ODEFSEY FILM-COATED TABLET 200MG/25MG/25MG [SIN16015P]

Product Info

ODEFSEY FILM-COATED TABLET 200MG/25MG/25MG

[SIN16015P]

Indications

ODEFSEY® is indicated as a complete regimen for the treatment of human immunodeficiency virus type-1 (HIV-1) infection in adults and pediatric patients (12 years of age and older with body weight at least 35 kg) with a viral load ≤ 100,000 HIV-1 RNA copies/mL at the start of therapy, and without known mutations associated with resistance to any of the three antiretroviral components. (see Pharmacological Properties – Clinical Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Dosage and Administration

Adults and Pediatric Patients 12 to less than 18 years of age and weighing ≥35 kg

The recommended dose of ODEFSEY® is one tablet taken orally once daily with food (see Pharmacological Properties – Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

If the patient misses a dose of ODEFSEY® within 12 hours of the time it is usually taken, the patient should take ODEFSEY® with food as soon as possible and resume the normal dosing schedule. If a patient misses a dose of ODEFSEY® by more than 12 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.

If the patient vomits within 4 hours of taking ODEFSEY®, another tablet should be taken with food. If a patient vomits more than 4 hours after taking ODEFSEY®, they do not need to take another dose of ODEFSEY® until the next regularly scheduled dose.

Special populations

Pediatrics (less than 12 years of age)

The safety and efficacy of ODEFSEY® have not been established in pediatric patients less than 12 years of age or weighing < 35 kg.

Elderly (65 years of age and older)

No data are available on which to make a dose recommendation for patients over the age of 65 years.

Renal impairment

No dose adjustment of ODEFSEY® is required in adult patients with estimated creatinine clearance greater than or equal to 30 mL/minute.

ODEFSEY® should not be initiated in patients with estimated creatinine clearance below 30 mL/minute as there are insufficient data available regarding the use of ODEFSEY® in this population.

No data are available to make dose recommendations in pediatric patients with renal impairment.

Hepatic impairment

No dose adjustment of ODEFSEY® is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. ODEFSEY® has not been studied in patients with severe hepatic impairment (Child-Pugh Class C). Hence, ODEFSEY® is not recommended for use in patients with severe hepatic impairment. (see Pharmacological Properties – Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Contraindications

Known hypersensitivity to emtricitabine (FTC), rilpivirine (RPV), tenofovir alafenamide (TAF), or to any of the excipients.

ODEFSEY® should not be coadministered with the following medicinal products, as significant decreases in RPV plasma concentrations may occur (due to CYP3A enzyme induction or gastric pH increase), which may result in loss of therapeutic effect of ODEFSEY® (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 rifampin, rifapentine

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

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

• St. John’s wort (Hypericum perforatum)