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.

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. Women w/ HIV should not breast-feed to avoid HIV transmission to infants. 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/ other 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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