Doravirine / Lamivudine / Tenofovir Disoproxil Dosage

Medically reviewed by Drugs.com. Last updated on Feb 16, 2024.

Applies to the following strengths: 100 mg-300 mg-300 mg

Usual Adult Dose for HIV Infection

1 tablet orally once a day

Use: As a complete regimen, for the treatment of HIV-1 infection in patients: with no prior antiretroviral treatment history, OR to replace the current antiretroviral regimen in patients virologically-suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the components of this drug

Usual Pediatric Dose for HIV Infection

At least 35 kg: 1 tablet orally once a day

Use: As a complete regimen, for the treatment of HIV-1 infection in patients: with no prior antiretroviral treatment history, OR to replace the current antiretroviral regimen in patients virologically-suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the components of this drug

Renal Dose Adjustments

Estimated CrCl less than 50 mL/min: Not recommended

If estimated CrCl falls below 50 mL/min during therapy: This drug should be discontinued.

Liver Dose Adjustments

Mild or moderate liver dysfunction (Child-Pugh A or B): No adjustment recommended
Severe liver dysfunction (Child-Pugh C): Data not available

Dose Adjustments

Coadministration with rifabutin: An additional 100 mg/day of doravirine is recommended, separated from this combination product by about 12 hours, for the duration of rifabutin coadministration.

Precautions

US BOXED WARNING:

POSTTREATMENT ACUTE EXACERBATIONS OF HEPATITIS B: Severe acute exacerbations of hepatitis B reported in patients coinfected with HBV and HIV-1 who have stopped lamivudine or tenofovir disoproxil fumarate, components of this drug. Hepatic function of HBV/HIV-1-coinfected patients should be monitored closely with clinical and laboratory follow-up for at least several months after stopping this drug. If appropriate and necessary, antihepatitis B therapy should be started.

CONTRAINDICATIONS:

Coadministration with strong CYP450 3A inducers (may significantly decrease doravirine plasma levels, which may decrease the efficacy of this drug) including, but not limited to, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, enzalutamide, rifampin, rifapentine, mitotane, St. John's wort
Previous hypersensitivity reaction to lamivudine

Safety and efficacy have not been established in pediatric patients weighing less than 35 kg.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

Test patients for HBV infection before or when starting this drug.
In all patients, assess serum creatinine, estimated CrCl, urine glucose, and urine protein before or when starting this drug, and during therapy with this drug as clinically appropriate; in patients with chronic kidney disease, also assess serum phosphorus.
May administer with or without food
If a dose is missed, administer it as soon as remembered unless it is almost time for the next dose, then skip the missed dose and administer the next dose at the regularly scheduled time; do not administer 2 doses at the same time.

Storage requirements:

Store at 20 to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
Store in original bottle and do not remove desiccants; keep bottle tightly closed to protect from moisture.

General:

Each 3-drug fixed-dose combination tablet contains doravirine 100 mg, lamivudine 300 mg, and tenofovir disoproxil fumarate 300 mg.

Monitoring:

Hepatic: Hepatic function of HIV-1/HBV-coinfected patients with clinical and laboratory follow-up (for at least several months after stopping therapy)
Infections/Infestations: For chronic HBV infection in all patients (before starting therapy)
Metabolic: Serum phosphorus in patients with chronic kidney disease (before or when starting and as clinically appropriate during therapy)
Musculoskeletal: Bone mineral density in patients with history of pathologic bone fracture or other risk factors for osteoporosis or bone loss
Renal: Serum creatinine, estimated CrCl, urine glucose, and urine protein in all patients (before or when starting and as clinically appropriate during therapy)

Patient advice: