Bizengri Dosage

Patient Selection

Select patients for treatment with BIZENGRI based on the presence of an NRG1 gene fusion in tumor specimens.

An FDA-approved test for the detection of NRG1 gene fusions is not currently available.

Recommended Evaluation Before Initiating BIZENGRI

Before initiating BIZENGRI, evaluate left ventricular ejection fraction (LVEF).

Recommended Dosage

• The recommended dosage of BIZENGRI is 750 mg as an intravenous (IV) infusion every 2 weeks until disease progression or unacceptable toxicity.
• Administer premedications before each BIZENGRI infusion as recommended to reduce the risk of infusion-related reactions.

Recommended Premedications

Prior to each infusion of BIZENGRI, administer premedications to reduce the risk of infusion-related reactions (IRRs) (see Table 1).

Dosage Modifications for Adverse Reactions

No dose reduction is recommended for BIZENGRI. The recommended dosage modifications of BIZENGRI for adverse reactions are provided in Table 2.

Preparation

Dilute and prepare BIZENGRI for intravenous infusion before administration.

For the initial infusion, prepare BIZENGRI as close to administration time as possible to allow for the possibility of extended infusion time in the event of an infusion-related reaction.

• Check that the BIZENGRI solution is clear to slightly opalescent, colorless to slightly yellow. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if discoloration or visible particles are present.
• Withdraw and then discard 37.5 mL 0.9% Sodium Chloride Injection from the 250 mL infusion bag. Only use infusion bags made of polyvinylchloride (PVC), polyolefin or polyolefin/polyamide coextruded plastic.
• Withdraw a total of 37.5 mL of BIZENGRI from 2 vials and add it to the infusion bag. The final volume in the infusion bag should be 250 mL. Discard any unused portion left in the vial.
• Gently invert the bag to mix the solution. Do not shake.
• If not used immediately, store the diluted solution refrigerated at 2°C to 8°C (36°F to 46°F) and protect from light after preparation unless the infusion is initiated within 2 hours of preparation.

Administration

• If the infusion time exceeds the recommended storage time, the infusion bag must be discarded and a new infusion bag prepared to continue the infusion. Diluted BIZENGRI solution must by administered within:
  • 6 hours from end of preparation of infusion solution stored at room temperature [15°C to 25°C (59°F to 77°F)]
  • 28 hours from end of preparation of infusion solution stored refrigerated [2°C to 8°C (36°F to 46°F)]
• If the diluted BIZENGRI solution has been refrigerated, allow it to reach room temperature (approximately 30 minutes) prior to administration.
• Administer diluted BIZENGRI solution by intravenous infusion using an infusion set made of either PVC, polyethylene (PE), polyurethane (PUR) or polybutadiene (PB) with an in-line, sterile, non-pyrogenic, low protein-binding polyethersulfone (PES) filter (pore size 0.2 micrometer).
• Do not infuse BIZENGRI concomitantly in the same IV line with other agents.
• Administer BIZENGRI infusion via a peripheral or central line.
• Monitor patients closely for signs and symptoms of infusion-related reactions during BIZENGRI infusion and monitor patients for at least 1 hour following completion of the first BIZENGRI infusion and as clinically indicated.
• Administer intravenous infusion over 4 hours.