Apretude Special Precautions

Overall HIV-1 infection prevention strategy: APRETUDE is not always effective in preventing HIV-1 acquisition (see Pharmacology: Pharmacodynamics: Clinical studies under Actions). The time to onset of protection after commencing APRETUDE is unknown.
APRETUDE should be used for pre-exposure prophylaxis as part of an overall HIV-1 infection prevention strategy, including the use of other HIV-1 prevention measures (e.g. knowledge of HIV-1 status, regular testing for other sexually transmitted infections, condom use).
APRETUDE should only be used to reduce the risk of acquiring HIV-1 in individuals confirmed to be HIV negative (see Contraindications). Individuals should be reconfirmed to be HIV-negative at frequent intervals (e.g. in line with local guidelines, but at no more than 3 month intervals) while taking APRETUDE for pre-exposure prophylaxis.
If clinical symptoms consistent with acute viral infection are present and recent (<1 month) exposures to HIV-1 are suspected, HIV-1 status should be reconfirmed.
Potential risk of resistance: There is a potential risk of developing resistance to APRETUDE if an individual acquires HIV-1 either before or during administration of APRETUDE, or following discontinuation of APRETUDE PrEP, (see Long-acting properties of APRETUDE injection as follows).
To minimise this, it is essential to clinically reassess individuals for risk of HIV acquisition and to frequently test to confirm HIV negative status. Individuals who are suspected or confirmed with HIV-1 should immediately begin ART.
Alternative forms of PrEP should be considered following discontinuation of APRETUDE for those individuals at continuing risk of HIV acquisition and initiated within 2 months of the final APRETUDE injection.
Long-acting properties of APRETUDE injection: Residual concentrations of cabotegravir injection may remain in the systemic circulation of individuals for prolonged periods (up to 12 months or longer), therefore, physicians should take the prolonged release characteristics of APRETUDE into consideration when the medicinal product is discontinued (see Interactions, Use in Pregnancy and Lactation, and Overdosage).
Importance of adherence: Individuals should be counselled periodically to strictly adhere to the recommended APRETUDE dosing schedule in order to reduce the risk of HIV-1 acquisition and the potential development of resistance.
Hypersensitivity reactions: Hypersensitivity reactions have been reported in association with integrase inhibitors. These reactions were characterised by rash, constitutional findings and sometimes organ dysfunction, including liver injury. Discontinue APRETUDE and other suspected agents immediately, should signs or symptoms of hypersensitivity develop (including, but not limited to, severe rash, or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial oedema, hepatitis, eosinophilia or angioedema). Clinical status, including liver aminotransferases, should be monitored and appropriate therapy initiated. (see Dosage & Administration, Contraindications, Adverse Reactions, Long-acting properties of APRETUDE injection as previously mentioned, Pharmacology: Pharmacodynamics: Clinical studies under Actions).
Hepatotoxicity: Hepatotoxicity has been reported in a limited number of individuals receiving APRETUDE with or without known pre-existing hepatic disease (see Adverse Reactions).
Clinical and laboratory monitoring should be considered and APRETUDE should be discontinued if hepatotoxicity is confirmed and individuals managed as clinically indicated (see Long-acting properties of APRETUDE injection as previously mentioned).
Interactions with medicinal products: Caution should be given when prescribing APRETUDE with medicinal products that may reduce its exposure (see Interactions).
Effects on Ability to Drive and Use Machines: There have been no studies to investigate the effect of APRETUDE on driving performance or the ability to operate machinery. The clinical status of the individual and the adverse event profile of APRETUDE should be borne in mind when considering the individual's ability to drive or operate machinery.