Active Ingredient: Lenacapavir
Lenacapavir is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents with increased HIV-1 acquisition risk, weighing at least 35 kg.
For this indication, competent medicine agencies globally authorize below treatments:
For:
In case that patient weight is ≥ 35 kg
Subcutaneous, 927 milligrams lenacapavir, one dose, over the duration of 1 day. Afterwards, oral, 600 milligrams lenacapavir, one dose. Afterwards, subcutaneous, 927 milligrams lenacapavir, once every 6 months.
The dosing schedule in adults and adolescents weighing at least 35 kg consists of a required initiation dosing (subcutaneous injections and oral tablets) (Table 1), followed by once every 6-month continuation dosing (subcutaneous injections).
On Day 1, the required dose is 927 mg of lenacapavir administered by subcutaneous injection and 600 mg taken orally. On Day 2, the required dose is 600 mg taken orally.
Table 1. Dosing schedule for lenacapavir initiation and continuation:
| Time | |
| Dose of lenacapavir: Initiationa | |
| Day 1 | 927 mg subcutaneous injection (2 x 1.5 mL injectionsb) 600 mg orally (2 x 300 mg tablets) |
| Day 2 | 600 mg orally (2 x 300 mg tablets) |
| Dose of lenacapavir: Continuation | |
| Every 6 Months (26 weeks)c +/- 2 weeks | 927 mg subcutaneous injection (2 x 1.5 mL injectionsb) |
a The complete initiation dosing schedule, consisting of subcutaneous injections and oral tablets, is required; the efficacy of lenacapavir has only been established with this dosing schedule.
b Two injections, with the second injection at least 5 centimetres from the first injection.
c From the date of the last injection.
If the Day 1 or Day 2 oral initiation dose (600 mg) is missed, it should be taken as soon as possible. Day 1 and Day 2 doses should not be taken on the same day.
During continuation dosing, if the scheduled 6-month injection is anticipated to be delayed by more than 2 weeks, lenacapavir tablets may be used for oral bridging on an interim basis (for up to 6 months if needed), until injections resume. Oral bridging should be initiated within 26 to 28 weeks from the last injection. The dosing schedule is 300 mg (1 tablet) taken orally once every 7 days. Resume the continuation injection dosage within 7 days after the last oral dose (see Table 1).
During the continuation period, if more than 28 weeks have elapsed since the last injection and lenacapavir tablets have not been taken for oral bridging, restart the initiation dosing schedule from Day 1 (see Table 1).
If the individual vomits within 3 hours of taking an oral dose of lenacapavir, another oral dose should be taken. If the individual vomits more than 3 hours after taking an oral dose of lenacapavir there is no need to take another oral dose of lenacapavir, and the scheduled dosing regimen should continue.
Lenacapavir injections must only be administered subcutaneously into the abdomen or thigh (two injections, with the second injection at least 5 centimetres from the first injection) by a healthcare professional. Do NOT administer intradermally.
Following lenacapavir injection, a subcutaneous drug depot forms whereby lenacapavir is slowly released from the site of administration. In some individuals, this may lead to a nodule at the injection site.
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