Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
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).
Therapy should be initiated by a physician experienced in the management of HIV infection.
Descovy should be administered as shown in Table 1.
Table 1. Dose of Descovy according to third agent in the HIV treatment regimen:
| Dose of Descovy | Third agent in HIV treatment regimen (see section 4.5) |
|---|---|
| Descovy 200/10 mg once daily | Atazanavir with ritonavir or cobicistat Darunavir with ritonavir or cobicistat1 Lopinavir with ritonavir |
| Descovy 200/25 mg once daily | Dolutegravir, efavirenz, maraviroc, nevirapine, rilpivirine, raltegravir |
1 Descovy 200/10 mg in combination with darunavir 800 mg and cobicistat 150 mg, administered as a fixed-dose combination tablet, was studied in treatment-naive subjects, see section 5.1.
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.
No dose adjustment of Descovy is required in elderly patients (see sections 5.1 and 5.2).
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).
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). 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.
No dose adjustment of Descovy is required in patients with hepatic impairment.
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.
Oral use.
Descovy should be taken once daily with or without food (see section 5.2). It is recommended that the film-coated tablet is not chewed or crushed due to the bitter taste.
For patients who are unable to swallow the tablet whole, the tablet may be split in half and both halves taken one after the other, ensuring that the full dose is taken immediately.
If overdose occurs the patient must be monitored for evidence of toxicity (see section 4.8). Treatment of overdose with Descovy consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.
Emtricitabine can be removed by haemodialysis, which removes approximately 30% of the emtricitabine dose over a 3 hour dialysis period starting within 1.5 hours of emtricitabine dosing. Tenofovir is efficiently removed by haemodialysis with an extraction coefficient of approximately 54%. It is not known whether emtricitabine or tenofovir can be removed by peritoneal dialysis.
3 years.
Store in the original package in order to protect from moisture. Keep the bottle tightly closed.
High density polyethylene (HDPE) bottle with a polypropylene continuous-thread, child-resistant cap, lined with an induction activated aluminium foil liner containing 30 film-coated tablets. Each bottle contains silica gel desiccant and polyester coil.
The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and outer cartons containing 60 (2 bottles of 30) and 90 (3 bottles of 30) film-coated tablets.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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