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Emtriva is a brand name for Emtricitabine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Emtriva is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus-1 (HIV-1) infected adults and children aged 4 months and over. This indication is based on studies in treatment-naïve patients and treatment-experienced patients with stable virological…
Verbatim from this product's EMA label. Tap a section to expand.
Therapy should be initiated by a physician experienced in the management of HIV infection. Posology Emtriva 200 mg hard capsules may be taken with or without food.
Adults:
The recommended dose of Emtriva is one 200 mg hard capsule, taken orally, once daily. If a patient misses a dose of Emtriva within 12 hours of the time it is usually taken, the patient should take Emtriva with or without food as soon as possible and resume their normal dosing schedule.
If a patient misses a dose of Emtriva by more than 12 hours and it is almost time for their next dose, the patient should not take the missed dose and simply resume the usual dosing schedule. If the patient vomits within 1 hour of taking Emtriva, another dose should be taken.
If the patient vomits more than 1 hour after taking Emtriva they do not need to take another dose. 3 Special populations Elderly: There are no safety and efficacy data available in patients over the age of 65 years. However, no adjustment in the recommended daily dose for adults should be required unless there is evidence of renal insufficiency.
2). 4). Table 1 below provides dose interval adjustment guidelines for the 200 mg hard capsules according to the degree of renal insufficiency. The safety and efficacy of the dose interval adjustments to every 72 or 96 hours in patients with creatinine clearance < 30 mL/min have not been clinically evaluated.
4). Patients with renal insufficiency can also be managed by administration of Emtriva 10 mg/mL oral solution to provide a reduced daily dose of emtricitabine. Please refer to the Summary of Product Characteristics for Emtriva 10 mg/mL oral solution.
Table 1:
Dose interval guidelines for 200 mg hard capsules adjusted according to creatinine clearance Creatinine clearance (mL/min) ≥ 30 15-29 < 15 (functionally anephric, requiring intermittent haemodialysis)* Recommended dose interval for 200 mg hard capsules One 200 mg hard capsule every 24 hours One 200 mg hard capsule every 72 hours One 200 mg hard capsule every 96 hours * Assumes a 3-hour haemodialysis session three times a week commencing at least 12 h after administration of the last dose of emtricitabine.
Patients with end-stage renal disease (ESRD) managed with other forms of dialysis such as ambulatory peritoneal dialysis have not been studied and no dose recommendations can be made.
0%). 8%) occurred more frequently in clinical trials involving HIV infected paediatric patients. 4). Tabulated summary of adverse reactions Assessment of adverse reactions from clinical study data is based on experience in three studies in adults (n = 1,479) and three paediatric studies (n = 169).
In the adult studies, 1,039 treatment-naïve and 440 treatment-experienced patients received emtricitabine (n = 814) or comparator medicinal product (n = 665) for 48 weeks in combination with other antiretroviral medicinal products.
The adverse reactions with suspected (at least possible) relationship to treatment in adults from clinical trial and post-marketing experience are listed in Table 2 below by body system organ class and frequency. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10) or uncommon (≥ 1/1,000 to < 1/100). 8, Description of selected adverse reactions for more details. 8, Paediatric population). 3 This adverse reaction, which was identified through post-marketing surveillance, was not observed in randomised controlled clinical trials in adults or paediatric HIV clinical trials of emtricitabine.
The frequency category of uncommon 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 selected adverse reactions Skin discolouration (increased pigmentation): Skin discolouration, manifested by hyperpigmentation mainly on the palms and/or soles, was generally mild, asymptomatic and of little clinical significance.
The mechanism is unknown. 4).
Immune Reactivation Syndrome:
In HIV infected patients with severe immune deficiency at the time of initiation of CART, an inflammatory reaction to asymptomatic or residual opportunistic infections may arise. 4).
General Emtricitabine is not recommended as monotherapy for the treatment of HIV infection. It must be used in combination with other antiretrovirals. Please also refer to the Summaries of Product Characteristics of the other antiretroviral medicinal products used in the combination regimen.
Co-administration of other medicinal products Emtriva should not be taken with any other medicinal products containing emtricitabine or medicinal products containing lamivudine. Opportunistic infections Patients receiving emtricitabine or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with HIV associated diseases.
Renal function Emtricitabine is principally eliminated by the kidney via glomerular filtration and active tubular secretion. Emtricitabine exposure may be markedly increased in patients with severe renal insufficiency (creatinine clearance < 30 mL/min) receiving daily doses of 200 mg emtricitabine as hard capsules or 240 mg as the oral solution.
Consequently, either a dose interval adjustment (using Emtriva 200 mg hard capsules) or a reduction in the daily dose of emtricitabine (using Emtriva 10 mg/mL oral solution) is required in all patients with creatinine clearance < 30 mL/min.
