GAZYVA, in combination with bendamustine followed by GAZYVA monotherapy, is indicated for the treatment of patients with Follicular Lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen

Subtype:

Follicular Lymphoma (FL)

License:

FDA

Class:

CD20 MAb

R/R

PIhttps://www.gene.com/download/pdf/gazyva_prescribing.pdf 

1. Approved Labelling

Gazyva, in combination with bendamustine followed by Gazyva monotherapy, is indicated for the treatment of patients with Follicular Lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen.

2. Treatment Regimen

  • Premedicate with glucocorticoid, acetaminophen and anti-histamine.
  • Dilute and administer as intravenous infusion. Do not administer as an intravenous push or bolus.

Each dose of Gazyva is 1000 mg administered intravenously according to Table 1. Patients who achieve stable disease, complete response, or partial response to the initial 6 cycles of Gazyva treatment in combination with bendamustine should continue on Gazyva 1000 mg as monotherapy for two years.

Table 1: Dose of Gazyva to Be Administered During 6 Treatment Cycles, Each of 28 days Duration, Followed by Gazyva Monotherapy for Patients with FL
Day of treatment cycle Dose of Gazyva Rate of infusion (in the absence of infusions/hypersensitivity during previous infusions)
Cycle 1 (loading doses) Day 1 1000 mg Administer at 50 mg/hr. The rate of the infusion can be escalated in 50 mg/hr increments every 30 minutes to a maximum of 400 mg/hr.
Day 8 1000 mg If no infusion reaction occurred during the previous infusion and the final infusion rate was 100 mg/hr or faster, infusions can be started at a rate of 100 mg/hr and increased by 100 mg/hr increments every 30 minutes to a maximum of 400 mg/hr.
Day 15  1000 mg
Cycles 2-6 Day 1 1000 mg 
Mono-therapy  Every two months for two years 1000 mg 

If a planned dose of Gazyva is missed, administer the missed dose as soon as possible. During Gazyva and bendamustine treatment, adjust the dosing schedule accordingly. During monotherapy, maintain the original dosing schedule for subsequent doses. 

3. AE/ Warnings

Please see section 5 of the PI

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