquid.