PIFELTRO FILM-COATED TABLET 100MG

1. INDICATIONS AND USAGE

PIFELTRO is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults infected with HIV-1 without past or present evidence of viral resistance to NNRTI.

3. CONTRAINDICATIONS

PIFELTRO 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 PIFELTRO [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

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 ].