Medicinal Products

DESCOVY 200mg / 25mg tablet film pack of 1 vial of 30

Generic drug of the therapeutic class: Infectiology - Parasitology
Active ingredients: [Emtricitabine + TÚnofovir alafà © namide, 4441]
laboratory: Gilead Sciences

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Indication

Descovy is indicated in combination with other antiretrovirals for the treatment of adults and adolescents (≥12 years of age, weighing at least 35 kg) infected with human immunodeficiency virus type 1 (HIV-1). ) (see sections Posology and method of administration and Pharmacodynamic properties ).

Dosage DESCOVY 200 mg / 25 mg tablet film boouche of 1 bottle of 30

Descovy is indicated in combination with other antiretrovirals for the treatment of adults and adolescents (≥12 years of age, weighing at least 35 kg) infected with human immunodeficiency virus type 1 (HIV-1). ) (see sections Posology and method of administration and Pharmacodynamic properties ).

Against indications

Hypersensitivity to the active substances or to any of the excipients listed under Composition .

Descovy side effects

Summary of the job security profile

The adverse reaction assessment is based on safety data from all Phase 2 and Phase 3 studies in which 2, 832 HIV-1 infected patients received drugs containing emtricitabine and tenofovir alafenamide. In clinical studies in 866 adult treatment-naive patients who received emtricitabine and tenofovir alafenamide with elvitegravir and cobicistat as a fixed-dose combination containing 150 mg elvitegravir / 150 mg cobicistat Emtricitabine / 200 mg tenofovir alafenamide (as fumarate) (E / C / F / TAF), the most commonly reported adverse events were diarrhea (7%), nausea (10%) and headache (6%).

Summary table of adverse effects

The adverse effects listed in Table 3 are presented by system organ class and frequency. Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100, <1/10), and uncommon (≥ 1/1000, <1/100).

Table 3: list of side effects 1

Frequency

Undesirable effect

Blood and lymphatic system disorders

Rare :

anemia 2

Psychiatric disorders

Frequent

abnormal dreams

Nervous system disorders

Frequent

headache, dizziness

Gastrointestinal disorders

Very common :

nausea

Frequent

diarrhea, vomiting, abdominal pain, flatulence

Rare :

dyspepsia

Skin and subcutaneous tissue disorders

Frequent

rash

Rare :

angioedema 2, 3, pruritus

Musculoskeletal and systemic disorders

Rare :

arthralgia

General disorders and administration site conditions

Frequent

tired

1 With the exception of angioedema and anemia (see notes 2 and 3), all adverse events have been identified in studies with F / TAF-containing products. Frequencies are from phase 3 clinical studies conducted with E / C / F / TAF in 866 adult treatment-naive patients over 48 weeks (GS-US-292-0104 and GS-US-292-0111).

2 This adverse reaction has not been observed in clinical studies with F / TAF-containing products, but has been identified in clinical or post-marketing studies for emtricitabine in combination with other antiretrovirals.

3 This adverse reaction has been identified in post-marketing experience with emtricitabine but has not been observed in randomized controlled clinical trials in adults or in clinical studies in pediatric patients with HIV with emtricitabine. The "infrequent" frequency category was estimated from a statistical calculation based on the total number of patients exposed to emtricitabine in these clinical studies (n = 1, 563).

Description of some specific adverse effects

Immune Restoration Syndrome

In HIV-infected patients with severe immune deficiency at the time of initiation of antiretroviral combination therapy, an inflammatory response to asymptomatic or residual opportunistic infections may occur. The occurrence of autoimmune diseases (such as Graves' disease) has also been reported. However, the time of onset that has been reported is more variable and these events may occur several months after initiation of treatment (see Warnings and Precautions section ).

osteonecrosis

Cases of osteonecrosis have been reported, particularly in patients with known risk factors, advanced HIV-related disease, or combination therapy with long-term antiretrovirals. Their frequency of occurrence is not known (see section Warnings and Precautions ).

Changes in lipid biological parameters

Increases over treatment initiation were observed in the groups receiving tenofovir alafenamide fumarate and tenofovir disoproxil fumarate treatment at week 48 for lipid parameters measured under fasting conditions: total cholesterol, cholesterol LDL and HDL direct and triglycerides. The median increase in these parameters between initiation of treatment and week 48 was greater in the E / C / F / TAF treated group than in the 150 mg elvitegravir / 150 mg cobicistat group. 200 mg emtricitabine / 245 mg tenofovir disoproxil (as fumarate) (E / C / F / TDF) (p <0.001 for the difference between treatment groups for fasting measurements of total cholesterol, LDL cholesterol and HDL direct and triglycerides). The median (Q1, Q3) change in the ratio of total cholesterol to HDL cholesterol between initiation of treatment and week 48 was 0.1 (-0.3, 0.5) in the I / C group. / F / TAF and 0.0 (-0.5; 0.4) in the group treated with E / C / F / TDF (p <0.001 for the difference between the treatment groups).

Metabolic parameters

Increased body weight, blood lipid and glucose levels may occur during antiretroviral therapy (see Warnings and Precautions section ).

Pediatric population

The safety of emtricitabine and tenofovir alafenamide was evaluated over 48 weeks in an open-label clinical study (GS-US-292-0106) during which pediatric patients infected with HIV-1, treatment-naive, aged 12 to <18 years, received emtricitabine and tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination. The safety profile of the combination emtricitabine and tenofovir alafenamide with elvitegravir and cobicistat observed in the 50 adolescent patients was similar to that seen in adults (see section 5.1 Pharmacodynamic properties ).

Other special populations

Patients with renal insufficiency

The safety of emtricitabine and tenofovir alafenamide was evaluated over 48 weeks in an open-label clinical study (GS-US-292-0112) in which 248 HIV-1 infected patients, naive treatment = 6) or virologically controlled (n = 242) and mild to moderate renal impairment (glomerular filtration rate estimated by the Cockcroft-Gault formula [ CG eGe]: 30 - 69 mL / min) received emtricitabine and tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination. The safety profile for patients with mild to moderate renal impairment was similar to that seen in patients with normal renal function (see section 5.1 ).

Patients co-infected with HIV and HBV

The safety of emtricitabine and tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination was evaluated in approximately 70 patients co-infected with HIV and HBV receiving treatment for HIV during an open clinical trial (GS-US-292-1249). In this limited experiment, the safety profile of Descovy in patients co-infected with HIV and HBV appears to be similar to that observed in patients infected with HIV-1 alone (see section 4.4). of employment ).

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals report any suspected adverse reactions via the national reporting system - see Annex V.

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