Medicinal Products

EMTRIVA 10 mg / mL

Generic drug of the therapeutic class: Infectiology - Parasitology
active ingredients: Emtricitabine
laboratory: Gilead Sciences Internat

Drinkable solution
Box of 1 Bottle (+ measuring cup) of 170 ml
All forms

Indication

- Emtriva is indicated in combination with other antiretrovirals for the treatment of adults and children infected with HIV-1.
- This indication is based on studies in antiretroviral-naive patients and pretreated patients with controlled viral load. There is no experience with the use of Emtriva in patients who are failing their current treatment or who have failed multiple lines of antiretroviral therapy (see section 5.1).
- Recourse to a new treatment in patients for whom previous antiretroviral therapy has failed, should be based on the rigorous analysis of the mutation patterns associated with the different drugs as well as the therapeutic history of each patient. Resistance tests may, if necessary, be useful.

Dosage EMTRIVA 10 mg / mL Oral solution Box of 1 Bottle (+ measuring cup) of 170 ml

- Treatment should be initiated by a physician experienced in the management of HIV infection.
- Emtriva 10 mg / ml oral solution can be taken with or without food. A dosing cup is provided (see section nature and contents of the pack).
- Adults: The recommended dose of Emtriva 10 mg / ml oral solution is 240 mg (24 ml) once a day.
- Children and adolescents up to 18 years: The recommended dose of Emtriva 10 mg / ml oral solution is 6 mg / kg up to a maximum of 240 mg (24 ml) once a day.
. Children weighing at least 33 kg can take emtricitabine either as a 200 mg capsule daily or as oral solution up to 240 mg once daily.
. There are no efficacy data and very little safety data for emtricitabine in infants under 4 months of age. Therefore, it is not recommended to use Emtriva in infants younger than 4 months of age (for pharmacokinetic data in this age group, see section 5.2).
- Emtriva 200 mg capsules is available for adults, adolescents and children weighing at least 33 kg and can swallow capsules. Please refer to the Summary of Product Characteristics of Emtriva 200 mg hard capsules. Due to a difference in the bioavailability of emtricitabine between capsule and solution formulations, a plasma concentration similar to that observed following administration of a 200 mg emtricitabine capsule can be achieved with 240 mg of emtricitabine administered in the form of emtricitabine. of oral solution (24 ml) (see section 5.2).
- Elderly: There are no safety and efficacy data available for patients over 65 years of age. However, no adjustment of the recommended daily dose in adults should be necessary in the absence of renal insufficiency.
- Renal impairment: Emtricitabine is excreted by renal excretion and exposure to emtricitabine has been significantly increased in patients with renal impairment (see section 5.2 Pharmacokinetic properties). Adjustment of dose or interval between administrations is required in all patients with creatinine clearance <50 ml / min (see section cautionary and precautions for use).
. The table below specifies the daily dose of Emtriva 10 mg / ml oral solution depending on the degree of renal impairment. As the safety and efficacy of these doses have not been clinically evaluated, the clinical response to treatment and renal function should be closely monitored in these patients (see section 4.4).
. Patients with renal impairment may also be treated with Emtriva 200 mg capsules by increasing the interval between doses. Please refer to the Summary of Product Characteristics for Emtriva 200 mg hard capsules.
. Creatinine clearance: Recommended dose of Emtriva 10 mg / ml oral solution per 24 hours .
Clcr> = 50 ml / min : 240 mg (24 ml).
Clcr 30-49 ml / min : 120 mg (12 ml).
Clcr 15-29 ml / min : 80 mg (8 ml).
Clcr <15 ml / min (renally impaired hemodialysis) * : 60 mg (6 ml).
* On the basis of a 3-hour hemodialysis session three times a week starting at least 12 hours after the last dose of emtricitabine.
. Patients with end-stage renal disease (ESRD) treated with other forms of dialysis such as ambulatory peritoneal dialysis have not been studied and no dose recommendation can be given.
. There are no data available to establish a dosing recommendation in children with renal impairment.
- Hepatic impairment: There are no data available to establish a dosing recommendation for hepatic impairment. However, because of the low metabolism and renal elimination pathway of emtricitabine, dose adjustment is unlikely to be required in patients with hepatic impairment (see section 5.2). If Emtriva is discontinued in patients co-infected with HIV and HBV, these patients should be closely monitored for signs of hepatitis exacerbations (see section cautionary statements and precautions for use).

