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.

​The loading dose of TROGARZO is administered as a diluted intravenous infusion (IV infusion). Maintenance doses of TROGARZO may be administered as a diluted IV infusion or undiluted intravenous push (IV push).

​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.

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.

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

​For intravenous infusion

​For administration as an IV infusion, the appropriate number of vials are diluted in 250 mL of 0.9% Sodium Chloride Injection, USP.

​• Remove the flip-off cap from the single-dose vial and wipe the stopper 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 (2oC to 8oC, 36oF to 46oF) 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.

​

​For intravenous push

​For administration as an IV push, undiluted TROGARZO solution is administered.

​• Allow the vials to stand at room temperature for approximately 5 minutes.

​• Remove the flip-off cap from the single-dose vial and wipe the stopper 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).

​• The undiluted TROGARZO solution should be administered immediately.

​• Discard partially used vials or empty vials of TROGARZO and any unused portion of the undiluted TROGARZO solution.

Administration

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

​Administer TROGARZO intravenously (as an IV infusion or IV push) 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.

​The duration of the first infusion (loading dose) should be no less than 30 minutes. If no infusion-associated adverse reactions have occurred, subsequent maintenance doses can be administered as an IV infusion in no less than 15 minutes or as an IV push over a 30-second period.

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

​After the IV push is complete, flush with 2 to 5 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 (loading dose). If the patient does not experience an infusion-associated adverse reaction, the post-administration observation time for the subsequent maintenance doses (IV infusion or IV push) can be reduced to 15 minutes.

​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.