2 are based on single dose pharmacokinetic data and modelling and have not been clinically evaluated. 2). 5). Weight and metabolic parameters An increase in weight and in levels of blood lipids and glucose may occur during antiretroviral therapy.
Such changes may in part be linked to disease control and life style. For lipids, there is in some cases evidence for a treatment effect, while for weight gain there is no strong evidence relating this to any particular treatment. For monitoring of blood lipids and glucose reference is made to established HIV treatment guidelines.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Hepatic insufficiency:
No data are available on which to make a dose recommendation for patients with hepatic insufficiency. 2). 4).
Paediatric population:
The recommended dose of Emtriva for children aged 4 months and over and adolescents up to 18 years of age weighing at least 33 kg who are able to swallow hard capsules is one 200 mg hard capsule, taken orally, once daily. There are no data regarding the efficacy and only very limited data regarding the safety of emtricitabine in infants below 4 months of age.
2). No data are available on which to make a dose recommendation in paediatric patients with renal insufficiency. Method of administration Emtriva 200 mg hard capsules should be taken once daily, orally with or without food. 4 Emtriva is also available as a 10 mg/mL oral solution for use in infants aged 4 months and over, children and patients who are unable to swallow hard capsules and patients with renal insufficiency.
Please refer to the Summary of Product Characteristics for Emtriva 10 mg/mL oral solution. 2).
Osteonecrosis:
Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to CART. 4). Paediatric population Assessment of adverse reactions in paediatric patients from clinical study data is based on experience in three paediatric studies (n = 169) where treatment-naïve (n = 123) and treatment-experienced (n = 46) paediatric HIV infected patients aged 4 months to 18 years were treated with emtricitabine in combination with other antiretroviral agents.
8%) in paediatric patients.
Other special population(s) Elderly:
Emtriva has not been studied in patients over the age of 65. 2).
Patients with renal impairment:
Emtricitabine is eliminated by renal excretion and exposure to emtricitabine was significantly increased in patients with renal insufficiency. 2).
HIV/HBV co-infected patients:
The adverse reaction profile in patients co-infected with HBV is similar to that observed in patients infected with HIV without co-infection with HBV. However, as would be expected in this patient population, elevations in AST and ALT occurred more frequently than in the general HIV infected population.
Exacerbations of hepatitis after […]
Lipid disorders should be managed as clinically appropriate. Liver function Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy (CART) and should be monitored according to standard practice.
Patients with chronic hepatitis B or C infection 5 treated with CART are at increased risk of experiencing severe, and potentially fatal, hepatic adverse events. In case of concomitant antiviral therapy for hepatitis B or C, please also refer to the relevant Summary of Product Characteristics for these medicinal products.
If there is evidence of exacerbations of liver disease in such patients, interruption or discontinuation of treatment must be considered. Patients co-infected with HBV Emtricitabine is active in vitro against HBV. However, limited data are available on the efficacy and safety of emtricitabine (as a 200 mg hard capsule once daily) in patients who are co-infected with HIV and HBV.
The use of emtricitabine in patients with chronic HBV induces the same mutation pattern in the YMDD motif observed with lamivudine therapy. The YMDD mutation confers resistance to both emtricitabine and lamivudine. Patients co-infected with HIV and HBV should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment with emtricitabine for evidence of exacerbations of hepatitis.
Such exacerbations have been seen following discontinuation of emtricitabine treatment in HBV infected patients without concomitant HIV infection and have been detected primarily by serum alanine aminotransferase (ALT) elevations in addition to re-emergence of HBV DNA.
In some of these patients, HBV reactivation was associated with more severe liver disease, including decompensation and liver failure. There is insufficient evidence to determine whether re-initiation of emtricitabine alters the course of post-treatment exacerbations of hepatitis.
In patients with advanced liver disease or cirrhosis, treatment discontinuation is not recommended since post-treatment exacerbations of hepatitis may lead to hepatic decompensation. Mitochondrial dysfunction following exposure in utero Nucleos(t)ide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine.
There have been reports of mitochondrial dysfunction in HIV negative infants exposed in utero and/or postnatally to nucleoside analogues; these have predominantly concerned treatment with regimens containing zidovudine. The main adverse reactions reported are haematological disorders (anaemia, neutropenia) and metabolic disorders (hyperlactatemia, hyperlipasemia).
These events have often been transitory. Late onset neurological disorders have been reported rarely (hypertonia, convulsion, abnormal behaviour). Whether such neurological disorders are transient or permanent is currently unknown. These findings should be considered for any child exposed in utero to nucleos(t)ide analogues, who present with severe clinical findings of unknown etiology, particularly neurologic findings.
These findings do not affect current national recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV. Immune Reactivation Syndrome In HIV infected patients with severe […]