PIFELTRO FILM-COATED TABLET 100MG

TABLET, FILM COATED

**2\. DOSAGE AND ADMINISTRATION** **2.1 General** PIFELTRO is a tablet containing 100 mg of doravirine. **2.2 Adult Patients** The recommended dosage regimen of PIFELTRO in adults is one 100 mg tablet taken orally once daily with or without food. Missed Dose If the patient misses a dose of PIFELTRO within 12 hours of the time it is usually taken, the patient should take PIFELTRO as soon as possible and resume the normal dosing schedule. If a patient misses a dose 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. **2.3 Pediatric Patients** Safety and efficacy of PIFELTRO 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 in patients aged 65 years and over. There is no evidence that elderly patients require a different dose than younger adult patients _\[see Use in Specific Populations (6.4) and Clinical Pharmacology (10.4)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_. No dose adjustment of PIFELTRO is needed in elderly patients. **2.5 Renal Impairment** No dose adjustment of PIFELTRO is required in patients with mild, moderate or severe renal impairment. PIFELTRO has not been adequately studied in patients with end-stage renal disease and has not been studied in dialysis patients _\[see Use in Specific Populations (6.5) and Clinical Pharmacology (10.4)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_. **2.6 Hepatic Impairment** No dose adjustment of PIFELTRO is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. PIFELTRO 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 PIFELTRO is co-administered with rifabutin, one tablet of PIFELTRO should be taken twice daily (approximately 12 hours apart) _\[see Drug Interactions and Other Forms of Interactions (5.1) and Clinical Pharmacology (10.5)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_.