Vocabria Dosage/Direction for Use

Vocabria should be prescribed by physicians experienced in the management of HIV infection.
Prior to starting Vocabria, healthcare professionals should carefully select patients who agree to the required injection schedule and counsel patients about the importance of adherence to scheduled dosing visits to help maintain viral suppression and reduce the risk of viral rebound and potential development of resistance with missed doses (see Precautions).
Tablet: Vocabria tablets are indicated for the short-term treatment of HIV in combination with rilpivirine tablets, therefore, the prescribing information for rilpivirine tablets should be consulted for recommended dosing.
Suspension for injection: Each injection should be administered by a healthcare professional.
Vocabria injection is indicated for the treatment of HIV-1 in combination with rilpivirine injection, therefore, the prescribing information for rilpivirine injection should be consulted for recommended dosing.
Following discontinuation of Vocabria and rilpivirine injection, it is essential to adopt an alternative, fully suppressive antiretroviral regimen no later than one month after the final injection of Vocabria when dosed monthly and no later than two months after the final injection of Vocabria when dosed every 2 months (see Precautions).
The healthcare provider and patient may decide to use cabotegravir tablets as an oral lead-in prior to the initiation of Vocabria injection to assess tolerability to cabotegravir (see Table 10) or may proceed directly to Vocabria injections (see Table 11 for monthly and Table 12 for every 2 month dosing recommendations).
Posology: Adults: Tablet: Oral lead-in: Prior to the initiation of cabotegravir injection, Vocabria tablets together with rilpivirine tablets should be taken for approximately one month (at least 28 days) to assess tolerability to cabotegravir and rilpivirine (see Precautions). One Vocabria 30 mg tablet should be taken with one rilpivirine 25 mg tablet, once daily. (See Table 9.)

Click on icon to see table/diagram/image

Oral dosing for missed injections of cabotegravir: If a patient plans to miss a scheduled injection visit by more than 7 days, oral therapy (one Vocabria 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.
Missed doses: If the patient misses a dose of Vocabria 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 Vocabria tablets, another Vocabria tablet should be taken. If a patient vomits more than 4 hours after taking Vocabria tablets, the patient does not need to take another dose of Vocabria until the next regular scheduled dose.
Suspension for injection: Oral lead-in: 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 (see Precautions). 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). (See Table 10.)

Click on icon to see table/diagram/image

Monthly dosing: 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 Vocabria injection in adults is a single 600 mg intramuscular injection. Vocabria 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 Vocabria in adults is a single 400 mg monthly intramuscular injection. Vocabria 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. (See Table 11.)

Click on icon to see table/diagram/image

Every 2 Month Dosing: Initiation Injections - one month apart (600 mg): On the final day of current antiretroviral therapy or oral lead-in therapy, the recommended initial Vocabria injection in adults is a single 600 mg intramuscular injection.
One month later, a second Vocabria 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.
Vocabria 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 Vocabria continuation injection dose in adults is a single 600 mg intramuscular injection administered every 2 months. Vocabria 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. (See Table 12.)

Click on icon to see table/diagram/image

Dosing recommendations when switching from monthly to every 2 month injections: 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.
Dosing recommendations when switching from every 2 month to monthly injections: 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.
Missed doses: Patients who miss a scheduled injection visit should be clinically reassessed to ensure resumption of therapy remains appropriate. See Tables 13 and 14 for dosing recommendations after a missed injection.
Missed monthly 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. Limited data is available on oral bridging with other fully suppressive antiretroviral therapy (ART) (mainly INI-based), see Pharmacology: Pharmacodynamics under Actions. 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 Vocabria and rilpivirine. Injection dosing should be resumed on the day oral dosing completes, as recommended in Table 13. (See Table 13.)

Click on icon to see table/diagram/image

Missed 2 month injection: If a patient plans to miss a scheduled Vocabria 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. Limited data is available on oral bridging with other fully suppressive ART (mainly INI-based), see Pharmacology: Pharmacodynamics under Actions. For oral therapy durations greater than two months, an alternative oral regimen is recommended.
The first dose of oral therapy should be taken approximately 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 14. (See Table 14.)

Click on icon to see table/diagram/image

Elderly: No dose adjustment is required in elderly patients. There are limited data available on the use of cabotegravir in patients aged 65 years and over (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No dosage adjustment is required in patients with mild to severe renal impairment (CrCL <30 mL/min and not on dialysis [see Pharmacology: Pharmacokinetics under Actions]). Cabotegravir has not been studied in patients with end-stage renal disease on renal replacement therapy. As cabotegravir is greater than 99% protein bound, dialysis is not expected to alter exposures of cabotegravir. If administered in a patient on renal replacement therapy, cabotegravir should be used with caution.
Hepatic impairment: No dosage adjustment is required in patients with mild or moderate hepatic impairment (Child-Pugh score A or B). Cabotegravir has not been studied in patients with severe hepatic impairment (Child-Pugh score C [see Pharmacology: Pharmacokinetics under Actions]). If administered in a patient with severe hepatic impairment, cabotegravir should be used with caution.
Paediatric population: The safety and efficacy of Vocabria in children and adolescents aged under 18 years have not been established. No data are available.
Method of administration: Tablet: Oral use.
Vocabria tablets may be taken with or without food. When taken at the same time as rilpivirine tablets, Vocabria tablets should be taken with a meal.
Suspension for injection: For intramuscular use. Care should be taken to avoid inadvertent injection into a blood vessel.
Vocabria injection should be administered by a healthcare professional. For instructions on administration, see Instructions for Use under Cautions for Usage.
Vocabria 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.
When administering Vocabria injection, healthcare professionals should take into consideration the Body Mass Index (BMI) of the patient to ensure that the needle length is sufficient to reach the gluteus muscle.
Hold the vial firmly and vigorously shake for a full 10 seconds. Invert the vial and check the resuspension. It should look uniform. If the suspension is not uniform, shake the vial again. It is normal to see small air bubbles.
Injections must be administered to the ventrogluteal (recommended) or the dorsogluteal sites.