Descovy

/ Gilead

Adults and adolescents aged 12 years and older, weighing at least 35 kg:
Dose of this formulation according to third agent in the HIV treatment regimen:
Descovy 200/10 mg once daily: Atazanavir with ritonavir or cobicistat; Darunavir with ritonavir or cobicistat*; Lopinavir with ritonavir.
Descovy 200/25 mg once daily: Dolutegravir, efavirenz, maraviroc, nevirapine, rilpivirine, raltegravir.
*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 prescribing information for full details.
If the patient misses a dose of this drug within 18 hours of the time it is usually taken, the patient should take the drug  as soon as possible and resume the normal dosing schedule. If a patient misses a dose  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 this drug  another tablet should be taken.
Elderly: No dose adjustment is required in elderly patients.
Renal impairment: No dose adjustment 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.
The drug should not be initiated in patients with estimated CrCl < 30 mL/min as there are limited data available regarding this population.
The drug should be discontinued in patients with estimated CrCl that declines below 30 mL/min during treatment.
Hepatic impairment: No dose adjustment is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. This formulation has not been studied in patients with severe hepatic impairment (Child-Pugh Class C); therefore, The drug  is not recommended for use in patients with severe hepatic impairment.
Paediatric population: The safety and efficacy of the drug 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. The film-coated tablet should not be chewed, crushed, or split as it has a very bitter taste and it may impact the absorption of Descovy.

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).

Hypersensitivity to the active substances or to any of the excipients.

This formulation should not be administered concurrently with certain anticonvulsants (e.g., carbamazepine, oxcarbazepine, phenobarbital and phenytoin), antimycobacterials (e.g., rifampicin, rifabutin, rifapentine), boceprevir, St. John’s wort and HIV protease inhibitors (PIs) other than atazanavir, lopinavir and darunavir.
This formulation should not be administered concomitantly with medicinal products containing tenofovir alafenamide, tenofovir disoproxil, emtricitabine, lamivudine or adefovir dipivoxil.
HCV/HBV (hepatitis B virus) co-infection due to an increased risk for sever and potentially fatal hepatic adverse reactions.
This formulation should not be initiated in patients with estimated CrCl<30 mL/min as there are limited data available regarding the use of this drug in this population.
This formulation should not be discontinued in patients with estimated CrCl that declines below 30 mL/min during treatment.
This formulation is not recommended for use in patients with severe hepatic impairment as the product has not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination with antiretroviral therapy (CART) and should be monitored according to standard practice.
This formulation should be avoided in antiretroviral-experienced patients with HIV-1 harbouring the K65R mutation.
See prescribing information for full details.

Very common: Nausea.
Common: Abnormal dreams, headache, dizziness, diarrhoea, vomiting, abdominal pain, flatulence, rash and fatigue.
See prescribing information for full details.

Interaction studies have only been performed in adults.
This medicine should not be administered concomitantly with medicinal products containing tenofovir alafenamide, tenofovir disoproxil, emtricitabine, lamivudine or adefovir dipivoxil.
Emtricitabine: In vitro and clinical pharmacokinetic drug-drug interaction studies have shown that the potential for CYP-mediated interactions involving emtricitabine with other medicinal products is low. Co-administration of emtricitabine with medicinal products that are eliminated by active tubular secretion may increase concentrations of emtricitabine, and/or the co-administered medicinal product. Medicinal products that decrease renal function may increase concentrations of emtricitabine.
Tenofovir alafenamide: Tenofovir alafenamide is transported by P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP). Medicinal products that strongly affect P-gp activity and BCRP may lead to changes in tenofovir alafenamide absorption. Medicinal products that induce P-gp activity (e.g., rifampicin, rifabutin, carbamazepine, phenobarbital) are expected to decrease the absorption of tenofovir alafenamide, resulting in decreased plasma concentration of tenofovir alafenamide, which may lead to loss of therapeutic effect of this drug  and development of resistance. Co-administration of This drug  with other medicinal products that inhibit P-gp (e.g., cobicistat, ritonavir, ciclosporin) are expected to increase the absorption and plasma concentration of tenofovir alafenamide. It is not known whether the co-administration of Descovy and xanthine oxidase inhibitors (e.g., febuxostat) would increase systemic exposure to tenofovir.
Tenofovir alafenamide is not an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP2D6 in vitro. It is not an inhibitor of CYP3A4 in vivo. Tenofovir alafenamide is a substrate of OATP1B1 and OATP1B3 in vitro. The distribution of tenofovir alafenamide in the body may be affected by the activity of OATP1B1 and OATP1B3.
Other interactions: Tenofovir alafenamide is not an inhibitor of human uridine diphosphate glucuronosyltransferase (UGT) 1A1 in vitro. It is not known whether tenofovir alafenamide is an inhibitor of other UGT enzymes. Emtricitabine did not inhibit the glucuronidation reaction of a non-specific UGT substrate in vitro.
See prescribing information for full details.

Pregnancy: There are no adequate and well-controlled studies of this drug or its components in pregnant women. Descovy should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Lactation: It is not known whether tenofovir alafenamide is excreted in human milk. Emtricitabine is excreted in human milk. There is insufficient information on the effects of emtricitabine and tenofovir in newborns/infants.
Therefore, Descovy should not be used during breast-feeding.
In order to avoid transmission of HIV to the infant it is recommended that HIV infected women do not breast-feed their infants under any circumstances.
See prescribing information for full details.

If overdose occurs the patient must be monitored for evidence of toxicity.Treatment of overdose with this drug 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.  

Storage: Store in the original package in order to protect from moisture. After first opening, use within 60 days.