Full Answer
Precautions
Before Taking This Medicine
You should not take Vemlidy if you are allergic to tenofovir.Do not take Vemlidy together with adefovir (Hepsera), or with combination medicines th...
How Should I Take Vemlidy?
Before you start treatment with Vemlidy, your doctor may perform tests to make sure you do not have HIV.Follow all directions on your prescription...
What Happens If I Miss A Dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to...
What Should I Avoid While Taking Vemlidy?
Avoid drinking alcohol. It may increase your risk of liver damage.Taking this medicine will not prevent you from passing hepatitis B to other people.
What Other Drugs Will Affect Vemlidy?
Vemlidy can harm your kidneys. This effect is increased when you also use certain other medicines, including: antivirals, chemotherapy, injected an...
What is the treatment for vemlidy?
Treatment of overdosage with Vemlidy consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient. Tenofovir is efficiently removed by hemodialysis with an extraction coefficient of approximately 54%.
What is vemlidy in pharmacology?
Vemlidy is a substrate of P-glycoprotein (P-gp) and BCRP. Drugs that strongly affect P-gp and BCRP activity may lead to changes in tenofovir alafenamide absorption (see Table 4 ). Drugs that induce P-gp activity are expected to decrease the absorption of tenofovir alafenamide, resulting in decreased plasma concentrations of tenofovir alafenamide, which may lead to loss of therapeutic effect of Vemlidy. Coadministration of Vemlidy with other drugs that inhibit P-gp and BCRP may increase the absorption and plasma concentration of tenofovir alafenamide.
How many mg of Vemlidy are in a bottle?
Vemlidy tablets containing 25 mg of tenofovir alafenamide are yellow, round, film-coated, debossed with "GSI" on one side and "25" on the other side. Each bottle contains 30 tablets (NDC 61958-2301-1), a silica gel desiccant, polyester coil, and is closed with a child-resistant closure.
What should be assessed before vemlidy?
Prior to or when initiating Vemlidy, and during treatment with Vemlidy on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus [see Warnings and Precautions (5.3) ].
Can you take vemlidy after hemodialysis?
On days of hemodialysis, administer Vemlidy after completion of hemodialysis treatment. Vemlidy is not recommended in patients with ESRD who are not receiving chronic hemodialysis [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Does vemlidy need to be adjusted?
No dosage adjustment of Vemlidy is required in patients with estimated creatinine clearance greater than or equal to 15 mL per minute, or in patients with end stage renal disease (ESRD; estimated creatinine clearance below 15 mL per minute) who are receiving chronic hemodialysis. On days of hemodialysis, administer Vemlidy after completion of hemodialysis treatment.
Can you test for HIV before vemlidy?
Testing Prior to Initiation of Vemlidy. Prior to initiation of Vemlidy, patients should be tested for HIV-1 infection. Vemlidy alone should not be used in patients with HIV-1 infection [see Warnings and Precautions (5.2)].
How should I take Vemlidy?
Take Vemlidy exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.
What happens if I overdose?
If you take too much Vemlidy, call your healthcare provider or go to the nearest hospital emergency room right away.
What other drugs will affect Vemlidy?
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
What is vemlidy used for?
Vemlidy and Viread are both used to treat chronic hepatitis B virus (HBV) infection, but Viread is also used in the treatment of human immunodeficiency virus-1 (HIV-1) infection.
What to do when your vemlidy supply runs low?
When your Vemlidy supply starts to run low, get more from your healthcare provider or pharmacy. This is very important because your HBV infection may get worse (flare-up) if you stop taking this medicine.
How long does it take for vemlidy to get worse?
Keep the bottle tightly closed when not in use. If you have hepatitis B, this virus may become active or get worse in the months after you stop using Vemlidy. You may need frequent liver function tests while using this medicine and for several months after your last dose.
What diseases can cause lactic acid build up in blood?
liver disease (especially hepatitis B if you also have HIV); HIV; kidney disease; or. low bone mineral density. You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions or if you are a woman. Ask your doctor about your risk.
What is a vemlid?
