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Vemlidy is a brand name for Tenofovir Alafenamide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Vemlidy is indicated for the treatment of chronic hepatitis B (CHB) in adults and paediatric patients 6 years of age and older weighing at least 25 kg (see section 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 CHB. Posology Adults and paediatric patients at least 6 years of age and older weighing at least 25 kg: one tablet once daily. 4). Regular reassessment is recommended after treatment discontinuation to detect virological relapse.
• In HBeAg-negative patients without cirrhosis, treatment should be administered at least until HBs seroconversion or until there is evidence of loss of efficacy. With prolonged treatment for more than 2 years, regular reassessment is recommended to confirm that continuing the selected therapy remains appropriate for the patient.
3 Missed dose If a dose is missed and less than 18 hours have passed from the time it is usually taken, the patient should take this medicinal product as soon as possible and then resume their normal dosing schedule. If more than 18 hours have passed from the time it is usually taken, the patient should not take the missed dose and should simply resume the normal dosing schedule.
If the patient vomits within 1 hour of taking the treatment, the patient should take another tablet. If the patient vomits more than 1 hour after taking the treatment, the patient does not need to take another tablet. 2). Renal impairment No dose adjustment of this medicinal product is required in adults or adolescents (aged at least 12 years and of at least 35 kg body weight) with estimated creatinine clearance (CrCl) ≥ 15 mL/min or in patients with CrCl < 15 mL/min who are receiving haemodialysis.
2). 4). No data are available to make dose recommendations in children aged less than 12 years and of less than 35 kg body weight with renal impairment. 2). Paediatric population The safety and efficacy of Vemlidy in children younger than 6 years of age or weighing < 25 kg have not yet been established.
No data are available. Method of administration Oral use. 2).
Summary of the safety profile Assessment of adverse reactions is based on clinical study data and postmarketing data. In pooled safety data from 2 controlled Phase 3 studies (GS-US-320-0108 and GS-US-320-0110; “Study 108” and “Study 110”, respectively), the most frequently reported adverse reactions at Week 96 analysis were headache (12%), nausea (6%), and fatigue (6%).
After Week 96, patients either remained on their original blinded treatment up to Week 144 or received open-label tenofovir alafenamide. The safety profile of tenofovir alafenamide was similar in virologically suppressed patients switching from tenofovir disoproxil to tenofovir alafenamide in Study 108, Study 110 and a controlled Phase 3 study GS-US-320-4018 (“Study 4018”).
1). 12 Tabulated summary of adverse reactions The following adverse reactions have been identified with tenofovir alafenamide in patients with CHB (Table 2). The adverse reactions are listed below by body system organ class and frequency based on the Week 96 analysis.
Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10) or uncommon (≥ 1/1,000 to < 1/100).
Table 2:
Adverse Reactions Identified with Tenofovir Alafenamide System organ class Frequency Adverse reaction Nervous system disorders Very common Headache Common Dizziness Gastrointestinal disorders Common Diarrhoea, vomiting, nausea, abdominal pain, abdominal distension, flatulence Hepatobiliary disorders Common Increased ALT Skin and subcutaneous tissue disorders Common Rash, pruritus Uncommon Angioedema1, urticaria1 Musculoskeletal and connective tissue disorders Common Arthralgia General disorders and administration site conditions Common Fatigue 1 Adverse reaction identified through post-marketing surveillance for tenofovir alafenamide-containing products.
Hepatitis B Virus (HBV) transmission Patients must be advised that this medicinal product does not prevent the risk of transmission of HBV to others through sexual contact or contamination with blood. Appropriate precautions must continue to be used.
e. class C). These patients may be at higher risk of experiencing serious hepatic or renal adverse reactions. 2). Exacerbation of hepatitis Flares on treatment Spontaneous exacerbations in CHB are relatively common and are characterised by transient increases in serum alanine aminotransferase (ALT).
After initiating antiviral therapy, serum ALT may increase in some patients. In patients with compensated liver disease, these increases in serum ALT are generally not accompanied by an increase in serum bilirubin concentrations or hepatic decompensation.
Patients with cirrhosis may be at a higher risk for hepatic decompensation following hepatitis exacerbation, and therefore should be monitored closely during therapy. Flares after treatment discontinuation Acute exacerbation of hepatitis has been reported in patients who have discontinued treatment for CHB, usually in association with rising HBV DNA levels in plasma.
