Note: This document contains side effect information about tenofovir alafenamide. Some dosage forms listed on this page may not apply to the brand name Vemlidy.

Summary

More frequent side effects include: decreased bone mineral density. Continue reading for a comprehensive list of adverse effects.

Applies to tenofovir alafenamide: oral tablet.

Serious side effects of Vemlidy

Along with its needed effects, tenofovir alafenamide (the active ingredient contained in Vemlidy) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking tenofovir alafenamide:

Incidence not known

• Agitation
• bloody urine
• coma
• confusion
• dark urine
• decreased appetite
• decreased frequency or amount of urine
• diarrhea
• dizziness
• fast, shallow breathing
• general feeling of discomfort
• headache
• hostility
• irritability
• lethargy
• light-colored stools
• loss of appetite
• lower back or side pain
• muscle pain, cramping, or twitching
• nausea and vomiting
• right upper abdominal or stomach pain and fullness
• seizures
• sleepiness
• stomach discomfort
• stupor
• swelling of the face, fingers, or lower legs
• trouble breathing
• unusual tiredness or weakness
• yellow eyes and skin

Other side effects of Vemlidy

Some side effects of tenofovir alafenamide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Acid or sour stomach
• belching
• cough
• difficulty in moving
• heartburn
• indigestion
• joint pain
• muscle stiffness

Less common

• Back pain

For Healthcare Professionals

Applies to tenofovir alafenamide: oral powder, oral tablet.

General

In clinical trials, the most common side effects reported with tenofovir alafenamide (the active ingredient contained in Vemlidy) were headache, nausea, and fatigue.

During controlled clinical trials, the most common side effects reported with tenofovir disoproxil fumarate (DF) in HIV-1-infected patients included rash, diarrhea, headache, pain, depression, asthenia, and nausea. The most common side effects associated with this drug in combination with other antiretrovirals have included mild to moderate gastrointestinal events (e.g., nausea, diarrhea, vomiting, and flatulence) in therapy-experienced patients and mild to moderate gastrointestinal events and dizziness in therapy-naive patients. About 1% of patients in clinical trials discontinued therapy due to gastrointestinal side effects.

During controlled clinical trials, the most common side effects reported with tenofovir DF in patients with chronic hepatitis B virus (HBV) infection and compensated liver disease included nausea, abdominal pain, diarrhea, headache, dizziness, fatigue, nasopharyngitis, back pain, and skin rash. In patients with chronic HBV and decompensated liver disease, the most common side effects reported during a controlled trial included abdominal pain, nausea, insomnia, pruritus, vomiting, dizziness, and pyrexia.^[Ref]

Gastrointestinal

Abdominal pain (any severity: 22%), nausea (any severity: 20%), and vomiting (any severity: 13%) have been in patients with chronic HBV and decompensated liver disease (n=45) using tenofovir DF.

Pancreatitis, abdominal pain, and elevated amylase have also been reported during postmarketing experience with tenofovir DF.^[Ref]

Tenofovir alafenamide:

-Common (1% to 10%): Abdominal pain (included upper abdominal pain, abdominal pain, lower abdominal pain, abdominal tenderness), nausea, diarrhea, dyspepsia, elevated serum amylase, vomiting, flatulence, abdominal distension

-Frequency not reported: Elevated amylase levels with associated symptoms (e.g., nausea, low back pain; abdominal tenderness, pain, distension; biliary pancreatitis, pancreatitis), elevated lipase

Tenofovir DF:

-Very common (10% or more): Abdominal pain (up to 22%), nausea (up to 20%), diarrhea (up to 16%), vomiting (up to 13%)

-Common (1% to 10%): Elevated serum amylase, flatulence, dyspepsia, abdominal distension, upper abdominal pain

-Uncommon (0.1% to 1%): Pancreatitis, elevated serum lipase^[Ref]

Other

In studies in chronic hepatitis B patients using tenofovir alafenamide (the active ingredient contained in Vemlidy) median serum phosphorus decreased by 0.1 mg/dL.

Pyrexia (any severity: 11%) was reported in patients with chronic HBV and decompensated liver disease (n=45) using tenofovir DF. Serum phosphorus less than 2 mg/dL was reported in a patient with chronic HBV and decompensated liver disease using tenofovir DF.

