Apretude Dosage/Direction for Use

Posology: Individuals must have had a documented negative HIV-1 test, in accordance with applicable guidelines, prior to initiating APRETUDE.
Prior to starting APRETUDE, individuals should be carefully selected to agree to the required dosing schedule and counselled about the importance of adherence to scheduled dosing visits to help reduce the risk of acquiring HIV-1 infection.
Method of Administration: Suspension for Injection: Refer to the Instructions for Use for detailed step by step injection procedure (see Patient Counselling Information).
The BMI of the individual should be taken into consideration to ensure that the needle length is sufficient to reach the gluteus muscle.
Adults, adolescents weighing at least 35 kg: Following discussion with the individual, the physician may proceed directly to APRETUDE injection, (see Table 7 for dosing recommendations).
Alternatively, APRETUDE tablets may be used as an oral lead in prior to the initiation of APRETUDE injection to assess tolerability to cabotegravir (see Table 7).
Oral lead-in (Film-coated tablets): When used for oral lead-in, APRETUDE oral tablets are recommended for approximately one month (at least 28 days) prior to the initiation of APRETUDE injection to assess tolerability to cabotegravir. (See Table 7.)

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Suspension for Injection: Initiation Injections: The recommended initial APRETUDE injection dose is a single 3 mL (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 3 mL (600 mg) intramuscular injection should be administered. Individuals may be given the second 3 mL (600 mg) initiation injection up to 7 days before or after the scheduled dosing date.
Continuation Injections: After the second initiation injection, the recommended APRETUDE continuation injection dose is a single 3 mL (600 mg) intramuscular injection administered every 2 months. Individuals may be given injections up to 7 days before or after the scheduled dosing date. (See Table 8.)

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Missed dose: Suspension for Injection: Adherence to the injection dosing schedule is strongly recommended.
Individuals who miss a scheduled injection visit should be clinically reassessed and an HIV test performed to ensure resumption of PrEP remains appropriate. See Table 9 for dosing recommendations after a missed injection.
If a delay of more than 7 days from a scheduled injection visit cannot be avoided, APRETUDE tablets (30 mg) may be used once daily to replace one scheduled injection visit. For oral PrEP durations greater than two months, an alternative regimen to oral PrEP is recommended.
The first dose of oral PrEP (or alternative oral PrEP regimen) should be taken two months (+/-7 days) after the last injection dose of APRETUDE. Injection dosing should be planned to resume on the last day of oral PrEP or within 3 days, thereafter, as recommended in Table 9. (See Table 9.)

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Adolescents and Children: The safety and efficacy of APRETUDE in children and adolescents weighing less than 35 kg have not been established.
Elderly: No dose adjustment is required in elderly individuals. There are limited data available on the use of APRETUDE in individuals aged 65 years and over (see Pharmacology: Pharmacokinetics: Special Patient Populations under Actions).
Renal impairment: No dosage adjustment is required in individuals with mild (creatinine clearance ≥60 to <90 mL/min), moderate (creatinine clearance ≥30 to <60 mL/min) or severe renal impairment (creatinine clearance ≥15 to <30 mL/min and not on dialysis) (see Pharmacology: Pharmacokinetics: Special Patient Populations under Actions).
Hepatic impairment: No dosage adjustment is required in individuals with mild or moderate hepatic impairment (Child-Pugh score A or B). APRETUDE has not been studied in individuals with severe hepatic impairment (Child-Pugh score C) (see Pharmacology: Pharmacokinetics: Special Patient Populations under Actions).