•Subsequent Infusions:
Standard Infusion: Initiate infusion at a rate of 100 mg/hr. In the absence of infusiontoxicity, increase rate by 100 mg/hr increments at 30-minute intervals, to a maximumof 400 mg/hr.
For previously untreated follicular NHL:
If patients did not experience a Grade 3 or 4 infusion related adverse event duringCycle 1, a 90-minute infusion can be administered in Cycle 2 with a glucocorticoidcontainingchemotherapy regimen.
Initiate at a rate of 20% of the total dose given in the first 30 minutes and theremaining 80% of the total dose given over the next 60 minutes. If the 90-minute
infusion is tolerated in Cycle 2, the same rate can be used when administering theremainder of the treatment regimen (through Cycle 6 or 8).
Patients who have clinically significant cardiovascular disease or who have acirculating lymphocyte count ≥5000/mm3 before Cycle 2 should not be administered
the 90-minute infusion [see Clinical Studies (14.3)].
•Interrupt the infusion or slow the infusion rate for infusion reactions [seeBoxed Warning, Warnings and Precautions (5.1)]. Continue the infusion at one-halfthe previous rate upon improvement of symptoms.
2.2 Recommended Dose for Non-Hodgkin’s Lymphoma (NHL)
The recommended dose is 375 mg/m2 as an intravenous infusion according to the followingschedules:
• Relapsed or Refractory, Low-Grade or Follicular, CD20-Positive, B-Cell NHL
Administer once weekly for 4 or 8 doses.
•Retreatment for Relapsed or Refractory, Low-Grade or Follicular, CD20Positive, B-Cell NHL
Administer once weekly for 4 doses.
•Previously Untreated, Follicular, CD20-Positive, B-Cell NHLAdminister on Day 1 of each cycle of chemotherapy, for up to 8 doses. In patientswith complete or partial response, initiate TRUXIMA maintenance eight weeksfollowing completion of a rituximab product in combination with chemotherapy.Administer TRUXIMA as a single-agent every 8 weeks for 12 doses.
•Non-progressing, Low-Grade, CD20-Positive, B-Cell NHL, after firstlineCVP chemotherapyFollowing completion of 6−8 cycles of CVP chemotherapy, administer once weeklyfor 4 doses at 6-month intervals to a maximum of 16 doses.
2.3 Recommended Dose for Premedication and Prophylactic MedicationsPremedicate with acetaminophen and an antihistamine before each infusion of TRUXIMA. For
patients administered TRUXIMA according to the 90-minute infusion rate, the glucocorticoidcomponent of their chemotherapy regimen should be administered prior to infusion [see ClinicalStudies (14.3)].
2.4 Administration and Storage
Use appropriate aseptic technique. Parenteral drug products should be inspected visually forparticulate matter and discoloration prior to administration. TRUXIMA should be a clear toopalescent, colorless to pale yellow solution. Do not use vial if particulates or discoloration ispresent.
Administration
Withdraw the necessary amount of TRUXIMA and dilute to a final concentration of 1 mg/mLto 4 mg/mL in an infusion bag containing either 0.9% Sodium Chloride, USP, or 5% DextroseInjection, USP. Gently invert the bag to mix the solution. Do not mix or dilute with otherdrugs. Discard any unused portion left in the vial.
Storage
Diluted TRUXIMA solutions for infusion may be stored at 2°C to 8°C (36°F to 46°F) for 24hours. Diluted TRUXIMA solutions for infusion have been shown to be stable for an addition |
