Last Reviewed by C. H. Weaver M.D., Medical Editor 8/1/2018
Class: Biological Therapy
How is this drug used? Remicade is used for selected patients with Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or plaque psoriasis. Remicade does not cure these conditions, but it can reduce symptoms.
What is the mechanism of action? Remicade helps to control the development of inflammation by blocking a protein (tumor necrosis factor-alpha) made by the immune system.
How is Remicade given (administered)? Remicade is given by intravenous (IV) infusion.
How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Remicade. Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems. Patients will be monitored for signs and symptoms of tuberculosis (TB), and may also undergo physical examinations or other measures to assess side effects and response to therapy.
What are the most common (occur in more than 10% of patients) side effects of treatment with Remicade?
- Infusion-related reactions
- Abdominal pain
What are some of the less common but potentially serious side effects of Remicade?
- Serious infection
- Hepatitis B virus reactivation
- Liver problems
- Heart failure
- Low blood cell counts
- Severe allergic reaction
- Worsening or new demyelinating disease
- Lupus-like syndrome
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
- Pay careful attention to the physician’s instructions, and discuss side effects with your physician.
Are there any special precautions patients should be aware of before starting treatment?
- Patients should be tested for tuberculosis (TB) before starting Remicade
- Patients should inform their physician about all medical conditions, including current infections, history of frequent infections, open cuts or sores, diabetes, immune system problems, TB or contact with someone who has TB, hepatitis B, potential exposure to certain fungal infections (the likelihood of exposure varies by region), heart problems, cancer, liver problems, COPD (chronic obstructive pulmonary disease), and nervous system conditions.
- Patients should inform their physician of any other medication or supplement they are taking (whether prescription or over-the-counter), including Kineret® (anakinra), Orencia® (abatacept), and Actemra® (tocilizumab).
- Patients should inform their physician if they have had phototherapy for psoriasis.
- Patients should inform their physician if they have recently received or are scheduled to receive a vaccine.
- Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future.
When should patients notify their physician?
Tell your doctor if you experience any side effects that bother you or don’t go away. Call your doctor immediately if you develop an infection or notice signs of an infection such as fever; cough; flu-like symptoms; fatigue; or warm, red, or painful skin. Also call your doctor if you have open cuts or sores, symptoms of heart failure (shortness of breath, swelling of ankles or feet, sudden weight gain), symptoms of liver problems (jaundice, dark brown urine, pain on right side of stomach area, fever, or extreme tiredness), symptoms of low blood cell counts (fever, easy bruising or bleeding, pallor), nervous system problems (changes in vision, weakness in arms or legs, numbness or tingling, seizures), signs of an allergic reaction (hives, difficulty breathing or swallowing, chest pain, high or low blood pressure, fever, chills, rash, headache, sore throat, muscle or joint pain, or swelling of the face and hands), symptoms of a lupus-like syndrome (chest discomfort, shortness of breath, joint pain, rash on cheeks or arms that gets worse in the sun), or new or worsening psoriasis.
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Important Limitations of Use
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