Asthenia has also been reported during postmarketing experience with tenofovir DF.^[Ref]

Tenofovir alafenamide:

-Common (1% to 10%): Fatigue, increased fasted low-density lipoprotein (LDL) cholesterol

-Frequency not reported: Decreased serum phosphorus, decreased fasted total cholesterol, decreased fasted high-density lipoprotein (HDL) cholesterol, increased fasted triglycerides

Tenofovir DF:

-Very common (10% or more): Elevated fasting cholesterol (up to 22%), pain (up to 13%), pyrexia/fever (up to 11%), asthenia (up to 11%), elevated triglycerides (up to 11%)

-Common (1% to 10%): Fatigue, weight loss, chest pain, procedural pain, elevated fasting triglycerides, elevated alkaline phosphatase

-Frequency not reported: Serum phosphorus less than 2 mg/dL, decreased fasted total cholesterol, decreased fasted HDL cholesterol, decreased fasted LDL cholesterol, decreased fasted triglycerides

Antiretroviral therapy:

-Frequency not reported: Increased weight, increased blood lipid levels^[Ref]

Dermatologic

Pruritus (any severity: 16%) has been reported in patients with chronic HBV and decompensated liver disease (n=45) using tenofovir DF.

Rash has also been reported during postmarketing experience with tenofovir DF.^[Ref]

Tenofovir alafenamide:

-Common (1% to 10%): Rash, pruritus

-Postmarketing reports: Angioedema, urticaria

Tenofovir DF:

-Very common (10% or more): Rash event (including rash, pruritus, maculopapular rash, urticaria, vesiculobullous rash, pustular rash, exfoliative rash, generalized rash, macular rash, pruritic rash, vesicular rash; up to 18%), pruritus (up to 16%)

-Common (1% to 10%): Sweating

-Uncommon (0.1% to 1%): Lipodystrophy

-Rare (0.01% to 0.1%): Angioedema

-Frequency not reported: Lichenoid drug eruption with eosinophilia^[Ref]

Psychiatric

Tenofovir DF:

-Very common (10% or more): Insomnia (up to 18%), depression (up to 11%)

-Common (1% to 10%): Anxiety, abnormal dreams

Insomnia (any severity: 18%) was reported in patients with chronic HBV and decompensated liver disease (n=45) using tenofovir DF.

Nervous system

Tenofovir alafenamide (the active ingredient contained in Vemlidy)

-Very common (10% or more): Headache (up to 12%)

-Common (1% to 10%): Dizziness

Tenofovir DF:

-Very common (10% or more): Headache (up to 14%), dizziness (up to 13%)

-Common (1% to 10%): Peripheral neuropathy (including peripheral neuritis and neuropathy)

-Frequency not reported: Somnolence, paresthesia^[Ref]

Dizziness (any severity: 13%) was reported in patients with chronic HBV and decompensated liver disease (n=45) using tenofovir DF.^[Ref]

Musculoskeletal

Tenofovir alafenamide (the active ingredient contained in Vemlidy)

-Common (1% to 10%): Back pain, arthralgia, elevated creatine kinase

-Frequency not reported: Decreased bone mineral density

Tenofovir DF:

-Very common (10% or more): Elevated creatine kinase (up to 12%)

-Common (1% to 10%): Arthralgia, myalgia, back pain

-Uncommon (0.1% to 1%): Rhabdomyolysis, muscular weakness

-Rare (less than 0.1%): Myopathy

-Frequency not reported: Decreased bone mineral density, increased biochemical markers of bone metabolism (serum bone-specific alkaline phosphatase, serum osteocalcin, serum C telopeptide, urinary N telopeptide), clinically relevant fractures (excluding fingers and toes), bone abnormalities (infrequently contributing to fractures), osteonecrosis

-Postmarketing reports: Osteomalacia (manifested as bone pain and which may contribute to fractures)^[Ref]

Rhabdomyolysis, muscular weakness, and myopathy have also been reported during postmarketing experience with tenofovir DF.

