AHFS Class:
8:18.08.04 HIV Entry and Fusion Inhibitors
Generic Name
Ibalizumab-uiyk is available as a 150-mg/mL solution for injection in 2-mL preservative-free single-dose vials.3925 Each vial delivers approximately 1.33 mL containing ibalizumab-uiyk 200 mg along with L-histidine 2.06 mg, polysorbate 80 0.6 mg, sodium chloride 4.04 mg and sucrose 69.2 mg.3925
pH
The injection solution has a pH of 6.3925
Trade Name(s)
Trogarzo
Ibalizumab-uiyk is administered undiluted as a direct intravenous injection (intravenous push) or by intravenous infusion following dilution.3925 The loading dose may be administered by intravenous push over at least 90 seconds or by intravenous infusion over at least 30 minutes.3925 Maintenance doses may be administered by intravenous push over at least 30 seconds or by intravenous infusion over at least 15 minutes.3925
For intravenous infusion, the appropriate dose should be diluted in 250 mL of sodium chloride 0.9%.3925 Flush the administration line with 30 mL of sodium chloride 0.9% following intravenous infusion.3925
For direct intravenous injection, the drug is administered undiluted.3925 Flush the administration line with 2 to 5 mL of sodium chloride 0.9% following intravenous push administration.3925
Intact vials of ibalizumab-uiyk injection should be stored at 2 to 8°C, protected from light.3925 Do not freeze.3925
Ibalizumab-uiyk injection is a colorless to slightly yellow, clear to slightly opalescent solution with no visible particles; discard the vial if the solution is discolored or cloudy or contains particulate matter.3925
Diluted solutions may be stored at room temperature (20 to 25°C) for up to 4 hours or refrigerated (2 to 8°C) for up to 24 hours.3925 If refrigerated, diluted solutions should be allowed to stand at room temperature for at least 30 minutes but no more than 4 hours prior to administration.3925
For a list of references cited in the text of this monograph, search the monograph titled References.