Against indications

CONTRAINDICATED:
Hypersensitivity to the active substance or to any of the excipients.
NOT RECOMMENDED :
- There are no efficacy data and very little safety data for emtricitabine in infants under 4 months of age. Therefore, it is not recommended to use Emtriva in infants under 4 months of age.
- Pregnancy: The safety of emtricitabine in pregnant women has not been established. Animal studies have not shown direct or indirect harmful effects of emtricitabine on pregnancy, fetal development, childbirth or postnatal development. Emtricitabine should only be used during pregnancy if necessary. However, since potential risks to fetal development are not known, the use of emtricitabine in women of childbearing potential should be accompanied by effective contraception.
- Breast-feeding: It is not known if emtricitabine is excreted in breast milk. In general, HIV-infected women are not advised to breast-feed their infants in order to prevent transmission of the virus to the newborn.
- Emtriva should not be taken with other medicines containing emtricitabine or lamivudine.
- The use of emtricitabine in combination with zalcitabine for the treatment of HIV infection can not be recommended to date.

Emtriva side effects

The adverse effects assessment is based on data from three studies in adults (n = 1479) and three pediatric studies (n = 169). In the adult studies, 1039 antiretroviral-naive patients and 440 pre-treated patients received emtricitabine (n = 814) or a comparator drug (n = 665) for 48 weeks in combination with other antiretroviral drugs. . In three pediatric studies, naïve children (n = 123) and pre-treated children (n = 46) aged 4 months to 18 years were treated with emtricitabine in combination with other antiretrovirals.
Adverse effects of at least possible imputability in adults are listed below by organ class and absolute frequency. Within each frequency group, adverse effects are presented in descending order of severity. The frequencies are defined according to the following categories: very frequent (> = 1/10), frequent (> = 1/100, = 1/1000, <1/100).
- Hematological and lymphatic system disorders:
. Frequent : neutropenia . Uncommon : anemia.
- Metabolism and nutrition disorders:
. Frequent : hypertriglyceridaemia, hyperglycemia.
. Cases of lactic acidosis, usually associated with hepatic steatosis, have been reported with the administration of nucleoside analogues (see section 4.4). - Psychiatric disorders:
Frequent : insomnia, abnormal dreams.
- disorders of the nervous system:
. Very common : headache.
. Frequent : vertigo.
- Gastrointestinal disorders:
. Very common : diarrhea, nausea.
. Frequent : vomiting, abdominal pain, elevation of amylase, including pancreatic amylase, elevation of serum lipases, dyspepsia.
- Hepatobiliary disorders:
Frequent : hyperbilirubinemia, elevated ASAT (aspartate aminotransferase) and / or ALAT (alanine aminotransferase) levels.
- Skin and subcutaneous tissue disorders:
Common : allergic reaction, urticaria, vesiculobullous rash, pustular rash, maculopapular rash, pruritus, rash, and skin dyschromia (hyperpigmentation).
- Musculoskeletal and systemic disorders:
Very common : elevation of creatine kinase.
- General disorders and anomalies at the site of administration:
Frequent : asthenia, pain.
In addition to the reported adverse effects in adults, anemia was common and skin dyschromia (hyperpigmentation) was very common in pediatric patients.
- The adverse event profile in patients co-infected with HBV is comparable to that seen in HIV-infected patients without co-infection with HBV; however, as expected for this category of patients, elevations in ASAT and ALT were more frequent than in the general HIV-infected population.
- Combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolemia, insulin resistance, hyperglycemia and hyperlactataemia (see section 4.4).
- Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV-infected patients, including loss of subcutaneous peripheral and facial adipose tissue, increased body mass intra-abdominal and visceral fat, breast hypertrophy and retrocervical fat accumulation (buffalo hump) (see section on warnings and precautions for use).
- In HIV-infected patients with severe immune deficiency at the time of initiation of antiretroviral combination therapy, an inflammatory reaction to asymptomatic or residual opportunistic infections may occur (see section 4.4). examples: cytomegalovirus retinitis, generalized and / or localized mycobacterial infections, and Pneumocystis carinii pneumonia ).
- 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 for use: pain, arthralgia, joint stiffness, difficulty in moving).
- The oral solution of Emtriva contains orange-yellow S (E110) which can cause allergic reactions of methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which can cause allergic reactions (possibly delayed).

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