Vemlidy

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 9/24/2021
Vemlidy Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Vemlidy?

Vemlidy (tenofovir alafenamide) is a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor and is indicated for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease.

What Are Side Effects of Vemlidy?

Common side effects of Vemlidy include:

  • headache,
  • abdominal pain,
  • fatigue,
  • cough,
  • nausea, and
  • back pain.

Dosage for Vemlidy

The recommended dosage of Vemlidy is 25 mg (one tablet) taken orally once daily with food.

What Drugs, Substances, or Supplements Interact with Vemlidy?

Vemlidy may interact with drugs that induce P-gp activity, antivirals, aminoglycosides, high-dose or multiple nonsteroidal anti-inflammatories (NSAIDs), anticonvulsants, antimycobacterials, and St. John's wort. Tell your doctor all medications and supplements you use.

Vemlidy During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Vemlidy. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to during pregnancy. It is unknown if Vemlidy passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Vemlidy (tenofovir alafenamide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Digestive Disorders: Common Misconceptions See Slideshow
Vemlidy Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Mild symptoms of lactic acidosis may worsen over time, and this condition can be fatal. Get emergency medical help if you have: unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired.

Call your doctor at once if you have:

  • sore throat, flu symptoms, easy bruising or unusual bleeding;
  • kidney problems--little or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; or
  • liver problems--swelling around your midsection, upper stomach pain, unusual tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Tenofovir affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

  • signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
  • trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
  • swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects may include:

  • stomach pain, nausea, vomiting, diarrhea;
  • fever, pain;
  • weakness, dizziness;
  • headache;
  • depressed mood;
  • itching, rash; or
  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Vemlidy (Tenofovir Alafenamide)

Vemlidy Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in other sections of the labeling:

  • Severe Acute Exacerbation of Hepatitis B [see WARNINGS AND PRECAUTIONS]
  • New Onset or Worsening of Renal Impairment [see WARNINGS AND PRECAUTIONS]
  • Lactic Acidosis/Severe Hepatomegaly with Steatosis [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adverse Reactions In Adult Subjects With Chronic Hepatitis B And Compensated Liver Disease

The safety assessment of VEMLIDY was based on pooled data through the Week 96 data analysis from 1298 subjects in two randomized, double-blind, active-controlled trials, Trial 108 and Trial 110, in adult subjects with chronic hepatitis B and compensated liver disease. A total of 866 subjects received VEMLIDY 25 mg once daily [see Clinical Studies]. Further safety assessment was based on pooled data from Trials 108 and 110 from subjects who continued to receive their original blinded treatment through Week 120 and additionally from subjects who received open-label

VEMLIDY from Week 96 through Week 120 (n = 361 remained on VEMLIDY; n = 180 switched from TDF to VEMLIDY at Week 96).

Based on the Week 96 analysis, the most common adverse reaction (all Grades) reported in at least 10% of subjects in the VEMLIDY group was headache. The proportion of subjects who discontinued treatment with VEMLIDY or TDF due to adverse reactions of any severity was 1.5% and 0.9%, respectively. Table 1 displays the frequency of the adverse reactions (all Grades) greater than or equal to 5% in the VEMLIDY group.

Table 1 : Adverse Reactionsa (All Grades) Reported in ≥5% of Subjects with Chronic HBV Infection and Compensated Liver Disease in Trials 108 and 110 (Week 96 analysisb)

VEMLIDY
(N=866)
TDF
(N=432)
Headache12%10%
Abdominal painc9%6%
Cough8%8%
Back pain6%6%
Fatigue6%5%
Nausea6%6%
Arthralgia5%6%
Diarrhea5%5%
Dyspepsia5%5%
a Frequencies of adverse reactions are based on all treatment-emergent adverse events, regardless of relationship to study drug.
b Double-blind phase.
c Grouped term including abdominal pain upper, abdominal pain, abdominal pain lower, and abdominal tenderness.

Additional adverse reactions occurring in less than 5% of subjects in Trials 108 and 110 included vomiting, rash, and flatulence.

The safety profile of VEMLIDY in subjects who continued to receive blinded treatment through Week 120 was similar to that at Week 96. The safety profile of VEMLIDY in subjects who remained on VEMLIDY in the open-label phase through Week 120 was similar to that in subjects who switched from TDF to VEMLIDY at Week 96.

