Odefsey

HIV-1 infection in adults & adolescents (≥12 yr weighing at least 35 kg) w/o known mutations associated w/ resistance to NNRTI class, tenofovir or emtricitabine & w/ viral load ≤100,000 HIV-1 RNA copies/mL.

1 tab once daily.

Should be taken with food: Do not chew/crush/split.

Hypersensitivity. Co-administration w/ medicinal products that can significantly decrease rilpivirine plasma conc (due to CYP3A enzyme induction or gastric pH increase), including carbamazepine, oxcarbazepine, phenobarb, phenytoin, rifabutin, rifampicin, rifapentine, omeprazole, esomeprazole, dexlansoprazole, lansoprazole, pantoprazole, rabeprazole, dexamethasone (oral & parenteral doses, except as single-dose treatment), St. John's wort.

Insufficient data to justify use in patients w/ prior NNRTI failure. Higher rate of treatment-emergent resistance to NNRTI class in patients w/ baseline viral load >100,000 HIV-1 RNA copies/mL who experienced virologic failure. Increased risk for severe & potentially fatal hepatic adverse reactions in patients w/ chronic hepatitis B or C treated w/ antiretroviral therapy. Safety & efficacy have not been established in patients co-infected w/ HIV-1 & HCV. Risk for severe acute exacerbations of hepatitis in patients co-infected w/ HIV & HBV who discontinue Odefsey, therefore closely monitor w/ both clinical & lab follow-up for at least several mth after stopping treatment. Safety & efficacy have not been established in patients w/ significant underlying liver disorders. Increased frequency of liver function abnormalities during combination antiretroviral therapy (CART) in patients w/ pre-existing liver dysfunction, including chronic active hepatitis. Interrupt or discontinue treatment if there is evidence of worsening liver disease. Risk of increases in wt & in blood lipid & glucose levels. Reports of mitochondrial dysfunction in HIV -ve infants exposed in utero &/or postnatally to nucleoside analogues. Risk of immune reactivation syndrome. Risk of opportunistic infections & other complications of HIV infection. Reports of osteonecrosis, particularly in patients w/ advanced HIV disease &/or long-term exposure to CART. Risk of renal impairment, including acute renal failure, proximal renal tubulopathy, & Fanconi syndrome. Increased risk of renal-related adverse reactions in patients taking tenofovir prodrugs who have impaired renal function & those taking nephrotoxic agents, including NSAIDs. Assess serum creatinine, estimated CrCl, urine glucose, & urine protein prior to or when initiating treatment & during treatment on a clinically appropriate schedule, & also assess serum P in patients w/ CKD. Discontinue treatment in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Caution when co-administered w/ medicinal products w/ known risk of torsade de pointes. Do not co-administer w/ other antiretroviral medicinal products. Do not co-administer w/ other medicinal products containing tenofovir alafenamide, lamivudine, tenofovir disoproxil or adefovir dipivoxil. Should not be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Minor influence on the ability to drive & use machines. Discontinue in patients w/ estimated CrCl that declines <30 mL/min during treatment. Avoid in patients w/ ESRD (estimated CrCl <15 mL/min) on chronic haemodialysis, but may be used w/ caution if potential benefits outweigh potential risks. Avoid in patients w/ estimated CrCl ≥15 to <30 mL/min, or <15 mL/min not on chronic haemodialysis. Caution in patients w/ moderate hepatic impairment. Not recommended in patients w/ severe hepatic impairment. Accompany use w/ effective contraception. Use during pregnancy only if potential benefit justifies potential risk to foetus. Do not breastfeed while on treatment. Safety & efficacy have not yet been established in childn <12 yr or weighing <35 kg.

Increased total cholesterol (fasted) & LDL-C (fasted); insomnia; headache, dizziness; nausea, increased pancreatic amylase; increased transaminases (AST &/or ALT). Decreased WBC count, Hb, & platelet count; decreased appetite, increased triglycerides (fasted); depression, abnormal dreams, sleep disorders, depressed mood; somnolence; abdominal pain, vomiting, increased lipase, abdominal discomfort, dry mouth, flatulence, diarrhoea; increased bilirubin; rash; fatigue.

Caution w/ QT-prolonging medicinal products. Risk for increases in plasma conc of dabigatran etexilate (intestinal P-gp inhibition). Emtricitabine: Co-administration w/ medicinal products that are eliminated by active tubular secretion may increase conc of emtricitabine &/or the co-administered medicinal product. Conc may be increased by medicinal products that decrease renal function. Rilpivirine: Decreased plasma conc w/ CYP3A inducers (eg, rifapentine, carbamazepine, oxcarbazepine, phenobarb, phenytoin, systemic dexamethasone [except for single-dose use], St. John's wort); PPIs (eg, omeprazole, lansoprazole, rabeprazole, pantoprazole, esomeprazole, dexlansoprazole), H₂-receptor antagonists (eg, famotidine, cimetidine, nizatidine, ranitidine), antacids (eg, Al or Mg hydroxide, Ca carbonate). Increased plasma conc w/ CYP3A inhibitors (eg, fluconazole, itraconazole, posaconazole, voriconazole, clarithromycin, erythromycin, ciclosporin). Tenofovir alafenamide: Decreased plasma conc w/ P-gp inducers (eg, rifampicin, rifapentine, rifabutin, carbamazepine, oxcarbazepine, phenobarb, phenytoin, St. John's wort). Increased plasma conc w/ P-gp inhibitors (eg, ketoconazole, fluconazole, itraconazole, posaconazole, voriconazole, clarithromycin, erythromycin, ciclosporin). Distribution may be affected by OATP1B1 & OATP1B3 activity.

Antivirals

J05AR19 - emtricitabine, tenofovir alafenamide and rilpivirine ; Belongs to the class of antivirals for treatment of HIV infections, combinations.

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