Active Ingredient: Cabotegravir
Cabotegravir tablets are indicated in combination with rilpivirine tablets for the short-term treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class for:
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral
30 - 30 mg
From 30 To 30 mg once every day for 28 day(s)
Prior to the initiation of cabotegravir injection, cabotegravir tablets together with rilpivirine tablets should be taken for approximately one month (at least 28 days) to assess tolerability to cabotegravir and rilpivirine. One cabotegravir 30 mg tablet should be taken with one rilpivirine 25 mg tablet, once daily.
Recommended Dosing Schedule in Adult Patients:
| ORAL LEAD IN | |
| Medicinal Product | During month 1 |
| Cabotegravir | 30 mg once daily |
| Rilpivirine | 25 mg once daily |
If a patient plans to miss a scheduled injection visit by more than 7 days, oral therapy (one cabotegravir 30 mg tablet and one rilpivirine 25 mg tablet once daily) may be used to replace up to 2 consecutive monthly injection visits or one, every 2 month injection visit. For oral therapy durations greater than two months, an alternative oral regimen is recommended.
The first dose of oral therapy should be taken one month ( +/ - 7 days) after the last injection doses of cabotegravir and rilpivirine for patients being given monthly injections. For patients being given every 2-month injections, the first dose of oral therapy should be taken 2 months ( +/ - 7 days) after the last injection doses of cabotegravir and rilpivirine. Injection dosing should be resumed on the day oral dosing completes.
If the patient misses a dose of cabotegravir tablets, the patient 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 patient should not take the missed dose and simply resume the usual dosing schedule.
If a patient vomits within 4 hours of taking cabotegravir tablets, another cabotegravir tablet should be taken. If a patient vomits more than 4 hours after taking cabotegravir tablets, the patient does not need to take another dose of cabotegravir until the next regular scheduled dose.
Cabotegravir tablets may be taken with or without food. When taken at the same time as rilpivirine tablets, cabotegravir tablets should be taken with a meal.
For:
Intramuscular
400 - 600 mg
From 400 To 600 mg once every 28 day(s)
600 mg
When used for oral lead-in, oral cabotegravir together with oral rilpivirine should be taken for approximately one month (at least 28 days) to assess tolerability to cabotegravir and rilpivirine. One cabotegravir 30 mg tablet should be taken with one rilpivirine 25 mg tablet, once daily. When administered with rilpivirine, cabotegravir tablets should be taken with a meal (see cabotegravir tablet prescribing information).
Table 1. Oral Lead-in Dosing Schedule in Adults:
| <b.ORAL LEAD-IN | |
| Medicinal product | For 1 month (at least 28 days), followed by the Initiation Injectiona |
| Cabotegravir | 30 mg once daily |
| Rilpivirine | 25 mg once daily |
a see Table 2 for monthly injection dosing schedule and Table 3 for every 2 month dosing schedule.
Initiation injection (600 mg corresponding to 3 mL dose):
On the final day of current antiretroviral therapy or oral lead-in therapy, the recommended initial dose of cabotegravir injection in adults is a single 600 mg intramuscular injection. Cabotegravir injection and rilpivirine injection should be administered at separate gluteal injection sites at the same visit.
Continuation injection (400 mg corresponding to 2 mL dose):
After the initiation injection, the continuation injection dose of cabotegravir in adults is a single 400 mg monthly intramuscular injection. Cabotegravir injection and rilpivirine injection should be administered at separate gluteal injection sites at the same visit. Patients may be given injections up to 7 days before or after the date of the monthly 400 mg injection schedule.
Table 2. Recommended monthly intramuscular dosing schedule in adults:
| b>INITIATION INJECTION | CONTINUATION INJECTION | ||
| b>Medicinal product | Direct to injection: month 1 or Following oral lead- in: month 2 | One month after initiation injection and monthly onwards | |
| Cabotegravir | 600 mg | 400 mg | |
| Rilpivirine | 900 mg | 600 mg |
Initiation Injections – one month apart (600 mg):
On the final day of current antiretroviral therapy or oral lead-in therapy, the recommended initial cabotegravir injection in adults is a single 600 mg intramuscular injection.
