Remicade (Infliximab)
What is a Generic Drug?
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
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Product Details
Description
Remicade (infliximab) is a medication given via intravenous infusion for the treatment of Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.
Directions
Recimade should be administered as prescribed by your doctor.
Your doctor will discuss your treatment regimen with you, including Remicade dosing. Remicade should be administered under direct medical supervision.
Ingredients
The active ingredient in Remicade is infliximab. Inactive ingredients include dibasic sodium phosphate dihydrate, monobasic sodium phosphate monohydrate, polysorbate 80, and sucrose.
Contraindications
Patients with moderate or severe heart failure should not receive doses greater than 5 mg/kg.
Patients who experienced a previous allergic reaction to infliximab or to any of the other ingredients in Remicade should not receive the medication.
Cautions
Remicade is associated with the following FDA Boxed Warnings:
- Remicade can increase the risk of serious infections that can result in hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens.
- Remicade should be stopped if a patient develops a serious infection.
- A latent TB test should be performed; if positive, TB treatment should be initiated before starting Remicade. All patients should be monitored for active TB during treatment, even if the initial latent TB test is negative.
- Lymphoma and other malignancies, which may potentially be fatal, have occurred in children and adolescent patients who received tumor necrosis factor (TNF) blockers, including Remicade.
- Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients who received TNF blockers, including Remicade. Nearly all had received azathioprine or 6-mercaptopurine with a TNF blocker at or before diagnosis. The majority of Remicade cases occurred in adolescent or young adult male patients with Crohn’s disease or ulcerative colitis.
- Before you begin treatment with Remicade, tell your doctor about:
- All the prescription and over-the-counter medications you take
- Your allergies
- Your current health conditions and past medical history
- Your pregnancy or breastfeeding status
- Remicade should not be given in the presence of an infection.
- Empiric antifungal therapy may be considered in patients who live in or travel to places where fungal infections occur.
- Malignancies such as invasive cervical cancer and lymphoma occurred more frequently in patients who received Remicade versus controls.
- Patients should receive TB testing before starting Remicade treatment. They should then be monitored for TB during treatment and for several months after stopping treatment.
- Heart failure can occur, or symptoms of heart failure may worsen, with Remicade treatment.
- Liver problems can occur with Remicade treatment.
- Abnormal blood cell counts can occur with Remicade treatment.
- Serious allergic reactions can occur with Remicade treatment.
- Cardiovascular and cerebrovascular reactions, such as heart attack and abnormal heart rhythms, can occur with Remicade treatment.
- Demyelinating disease can occur, or symptoms of demyelinating disease can worsen during Remicade treatment.
- Lupus-like syndrome can occur with Remicade treatment.
- Patients should be up to date on all vaccinations before starting treatment with Remicade. Live vaccines should not be administered during Remicade treatment.
Side Effects
The most common Remicade infusion side effects include infections, infusion-related reactions, headache, and stomach pain. However, other side effects may also occur. Contact your doctor right away if you have side effects that bother you or won’t go away.
Reference
Remicade (infliximab). Horsham, PA: Janssen Biotech, Inc.; 2021.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 2355
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