Lenacapavir

  • Abbreviation: LEN
    Antiretroviral Subclass:
    Capsid inhibitors

Background

Formulations and Dosing

  • Lenacapavir can be initiated using one of two recommended dosage regimens, see tables below.

    Table 1. Recommended Treatment Regimen for Lenacapavir Initiation and Maintenance, Option 1

    Treatment Time Initiation Dosage
    Day 1 927 mg by subcutaneous injection (2 × 1.5 mL injections)
    600 mg orally (2 × 300 mg tablets)
    Day 2 600 mg orally (2 × 300 mg tablets)

     

    Table 2. Recommended Treatment Regimen for Lenacapavir Initiation and Maintenance, Option 2

    Treatment Time Initiation Dosage
    Day 1 600 mg orally (2 × 300 mg tablets)
    Day 2 600 mg orally (2 × 300 mg tablets)
    Day 8 300 mg orally (1 × 300 mg tablet)
    Day 15 927 mg by subcutaneous injection (2 × 1.5 mL injections)

    Adult Dosing

    Dosage Formulation Notes
    2 x 300 mg tablets on days 1 and 2.
    1 x 300 mg tablet on day 8 if using initiation option 2.    		 Film-Coated Tablets

    Initiation phase only
    927 mg by subcutaneous injection (2 × 1.5 mL injections), on day 1 of initiation for option 1, or day 15 for options 2. Then every 6 months (26 weeks from last injection) +/-2 weeks Subcutaneous Injection

    After initiation phase, administer every 6 months or 26 weeks.

    Pediatric Dosing

    Age Dosage Formulation Weight
           

    Formulations

    300 mg
    463.5 mg in 1.5 mL single dose vial

Coformulations

Clinical Use

  • Lenacapavir, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.

Resources and Links

U.S. FDA Label: Label
Assistance Programs: Gilead Advancing Access program

  • References