Infliximab

Infliximab is a prescription medication used to treat several types of autoimmune disorders.

Infliximab belongs to a group of drugs called tumor necrosis factor-alpha inhibitors. These work by blocking the action of a substance in the body that causes inflammation.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects of infliximab include infections, headache, and abdominal pain.

Infliximab is a prescription medication used to treat several types of autoimmune disorders including:

• rheumatoid arthritis
• Crohn’s disease
• ulcerative colitis
• ankylosing spondylitis
• psoriasis
• psoriatic arthritis

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Infliximab may be found in some form under the following brand names:

• Remicade

Serious side effects have been reported with infliximab. See the “Infliximab Precautions” section.

Common side effects of infliximab include the following:

• stomach pain
• nausea
• heartburn
• headache
• runny nose
• back pain
• white patches in the mouth
• vaginal itching, burning, and pain, or other signs of a yeast infection
• flushing

This is not a complete list of infliximab side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• abatacept (Orencia)
• anakinra (Kineret)
• methotrexate (Rheumatrex)
• steroids such as dexamethasone, methylprednisolone (Medrol), prednisolne (Prelone), or prednisone
• tocilizumab (Actemra)
• anticoagulants (blood thinners) such as warfarin (Coumadin, Jantoven)
• cyclosporine (Gengraf, Neoral, Sandimmune)
• theophylline (Theochron, Theoloair, Uniphyl)

This is not a complete list of infliximab drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with infliximab including the following:

• serious infections, including fungal infections. Do not administer infliximab during an active infection. If an infection develops, monitor carefully and stop infliximab if infection becomes serious.
• increased risk of malignancies. The incidence of malignancies including lymphoma is greater in patients treated with infliximab.
• hepatitis B virus (HBV) reactivation. Patients should be tested for HBV infection before starting infliximab. Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop infliximab and begin anti-viral therapy.
• hepatotoxicity (liver damage). Rare severe liver reactions, some fatal or necessitating liver transplantation, have occurred in patients receiving infliximab. Tell your doctor if you notice yellowing of the skin or eyes while receiving infliximab.
• heart failure. New onset or worsening symptoms of heart failure may occur.
• hypersensitivity. Serious infusion reactions including anaphylaxis or serum sickness-like reactions may occur. Tell your doctor or get medical help right away if you get any of these symptoms during or after an infusion this medication:
  • hives (red itchy welts) or rash
  • itching
  • swelling of your lips, tongue, throat or face
  • sudden cough
  • shortness of breath, difficulty breathing, or wheezing
  • weakness
  • dizziness or feel faint
  • palpitations (feel like your heart is racing or fluttering)
  • chest pain

Do not take infliximab if you are allergic to infliximab or to any of its ingredients.

Do not use high doses of infliximab if you have moderate or severe heart failure.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of infliximab, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking infliximab, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to infliximab or to any of its ingredients
• think you have an infection, are being treated for an infection, or have signs of an infection, such as a fever, cough, flu-like symptoms
• have any open cuts or sores on your body
• get a lot of infections or have infections that keep coming back.
• have diabetes or an immune system problem
• have tuberculosis (TB) or have been in close contact with someone with TB
• live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis)
• have or have had hepatitis B virus infection
• have or have had heart disease, especially congestive heart failure
• have ever been treated with phototherapy (a treatment for psoriasis that involves exposing the skin to ultraviolet light)
• have or have had a disease that affects your nervous system, such as multiple sclerosis, Guillain-Barre syndrome, or optic neuritis
• have numbness or burning or tingling in any part of your body
• have or have had seizures
• have chronic obstructive pulmonary disease
• have or have had any type of cancer
• have or have had bleeding problems or diseases that affect your blood
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Infliximab falls into category B. There are no well-done studies that have been done in humans with infliximab. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if infliximab crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using infliximab.

Take infliximab exactly as prescribed.

This medication is available in an injectable form to be given directly into a vein (IV)by a healthcare professional.

If you miss a dose, call your healthcare provider right away to reschedule your appointment.

Take this medication exactly as prescribed by your doctor.

The dose your doctor recommends may be based on the following:

• the condition being treated
• how you respond to this medication
• your weight

Infliximab should be administered by infusion directly into a vein over a period of not less than 2 hours.

The recommended dose of infliximab for the treatment of Crohn's disease is 5 mg/kg at 0, 2, and 6 weeks, then every 8 weeks. Some adult patients who initially respond to treatment may benefit from increasing the dose to 10 mg/kg if they later lose their response.

The recommended dose of infliximab for the treatment of pediatric Crohn's disease is 5 mg/kg at 0, 2, and 6 weeks, then every 8 weeks.

The recommended dose of infliximab for the treatment of ulcerative colitis is 5 mg/kg at 0, 2, and 6 weeks, then every 8 weeks.

The recommended dose of infliximab for the treatment of pediatric ulcerative colitis is 5 mg/kg at 0, 2, and 6 weeks, then every 8 weeks.

The recommended dose of infliximab for the treatment of rheumatoid arthritis is 3 mg/kg at 0, 2, and 6 weeks, then every 8 weeks. Infliximab should be used in conjunction with methotrexate in the treatment of rheumatoid arthritis. Some patients may benefit from increasing the dose up to 10 mg/kg or treating as often as every 4 weeks.

The recommended dose of infliximab for the treatment of ankylosing spondylitis is 5 mg/kg at 0, 2, and 6 weeks, then every 6 weeks.

The recommended dose of infliximab for the treatment of psoriatic arthritis and plaque psoriasis is 5 mg/kg at 0, 2, and 6 weeks, then every 8 weeks.

If you take too much infliximab, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If infliximab is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Keep this and all medicines out of the reach of children.
• Keep all appointments with your doctor and the laboratory.

WARNING: SERIOUS INFECTIONS and MALIGNANCY

SERIOUS INFECTIONS

Patients treated with REMICADE® are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

REMICADE should be discontinued if a patient develops a serious infection or sepsis.

Reported infections include:

Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before REMICADE use and during therapy. Treatment for latent infection should be initiated prior to REMICADE use.

Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.

Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.

The risks and benefits of treatment with REMICADE should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with REMICADE, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

MALIGNANCY

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including REMICADE.

Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including REMICADE. These cases have had a very aggressive disease course and have been fatal. Almost all patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF-blocker at or prior to diagnosis. The majority of reported REMICADE cases have occurred in patients with Crohn's disease or ulcerative colitis and most were in adolescent and young adult males.