EDURANT FILM-COATED TABLET 25 MG [SIN14363P]

Product Info

EDURANT FILM-COATED TABLET 25 MG

[SIN14363P]

Indications

Adults
EDURANT®, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve adult patients with a viral load ≤ 100,000 HIV-1 RNA copies/mL at the start of therapy (see Clinical Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Pediatric patients (12 to 17 years of age and weighing at least 32 kg)
EDURANT®, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve pediatric patients 12 to 17 years with a viral load of ≤100000 HIV-1 RNA copies/mL.

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).

Pediatrics (≥12 to 17 years of age and weighing at least 32 kg)
The recommended dose of EDURANT® is one 25 mg tablet once daily taken orally with a meal.

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 (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.

Administration

EDURANT® 25 mg tablet
The recommended dose of EDURANT® is one 25 mg tablet once daily taken orally with a meal.

Contraindications
Hypersensitivity to rilpivirine or to any of the excipients.

EDURANT® should not be co-administered with the following medicinal products, as significant decreases in rilpivirine plasma concentrations may occur (due to CYP3A enzyme induction or gastric pH increase), which may result in loss of therapeutic effect of EDURANT® (see Interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information):

• the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin

• the antimycobacterials rifampicin, rifapentine

• proton pump inhibitors, such as omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole

• the glucocorticoid systemic dexamethasone, except as a single dose treatment

• St John’s wort (Hypericum perforatum)