Rituxan is dosed once weekly for 4 weeks
Prior to initiating Rituxan
Glucocorticoids administered as methylprednisolone 1000 mg intravenously per day for 1 to 3 days followed by oral prednisone 1 mg/kg/day (not to exceed 80 mg/day and tapered per clinical need) are recommended to treat severe vasculitis symptoms. This regimen should begin within 14 days prior to or with the initiation of Rituxan and may continue during and after the 4-week course of Rituximab treatment.
- Step 1.
- Calculate body surface area (BSA) of the patient using his/her height and weight
- Step 2.
- Using the patient's BSA, calculate the weekly Rituxan dose with the following formula
- Weekly dose = BSA (m2) x 375 mg
- Step 3.
- Rituxan should be administered each week for 4 weeks
- — Following methylprednisolone infusions, oral prednisone 1 mg/kg/day is recommended (not to exceed 80 mg/day, and tapered per clinical need)
PCP and Prophylaxis
PCP prophylaxis is also recommended for patients with GPA and MPA during treatment and for at least 6 months following the last Rituxan infusion
Retreatment in Patients with GPA and MPA
Limited data are available on the safety and efficacy of subsequent courses of Rituxan in patients with GPA and MPA. In the active-controlled, double-blind study, subsequent courses of Rituxan were allowed for patients experiencing a relapse of disease. The safety and efficacy of retreatment with Rituxan have not been established.
Reference
- 1.
- Data on file, Genentech USA/Biogen Idec.
INDICATION
Rituxan (rituximab), in combination with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA).
Rituxan is not recommended for treatment of patients with severe active infections.
IMPORTANT SAFETY INFORMATION
BOXED WARNINGS
Rituxan administration can result in serious, including fatal, adverse reactions. These include:
- infusion reactions
- tumor lysis syndrome (TLS)
- severe mucocutaneous reactions
- progressive multifocal leukoencephalopathy (PML)
Warnings and Precautions
Rituxan administration can also result in additional serious, including fatal, adverse reactions including:
- hepatitis B reactivation
- other infections including bacterial, fungal, new or reactivated viral infections
- cardiovascular events
Use of concomitant immunosuppressants other than corticosteroids has not been studied in GPA or MPA patients exhibiting peripheral B-cell depletion following treatment with Rituxan.
Observe patients closely for signs of infection if immunosuppressants other than corticosteroids are used concomitantly.
Common adverse reactions include infections, nausea, diarrhea, headache, muscle spasms, anemia and peripheral edema.