EDURANT FILM-COATED TABLET 25 MG

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Therapeutic

Prescription Only

TABLET, FILM COATED

**Dosage and Administration** EDURANT® must always be given in combination with other antiretroviral medicinal products. **Dosage (Adults)** The recommended dose of EDURANT® is one 25 mg tablet taken orally once daily. EDURANT® **must be taken** with a meal (see _Pharmacokinetic Properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _**Dose adjustment with rifabutin coadministration**_ For patients concomitantly receiving rifabutin, the EDURANT® dose should be increased to 50 mg (two tablets of 25 mg each) once daily, taken with a meal. When rifabutin co-administration is stopped, the EDURANT® dose should be decreased to 25 mg once daily, taken with a meal (see _Interaction with Other Medicinal Products and Other Forms of Interaction_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Special populations** _**Pediatrics (12 to 17 years)**_ The recommended dose of EDURANT® is one 25 mg tablet once daily taken orally with a meal (see _Pharmacokinetic properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _**Pediatrics (less than 12 years of age)**_ The safety and efficacy of EDURANT® in children less than 12 years have not been established (see _Pharmacokinetic Properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Treatment with EDURANT® is not recommended in children less than 12 years of age. _**Pregnancy and Postpartum**_ Lower exposures of rilpivirine were observed during pregnancy, therefore viral load should be monitored closely (see _Pregnancy, Breastfeeding and Fertility and Pharmacokinetic Properties-Special Populations – Pregnancy and Postpartum_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _**Elderly (65 years of age and older)**_ There is limited information regarding the use of EDURANT® in patients >65 years of age. No dose adjustment of EDURANT® is required in elderly patients (see _Pharmacokinetic Properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). EDURANT® should be used with caution in this population. _**Renal Impairment**_ EDURANT® has mainly been studied in patients with normal renal function. No dose adjustment of EDURANT® is required in patients with mild or moderate renal impairment. In patients with severe renal impairment or end-stage renal disease, EDURANT® should be used with caution. In patients with severe renal impairment or end-stage renal disease, the combination of EDURANT® with a strong CYP3A inhibitor (e.g., ritonavir-boosted HIV protease inhibitor) should only be used if the benefit outweighs the risk (see _Pharmacokinetic Properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Treatment with EDURANT® resulted in an early small increase of mean serum creatinine levels which remained stable over time and is not considered clinically relevant (see _Adverse Reactions_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _**Hepatic Impairment**_ There is limited information regarding the use of EDURANT® in patients with mild or moderate hepatic impairment (Child-Pugh score A or B). No dose adjustment of EDURANT® is required in patients with mild or moderate hepatic impairment. EDURANT® should be used with caution in patients with moderate hepatic impairment. EDURANT® has not been studied in patients with severe hepatic impairment (Child-Pugh score C). Therefore, EDURANT® is not recommended in patients with severe hepatic impairment (see _Pharmacokinetic Properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _**Timing of Dosing**_ If the patient misses a dose of EDURANT® within 12 hours of the time it is usually taken, the patient should take EDURANT® with a meal as soon as possible and then take the next dose of EDURANT® at the regularly scheduled time. If a patient misses a dose of EDURANT® by more than 12 hours, the patient should not take the missed dose, but resume the usual dosing schedule.