Renal Laboratory Tests

In a pooled analysis of Trials 108 and 110 in adult subjects with chronic hepatitis B and a median baseline estimated creatinine clearance between 106 and 105 mL per minute (for the VEMLIDY and TDF groups, respectively), mean serum creatinine increased by less than 0.1 mg/dL and median serum phosphorus decreased by 0.1 mg/dL in both treatment groups at Week 96. Median change from baseline to Week 96 in estimated creatinine clearance was -1.2 mL per minute in the VEMLIDY group and -4.8 mL per minute in those receiving TDF.

In subjects who remained on blinded treatment beyond Week 96 in Trials 108 and 110, change from baseline in renal laboratory parameter values in each group at Week 120 were similar to those at Week 96. In the open-label phase, median change in estimated creatinine clearance by Cockcroft-Gault method from Week 96 to Week 120 was -0.6 mL per minute in subjects who remained on VEMLIDY and +1.8 mL per minute in those who switched from TDF to VEMLIDY at Week 96. Mean serum creatinine and median serum phosphorus values at Week 120 were similar to those at Week 96 in subjects who remained on VEMLIDY and in subjects who switched from TDF to VEMLIDY.

The long-term clinical significance of these renal laboratory changes on adverse reaction frequencies between VEMLIDY and TDF is not known.

Bone Mineral Density Effects

In a pooled analysis of Trials 108 and 110, the mean percentage change in bone mineral density (BMD) from baseline to Week 96 as assessed by dual-energy X-ray absorptiometry (DXA) was -0.7% with VEMLIDY compared to -2.6% with TDF at the lumbar spine and -0.3% compared to -2.5% at the total hip. BMD declines of 5% or greater at the lumbar spine were experienced by 11% of VEMLIDY subjects and 25% of TDF subjects at Week 96. BMD declines of 7% or greater at the femoral neck were experienced by 5% of VEMLIDY subjects and 13% of TDF subjects at Week 96.

In subjects who remained on blinded treatment beyond Week 96 in Trials 108 and 110, mean percentage change in BMD in each group at Week 120 was similar to that at Week 96. In the open-label phase, mean percentage change in BMD from Week 96 to Week 120 in subjects who remained on VEMLIDY was 0.6% at the lumbar spine and 0% at the total hip, compared to 1.7% at the lumbar spine and 0.6% at the total hip in those who switched from TDF to VEMLIDY.

The long-term clinical significance of these BMD changes is not known.

Laboratory Abnormalities

The frequency of laboratory abnormalities (Grades 3-4) occurring in at least 2% of subjects receiving VEMLIDY in Trials 108 and 110 are presented in Table 2.

Table 2 : Laboratory Abnormalities (Grades 3-4) Reported in ≥2% of Subjects with Chronic HBV Infection and Compensated Liver Disease in Trials 108 and 110 (Week 96 analysisa)

Laboratory Parameter AbnormalitybVEMLIDY
(N=866)
TDF
(N=432)
ALT (>5 x ULN)8%10%
LDL-cholesterol (fasted) (>190 mg/dL)6%1%
Glycosuria (≥3+)5%2%
AST (>5 x ULN)3%5%
Creatine Kinase (≥10 x ULN)3%3%
Serum Amylase (>2.0 x ULN)3%3%
ULN=Upper Limit of Normal
a Double-blind phase
b Frequencies are based on treatment-emergent laboratory abnormalities.

The overall incidence of blinded treatment ALT flares (defined as confirmed serum ALT greater than 2 x baseline and greater than 10 x ULN at 2 consecutive postbaseline visits, with or without associated symptoms) was similar between VEMLIDY (0.6%) and TDF (0.9%) through Week 96. ALT flares generally were not associated with coincident elevations in bilirubin, occurred within the first 12 weeks of treatment, and resolved without recurrence.

Based on the Week 120 analysis, the frequencies of lab abnormalities in subjects who remained on VEMLIDY in the open-label phase were similar to those in subjects who switched from TDF to VEMLIDY at Week 96.