One month later, a second cabotegravir 600 mg intramuscular injection should be administered. Patients may be given the second 600 mg initiation injection up to 7 days before or after the scheduled dosing date.
Cabotegravir injection and rilpivirine injection should be administered at separate gluteal injection sites at the same visit.
Continuation Injections – 2 months apart (600 mg):
After the initiation injections, the recommended cabotegravir continuation injection dose in adults is a single 600 mg intramuscular injection administered every 2 months. Cabotegravir injection and rilpivirine injection should be administered at separate gluteal injection sites at the same visit. Patients may be given injections up to 7 days before or after the date of the every 2 month, 600 mg injection schedule.
Table 3. Recommended every 2 month intramuscular dosing schedule in adults:
| b>INITIATION INJECTIONS | CONTINUATION INJECTIONS | ||
| 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 | |
| Rilpivirine | 900 mg | 900 mg |
Patients switching from a monthly continuation injection schedule to an every 2 month continuation injection schedule should receive a single 600 mg intramuscular injection of cabotegravir one month after the last 400 mg continuation injection dose and then 600 mg every 2 months thereafter.
Patients switching from an every 2 month continuation injection schedule to a monthly continuation dosing schedule should receive a single 400 mg intramuscular injection of cabotegravir 2 months after the last 600 mg continuation injection dose and then 400 mg monthly thereafter.
Patients who miss a scheduled injection visit should be clinically reassessed to ensure resumption of therapy remains appropriate. See Tables 4 and 5 for dosing recommendations after a missed injection.
If a patient plans to miss a scheduled injection visit by more than 7 days, oral therapy (one 30 mg cabotegravir tablet and one 25 mg rilpivirine tablet once daily) may be used to replace up to 2 consecutive monthly injection visits. For oral therapy durations greater than two months, an alternative oral regimen is recommended.
The first dose of oral therapy should be taken one month (+/- 7 days) after the last injection doses of cabotegravir and rilpivirine. Injection dosing should be resumed on the day oral dosing completes, as recommended in Table 4.
Table 4. Cabotegravir injection dosing recommendations after missed injections or oral therapy for patients on monthly injection dosing:
| Time since last injection | Recommendation |
| ≤2 months: | Continue with the monthly 400 mg injection schedule as soon as possible |
| >2 months: | Re-initiate the patient on the 600 mg dose, and then continue to follow the monthly 400 mg injection schedule. |
If a patient plans to miss a scheduled cabotegravir injection visit by more than 7 days, oral therapy (one 30 mg cabotegravir tablet and one 25 mg rilpivirine tablet, once daily) may be used to replace one, 2-monthly injection visit. For oral therapy durations greater than two months, an alternative oral regimen is recommended.
The first dose of oral therapy should be taken two months (+/- 7 days) after the last injection doses of cabotegravir and rilpivirine. Injection dosing should be resumed on the day oral dosing completes, as recommended in Table 5.
Table 5. Cabotegravir injection dosing recommendations after missed injections or oral therapy for patients on every 2 month injection dosing:
| Missed Injection Visit | Time since last injection | Recommendation (all injections are 3 mL) |
| Injection 2 | ≤2 months | Resume with 600 mg injection as soon as possible and then continue with the every 2 month injection schedule. |
| >2 months | Re-initiate the patient on the 600 mg dose, followed by a second 600 mg initiation injection one month later. Then follow the every 2 month injection schedule. | |
| Injection 3 or later | ≤3 months | Resume with 600 mg injection as soon as possible and then continue with the every 2 month injection schedule. |
| >3 months | Re-initiate the patient on the 600 mg dose, followed by a second 600 mg initiation injection one month later. Then follow the every 2 month injection schedule. |
Care should be taken to avoid inadvertent injection into a blood vessel.
Cabotegravir injection should always be co-administered with rilpivirine injection. The order of injections is not important. The prescribing information for rilpivirine injection should be consulted for recommended dosing.
Injections must be administered to the ventrogluteal (recommended) or the dorsogluteal sites.
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