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

MSD PHARMA (SINGAPORE) PTE. LTD.

MSD PHARMA (SINGAPORE) PTE. LTD.

Therapeutic

Prescription Only

TABLET, FILM COATED

**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 _\[see Drug Interactions and Other Forms of Interactions (5.2) and Clinical Pharmacology (10.5)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_.