Active Ingredient: Lenacapavir
Lenacapavir tablet, in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen, for oral loading prior to administration of long-acting lenacapavir injection
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 600 milligrams lenacapavir, once daily, 2 doses in total, over the duration of 7 days. Afterwards, oral, 300 milligrams lenacapavir, once daily, one dose, over the duration of 7 days. Afterwards, subcutaneous, 927 milligrams lenacapavir, one dose.
Initiation of treatment with lenacapavir requires lenacapavir film-coated tablets to be taken as oral loading prior to administration of lenacapavir injection.
On treatment Day 1 and Day 2, the recommended dose of lenacapavir is 600 mg per day taken orally. On treatment Day 8, the recommended dose is 300 mg taken orally. Then, on treatment Day 15, the recommended dose is 927 mg administered by subcutaneous injection.
Table 1. Recommended treatment regimen for lenacapavir: initiation:
| Treatment time | Dose of lenacapavir: initiation |
| 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 subcutaneous injection (2 × 1.5 mL injectionsa) |
a Two injections, each at a separate site in the abdomen.
If the Day 2 (600 mg) oral dose is missed by:
If the Day 8 (300 mg) oral dose is missed by:
Regardless of when the Day 2 or Day 8 oral dose is being taken, subcutaneous injection should be administered on Day 15 as described in Table 1.
If the patient vomits within 3 hours of taking an oral dose of lenacapavir, another oral dose should be taken. If the patient 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 tablets should be taken orally with or without food.
For:
Subcutaneous
927 - 927 mg
From 927 To 927 mg once every 180 day(s)
On treatment Day 1 and Day 2, the recommended dose of lenacapavir is 600 mg per day taken orally. On treatment Day 8, the recommended dose is 300 mg taken orally. Then, on treatment Day 15, the recommended dose is 927 mg administered by subcutaneous injection.
Oral tablets can be taken with or without food (see lenacapavir tablet SmPC.
The recommended dose is 927 mg of lenacapavir administered by subcutaneous injection once every 6 months (26 weeks) from the date of the last injection (+/- 2 weeks).
Table 1. Recommended treatment regimen for lenacapavir: initiation and maintenance dosing schedule:
| Treatment time | |
| Dose of lenacapavir: initiation | |
| 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 subcutaneous injection (2 × 1.5 mL injectionsa) |
| Dose of lenacapavir: maintenance | |
| Every 6 Months (26 weeks)b +/- 2 weeks | 927 mg subcutaneous injection (2 × 1.5 mL injectionsa) |
a Two injections, each at a separate site in the abdomen.
b From the date of the last injection.
During the maintenance period, if more than 28 weeks have elapsed since the last injection and if clinically appropriate to continue lenacapavir treatment, the regimen should be restarted from Day 1 (see table 1).
Lenacapavir injections should be administered into the abdomen (two injections, each at a separate site) by a healthcare professional.
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