ients with ≥ 25% lymphoma marrow involvement and/or impaired bone marrow reserve [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)].
Severe Cutaneous and Mucocutaneous Reactions: Severe cutaneous and mucocutaneous reactions, some fatal, can occur with the Zeva lin therapeutic regimen. Discontinue rituximab, In-111 Zeva lin, and Y-90 Zeva lin infusions in patients experiencing severe cutaneous or mucocutaneous reactions [see Warnings and Precautions (5.3) and Adverse Reactions (6.3)].
Dosing: The dose of Y-90 Zeva lin should not exceed 32.0 mCi (1184 MBq). Do not administer Y-90 Zeva lin to patients with altered biodistribution as determined by imaging with In-111 Zeva lin [see Dosage and Administration (2.2)].
1 INDICATIONS AND USAGE
1.1 Relapsed or Refractory, Low-grade or Follicular NHL
Zeva lin is indicated for the treatment of relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL).
1.2 Previously Untreated Follicular NHL
Zeva lin is indicated for the treatment of previously untreated follicular NHL in patients who achieve a partial or complete response to first-line chemotherapy.
2 DOSAGE AND ADMINISTRATION
Recommended Dosing Schedule:
Administer the Zeva lin therapeutic regimen as outlined in Section 2.1.
Initiate the Zeva lin therapeutic regimen following recovery of platelet counts to ≥150,000/mm3 at least 6 weeks, but no more than 12 weeks, following the last dose of first-line chemotherapy.
2.1 Overview of Dosing Schedule
2.2 Zeva lin Therapeutic Regimen Dosage and Administration
Day 1:
Premedicate with acetaminophen 650 mg orally and diphenhydramine 50 mg orally prior to rituximab infusion.
Administer rituximab 250 mg/m2 intravenously at an initial rate of 50 mg/hr. In the absence of infusion reactions, escalate the infusion rate in 50 mg/hr increments every 30 minutes to a maximum of 400 mg/hr. Do not mix or dilute rituximab with other drugs.
Immediately stop the rituximab infusion for serious infusion reactions and discontinue the Zeva lin therapeutic regimen [see Boxed Warning and Warnings and Precautions (5.1)].
Temporarily slow or interrupt the rituximab infusion for less severe infusion reactions. If symptoms improve, continue the infusion at one-half the previous rate.
Administer 5 mCi In-111 Zeva lin over 10 minutes as an intravenous injection within 4 hours following completion of the rituximab infusion. Use a 0.22 micron low-protein-binding in-line filter between the syringe and the infusion port. After injection, flush the line with at least 10 mL of normal saline.
Day 7, 8 or 9:
Verify that expected biodistribution is present [see Dosage and Administration (2.5)].
Premedicate with acetaminophen 650 mg orally and diphenhydramine 50 mg orally prior to rituximab infusion.
Administer rituximab 250 mg/m2 intravenously at an initial rate of 100 mg/hr. Increase rate by 100 mg/hr increments at 30 minute intervals, to a maximum of 400 mg/hr, as tolerated. If infusion reactions occurred during rituximab infusion on Day 1 of treatment, administer rituximab at an initial rate of 50 mg/hr and escalate the infusion rate in 50 mg/hr increments every 30 minutes to a maximum of 400 mg/hr.
Administer Y-90 Zeva lin injection through a free flowing intravenous line within 4 hours following completion of rituximab infusion. Use a 0.22 micron low-protein-binding in-line filter between the syringe and the infusion por |
