INFLECTRA® (Infliximab-dyyb)

INFLECTRA®

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Important Safety Information

Inflectra may increase the risk of developing serious infections and lead to hospitalization or death. Reported infections include tuberculosis (TB), histoplasmosis, candidiasis, aspergillosis, blastomycosis, coccidioidomycosis, pneumocystosis, cryptococcosis, legionella, salmonella, and listeria. Patients with chronic infections — and those who are at risk for invasive fungal infections — should talk to their doctor about empiric anti-fungal therapy.

Prior to starting treatment, patients should be tested for latent tuberculosis. If results are positive, TB should be treated and controlled before beginning Inflectra infusion therapy.

What is the most important information I should know about Inflectra?

Patients at a higher risk of infection include pediatric patients, individuals undergoing immunosuppressant therapy, and those who are 65 years of age or older. Such patients may develop skin ulcerations, abscesses, cellulitis, or pneumonia.

Inflectra is not recommended if you’re taking ACTEMRA® (tocilizumab), Kineret (anakinra), ORENCIA® (abatacept), or other biologic agents to treat your health conditions. Talk to your doctor about the likelihood of overlapping biological activity, as this may increase the risk of infection.

If the patient is a child, all vaccinations should be up-to-date prior to starting treatment with Inflectra. If the patient is an infant, your doctor may recommend a six-month waiting period if the baby was exposed to Inflectra while in utero.

Inflectra is not recommended for patients with moderate to severe congestive heart failure at doses greater than 5 mg. Higher dosage rates could result in death. Treatment with Inflectra should be discontinued in patients who experience symptoms of heart failure, such as chest pain, abdominal swelling, fast heartbeat, severe shortness of breath, increased need to urinate at night, nausea, fatigue, weakness, and lack of appetite.

Side Effects of Inflectra

As with any prescription medication, treatment with Inflectra carries a risk of side effects. The most common ones include:

  • Headaches
  • Abdominal pain
  • Sinusitis
  • Pharyngitis
  • Infections of the upper respiratory tract

Additional side effects may include more serious health conditions, including:

Hepatitis B

Inflectra may reactivate hepatitis B in patients who are carriers of the Hep B virus (HBV). If you’ve had hepatitis B in the past, get tested for infection prior to starting treatment. Tell your doctor immediately if you experience fever, chills, abdominal pain, dark urine, yellowing of the skin or whites of the eyes, fatigue, nausea, and/or vomiting.

Hepatotoxicity

Inflectra may cause severe hepatic reactions. This can include jaundice, cholestasis, and/or acute liver failure. In most severe cases, the patient may need a liver transplant. Patients should be closely monitored by their physician to ensure that their liver enzyme elevations remain normal. Tell your doctor immediately if you experience fever, fatigue, skin rash, yellowing of skin and/or eyes, abdominal pain, fatigue, loss of appetite, dark urine, and/or light-colored stools.

Cardiovascular and Cerebrovascular Reactions

Inflectra may cause myocardial infarction, hypotension, hypertension, or arrhythmia, up to 24 hours after an infusion treatment. Some patients have also experienced temporary vision loss within two hours of commencing treatment. Tell your doctor immediately if you experience chest, back, or jaw pain, tightness of the chest, shortness of breath, dizziness, rapid heart rate, coughing, anxiety, nausea, or vomiting.

Neurologic Issues

Inflectra may cause seizures, optic neuritis, peripheral demyelinating disorders, vasculitis, and/or Guillain-Barré syndrome. Tell your doctor immediately if you experience fever, skin rash, night sweats, numbness, muscle spasms, muscle weakness, vision loss, stiffness, difficulty moving your eyes, swallowing, or walking steadily, severe lower back pain, and/or changes in your bowel movements.

Hematologic Events

Inflectra may cause leukopenia, neutropenia, or thrombocytopenia. Risks are increased in patients who have a history of hematologic abnormalities, blood dyscrasias, or infections. Tell your doctor immediately if you experience fever, chills, coughing, shortness of breath, inflammation around the mouth, sore throat, abdominal pain, a burning sensation when urinating, pain or sore around the anus, diarrhea, unusual vaginal discharge, and/or recurring infections.

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

Inflectra is designed to treat pediatric patients and adults with Crohn’s disease, ulcerative colitis, rheumatoid arthritis (RA), psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. Each infusion treatment should only be administered with a medical professional closely monitoring the therapy and scheduling regular follow-up visits.

Please refer to the full prescribing information.