The majority of cases are self-limited but severe exacerbations, including fatal outcomes, may occur after discontinuation of treatment for CHB. Hepatic function should be monitored at repeated intervals with both clinical and laboratory follow-up for at least 6 months after discontinuation of treatment for CHB.
If appropriate, resumption of CHB therapy may be warranted. In patients with advanced liver disease or cirrhosis, treatment discontinuation is not recommended since post-treatment exacerbation of hepatitis may lead to hepatic decompensation.
Liver flares are especially serious, and sometimes fatal in patients with decompensated liver disease. 1). 2). 2). Nephrotoxicity Post-marketing cases of renal impairment, including acute renal failure and proximal renal tubulopathy have been reported with tenofovir alafenamide-containing products.
1.
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In the open-label Phase 2 study (GS-US-320-4035; “Study 4035”) to evaluate the efficacy and safety of switching from another antiviral regimen to tenofovir alafenamide in virologically suppressed HBV infected patients, small median increases in fasting total cholesterol, direct low density lipoprotein (LDL), high density lipoprotein (HDL), and triglycerides from baseline to Week 96 were observed in patients with moderate or severe renal impairment (Part A Cohort 1) and patients with moderate or severe hepatic impairment (Part B), consistent with changes observed in Studies 108 and 110.
Small median decreases in total cholesterol, LDL and triglycerides were observed in patients with ESRD on hemodialysis in Part A Cohort 2, while small median increases were observed in HDL from baseline to Week 96. 4) in patients with moderate or severe hepatic impairment.
Metabolic parameters Body weight and levels of blood lipids and glucose may increase during therapy. Special populations In Study 4035 in virologically suppressed patients with moderate to severe renal impairment (eGFR by Cockcroft-Gault method 15 to 59 mL/min; Part A, Cohort 1, N = 78), end stage renal disease (ESRD) (eGFR < 15 mL/min) on haemodialysis (Part A, Cohort 2, N = 15), and/or moderate to severe hepatic impairment (Child-Pugh Class B or C at screening or by history; Part B, N = 31) who switched from another antiviral regimen to tenofovir alafenamide, no additional adverse reactions to tenofovir alafenamide were identified through Week 96.
Paediatric population The safety of tenofovir alafenamide was evaluated in 88 HBV-infected treatment-naïve and treatment- experienced paediatric patients between the ages of 12 to < 18 years weighing ≥ 35 kg (tenofovir alafenamide group N=47, placebo group N=23) and 6 to < 12 years weighing ≥ 25 kg (tenofovir alafenamide group N=12, placebo group N=6) through Week 24 in a randomised, double-blind, placebo-controlled clinical study GS-US-320-1092 (“Study 1092”).
After the double-blind phase, 13 patients were switched to open-label tenofovir alafenamide at Week 24. The safety profile of tenofovir alafenamide in paediatric patients was comparable to that in adults. 1). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
3). It is recommended that renal function is assessed in all patients prior to, or when initiating, therapy with this treatment 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 this medicinal product should be considered.
5 Patients co-infected with HBV and hepatitis C or D virus There are no data on the safety and efficacy of tenofovir alafenamide in patients co-infected with hepatitis C (HCV) or D (HDV) virus. 5). HBV and Human Immunodeficiency Virus (HIV) co-infection HIV antibody testing should be offered to all HBV infected patients whose HIV-1 infection status is unknown before initiating therapy with this medicinal product.
5). Co-administration with other medicinal products This medicinal product should not be co-administered with medicinal products containing tenofovir alafenamide, tenofovir disoproxil or adefovir dipivoxil. g. g. rifampicin, rifabutin and rifapentine) or St.
John’s wort, all of which are inducers of P-glycoprotein (P-gp) and may decrease tenofovir alafenamide plasma concentrations, is not recommended. g. itraconazole and ketoconazole) may increase tenofovir alafenamide plasma concentrations.
Co-administration is not recommended. 1). The long-term effects of changes in BMD on the growing bone, including the risk of fracture, are uncertain. A multidisciplinary approach is recommended to decide the appropriate monitoring during treatment.
Excipients with known effect This medicinal product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.