By Gary M. White, MD
Caution: Facts about drugs change frequently. The latest research, package insert, and FDA information should be consulted before prescribing.
Rituximab was approved in 1997 by the FDA to treat B cell non-Hodgkin lymphoma and in 2006 to treat rheumatoid arthritis. Rituximab is a human-mouse chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells and induces B-lymphocyte apoptosis. In dermatology, it is particularly helpful in pemphigus vulgaris.
Black Box Warnings
There are black box warnings for:
Fatal infusion reactions may occur within 24 hours of Rituxan infusion; approximately 80% of fatal reactions occur with first infusion. Symptoms may include hives (red itchy welts) or rash, itching, swelling of lips, tongue, throat or face, sudden cough, shortness of breath, difficulty breathing, or wheezing, weakness, dizziness or feel faint, palpitations, and chest pain.
Severe mucocutaneous reactions, some with fatal outcomes.
- Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death.
- Progressive multifocal leukoencephalopathy (PML) resulting in death.
The most common side effects are:
- Infusion reactions
- Infections, e.g. upper respiratory tract infection, nasopharyngitis, urinary tract infection, and bronchitis
- Body aches
- Low white blood counts.
Many other side effects are possible including nausea, vomiting, cardiac arrhythmias, and renal toxicity.
Contraindications (not all inclusive)
- Severe, active infection
- Immune suppression
- Recent live vaccination
- Relative contraindications include history of heart (e.g. arrhythmias), lung or kidney disease, pregnancy or breast feeding.
Time to respond
Average time to response is about 60 days.
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