Apretude

Pre-exposure prophylaxis (PrEP) to reduce risk of sexually acquired HIV-1 infection in at-risk adults & adolescents at least 12 yr & 35 kg.

IM Adult & adolescent at least 35 kg Initially 1 inj, 1st inj on last day of oral lead-in or w/in 3 days thereafter if oral lead-in has been used. 2nd initiation inj given 1 mth later up to 7 days before or after scheduled dosing date. Continuation: 1 inj after 2nd initiation inj given every 2 mth up to 7 days before or after scheduled dosing date.

Hypersensitivity. Patients w/ +ve HIV-1 status. Concomitant use w/ rifampicin, rifapentine, phenytoin, phenobarb, carbamazepine & oxcarbazepine.

Not to be inj IV. For PrEP as part of overall HIV-1 infection prevention strategy including use of other HIV-1 prevention measures eg, knowledge of HIV-1 status, regular testing for other sexually transmitted infections, condom use. Discontinue use & other suspected agents immediately if signs or symptoms of hypersensitivity develop; hepatotoxicity is confirmed. Rash, constitutional findings & sometimes organ dysfunction including liver injury. Potential risk of developing resistance. Reconfirm individuals to be HIV -ve at frequent intervals (no >3 mth interval); HIV-1 status if clinical symptoms consistent w/ acute viral infection are present & recent (<1 mth) exposures to HIV-1 are suspected. Consider alternative forms of PrEP following discontinuation for individuals at continuing risk of HIV acquisition & initiated w/in 2 mth of final inj; clinical & lab monitoring. Monitor clinical status including liver aminotransferases. Residual conc may remain in systemic circulation for up to ≥12 mth after treatment discontinuation. Concomitant use w/ medicinal products reducing cabotegravir exposure. Severe hepatic impairment (Child-Pugh score C); hepatotoxicity w/ or w/o known pre-existing hepatic disease. Pregnancy & lactation. Childn & adolescents <35 kg. Elderly ≥65 yr.

Headache; diarrhoea; increased transaminase; pyrexia, inj site pain, tenderness, nodule, induration. Abnormal dreams, insomnia, depression; dizziness; nausea, abdominal pain, flatulence, vomiting; rash; myalgia; fatigue, malaise, inj site swelling, bruising, erythema, warmth, pruritus, anaesth.

Decreased plasma conc w/ strong UGT1A1 or UGT1A9 inducers; rifampicin, rifapentine; anticonvulsants eg, carbamazepine, oxcarbazepine, phenytoin, phenobarb. Concomitant use w/ rifabutin.

Antivirals

J05AJ04 - cabotegravir ; Belongs to the class of integrase inhibitors. Used as direct acting antiviral in the systemic treatment of viral infections.

B