What is VEMLIDY? VEMLIDY is a prescription medicine used to treat chronic (long-lasting) hepatitis B virus (HBV) in adults with stable (compensated) liver disease. VEMLIDY may lower the amount of HBV in your body. VEMLIDY may improve the condition of your liver.
What are the side effects of vemlid?
What is the most important information I should know about VEMLIDY? VEMLIDY can cause serious side effects, including: Worsening of hepatitis B virus (HBV) infection. Your HBV infection may get worse (flare-up) if you take VEMLIDY and then stop taking it.
Can you get pregnant with a vemlid?
It is not known if VEMLIDY will harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with VEMLIDY. If you are breastfeeding or plan to breastfeed. It is not known if VEMLIDY passes into your breast milk.
Can you get HIV before taking vemlid?
Your healthcare provider may test you for HIV infection before starting VEMLIDY. If you have HIV and only take VEMLIDY, the HIV virus may develop resistance and become harder to treat. If you are pregnant or plan to become pregnant. It is not known if VEMLIDY will harm your unborn baby.
Does vemlidy cause headaches?
The most common side effect of VEMLIDY is headache. These are not all the possible side effects of VEMLIDY. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Click here for Important Facts about VEMLIDY, including important warnings.
What is a vemlid?
VEMLIDY is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease [see Clinical Studies (14)].
What should be assessed before a patient starts vemlidy?
Prior to or when initiating VEMLIDY, and during treatment with VEMLIDY on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus [see Warnings and Precautions (5.3) ].
What is the primary efficacy endpoint of the 4018 trial?
The primary efficacy endpoint was the proportion of subjects with plasma HBV DNA levels ≥20 IU/mL at Week 48. Additional efficacy endpoints in Trial 4018 included the proportion of subjects with HBV DNA <20 IU/mL, ALT normal and normalization, HBsAg loss and seroconversion, and HBeAg loss and seroconversion.
What is the treatment for overdose with venolid?
Treatment of overdosage with VEMLIDY consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient. Tenofovir is efficiently removed by hemodialysis with an extraction coefficient of approximately 54%.
Is vemlidy safe for ESRD?
VEMLIDY is not recommended in patients with ESRD who are not receiving chronic hemodialysis [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Can you test for HIV before using VEMLIDY?
HIV antibody testing should be offered to all HBV-infected patients before initiating therapy with VEMLIDY, and, if positive, an appropriate antiretroviral combination regimen that is recommended for patients coinfected with HIV-1 should be used.
Can you discontinue vemliy?
Discontinuation of anti-hepatitis B therapy, including VEMLIDY, may result in severe acute exacerbations of hepatitis B. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy, including VEMLIDY. If appropriate, resumption of anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1)].
Drug Interactions
Tenofovir alafenamide is used to treat chronic hepatitis B infection, a viral infection of the liver.
May Treat: Chronic hepatitis B
Drug Class: Hepatitis B Treatment- Nucleotide Analogs (Antiviral)
Availability: Prescription Required
Pregnancy: Consult a doctor before using
Lactation: Consult a doctor before using
May Treat: Chronic hepatitis B
Drug Class: Hepatitis B Treatment- Nucleotide Analogs (Antiviral)
Availability: Prescription Required
Pregnancy: Consult a doctor before using
Lactation: Consult a doctor before using
Alcohol: Limit intake while taking this medication
Driving: May cause drowsiness or dizziness. Use caution
Manufacturer: GILEAD SCIENCES
- If available, read the patient package insert
- Seek medical care if breathing trouble occurs
- Call MD if new abdominal pain/yellowing eyes/skin
- If available, read the patient package insert
- Seek medical care if breathing trouble occurs
- Call MD if new abdominal pain/yellowing eyes/skin
- Take with food
- Do not stop medicine without calling doctor
- Use latex or polyurethane condoms during sex.
- Tell doctor your complete medical history
- Review all drugs you are taking with your doctor
Major Toxicities
Resistance
Pediatric Use
Formulations
Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate
- More common: Nausea, diarrhea, headache. Greater weight gain has been reported with the use of TAF than with tenofovir disoproxil fumarate (TDF) in adults and children6 (see Table 15h. Lipodystroph...
