TROGARZO Solution for injection Ref.[10292] Active ingredients: Ibalizumab

2.1 Recommended Dosage

TROGARZO is available in a single-dose, 2 mL vial containing 150 mg/mL of ibalizumab-uiyk. Each vial delivers approximately 1.33 mL containing 200 mg of ibalizumab-uiyk.

TROGARZO is administered intravenously (IV), after diluting the appropriate number of vials in 250 mL of 0.9% Sodium Chloride Injection, USP. Patients should receive a single loading dose of 2,000 mg followed by a maintenance dose of 800 mg every 2 weeks.

Dose modifications of TROGARZO are not required when administered with any other antiretroviral or any other treatments.

2.2 Preparation

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard vial if solution is cloudy, if there is pronounced discoloration or if there is foreign particulate matter.

See Table 1 for the appropriate number of vials required to prepare both the loading dose of 2,000 mg and the maintenance doses of 800 mg.

Table 1. Recommended TROGARZO Dose and Number of Vials Per Administration:

TROGARZO solution for infusion should be prepared by a trained medical professional using aseptic technique as follows:

• Remove the flip-off cap from the single-dose vial and wipe with an alcohol swab.
• Insert sterile syringe needle into the vial through the center of the stopper and withdraw 1.33 mL from each vial (NOTE: a small residual amount may remain in the vial, discard unused portion) and transfer into a 250 mL intravenous bag of 0.9% Sodium Chloride Injection, USP. Other intravenous diluents must not be used to prepare the TROGARZO solution for infusion.
• Once diluted, the TROGARZO solution should be administered immediately.
• If not administered immediately, store the diluted TROGARZO solution at room temperature (20°C to 25°C, 68°F to 77°F) for up to 4 hours, or refrigerated (2°C to 8°C, 36°F to 46°F) for up to 24 hours. If refrigerated, allow the diluted TROGARZO solution to stand at room temperature (20°C to 25°C, 68°F to 77°F) for at least 30 minutes but no more than 4 hours prior to administration.
• Discard partially used vials or empty vials of TROGARZO and any unused portion of the diluted TROGARZO solution.

2.3 Administration

Diluted TROGARZO solution should be administered by a trained medical professional.

Administer TROGARZO as an IV infusion in the cephalic vein of the patient’s right or left arm. If this vein is not accessible, an appropriate vein located elsewhere can be used. Do not administer TROGARZO as an intravenous push or bolus.

The duration of the first infusion (loading dose) should be no less than 30 minutes. If no infusion-associated adverse reactions have occurred, the duration of the subsequent infusions (maintenance doses) can be decreased to no less than 15 minutes.

After the infusion is complete, flush with 30 mL of 0.9% Sodium Chloride Injection, USP.

All patients must be observed for 1 hour after completion of TROGARZO administration for at least the first infusion. If the patient does not experience an infusion-associated adverse reaction, the post-infusion observation time can be reduced to 15 minutes thereafter.

If a maintenance dose (800 mg) of TROGARZO is missed by 3 days or longer beyond the scheduled dosing day, a loading dose (2,000 mg) should be administered as early as possible. Resume maintenance dosing (800 mg) every 14 days thereafter.

Store vials under refrigeration at 2 to 8ºC (36-46 ºF). Do not freeze and protect from light.

Once diluted, the TROGARZO solution should be administered immediately [see Dosage and Administration (2.2)].