APRETUDE

). • Prior to starting APRETUDE, the healthcare professional should discuss safer sex practices so as to reduce the risk of developing HIV-1. This may include being tested for other sexually transmitted infections, if appropriate. • APRETUDE tablets may be used as an oral lead-in prior to the initiation of APRETUDE injection to assess tolerability to cabotegravir (see Table 1).

• Alternatively, the healthcare professional and individual may proceed directly to injection therapy with APRETUDE injection (see Table 2). • Clinical and laboratory monitoring should be considered and APRETUDE should not be administered if hepatotoxicity is suspected.

If hepatotoxicity is confirmed, APRETUDE should be discontinued and the individuals managed as clinically indicated. 2 Recommended Dose and Dosage Adjustment Adults, adolescents weighing ≥ 35 kg When an oral lead-in is used, dosing for APRETUDE consists of 3 distinct phases: • An oral lead-in with APRETUDE tablets, • Initiation injections of APRETUDE injection (3 mL), and • Continuation injections with APRETUDE injection (3 mL every 2 months).

APRETUDE injection may also be initiated without an oral lead-in. No safety and efficacy data are available for use of APRETUDE without an oral lead-in (see 8 Adverse Reactions and 14 Clinical Trials). However, in HIV-1 treatment clinical trials, data show that an oral lead-in is not needed to ensure adequate plasma cabotegravir exposure upon initiation of injections and that the safety and efficacy results of CABENUVA (cabotegravir extended-release injectable suspension; rilpivirine extended- release injectable suspension) were similar when administered with and without an oral lead-in.

Refer to the recommended dosing section below (see Table 2). Oral lead-in The recommended dose of APRETUDE tablets is one 30 mg tablet orally once daily with or without food. APRETUDE tablets is recommended to be administered for approximately one month (at least 28 days) prior to the initiation of APRETUDE injection to assess tolerability of the individual to cabotegravir.

See Table 1 for recommended oral dosing schedule. Intramuscular Injection Dosing Initiation Injections Initiation injections should be administered on the last day of oral lead-in if used or within 3 days thereafter (see Table 1). The recommended initial dose of APRETUDE injection is a single 3 mL (600 mg) intramuscular injection.

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 injection visit (see Table 1 or Table 2, as applicable).

Continuation Injections After the second initiation injection, the recommended continuation dose of APRETUDE injection is a single 3 mL (600 mg) intramuscular injection administered every 2 months. Individuals may be given APRETUDE injection up to 7 days before or after the scheduled injection visit (see Table 1 or Table 2, as applicable).