Delstrigo Dosage/Direction for Use

Therapy should be initiated by a physician experienced in the management of HIV infection.
Posology: The recommended dose of Delstrigo is one 100/300/300 mg tablet taken orally once daily with or without food.
Dose adjustment: If Delstrigo is co-administered with rifabutin, the doravirine dose should be increased to 100 mg twice daily. This is achieved by adding one 100 mg tablet of doravirine (as a single agent), to be taken approximately 12 hours apart from the dose of Delstrigo (see Interactions).
Co-administration of doravirine with other moderate CYP3A inducers has not been evaluated, but decreased doravirine concentrations are expected. If co-administration with other moderate CYP3A inducers (e.g., dabrafenib, lesinurad, bosentan, thioridazine, nafcillin, modafinil, telotristat ethyl) cannot be avoided, one 100 mg tablet of doravirine should be taken daily, approximately 12 hours after the dose of Delstrigo (see Interactions).
Missed dose: If the patient misses a dose of Delstrigo within 12 hours of the time it is usually taken, the patient should take Delstrigo as soon as possible and resume the normal dosing schedule. If a patient misses a dose of Delstrigo by more than 12 hours, the patient should not take the missed dose and instead take the next dose at the regularly scheduled time. The patient should not take 2 doses at one time.
Special populations: Elderly: There are limited data available on the use of doravirine, lamivudine, and tenofovir disoproxil in patients aged 65 years and over. There is no evidence that elderly patients require a different dose than younger adult patients (see Pharmacology: Pharmacokinetics under Actions). Special care is advised in this age group due to age associated changes such as decreases in renal function (see Precautions).
Renal impairment: No dose adjustment of Delstrigo is required in adults with estimated creatinine clearance (CrCl) ≥ 50 mL/min.
Delstrigo should not be initiated in patients with estimated CrCl < 50 mL/min (see Precautions and Pharmacology: Pharmacokinetics under Actions). Delstrigo should be discontinued if estimated CrCl declines below 50 mL/min (see Precautions). Patients with moderate or severe renal impairment require a dose interval adjustment of lamivudine and tenofovir disoproxil that cannot be achieved with the combination tablet (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No dose adjustment of doravirine/lamivudine/tenofovir disoproxil is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. Doravirine has not been studied in patients with severe hepatic impairment (Child-Pugh Class C). It is not known whether the exposure to doravirine will increase in patients with severe hepatic impairment. Therefore, caution is advised when doravirine/lamivudine/tenofovir disoproxil is administered to patients with severe hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: Safety and efficacy of Delstrigo in children aged less than 12 years or weighing less than 35 kg have not been established.
Method of administration: Delstrigo must be taken orally, once daily with or without food and swallowed whole (see Pharmacology: Pharmacokinetics under Actions).