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Infliximab (Murine) Solution for injection

It is used to treat Crohn's disease and ulcerative colitis

Generic Name: infliximab  |  Brand Name: Remicade

Brand Names: Remicade

There is an FDA Alert for this drug. Click here to view it.

Special Alerts:

CORRECTION NOTICE:

The Editors of AHFS Drug Information® (AHFS DI®) and AHFS DI Essentials® wish to inform you of an error in the Infliximab (Systemic) monograph. The error appears under the subhead IV Administration: Rate of Administration, in Dosage and Administration: Administration. In Table 1: Rate Titration Schedule, the entry in column 1, line 4 should read: 80 mL/hour.

The originally stated infusion rate of 80 mL/minute is incorrect. The correct infusion rate is 80 mL/hour.

MEDWATCH ALERT:

[Posted 09/07/2011] ISSUE: FDA notified healthcare professionals that the Boxed Warning for the entire class of Tumor Necrosis Factor-alpha (TNFα) blockers has been updated to include the risk of infection from two bacterial pathogens, Legionella and Listeria. In addition, the Boxed Warning and Warnings and Precautions sections of the labels for all of the TNFα blockers have been revised so that they contain consistent information about the risk for serious infections and the associated disease-causing pathogens.

Patients treated with TNFα blockers are at increased risk for developing serious infections involving multiple organ systems and sites that may lead to hospitalization or death due to bacterial, mycobacterial, fungal, viral, parasitic, and other opportunistic pathogens.

BACKGROUND: The class of TNFα blockers are used to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and/or juvenile idiopathic arthritis.

RECOMMENDATION: The risks and the benefits of TNFα blockers should be considered prior to initiating therapy in patients with chronic or recurrent infection and patients with underlying conditions that may predispose them to infection. See the Drug Safety Communication for a listing of recommendations for healthcare professionals and patients, as well as a data summary. For more information visit the FDA website at: [Web] and [Web].

[Posted 04/14/2011] ISSUE: FDA continues to receive reports of a rare cancer of white blood cells (known as Hepatosplenic T-Cell Lymphoma or HSTCL, primarily in adolescents and young adults being treated for Crohn’s disease and ulcerative colitis with medicines known as tumor necrosis factors (TNF) blockers, as well as with azathioprine, and/or mercaptopurine. TNF blockers include infliximab (Remicade), etancercept (Enbrel), adalimumab (Humira), certolizumab pegol (Cimzia) and golimumab (Simponi).

BACKGROUND: HSTCL is an aggressive (fast-growing) cancer and is usually fatal. The majority of cases reported were in patients being treated for Crohn’s disease or ulcerative colitis, but also included a patient being treated for psoriasis and two patients being treated for rheumatoid arthritis. FDA is now updating the number of reported cases of HSTCL.

Although most reported cases of HSTCL occurred in patients treated with a combination of medicines known to suppress the immune system, including the TNF blockers, azathioprine, and/or mercaptopurine, there have been cases reported in patients receiving azathioprine or mercaptopurine alone.

  • Educate patients and caregivers about the signs and symptoms of malignancies such as HSTCL so that they are aware of and can seek evaluation and treatment of any signs or symptoms. These may include splenomegaly, hepatomegaly, abdominal pain, persistent fever, night sweats, and weight loss.
  • Monitor for the emergence of malignancies when a patient has been treated with TNF blockers, azathioprine, and/or mercaptopurine.
  • Know that people with rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis may be more likely to develop lymphoma than the general U.S. population. Therefore, it may be difficult to measure the added risk of TNF blockers, azathioprine, and/or meracaptopurine.

Read the Drug Safety Communications for other specific recommendations for Healthcare Professionals and Patients and the Data Summary for additional information. For more information visit the FDA website at: [Web] and [Web].

REMS:

FDA approved a REMS for infliximab to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).

What is this medicine?

INFLIXIMAB (in FLIX i mab) is used to treat Crohn's disease and ulcerative colitis. It is also used to treat ankylosing spondylitis, psoriasis, and some forms of arthritis.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • diabetes
  • exposure to tuberculosis
  • heart failure
  • hepatitis or liver disease
  • immune system problems
  • infection
  • lung or breathing disease, like COPD
  • multiple sclerosis
  • current or past resident of Ohio or Mississippi river valleys
  • seizure disorder
  • an unusual or allergic reaction to infliximab, mouse proteins, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

This medicine is for injection into a vein. It is usually given by a health care professional in a hospital or clinic setting.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

Do not take this medicine with any of the following medications:
  • anakinra
  • rilonacept

This medicine may also interact with the following medications:

  • vaccines

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress.

If you get a cold or other infection while receiving this medicine, call your doctor or health care professional. Do not treat yourself. This medicine may decrease your body's ability to fight infections. Before beginning therapy, your doctor may do a test to see if you have been exposed to tuberculosis.

This medicine may make the symptoms of heart failure worse in some patients. If you notice symptoms such as increased shortness of breath or swelling of the ankles or legs, contact your health care provider right away.

If you are going to have surgery or dental work, tell your health care professional or dentist that you have received this medicine.

If you take this medicine for plaque psoriasis, stay out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:
  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • chest pain
  • fever or chills, usually related to the infusion
  • muscle or joint pain
  • red, scaly patches or raised bumps on the skin
  • signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine
  • swollen lymph nodes in the neck, underarm, or groin areas
  • unexplained weight loss
  • unusual bleeding or bruising
  • unusually weak or tired
  • yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • headache
  • heartburn or stomach pain
  • nausea, vomiting

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.


Last Updated: August 05, 2009
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