Does rituximab have a black box warning?
The FDA has added a new black box warning to 2 drugs, rituximab (Rituxan) and ofatumumab (Arzerra) for the potential of either drug to cause reactivation of hepatitis B virus (HBV) as well as fulminant and fatal HBV infection in HBV carriers who have not had any prior instances of HBV virus activation.
What are the long-term side effects of rituximab?
Does Rituxan cause any long-term side effects?
- heart problems, such as heart attack or ventricular fibrillation (a type of abnormal heart rhythm)
- blockage or tearing of your intestines.
- kidney failure or other serious kidney problems.
- serious infections, such as shingles.
- reactivation of the hepatitis B virus*
Does Rituxan have polysorbate 80?
RITUXAN is supplied at a concentration of 10 mg/mL in either 100 mg (IO mL) or 500 mg (50 mL) single-use vials. The product is formulated for intravenous administration in 9.0 mg/mL sodium chloride. 7.35 mg/mL sodium citrate dihydnte. 0.7 mg/mL polysorbate 80.
Is rituximab Approved by FDA?
AIDS: The Food and Drug Administration (FDA) approved rituximab (Rituxan) for treating patients with relapsed or refractory low-grade or follicular, CD20 positive, B-cell non-Hodgkin’s lymphoma. The November 26 action was the first approval of a monoclonal antibody to treat cancers.
What drug class is Rituxan?
Rituximab injection (Rituxan) is used to treat pemphigus vulgaris (a condition that causes painful blisters on the skin and the lining the mouth, nose, throat and genitals). Rituximab injection products are in a class of medications called monoclonal antibodies.
What are the currently FDA approved indications for Rituxan rituximab )?
Rituxan (rituximab) is a CD20-directed cytolytic antibody indicated for the treatment of patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, and pemphigus vulgaris.
When was rituximab approved for intravenous use?
RITUXAN (rituximab) Injection for Intravenous Use Initial U.S. Approval: 1997 WARNING: FATAL INFUSION REACTIONS, TUMOR LYSIS SYNDROME (TLS), SEVERE MUCOCUTANEOUS REACTIONS, and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY screen high risk patients and mon See full prescribing information for complete boxed warning.
Is rituximab safe for rheumatoid arthritis?
Despite the low risk, the FDA issued a black box warning for rituximab in relation to rheumatoid arthritis patients. 3 It informs physicians of the following: “Fatal infusion reactions within 24 hours of Rituxan infusion occur; approximately 80% of fatal reactions occurred with first infusion.
Can rituximab cause PML?
While the number of cases is very low, some rituximab patients have developed PML. As a result, the U.S. Food and Drug Administration (FDA) and the drug’s manufacturer have issued a warning about the association. If you are on or considering starting Rituxan, educate yourself about the potential risks.