Isentress

Raltegravir

400 mg FC tab In combination w/ other antiretroviral agents for the treatment of HIV-1 infection in adults, adolescents & childn ≥6 yr weighing at least 25 kg. 600 mg FC tab In combination w/ other antiretroviral agents for the treatment of HIV-1 infection in adults & paed patients weighing at least 40 kg.

400 mg FC tab Adult, adolescent & childn ≥6 yr & weighing at least 25 kg 1 tab bd. 600 mg FC tab Adult & paed patient weighing at least 40 kg 2 tab (1,200 mg) once daily for treatment-naïve patients or patients who are virologically suppressed on initial regimen of Isentress 400 mg bd.

May be taken with or without food.

Hypersensitivity.

Residual risk of HIV transmission. Reports of depression, including suicidal ideation & behaviours, particularly in patients w/ pre-existing history of depression or psychiatric illness. Increased frequency of liver function abnormalities during combination antiretroviral therapy (CART) in patients w/ pre-existing liver dysfunction including chronic hepatitis. Increased risk of severe & potentially fatal hepatic adverse reactions in patients w/ chronic hepatitis B or C treated w/ CART. Caution in patients w/ severe hepatic impairment. Reports of osteonecrosis particularly in patients w/ advanced HIV &/or long-term exposure to CART. Risk of immune reactivation syndrome during initiation of CART in HIV patients w/ severe immune deficiency. Reports of myopathy & rhabdomyolysis. Reports of severe skin & hypersensitivity reactions including SJS & TEN. More common occurrence of rash when combined w/ darunavir. Patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Not recommended w/ Al- &/or Mg-containing antacids. In treatment-naïve patients, clinical study data are limited to raltegravir use in combination w/ 2 NRTIs (emtricitabine & tenofovir disoproxil fumarate). May influence ability to drive & use machines. Do not use during breast-feeding. Caution in the elderly. 400 mg FC tab: Do not use to administer 1,200 mg once daily regimen. Caution w/ strong UGT1A1 inducers (eg, rifampicin). Raltegravir 400 mg bd can be used during pregnancy if clinically needed. Safety & efficacy in childn <6 yr have not been established. 600 mg FC tab (1,200 mg once daily): Not recommended w/ atazanavir; tipranavir/ritonavir; Ca carbonate-containing antacids; strong UGT1A1 inducers (eg, rifampicin). Not recommended during pregnancy. Do not use in childn weighing <40 kg.

Decreased appetite; abnormal dreams, insomnia, nightmare, abnormal behaviour, depression; dizziness, headache, psychomotor hyperactivity; vertigo; abdominal distention, abdominal pain, diarrhoea, flatulence, nausea, vomiting, dyspepsia; rash; asthenia, fatigue, pyrexia; atypical lymphocytes, increased ALT, AST, blood triglycerides, lipase, & blood pancreatic amylase.

Decreased plasma levels w/ strong UGT1A1 inducers (eg, rifampicin); Al- &/or Mg-containing antacids; Fe salts. Increased plasma levels w/ potent UGT1A1 inhibitors (eg, atazanavir). 400 mg bd: Increased plasma levels w/ less potent UGT1A1 inhibitors (eg, indinavir, saquinavir). 1,200 mg once daily: Decreased plasma levels w/ tipranavir/ritonavir; Ca carbonate-containing antacids. Caution w/ sensitive OAT1 &/or OAT3 substrates. Not recommended w/ strong UGT1A1 inducers (eg, phenytoin, phenobarb).

Antivirals

J05AJ01 - raltegravir ; Belongs to the class of integrase inhibitors. Used as direct acting antiviral in the systemic treatment of viral infections.

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