Active Ingredient: Cabotegravir
Cabotegravir is indicated in combination with safer sex practices for short term pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in high-risk adults and adolescents, weighing at least 35 kg.
Cabotegravir tablets may be used as:
For this indication, competent medicine agencies globally authorize below treatments:
For:
In case that patient weight is ≥ 35 kg, oral, 30 milligrams cabotegravir, once daily.
When used for oral lead-in, cabotegravir tablets should be taken for approximately one month (at least 28 days) to assess tolerability to cabotegravir. 30 mg of cabotegravir should be taken, once daily.
Table 1. Recommended dosing schedule:
| Oral lead-in | |
|---|---|
| Medicinal product | During month 1 |
| Cabotegravir | 30 mg once daily |
If a delay of more than 7 days from a scheduled injection visit cannot be avoided, cabotegravir 30 mg tablets may be used once daily to replace one scheduled injection visit. The first dose of oral cabotegravir (or an alternative oral PrEP therapy) should be taken two months (+/- 7 days) after the last injection of cabotegravir. For oral PrEP durations greater than two months, an alternative PrEP regimen to oral cabotegravir is recommended.
Injection dosing should be resumed on the day oral cabotegravir dosing completes or within 3 days, thereafter (see cabotegravir injection SmPC).
If the individual misses a dose of cabotegravir tablets, the individual should take the missed dose as soon as possible, providing the next dose is not due within 12 hours. If the next dose is due within 12 hours, the individual should not take the missed dose and simply resume the usual dosing schedule.
If an individual vomits within 4 hours of taking cabotegravir tablets, another cabotegravir tablet should be taken. If an individual vomits more than 4 hours after taking cabotegravir tablets, the individual does not need to take another tablet until the next regularly scheduled dose.
For:
In case that patient weight is ≥ 35 kg, intramuscular, 600 milligrams cabotegravir, 1 one dose, over the duration of 1 month. Afterwards, in case that patient weight is ≥ 35 kg, intramuscular, 600 milligrams cabotegravir, once every 2 months.
The recommended initial dose is a single 600 mg intramuscular injection. If oral lead-in has been used, the first injection should be planned for the last day of oral lead-in or within 3 days thereafter.
One month later, a second 600 mg intramuscular injection should be administered. Individuals may be given the second 600 mg initiation injection up to 7 days before or after the scheduled dosing date.
After the second initiation injection, the recommended continuation injection dose in adults is a single 600 mg intramuscular injection administered every 2 months. Individuals may be given injections up to 7 days before or after the date of the scheduled injection date.
Table 1. Recommended intramuscular dosing schedule:
| Initiation injections (one month apart) | Continuation injections (two months apart) | |
| Medicinal product | Direct to injection: months 1 and 2 or Following oral lead-in: months 2 and 3 | Two months after final initiation injection and every 2 months onwards |
| Cabotegravir | 600 mg | 600 mg |
Individuals who miss a scheduled injection visit should be reassessed to ensure resumption of PrEP remains appropriate.
If a delay of more than 7 days from a scheduled injection date cannot be avoided, it will be a missed dose, therefore, cabotegravir 30 mg tablets may be used once daily, for a duration of up to two months, to replace one scheduled injection visit. The first dose of oral cabotegravir (or an alternative oral PrEP therapy) should be taken approximately two months (+/- 7 days) after the last injection of cabotegravir. For oral PrEP durations greater than two months, an alternative PrEP regimen to oral cabotegravir is recommended.
Injection dosing should be resumed on the day oral cabotegravir dosing completes or within 3 days, thereafter, as recommended in Table 2.
Table 2. Injection dosing recommendations after missed injections or following oral cabotegravir (PrEP) to replace an injection:
| Missed Doses | ||
| Time since last injection | Recommendation | |
| If second injection is missed and time since first injection is: | ||
| ≤2 months | Administer one 600 mg injection as soon as possible and continue with the every 2 month injection dosing schedule. | |
| >2 months | Restart the individual on one 600 mg initiation injection, followed by a second 600 mg initiation injection one month later. Then follow the every two month injection dosing schedule. | |
| If 3rd or subsequent injection is missed and time since prior injection is: | ||
| ≤3 months | Administer one 600 mg injection as soon as possible and continue with the every 2 month injection dosing schedule. | |
| >3 months | Restart the individual on one 600 mg initiation injection, followed by a second 600 mg initiation injection one month later. Then follow the every two month injection dosing schedule. | |
Injections must be administered to the ventrogluteal (recommended as it is located away from major nerves and blood vessels) or the dorsogluteal sites.
Care should be taken to avoid inadvertent injection into a blood vessel.
When administering cabotegravir injection, healthcare professionals should take into consideration the Body Mass Index (BMI) of the individual to ensure that the needle length is sufficient to reach the gluteus muscle.
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