DESCOVY FILM COATED TABLET 200 MG/25 MG [SIN15322P]

Product Info

DESCOVY FILM COATED TABLET 200 MG/25 MG

[SIN15322P]

4.1 Therapeutic indications

Descovy is indicated in combination with other antiretroviral agents for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus type 1(HIV-1) (see sections 4.2 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Posology and method of administration

Therapy should be initiated by a physician experienced in the management of HIV infection.

Posology

Adults and adolescents aged 12 years and older, weighing at least 35 kg

Descovy should be administered as shown in Table 1.

If the patient misses a dose of Descovy within 18 hours of the time it is usually taken, the patient should take Descovy as soon as possible and resume the normal dosing schedule. If a patient misses a dose of Descovy by more than 18 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.

If the patient vomits within 1 hour of taking Descovy another tablet should be taken.

Elderly
No dose adjustment of Descovy is required in elderly patients (see sections 5.1 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment
No dose adjustment of Descovy is required in adults or adolescents (aged at least 12 years and of at least 35 kg body weight) with estimated creatinine clearance (CrCl) ≥ 30 mL/min. Descovy should be discontinued in patients with estimated CrCl that declines below 30 mL/min during treatment (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

No dose adjustment of Descovy is required in adults with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis; however, Descovy should generally be avoided but may be used in these patients if the potential benefits are considered to outweigh the potential risks (see sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). On days of haemodialysis, Descovy should be administered after completion of haemodialysis treatment.

Descovy should be avoided in patients with estimated CrCl ≥ 15 mL/min and < 30 mL/min, or < 15 mL/min who are not on chronic haemodialysis, as the safety of Descovy has not been established in these populations.

No data are available to make dose recommendations in children less than 18 years with end stage renal disease.

Hepatic impairment
No dose adjustment of Descovy is required in patients with hepatic impairment.

Paediatric population
The safety and efficacy of Descovy in children younger than 12 years of age, or weighing < 35 kg, have not yet been established. No data are available.

Method of administration

Descovy should be taken orally, once daily with or without food (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The film-coated tablet should not be chewed, crushed, or split.

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.