Long-acting HIV injection dosing windows

Updated October 8, 2026 · 2 min read

The FDA labels for injectable cabotegravir, given with rilpivirine for HIV treatment or alone for PrEP, allow each injection after the first up to 7 days before or after its scheduled date. The lenacapavir labels set the next injection 26 weeks after the last one, plus or minus 2 weeks. Book visits early in the window so a missed visit can be rebooked before it closes.

What each label allows

Continuation dosing windows in the current FDA labels
ProductUseContinuation dosingWindow in the labelLabel revised
Cabotegravir and rilpivirine (Cabenuva)TreatmentMonthly or every 2 monthsUp to 7 days before or after the scheduled date11/2025
Cabotegravir (Apretude)PrEPEvery 2 monthsUp to 7 days before or after the scheduled date4/2025
Lenacapavir (Sunlenca)Treatment, with other HIV drugs, in heavily treatment-experienced adultsEvery 26 weeks26 weeks from the last injection, plus or minus 2 weeks8/2026
Lenacapavir (Yeztugo)PrEPEvery 26 weeks26 weeks from the last injection, plus or minus 2 weeks8/2026

The two kinds of label count differently. The cabotegravir labels set the window around the date the person is scheduled to receive the injection. The lenacapavir labels count 26 weeks from the date of the last injection.

Window: 7 days before to 7 days after−10 d−7 dTarget+7 d+10 dGiven on day +3: inside
A target injection date with the window the cabotegravir labels allow, from 7 days before to 7 days after.

Worked example: planning a PrEP visit

A person on every-2-month cabotegravir PrEP is scheduled for Thursday, November 12, 2026. The label window runs from Thursday, November 5 to Thursday, November 19. A team that books the home visit for Friday, November 6 still has 13 days to try again if no one is home. Booking it for November 18 leaves one day.

The visit has to bring together a clinician who can give the injection, the medicine kept at the right temperature, and the person. The cabotegravir labels say a healthcare provider gives the injection into the gluteal muscle. The PrEP labels require an HIV-1 test before each injection, so the visit also needs testing supplies.

If the visit falls outside the window

All four labels say a person who misses an injection visit should be clinically reassessed. Each then sets cut-offs by time since the last injection:

  • Cabotegravir and rilpivirine, monthly: 2 months or less, resume monthly injections as soon as possible; more than 2 months, re-initiate.
  • Cabotegravir and rilpivirine every 2 months, and cabotegravir PrEP, from the third injection on: 3 months or less, resume as soon as possible; more than 3 months, restart with two initiation injections 1 month apart.
  • Lenacapavir: more than 28 weeks with no oral bridging tablets, restart from Day 1 if clinically appropriate.
  • Planned gaps: each label describes oral dosing to cover a planned delay of more than 7 days for cabotegravir or more than 2 weeks for lenacapavir.

Getting the clinician, the medicine and the person together

The hard part is repeating that meeting inside the window, visit after visit. Capillary's HIV care logistics plans where a clinician, the medicine and the person meet so long-acting HIV injections happen inside their dosing windows. It was a Phase 1 winner of the NIH ARISE-HIV LAUNCH Challenge in 2026.

Common questions

Does the 7-day window apply to the first injection?
The cabotegravir labels give the window for the injections after the first. The first is tied to the start date: for treatment, the last day of current therapy or of the oral lead-in; for PrEP, the last day of an oral lead-in, if one is used, or within 3 days after.
Can the injection be given at home?
The cabotegravir labels say a healthcare provider must give it, into the gluteal muscle; they do not name a setting. A home visit has to bring the provider, the medicine at the right temperature and, for PrEP, the HIV test.
How long can the treatment kit stay out of the refrigerator?
The treatment kit is stored at 2°C to 8°C. Its label allows the vials up to 6 hours at room temperature in the carton, says not to put them back in the refrigerator, and allows filled syringes up to 2 hours. Cabotegravir for PrEP is stored at 2°C to 25°C.

Keep long-acting HIV injections inside their windows.

Capillary plans where the clinician, the medicine and the person meet. Phase 1 winner of the NIH ARISE-HIV LAUNCH Challenge.

Sources

  1. CABENUVA prescribing information, FDA, revised 11/2025
  2. APRETUDE prescribing information, FDA, revised 4/2025
  3. SUNLENCA prescribing information, DailyMed, revised 8/2026
  4. YEZTUGO prescribing information, DailyMed, revised 8/2026