DELSTRIGO FILM COATED TABLET 100MG/300MG/300MG

1. INDICATIONS AND USAGE

DELSTRIGO is indicated for the treatment of adults infected with HIV-1 without past or present evidence of viral resistance to NNRTIs, lamivudine, or tenofovir.

3. CONTRAINDICATIONS

DELSTRIGO should not be co-administered with drugs that are strong cytochrome P450 CYP3A enzyme inducers as significant decreases in doravirine plasma concentrations may occur, which may decrease the effectiveness of DELSTRIGO [see Clinical Pharmacology (10.5) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information ]. These drugs include, but are not limited to, the following:

• the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin
• the androgen receptor inhibitor enzalutamide
• the antimycobacterials rifampin, rifapentine
• the cytotoxic agent mitotane
• St. John’s wort (Hypericum perforatum)
• lumacaftor

DELSTRIGO is contraindicated in patients with a previous hypersensitivity reaction to any component of this combination.

2. DOSAGE AND ADMINISTRATION

2.1 General

DELSTRIGO is a fixed-dose combination product containing 100 mg of doravirine, 300 mg of lamivudine, and 300 mg of tenofovir disoproxil fumarate (tenofovir DF).

2.2 Adult Patients

The recommended dosage regimen of DELSTRIGO in adults is one tablet taken orally once daily with or without food.

Missed Dose

If the patient misses a dose of DELSTRIGO, the patient should take DELSTRIGO as soon as possible unless it is almost time for the next dose. The patient should not take 2 doses at one time and instead take the next dose at the regularly scheduled time.

2.3 Pediatric Patients

Safety and efficacy of DELSTRIGO have not been established in patients younger than 18 years of age [see Clinical Pharmacology (10.4) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information ].

2.4 Elderly Patients

There are limited data available on the use of doravirine, lamivudine and tenofovir DF in patients aged 65 years and over. There is no evidence that elderly patients require a different dose than younger adult patients [see Use in Specific Populations (6.4) and Clinical Pharmacology (10.4) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information ]. Special care is advised in this age group due to age associated changes such as decreases in renal function.

2.5 Renal Impairment

Because DELSTRIGO is a fixed-dose combination tablet and the dosage of lamivudine and tenofovir DF cannot be altered, patients with estimated creatinine clearance less than 50 mL/min should not receive DELSTRIGO [see Warnings and Precautions (4.2), Use in Specific Populations (6.5) and Clinical Pharmacology (10.4) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information ].

2.6 Hepatic Impairment

No dose adjustment of DELSTRIGO is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. DELSTRIGO has not been studied in patients with severe hepatic impairment (Child-Pugh Class C) [see Use in Specific Populations (6.6) and Clinical Pharmacology (10.4) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information ].

2.7 Co-administration with Rifabutin

If DELSTRIGO is co-administered with rifabutin, one tablet of doravirine (PIFELTRO) should be taken approximately 12 hours after the dose of DELSTRIGO [see Drug Interactions and Other Forms of Interactions (5.2) and Clinical Pharmacology (10.5) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information ].