RENFLEXIS® (Infliximab-abda)

RENFLEXIS®

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Important Safety Information

RENFLEXIS® (infliximab-abda) is a prescription infusion medication used to treat several conditions — including ulcerative colitis (UC) and Crohn’s disease in adults and pediatric patients. It can also treat rheumatoid arthritis (RA), psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis in adults.

Tell your doctor about all medications you’re currently taking — whether they’re prescription, over-the-counter, vitamins, or herbal supplements, as these may interfere with RENFLEXIS®. Medications that may increase the risk of harm when combined with RENFLEXIS® include Kineret (anakinra), ORENCIA® (abatacept), ACTEMRA® (tocilizumab), or biologics. In addition, let your doctor know if you have recently received or are scheduled to receive a vaccine. Both pediatric and adult patients treating with RENFLEXIS® should avoid live vaccines or treatment with weakened bacteria.

If you have received RENFLEXIS® treatment while pregnant or breastfeeding, talk with your medical provider about how this medication may affect your baby. If your child receives a live vaccine within six months after birth, your baby may develop infections and life-threatening complications.

What is the most important information I should know about RENFLEXIS®?

RENFLEXIS® may lower your immune system’s ability to fight infections. This risk is especially heightened in patients who are 65 years of age or older, as well as in patients with a medical history that includes any of the following conditions:

  • Serious infections caused by viruses, fungi, or bacteria
  • Tuberculosis
  • Histoplasmosis
  • Diabetes
  • Any type of cancer or a risk factor for developing cancer
  • Heart failure
  • Nervous system disorders
  • Hepatitis B virus

Some cases of unusual cancers have been reported in pediatric patients — including hepatosplenic T-cell lymphoma. This type of cancer has affected mostly teenage and young adult males with Crohn’s disease or ulcerative colitis.

Side Effects of RENFLEXIS®

As with any prescription medication, RENFLEXIS® carries the risk of side effects. The most common ones include:

  • Headache
  • Coughing
  • Stomach pain
  • Rash
  • Sinus infections
  • Sore throat

In rare cases, patients may experience more serious, life-threatening — sometimes fatal — side effects. Seek emergency medical care immediately if you experience any of the following:

  • Infections
  • Pneumonia
  • Shortness of breath
  • Painful skin or open sores
  • Swelling of your ankles or feet
  • Sudden weight gain
  • Jaundice (yellow skin and eyes)
  • Dark brown urine
  • Pain on the right side of the abdomen
  • Severe tiredness
  • Bruising
  • Severe paleness
  • Unusual bleeding
  • Numbness or tingling
  • Vision changes
  • Seizures
  • Confusion
  • Dizziness
  • Trouble walking
  • Sudden, severe headache
  • Joint pain
  • A rash that gets worse in the sun
  • Red, scaly patches on the skin
  • Raised bumps that are filled with pus
  • Hives
  • Breathing difficulties
  • Swelling of the face, throat, tongue, and/or lips
  • Chest tightness or pain

These symptoms could be an indication that you are experiencing reactivation of hepatitis B virus, heart problems, liver injury, nervous system disorders, an allergic reaction, lupus, or psoriasis. RENFLEXIS® could also lead to lymphoma, skin cancer, cervical cancer, heart failure, or stroke.

Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.

Indications

RENFLEXIS® is used to treat ulcerative colitis (UC) and Crohn’s disease in adults and pediatric patients, rheumatoid arthritis (RA), psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis in adults. The dosage and frequency will vary depending on the health condition that’s being treated.

Please refer to the full prescribing information.