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Emtricitabine / Tenofovir Alafenamide Viatris is a brand name for Emtricitabine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Emtricitabine/Tenofovir alafenamide Viatris 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).
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 Emtricitabine/Tenofovir alafenamide Viatris should be administered as shown in Table 1. 1. Missed doses If the patient misses a dose of Emtricitabine/Tenofovir alafenamide Viatris within 18 hours of the time it is usually taken, the patient should take Emtricitabine/Tenofovir alafenamide Viatris as soon as possible and resume the normal dosing schedule.
If a patient misses a dose of Emtricitabine/Tenofovir alafenamide Viatris 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 Emtricitabine/Tenofovir alafenamide Viatris another tablet should be taken.
2). Renal impairment No dose adjustment of Emtricitabine/Tenofovir alafenamide Viatris 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.
2). 2). On days of haemodialysis, Emtricitabine/Tenofovir alafenamide Viatris should be administered after completion of haemodialysis treatment. Emtricitabine/Tenofovir alafenamide Viatris 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 Emtricitabine/Tenofovir alafenamide Viatris 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. Hepatic impairment No dose adjustment of Emtricitabine/Tenofovir alafenamide Viatris is required in patients with hepatic impairment.
Paediatric population The safety and efficacy of Emtricitabine/Tenofovir alafenamide in children younger than 12 years of age, or weighing < 35 kg, have not yet been established. No data are available. 4 Method of administration Oral use.
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.
Summary of the safety profile Assessment of adverse reactions is based on safety data from across all Phase 2 and 3 studies in which HIV-1 infected patients received medicinal products containing emtricitabine and tenofovir alafenamide and from post-marketing experience.
In clinical studies of treatment- naïve adult patients receiving emtricitabine and tenofovir alafenamide with elvitegravir and cobicistat as the fixed-dose combination tablet elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide (as fumarate) 10 mg (E/C/F/TAF) through 144 weeks, the most frequently reported adverse reactions were diarrhoea (7%), nausea (11%), and headache (6%).
Tabulated summary of adverse reactions The adverse reactions in Table 3 are listed by system organ class and frequency. Frequencies are defined as follows: very common (≥1/10), common (≥1/100 to <1/10) and uncommon (≥1/1 000 to <1/100).
Table 3:
Tabulated list of adverse reactions1 Frequency Adverse reaction Blood and lymphatic system disorders Uncommon: anaemia2 Psychiatric disorders Common: abnormal dreams Nervous system disorders Common: headache, dizziness Gastrointestinal disorders Very common: nausea Common: diarrhoea, vomiting, abdominal pain, flatulence Uncommon: dyspepsia Skin and subcutaneous tissue disorders Common: Rash Uncommon: angioedema3, 4, pruritus, urticaria4 Musculoskeletal and connective tissue disorders Uncommon: arthralgia General disorders and administration site conditions Common: fatigue 16 1 With the exception of angioedema, anaemia and urticaria (see footnotes 2,3 and 4), all adverse reactions were identified from clinical studies of F/TAF containing products.
The frequencies were derived from Phase 3 E/C/F/TAF clinical studies in 866 treatment-naïve adult patients through 144 weeks of treatment (GS-US-292-0104 and GS-US-292-0111). 2 This adverse reaction was not observed in the clinical studies of F/TAF-containing products but identified from clinical studies or post-marketing experience for emtricitabine when used with other antiretrovirals.
Patients co-infected with HIV and hepatitis B or C virus Patients with chronic hepatitis B or C treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions. The safety and efficacy of Emtricitabine/Tenofovir alafenamide Viatris in patients co-infected with HIV-1 and hepatitis C virus (HCV) have not been established.
Tenofovir alafenamide is active against hepatitis B virus (HBV). Discontinuation of Emtricitabine/Tenofovir alafenamide Viatris therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis.
Patients co-infected with HIV and HBV who discontinue Emtricitabine/Tenofovir alafenamide Viatris should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment. 2). 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.
If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered. 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.
Lipid disorders should be managed as clinically appropriate. 5 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.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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3 This adverse reaction was identified through post-marketing surveillance for emtricitabine-containing products. 4 This adverse reaction was identified through post-marketing surveillance for tenofovir alafenamide-containing products.
Description of selected adverse reactions 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). 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). Changes in lipid laboratory tests In studies in treatment-naïve patients, increases from baseline were observed in both the tenofovir alafenamide fumarate and tenofovir disoproxil fumarate containing treatment groups for the fasting lipid parameters total cholesterol, direct low-density lipoprotein (LDL)- and high-density lipoprotein (HDL)-cholesterol, and triglycerides at Week 144.
001 for the difference between treatment groups for fasting total cholesterol, direct LDL- and HDL-cholesterol, and triglycerides). 006 for the difference between treatment groups). 009 for the difference between groups in changes from baseline).
There was little change from baseline in median fasting values for HDL cholesterol and glucose, or in the fasting total cholesterol to HDL cholesterol ratio in either treatment arm at Week 96. None of the changes was considered clinically relevant.
In a study of virologically suppressed adult patients switching from abacavir/lamivudine to Emtricitabine/Tenofovir alafenamide while maintaining the third antiretroviral agent (Study GS-US-311-1717), there were minimal changes in lipid parameters.
4). Paediatric population The safety of emtricitabine and tenofovir alafenamide was evaluated through 48 weeks in an open-label clinical study (GS-US-292-0106) in which HIV-1 infected, treatment-naïve paediatric patients aged 12 to < 18 years received emtricitabine and tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination tablet.
1). Other special populations Patients with renal impairment The safety of emtricitabine and tenofovir alafenamide was evaluated through 144 weeks in an open-label clinical study (GS-US-292-0112) in which 248 HIV-1 infected patients who were […]
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 aetiology, 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 immune deficiency at the time of institution of CART, an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Typically, such reactions have been observed within the first few weeks or months of initiation of CART. Relevant examples include cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia.
Any inflammatory symptoms should be evaluated and treatment instituted when necessary. Autoimmune disorders (such as Graves’ disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable, and these events can occur many months after initiation of treatment.
1). Triple nucleoside therapy There have been reports of a high rate of virological failure and of emergence of resistance at an early stage when tenofovir disoproxil was combined with lamivudine and abacavir as well as with lamivudine and didanosine as a once daily regimen.
Therefore, the same problems may be seen if Emtricitabine/Tenofovir alafenamide Viatris is administered with a third nucleoside analogue. Opportunistic infections Patients receiving Emtricitabine/Tenofovir alafenamide Viatris 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.
Osteonecrosis Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV disease and/or long-term exposure to CART.
Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement. 6 Nephrotoxicity Post-marketing cases of renal impairment, including acute renal failure and proximal renal tubulopathy have been reported with tenofovir alafenamide-containing products.
3). It is recommended that renal function is assessed in all patients prior to, or when initiating, therapy with Emtricitabine/Tenofovir alafenamide Viatris and that it is also monitored during therapy in all patients as clinically appropriate.
In patients who […]