Apretude

FC tab: Short term pre-exposure prophylaxis (PrEP) to reduce risk of sexually acquired HIV-1 infection in at-risk individuals weighing at least 35 kg. Oral lead-in to assess tolerability prior to inj administration; oral PrEP in individuals who will miss planned dosing w/ inj. PR susp for inj: PrEP to reduce risk of sexually acquired HIV-1 infection in at-risk individuals weighing at least 35 kg.

FC tab Adult & adolescent weighing at least 35 kg Oral lead-in 30 mg once daily for approx 1 mth (at least 28 days) prior to initiation of inj. PR susp for inj IM Adult & adolescent weighing at least 35 kg Initiation inj: 600 mg (3 mL) on the last day of oral lead-in or w/in 3 days thereafter. Give 2nd 600 mg (3 mL) inj 1 mth later up to 7 days before or after scheduled dosing date. Continuation inj: 600 mg (3 mL) after 2nd initiation inj, every 2 mth up to 7 days before or after scheduled dosing date.

FC tab: May be taken with or without food.

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

Rash, constitutional findings & sometimes organ dysfunction including liver injury. Not effective in preventing HIV-1 acquisition. Discontinue treatment & other suspected agents immediately if signs or symptoms of hypersensitivity develop (eg, severe rash, or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial oedema, hepatitis, eosinophilia or angioedema); hepatotoxicity is confirmed. 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 treatment discontinuation for those individuals at continuing risk of HIV acquisition & initiated w/in 2 mth of final inj; clinical & lab monitoring. Monitor clinical status including liver aminotransferases. Concomitant use w/ medicinal products that may reduce cabotegravir exposure. Severe hepatic impairment (Child-Pugh score C). Hepatotoxicity w/ or w/o known pre-existing hepatic disease. Pregnancy & lactation. Childn & adolescents weighing <35 kg. Elderly ≥65 yr. PR susp for inj: Do not inj IV. Residual conc may remain in systemic circulation for up to ≥12 mth after treatment discontinuation.

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

Decreased plasma conc w/ strong UGT1A1 or UGT1A9 inducers; rifampicin; rifapentine; anticonvulsants eg, carbamazepine, oxcarbazepine, phenytoin, phenobarb. FC tab: Concomitant use w/ antacids containing polyvalent cations. PR susp for inj: 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.

S