Everything You Need to Know About Rituximab Prescribing Information
Rituximab is a prescription medication that has been approved by the FDA for the treatment of various conditions, including non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis. However, it is important to have a thorough understanding of rituximab prescribing information before prescribing or taking this medicine.
In this article, we will cover everything you need to know about rituximab prescribing information, including its indications, dosages, administration, adverse reactions, and other important considerations.
Indications
Rituximab is indicated for the treatment of:
1. Non-Hodgkin’s Lymphoma (NHL)
2. Chronic Lymphocytic Leukemia (CLL)
3. Rheumatoid Arthritis (RA)
Non-Hodgkin’s Lymphoma: Rituximab is approved for the treatment of relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent; and previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy.
Chronic Lymphocytic Leukemia: Rituximab is indicated, in combination with fludarabine and cyclophosphamide (FC), for the treatment of patients with previously untreated and previously treated CD20-positive CLL.
Rheumatoid Arthritis: Rituximab, in combination with methotrexate (MTX), is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.
Dosages
The dosages of rituximab depend on the indication for which it is being used. Below are the recommended doses for each indication:
Non-Hodgkin’s Lymphoma:
• Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent: 375 mg/m2 intravenously once weekly for 4 or 8 doses
• Previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy: 375 mg/m2 intravenously once weekly for 4 or 8 doses, starting on day 1 of chemotherapy
• Maintenance therapy for patients achieving a complete or partial response to rituximab in combination with chemotherapy: 375 mg/m2 intravenously once every 2 months for up to 2 years after completion of chemotherapy
Chronic Lymphocytic Leukemia:
• 375 mg/m2 intravenously once weekly for 8 doses in combination with fludarabine and cyclophosphamide (FC) for previously untreated patients
• 500 mg/m2 intravenously, administered as two infusions of 250 mg/m2 on day 1 and day 15 of each cycle of FC chemotherapy for previously treated patients
Rheumatoid Arthritis:
• 1000 mg intravenously on days 1 and 15, followed by 1000 mg intravenously at 6-month intervals
Administration
Rituximab should only be administered by a healthcare professional in a facility equipped to manage anaphylaxis. The drug should be diluted in sterile saline to a final concentration of 1 to 4 mg/mL before administration. It should be administered as an intravenous infusion over several hours with appropriate monitoring, including vital signs, during and after the infusion.
The first infusion should be administered over several hours, and subsequent infusions can be administered more quickly if the patient has tolerated the prior infusion. If there are any signs of hypersensitivity or infusion-related reactions, the infusion should be stopped and appropriate treatment should be given.
Adverse Reactions
Like any medication, rituximab can cause adverse reactions. The most common adverse reactions associated with rituximab treatment include:
• Infusion-related reactions (IRRs)
• Infections
• Tumor lysis syndrome
• Severe mucocutaneous reactions
IRRs are the most commonly reported adverse reactions and typically occur during the first infusion. Symptoms of IRRs may include fever, chills, pruritus, rash, hypotension, bronchospasm, and angioedema. The incidence and severity of IRRs can be reduced by premedication with acetaminophen, an antihistamine, and a glucocorticosteroid. If an IRR occurs, the infusion should be stopped and appropriate treatment should be given.
Other Considerations
Patients should be evaluated for hepatitis B virus (HBV) infection before starting rituximab treatment. Retreatment with rituximab after a previous course of treatment carries an increased risk of adverse reactions.
Additionally, rituximab has been associated with the development of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection. Rituximab should be discontinued immediately if PML is suspected or diagnosed.
Conclusion
In conclusion, rituximab is a prescription medication that is used for the treatment of various conditions, including non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis. Understanding the rituximab prescribing information is critical for healthcare professionals to ensure safe and effective treatment. This article has provided an overview of the indications, dosages, administration, adverse reactions, and other important considerations of rituximab prescribing information.
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