Zevalin is indicated for the treatment of previously untreated Follicular Non-Hodgkin Lymphoma (NHL) in patients who achieve a partial or complete response to first-line chemotherapy.

Subtype:

Follicular Lymphoma (FL)

License:

FDA

Class:

CD20 MAb

Newly Diagnosed

PI: http://www.zevalin.com/downloads/Zevalin_Package_Insert.pdf

1. Approved Labelling

Zevalin is indicated for the treatment of previously untreated Follicular Non-Hodgkin Lymphoma (NHL) in patients who achieve a partial or complete response to first-line chemotherapy.

 

2. Treatment Regimen

Initiate the Zevalin 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.

 

Only administer Rituxan/Zevalin in facilities where immediate access to resuscitative measures is available.

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 Zevalin therapeutic regimen.
  • Temporarily slow or interrupt the rituximab infusion for less severe infusion reactions. If symptoms improve, continue the infusion at one-half the previous rate.

 

Day 7, 8 or 9:

 

  • 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 Zevalin 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 port. After injection, flush the line with at least 10 mL of normal saline.

 

    • If platelet count ≥ 150,000/mm3, administer Y-90 Zevalin over 10 minutes as an intravenous injection at a dose of Y-90 0.4 mCi per kg (14.8 MBq per kg) actual body weight.
    • Do not administer more than 32 mCi (1184 MBq) Y-90 Zevalin dose regardless of the patient’s body weight. 
  • Monitor patients closely for evidence of extravasation during the injection of Y-90 Zevalin. Immediately stop infusion and restart in another limb if any signs or symptoms of extravasation occur.

3. AE/Warnings

Please see section 5 of the PI

 

 

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