APRETUDE Film-coated tablet Ref.[114751] Active ingredients: Cabotegravir

Apretude should be prescribed by a healthcare professional experienced in the management of HIV PrEP.

Individuals must be tested for HIV-1 prior to initiating cabotegravir (see section 4.3). A combined antigen/antibody test as well as an HIV-RNA-based test should both be negative. Prescribers are advised to perform both tests, even if the result of the HIV-RNA-based test will become available after oral administration. If a combined testing strategy including both tests is not available, testing should follow local guidelines.

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.

The healthcare provider and individual may decide to use cabotegravir tablets as an oral lead-in prior to the initiation of Apretude injection to assess tolerability (see Table 1) or may proceed directly to Apretude injections (see Apretude injection SmPC).

Posology

Oral lead-in

When used for oral lead-in, cabotegravir tablets should be taken for approximately one month (at least 28 days) to assess tolerability to cabotegravir (see section 4.4). One Apretude 30 mg tablet should be taken, once daily with or without food.

Table 1. Recommended dosing schedule:

Oral dosing for missed injections of cabotegravir.

If a delay of more than 7 days from a scheduled injection visit cannot be avoided, Apretude 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 Apretude injection SmPC).

Missed doses

If the individual misses a dose of Apretude 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.

Vomiting

If an individual vomits within 4 hours of taking Apretude tablets, another Apretude tablet should be taken. If an individual vomits more than 4 hours after taking Apretude tablets, the individual does not need to take another tablet until the next regularly scheduled dose.

Special populations

Elderly

No dose adjustment is required in elderly individuals. There are limited data available on the use of cabotegravir in individuals aged 65 years and over (see section 5.2).

Hepatic impairment

No dose adjustment is required in individuals with mild or moderate hepatic impairment (Child-Pugh score A or B). Cabotegravir has not been studied in individuals with severe hepatic impairment (Child- Pugh score C [see section 5.2]).

If administered in an individual with severe hepatic impairment, cabotegravir should be used with caution.

Renal impairment

No dose 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 section 5.2]). Cabotegravir has not been studied in individuals 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 an individual on renal replacement therapy, cabotegravir should be used with caution.

Paediatric population

The safety and efficacy of cabotegravir in children and adolescents weighing less than 35 kg have not been established. No data are available.

Method of administration

Oral use.

There is no specific treatment for Apretude overdose. If overdose occurs, the individual should be treated supportively with appropriate monitoring as necessary.

Cabotegravir is known to be highly protein bound in plasma; therefore, dialysis is unlikely to be helpful in removal of medicinal product from the body.

5 years.

This medicinal product does not require any special storage conditions.

White HDPE (high density polyethylene) bottles closed with polypropylene child-resistant closure, with a polyethylene faced induction heat seal liner. Each bottle contains 30 film-coated tablets.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.