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GAZYVA should be administered as an intravenous infusion through a dedicated line in an environment where full resuscitation facilities are immediately available and under the close supervision of an experienced physician. GAZYVA infusions should not be administered as an intravenous push or bolus. Isotonic 0.9% sodium chloride solution should be used as the infusion vehicle (see Special Instructions for Use, Handling and Disposal under Cautions for Usage).
Prophylaxis and Premedication for Tumour Lysis Syndrome (TLS): Patients with a high tumour burden and/or a high circulating lymphocyte count (> 25 x 109/L) and/or renal impairment (CrCl <70 mL/min) are considered at risk of TLS and should receive prophylaxis. Prophylaxis should consist of adequate hydration and administration of uricostatics (e.g. allopurinol) or suitable alternative such as a urate oxidase (e.g. rasburicase), prior to start of GAZYVA infusion as per standard practice (see General under Precautions). Patients should continue to receive repeated prophylaxis prior to each subsequent infusion, if deemed appropriate.
Prophylaxis and Premedication for Infusion Related Reactions (IRR): Premedication to reduce the risk of infusion related reactions (see General under Precautions) is outlined in Table 4. Corticosteroid premedication is recommended for FL patients and mandatory for CLL patients for the first infusion. Premedication for subsequent infusions and other premedication should be administered as described as follows.
Hypotension, as a symptom of IRR, may occur during GAZYVA intravenous infusions. Therefore, withholding of antihypertensive treatments should be considered for 12 hours prior to and throughout each GAZYVA infusion and for the first hour after administration (see General under Precautions). (See Table 4.)
Click on icon to see table/diagram/imageStandard Dosage: Chronic Lymphocytic Leukaemia (in combination with chlorambucil 1): Cycle 1: The recommended dosage of GAZYVA is 1000 mg administered over Day 1 and Day 2 and on Day 8 and Day 15 of the first 28 day treatment cycle as shown in Table 5.
Two infusion bags should be prepared for the first dose 100 mg for the first infusion and 900 mg for the second infusion. If the 100mg dose is completed without modifications of the infusion rate or interruptions, the 900mg dose can be administered on the same day (without dose delay) provided that appropriate time, conditions and medical supervision are available throughout the infusion. If there are any modifications of the infusion rate or interruptions during the first 100 mg the 900mg infusion must be administered the following day (see Table 5).
Cycle 2-6: The recommended dosage of GAZYVA is 1000 mg administered on Day 1 for each 28 day treatment cycle as shown in Table 5. (See Table 5.)
Click on icon to see table/diagram/imageDelayed or missed doses (CLL): If a planned dose of GAZYVA is missed, it should be administered as soon as possible; do not wait until the next planned dose. The planned treatment interval for GAZYVA should be maintained between doses.
Follicular Lymphoma: The recommended dosage of GAZYVA is 1000 mg administered intravenously according to Table 6.
Previously Untreated Follicular Lymphoma: For patients with previously untreated follicular lymphoma, GAZYVA should be administered with chemotherapy as follows: Six 28 day cycles in combination with bendamustine2 or, Six 21 day cycles in combination with CHOP, followed by 2 additional cycles of GAZYVA alone or, Eight 21 day cycles in combination with CVP.
Previously untreated patients who achieve a complete or partial response to GAZYVA plus chemotherapy should continue to receive GAZYVA (1000 mg) alone as maintenance therapy once every 2 months until disease progression or for up to 2 years.
Relapsed/Refractory Follicular Lymphoma: For patients with follicular lymphoma who have relapsed after or who are refractory to rituximab or a rituximab-containing regimen, GAZYVA should be administered in six 28 day cycles in combination with bendamustine2.
Relapsed/Refractory patients who achieve complete or partial response or have stable disease should continue to receive GAZYVA 1000 mg alone as maintenance therapy once every 2 months until disease progression or for up to 2 years. (See Table 6.)
Click on icon to see table/diagram/imageDelayed or missed doses (FL): If a planned dose of GAZYVA is missed, it should be administered as soon as possible; do not omit it or wait until the next planned dose.
If toxicity occurs before Cycle 1 Day 8 or Cycle 1 Day 15, requiring delay of treatment, these doses should be given after resolution of toxicity. In such instances, all subsequent visits and the start of Cycle 2 will be shifted to accommodate for the delay in Cycle 1.
During maintenance, maintain the original dosing schedule for subsequent doses.
Dosage modifications during treatment (all indications): No dose reductions of GAZYVA are recommended.
For management of symptomatic adverse events (including IRRs), see Table 7 as follows and Precautions. (See Table 7.)
Click on icon to see table/diagram/imageSpecial Dosage Instructions: Pediatric use: The safety and efficacy of GAZYVA in children below 18 years of age have not been established.
Geriatric use: No dose adjustment is required in patients ≥ 65 years of age (see Use in Elderly under Precautions).
Renal impairment: No dose adjustment is required in patients with mild or moderate renal impairment. GAZYVA has not been studied in patients with a CrCl <30mL/min (see Renal Impairment under Precautions and Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions).
Hepatic Impairment: The safety and efficacy of GAZYVA in patients with hepatic impairment have not been established.