- Less common (more severe):Cases of lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside reverse transcriptase in…
- More common: Nausea, diarrhea, headache. Greater weight gain has been reported with the use of TAF than with tenofovir disoproxil fumarate (TDF) in adults and children6 (see Table 15h. Lipodystroph...
- Less common (more severe):Cases of lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside reverse transcriptase inhibitors (NRT...
Tenofovir Alafenamide Efficacy in Clinical Trials in Adults
- The International Antiviral Society–USA maintains a list of updated resistance mutations, and the Stanford University HIV Drug Resistance Databaseoffers a discussion of each mutation.
Tenofovir Alafenamide Efficacy in Clinical Trials in Adolescents and Children
- TAF is available as a component of several fixed-dose combination (FDC) tablets. These FDC tablets are listed in Appendix A, Table 1 and Appendix A, Table 2. Descovy, an FDC tablet that contains FTC and TAF (FTC/TAF), is approved by the U.S. Food and Drug Administration (FDA) for use in children who weigh ≥14 kg to <25 kg at a dose of FTC 120 mg/TAF 15 mg and for child…
Pharmacokinetics
- TAF-containing pills are smaller than their TDF-containing counterparts, a significant advantage for some pediatric patients who may have trouble swallowing larger pills (see Appendix A, Table 2). EVG/c/FTC/TAF contains TAF 10 mg, whereas FTC/TAF and FTC/RPV/TAF contain TAF 25 mg. BIC/FTC/TAF is available in two strengths: one containing TAF 15 mg for children aged ≥2 y…
Toxicity
- Both TDF and TAF are prodrugs of the NRTI TFV. After oral administration, TDF is well absorbed13,14 and is so rapidly metabolized to TFV that TDF itself cannot be measured in blood (even when plasma is sampled within 5 minutes of administration).15TFV is the main compound that is measurable in plasma after TDF administration. From the bloodstream, TFV enters cells …
Indications and Usage For Vemlidy
- In adults, TAF is noninferior to TDF in its ability to control viral load over 48 to 96 weeks when used in combination with EVG, COBI, and FTC27-30; with FTC and RPV31; with DRV, COBI, and FTC32-34; and when TAF and FTC are administered in combination with other ARV drugs.35 In a switch study of adults who were virologically suppressed on a three-drug regimen that included …
Vemlidy Dosage and Administration
- The combination of EVG, COBI, FTC, and TAF has been shown to have similar efficacy when used in adults and two groups of children: those weighing ≥35 kg and aged ≥12 years40 and those weighing ≥25 kg and aged ≥6 years41 (see the Elvitegravir section for details). In a switch study, treatment with BIC/FTC/TAF resulted in viral load suppression at 48 weeks in 49 of 50 (9…
Dosage Forms and Strengths
- Virologic suppression in people who are taking TAF or TDF is most closely related to intracellular TFV‑DP concentrations. In adults, TAF generates peripheral blood mononuclear cell TFV-DP concentrations that are twofold22 to sevenfold higher than those generated with TDF, at clinically meaningful doses.18,21,27 Higher TFV-DP concentrations result in a stronger antiviral potency1…
Warnings and Precautions
- TAF causes bone toxicity less frequently than TDF.27-29,32-35,52,53 For example, in one study of 1,733 randomized adult participants with HIV, those treated with EVG/c/FTC/TAF had a smaller decrease in BMD at the spine (mean change −1.30% vs. −2.86%; P < 0.0001) and hip (−0.66% vs. −2.95%; P < 0.0001) at 48 weeks than those given EVG/c/FTC/TDF.27 These differences w…
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
- Severe Acute Exacerbation of Hepatitis B after Discontinuation of Treatment
Discontinuation of anti-hepatitis B therapy, including Vemlidy, may result in severe acute exacerbations of hepatitis B. Patients who discontinue Vemlidy should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment. If appr… - Risk of Development of HIV-1 Resistance in Patients Coinfected with HBV and HIV-1
Due to the risk of development of HIV-1 resistance, Vemlidy alone is not recommended for the treatment of HIV-1 infection. The safety and efficacy of Vemlidy have not been established in patients coinfected with HBV and HIV-1. HIV antibody testing should be offered to all HBV-infect…
Vemlidy Description
Vemlidy - Clinical Pharmacology