Sign Out
Dosing Considerations: Viral load must be determined prior to initiation of therapy. Therapy must not be initiated in patients with a viral load ≥ 100 000 copies/mL.
EDURANT (rilpivirine) must always be given in combination with other antiretroviral medicinal products.
EDURANT must always be given with a meal.
Recommended Dose and Dosage Adjustment: Adults: The recommended dose of EDURANT is one 25 mg tablet once daily which must be taken with a meal (see Pharmacology: Pharmacokinetics: Absorption: Effect of food on absorption under Actions).
Geriatric Patients: Clinical studies of EDURANT did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from adult subjects < 65 years of age.
EDURANT should be used with caution in this population (see Geriatrics: Geriatrics (> 65 years of age) under Indications/Uses, Use in Elderly under Precautions, and Pharmacology: Pharmacokinetics: Special Populations and Conditions: Geriatrics under Actions).
Pediatric Patients: Pediatric (12 to <18 years of age and weighing ≥ 35 kg): The recommended dose of EDURANT for pediatric patients 12 years to <18 years of age and weighing at least 35 kg is one 25 mg tablet once daily which must be taken with a meal (see Pharmacology: Pharmacokinetics: Absorption: Effect of food on absorption under Actions).
Pediatric (less than 12 years of age or < 35 kg): The safety and efficacy of EDURANT in children less than 12 years of age or weighing < 35 kg has not been established. (See Pediatrics: Pediatrics (<12 years of age) under Indications/Uses, Use in Children under Precautions, and Pharmacology: Pharmacokinetics: Special Populations and Conditions: Pediatrics under Actions.)
Pregnancy and Postpartum: The recommended dose of EDURANT in pregnant patients is one 25 mg tablet once daily taken with a meal. Lower exposures of rilpivirine were observed during the 2nd and 3rd trimesters of pregnancy, therefore viral load should be monitored closely (see Use in Pregnancy under Precautions, Pregnant Women under Use in Pregnancy & Lactation, and Pharmacology: Pharmacokinetics: Special Populations and Conditions: Pregnancy and Breast-feeding: Pregnancy and Postpartum under Actions).
Hepatic Impairment: EDURANT has not been studied in patients with severe hepatic impairment (Child-Pugh score C) and the use of EDURANT is not recommended in this population. No dose adjustment of EDURANT is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. However, given that the metabolism of EDURANT is cytochrome P450-mediated and that clinical experience in patients with mild or moderate hepatic impairment is limited, caution should be exercised when administering EDURANT to this population (see Hepatic/Biliary/Pancreatic: Hepatic Impairment under Precautions and Pharmacology: Pharmacokinetics: Special Populations and Conditions: Hepatic Insufficiency under Actions).
Renal Impairment: EDURANT has not been studied in patients with renal impairment. Caution should be exercised when administering EDURANT to patients with severe renal impairment or end-stage renal disease whose drug absorption, distribution and metabolism may be altered secondary to renal dysfunction. No dose adjustment of EDURANT is required in patients with mild to moderate renal impairment. As 99.7% of rilpivirine is bound to plasma proteins, it is unlikely that it will be significantly removed by hemodialysis or peritoneal dialysis (see Renal: Renal Impairment under Precautions and Pharmacology: Pharmacokinetics: Special Populations and Conditions: Renal Insufficiency under Actions).
Missed Dose: 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.
Co-administration with Rifabutin: 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 Drug-Drug Interactions: Table 12 under Interactions).
