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Genvoya is a brand name for Elvitegravir. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Genvoya is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir in adults and paediatric patients aged from 2 years and with body weight at least 14 kg. See sections 4.2 and…
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 Adults and paediatric patients weighing at least 25 kg One 150 mg/150 mg/200 mg/10 mg tablet to be taken once daily with food. Paediatric patients aged 2 years and older, weighing at least 14 kg to less than 25 kg One 90 mg/90 mg/120 mg/6 mg tablet to be taken once daily with food.
If the patient misses a dose of Genvoya within 18 hours of the time it is usually taken, the patient should take Genvoya with food as soon as possible and resume the normal dosing schedule. If a patient misses a dose of Genvoya 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 Genvoya another tablet should be taken. 2). Renal impairment No dose adjustment of Genvoya 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, Genvoya should be administered after completion of haemodialysis treatment. Genvoya 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 Genvoya has not been established in these populations.
No data are available to make dose recommendations in children aged less than 12 years with renal impairment or in children less than 18 years with end stage renal disease. Hepatic impairment No dose adjustment of Genvoya is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment.
2). Paediatric population The safety and efficacy of Genvoya in children younger than 2 years of age, or weighing < 14 kg, have not yet been established. No data are available. 2). Due to the bitter taste, it is recommended that the film-coated tablet not be chewed or crushed.
For patients who are unable to 4 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 with Genvoya and from post-marketing experience. The most frequently reported adverse reactions in clinical studies through 144 weeks were nausea (11%), diarrhoea (7%), and headache (6%).
Tabulated summary of adverse reactions The adverse reactions in Table 2 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 2:
Tabulated list of adverse reactions Frequency Adverse reaction Blood and lymphatic system disorders Uncommon: anaemia1 Psychiatric disorders Common: abnormal dreams Uncommon: suicidal ideation and suicide attempt (in patients with a pre-existing history of depression or psychiatric illness), depression2 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 General disorders and administration site conditions Common: fatigue 1 This adverse reaction was not observed in the Phase 3 clinical studies for Genvoya but identified from clinical studies or post-marketing experience for emtricitabine when used with other antiretrovirals.
2 This adverse reaction was not observed in the Phase 3 clinical studies for Genvoya but identified from clinical studies for elvitegravir when used with other antiretrovirals. 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. 4). 23 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.
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 Genvoya 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 Genvoya 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 Genvoya should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment.
Liver disease The safety and efficacy of Genvoya in patients with significant underlying liver disorders have not been established. Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy (CART) and 5 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. 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. Co-administration with medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious or life-threatening adverse reactions. 5): • alpha 1-adrenoreceptor antagonists: alfuzosin • antiarrhythmics: amiodarone, quinidine • ergot derivatives: dihydroergotamine, ergometrine, ergotamine • gastrointestinal motility agents: cisapride • HMG Co-A reductase inhibitors: lovastatin, simvastatin • lipid-modifying agent: lomitapide • neuroleptics/antipsychotics: pimozide, lurasidone • PDE-5 inhibitors: sildenafil for the treatment of pulmonary arterial hypertension • sedatives/hypnotics: orally administered midazolam, triazolam Co-administration with medicinal products that are strong inducers of CYP3A due to the potential for loss of virologic response and possible resistance to Genvoya.
5): • anticonvulsants: carbamazepine, phenobarbital, phenytoin • antimycobacterials: rifampicin • herbal products: St. 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 serum creatinine Cobicistat increases serum creatinine due to inhibition of tubular secretion of creatinine without affecting renal glomerular function.
In clinical studies of Genvoya, increases in serum creatinine occurred by Week 2 of treatment and remained stable through 144 weeks. 6 μmol/L) was observed after 144 weeks of treatment. 001). Changes in lipid laboratory tests In studies in treatment-naïve patients, increases from baseline were observed in both 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). Paediatric population The safety of Genvoya was evaluated through 48 weeks in HIV-1 infected adolescent patients aged 12 to < 18 years weighing ≥ 35 kg (n = 100), in children aged 7 to < 12 years weighing > 25 kg (n = 52), and in children aged 3 to 9 years and weighing ≥ 14 to < 25 kg (n = 27).
The safety profile in paediatric patients who received treatment with Genvoya was similar to that in adults. 0% of children aged at least 3 years and weighing at least 14 kg to < 25 kg respectively. Other special populations Patients with renal impairment The safety of Genvoya in 248 HIV-1 infected patients who were either treatment-naïve (n = 6) or virologically suppressed (n = 242) with mild to moderate renal impairment (estimated glomerular filtration rate by Cockcroft-Gault method [eGFRCG]: 30-69 mL/min) was evaluated through 144 weeks in an open-label clinical study (GS-US-292-0112).
1). The safety of Genvoya in 55 virologically suppressed HIV-1 infected patients with end stage renal disease (eGFRCG < 15 mL/min) on chronic haemodialysis was evaluated through 48 weeks in a single arm, open-label clinical study (GS-US-292-1825).
2). 24 Patients co-infected with HIV and HBV The safety of Genvoya was evaluated in 72 HIV/HBV co-infected patients […]
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 (hyperlactataemia, hyperlipasaemia).
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.
Opportunistic infections Patients receiving Genvoya 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 Genvoya and that it is also monitored during therapy in all patients as clinically appropriate. In patients who develop clinically significant decreases in renal function, or evidence of proximal renal tubulopathy, discontinuation of Genvoya should be considered.
2). In a study of Genvoya in HIV-1 infected adults with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis, efficacy was maintained through 48 weeks but emtricitabine exposure was significantly higher than in patients with normal renal function.
2). […]