Amylase And Lipase Elevations And Pancreatitis

At Week 96, in Trials 108 and 110, eight subjects treated with VEMLIDY with elevated amylase levels had associated symptoms, such as nausea, low back pain; abdominal tenderness, pain, and distension; and biliary pancreatitis and pancreatitis. Of these eight, two subjects discontinued VEMLIDY due to elevated amylase and/or lipase; one subject experienced recurrence of adverse events when VEMLIDY was restarted. No subject treated with TDF had associated symptoms or discontinued treatment.

From Week 96 to Week 120, one additional subject who continued open-label VEMLIDY and none of the subjects who switched from TDF to VEMLIDY had elevated amylase levels and associated symptoms.

Serum Lipids

Changes from baseline in total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, and total cholesterol to HDL ratio among subjects treated with VEMLIDY and TDF in Trials 108 and 110 are presented in Table 3.

Table 3 : Lipid Abnormalities: Mean Change from Baseline in Lipid Parameters in Patients with Chronic HBV Infection and Compensated Liver Disease in Trials 108 and 110 (Week 96 analysis)

VEMLIDY
(N=866)
TDF
(N=432)
Baseline mg/dLWeek 96 ChangeaBaseline mg/dLWeek 96 Changea
Total Cholesterol (fasted)188 [n=835]-1 [n=742]193 [n=423]-25 [n=368]
HDL-Cholesterol (fasted)60 [n=835]-5 [n=740]61 [n=423]-12 [n=368]
LDL-Cholesterol (fasted)116 [n=835]+7 [n=741]120 [n=423]-10 [n=368]
Triglycerides (fasted)102 [n=836]+13 [n=743]102 [n=423]-7 [n=368]
Total Cholesterol to HDL ratio3 [n=835]0 [n=740]3 [n=423]0 [n=368]
a The change from baseline is the mean of within-subject changes from baseline for subjects with both baseline and Week 96 values.

In the open-label phase, lipid parameters at Week 120 in subjects who remained on VEMLIDY were similar to those at Week 96. In subjects who switched from TDF to VEMLIDY, mean change from Week 96 to Week 120 in total cholesterol was 23 mg/dL, HDL-cholesterol was 5 mg/dL, LDL-cholesterol was 16 mg/dL, triglycerides was 30 mg/dL, and total cholesterol to HDL ratio was 0 mg/dL.

Adverse Reactions In Virologically Suppressed Adult Subjects With Chronic Hepatitis B

The safety of VEMLIDY in virologically suppressed adults is based on Week 48 data from a randomized, double-blind, active-controlled trial (Trial 4018) in which subjects taking TDF at baseline were randomized to switch to VEMLIDY (N=243) or to continue their TDF treatment (N=245). Adverse reactions observed with VEMLIDY in Trial 4018 were similar to those in Trials 108 and 110 [see Clinical Studies].

Renal Laboratory Tests, Bone Mineral Density Effects, And Serum Lipids

In virologically suppressed adults in Trial 4018, changes from baseline in renal function, BMD, and lipid parameters in the VEMLIDY and TDF groups at Week 48 were similar to those observed in Trials 108 and 110 at Week 96.

Adverse Reactions In Adult Subjects With Chronic Hepatitis B And Renal Impairment

In an open-label trial (Trial 4035) in virologically suppressed adult subjects with chronic hepatitis B switching to VEMLIDY 25 mg, the safety of VEMLIDY was assessed in 78 subjects with moderate to severe renal impairment (estimated creatinine clearance between 15 and 59 mL per minute by Cockcroft-Gault method; Part A, Cohort 1) and 15 subjects with ESRD (estimated creatinine clearance below 15 mL per minute) receiving chronic hemodialysis (Part A, Cohort 2). The safety of VEMLIDY, including changes from baseline in renal function, BMD, and lipid parameters, was similar to that observed in clinical trials of VEMLIDY in subjects with compensated liver disease but without renal impairment [see Use In Specific Populations and Clinical Studies].

Postmarketing Experience

The following adverse reactions have been identified during post approval use of VEMLIDY. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Skin And Subcutaneous Tissue Disorders

Angioedema, urticaria

Read the entire FDA prescribing information for Vemlidy (Tenofovir Alafenamide)

© Vemlidy Patient Information is supplied by Cerner Multum, Inc. and Vemlidy Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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