Delstrigo

Doravirine 100 mg, lamivudine 300 mg, tenofovir disoproxil fumarate 300 mg

HIV-1 infection in adults w/o past or present evidence of resistance to the NNRTI class, lamivudine, or tenofovir. HIV-1 infection in adolescents (≥12 yr & weighing at least 35 kg) w/o past or present evidence of resistance to the NNRTI class, lamivudine, or tenofovir & who have experienced toxicities which preclude the use of other regimens that do not contain tenofovir disoproxil.

1 tab once daily.

May be taken with or without food.

Hypersensitivity. Co-administration w/ strong CYP3A inducers (eg, carbamazepine, oxcarbazepine, phenobarb, phenytoin, rifampicin, rifapentine, St. John's wort, mitotane, enzalutamide, lumacaftor).

Test all HIV-1 patients for HBV presence before initiating antiretroviral therapy. Reports of severe acute exacerbations of hepatitis B in patients co-infected w/ HIV-1 & HBV, & have discontinued lamivudine or tenofovir disoproxil. Reports of renal impairment (including cases of acute renal failure & Fanconi syndrome) w/ use of tenofovir disoproxil. Assess estimated CrCl prior to initiating therapy & as clinically appropriate during therapy. Patients at risk of renal dysfunction, including patients who have previously experienced renal events while receiving adefovir dipivoxil, should also assess serum P, urine glucose & urine protein prior to treatment initiation, & frequently monitor renal function as appropriate. Discontinue treatment if estimated CrCl declines to <50 mL/min. Risk of bone loss & mineralisation defects. Assess bone mineral density in patients w/ history of pathologic bone fracture or other risk factors for osteoporosis or bone loss. Reports of immune reactivation syndrome. Avoid concurrent or recent use of nephrotoxic medicinal products. Do not co-administer w/ other medicinal products containing lamivudine, or w/ medicinal products containing tenofovir disoproxil or tenofovir alafenamide, or w/ adefovir dipivoxil. Do not co-administer w/ doravirine unless needed for dose adjustment (eg, w/ rifabutin). Caution when co-administered w/ CYP3A inducers; in patients w/ severe hepatic impairment; elderly. Patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Minor influence on the ability to drive & use machines. Avoid use during pregnancy. Do not breast-feed to avoid HIV transmission. Safety & efficacy have not been established in childn <12 yr or weighing <35 kg. No sufficient clinical evidence to support use of doravirine in HIV-1 patients w/ evidence of resistance to NNRTI class.

Abnormal dreams, insomnia; headache, dizziness, somnolence; cough, nasal symptoms; nausea, diarrhoea, abdominal pain, vomiting, flatulence; alopecia, rash; muscle disorders; fatigue, fever; increased ALT.

Doravirine: Decreased plasma conc w/ strong CYP3A inducers; moderate CYP3A inducers (eg, rifabutin, dabrafenib, lesinurad, bosentan, thioridazine, nafcillin, modafinil, telotristat ethyl). Increased plasma conc w/ CYP3A inhibitors. Decreased exposure of midazolam (sensitive CYP3A substrate). Caution when co-administered w/ sensitive CYP3A substrates that also have a narrow therapeutic window (eg, tacrolimus & sirolimus). Lamivudine: Increased serum conc w/ medicinal products that reduce renal function or compete for active tubular secretion. Tenofovir disoproxil: Increased serum conc w/ medicinal products that reduce renal function or compete for active tubular secretion via OAT1, OAT3 or MRP4. Avoid concurrent or recent use of nephrotoxic medicinal products (eg, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides, high-dose or multiple NSAIDs).

Antivirals

J05AR24 - lamivudine, tenofovir disoproxil and doravirine ; Belongs to the class of antivirals for treatment of HIV infections, combinations.

P₁S₁S₃