2 DOSAGE AND ADMINISTRATION 

2.1 Recommended Dosage 

 

The recommended dose of ALIQOPA is 60 mg administered as a 1-hour intravenous infusion on Days 1, 8, and 15 of a 28-day treatment cycle on an intermittent schedule (three weeks on and one week off). Continue treatment until disease progression or unacceptable toxicity [see Warnings and Precautions (5)].

 

2.2 Preparation and Administration 

 

For intravenous infusion only.

 

Administer ALIQOPA as a single agent, following reconstitution and dilution. Mix only with 0.9% sodium chloride (NaCl) solution. Do not mix or inject ALIQOPA with other drugs or other diluents. 

 

2.3 Reconstitution Instructions 

 

Reconstitute ALIQOPA with 4.4 mL of sterile 0.9% NaCl solution leading to a concentration of 15 mg/mL. 

• Withdraw 4.4 mL of sterile 0.9% NaCl solution by using a 5 mL sterile syringe with needle. • Inject the measured volume through the disinfected stopper surface into the vial of ALIQOPA. • Dissolve the lyophilized solid by gently shaking the injection vial for 30 seconds. • Allow to stand for one minute to let bubbles rise to the surface. • Check if any undissolved substance is still seen. If yes, repeat the gentle shaking and settling procedure. • Inspect visually for discoloration and particulate matter. After reconstitution, the solution should be colorless to slightly yellowish. • Once the solution is free of visible particles, withdraw the reconstituted solution for further dilution. 

 

2.4 Dilution Instructions for Intravenous Use 

 

Further dilute the reconstituted solution in 100 mL sterile 0.9% NaCl solution for injection. With a sterile syringe, withdraw the required amount of the reconstituted solution for the desired dosage: 

 

60 mg: Withdraw 4 mL of the reconstituted solution with a sterile syringe.

 

45 mg: Withdraw 3 mL of the reconstituted solution with a sterile syringe.

 

30 mg: Withdraw 2 mL of the reconstituted solution with a sterile syringe.

 

Inject the contents of the syringe into the patient infusion bag of 100 mL sterile 0.9% NaCl solution. Mix the dose well by inverting.

Discard any unused reconstituted or diluted solution appropriately.

Use reconstituted and diluted ALIQOPA immediately or store the reconstituted solution in the vial or diluted solution in the infusion bag at 2°C to 8°C (36°F to 46°F) for up to 24 hours before use. Allow the product to adapt to room temperature before use following refrigeration. Avoid exposure of the diluted solution to direct sunlight.

2.5 Dose Modification for Toxicities 

 

Manage toxicities per Table 1 with dose reduction, treatment delay, or discontinuation of ALIQOPA. Discontinue ALIQOPA if life-threatening ALIQOPA-related toxicity occurs.

Table 1: Dose Modification and Toxicity Managementa 

Toxicities

 

Adverse Reaction Gradeb

 

Recommended Management

Infections 

Grade 3 or higher 

 

Withhold ALIQOPA until resolution. 

Suspected pneumocystis jiroveci pneumonia (PJP) infection of any grade