Rhabdomyolysis, osteomalacia, muscular weakness, and myopathy may occur as a result of proximal renal tubulopathy.^[Ref]

Metabolic

Tenofovir DF:

-Very common (10% or more): Hypophosphatemia

-Common (1% to 10%): Anorexia, elevated serum glucose/hyperglycemia

-Uncommon (0.1% to 1%): Hypokalemia

-Rare (0.01% to 0.1%): Lactic acidosis

-Frequency not reported: Higher 1,25 vitamin D levels

Antiretroviral therapy:

-Frequency not reported: Redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance"), increased glucose levels^[Ref]

Lactic acidosis, hypokalemia, and hypophosphatemia have also been reported during postmarketing experience with tenofovir DF.

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.

Hypokalemia and hypophosphatemia may occur as a result of proximal renal tubulopathy.^[Ref]

Hepatic

Death due to progression of liver disease has been reported in 4% of patients with chronic HBV and decompensated liver disease (n=45) using tenofovir DF.

On-treatment ALT or hepatic flares have been reported in patients with chronic HBV using tenofovir DF. In general, ALT flares occurred within the first 4 to 8 weeks of therapy, accompanied by decreases in HBV-DNA levels, and resolved within 4 to 8 weeks without changes to therapy.

Hepatic steatosis and hepatitis have also been reported during postmarketing experience with tenofovir DF.

Severe acute exacerbations of hepatitis have been reported in patients with hepatitis B after discontinuation of this drug.

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.^[Ref]

Tenofovir alafenamide:

-Common (1% to 10%): Elevated ALT, elevated AST

-Uncommon (0.1% to 1%): Treatment ALT flares

Tenofovir DF:

-Common (1% to 10%): Elevated transaminases, elevated ALT, elevated AST, death due to progression of liver disease

-Uncommon (0.1% to 1%): Treatment ALT flares

-Rare (0.01% to 0.1%): Hepatic steatosis, hepatitis

-Frequency not reported: On-treatment ALT or hepatic flares, severe hepatomegaly with steatosis (including fatal cases), severe acute exacerbations of hepatitis

-Postmarketing reports: Elevated liver enzymes (primarily AST, ALT, GGT)^[Ref]

Renal

In studies in chronic hepatitis B patients using tenofovir alafenamide (the active ingredient contained in Vemlidy) mean serum creatinine increased by less than 0.1 mg/dL.

A confirmed increase in serum creatinine of 0.5 mg/dL was reported in 9% of patients with chronic HBV and decompensated liver disease (n=45) using tenofovir DF; however, since tenofovir DF and decompensated liver disease may have an impact on renal function, the contribution of tenofovir DF to renal impairment in these patients was difficult to ascertain.

Proximal renal tubulopathy generally resolved or improved after this drug was stopped; however, decreased CrCl did not completely resolve in some patients after stopping tenofovir DF. Rhabdomyolysis, osteomalacia, bone abnormalities (infrequently contributing to fractures), hypokalemia, muscular weakness, myopathy, and hypophosphatemia may occur as a result of proximal renal tubulopathy.

Renal failure, acute renal failure, Fanconi syndrome, proximal renal tubulopathy, increased creatinine, nephrogenic diabetes insipidus, and acute tubular necrosis have also been reported during postmarketing experience with tenofovir DF.^[Ref]

Tenofovir alafenamide:

-Frequency not reported: Increased serum creatinine

Tenofovir DF:

-Common (1% to 10%): Increased creatinine

-Uncommon (0.1% to 1%): Proximal renal tubulopathy (including Fanconi syndrome)

-Rare (0.01% to 0.1%): Acute renal failure, renal failure, acute tubular necrosis, nephrogenic diabetes insipidus

-Frequency not reported: New onset or worsening renal impairment, nephritis, decreased CrCl

-Postmarketing reports: Renal insufficiency, interstitial nephritis (including acute cases)^[Ref]

Respiratory

Tenofovir alafenamide (the active ingredient contained in Vemlidy)

-Common (1% to 10%): Cough

Tenofovir DF:

-Common (1% to 10%): Sinusitis, upper respiratory tract infections, nasopharyngitis, pneumonia, pharyngolaryngeal pain

-Frequency not reported: Nasal congestion

-Postmarketing reports: Dyspnea^[Ref]

Hematologic

Tenofovir DF:

-Common (1% to 10%): Decreased neutrophils^[Ref]

Genitourinary

Tenofovir alafenamide (the active ingredient contained in Vemlidy)

-Common (1% to 10%): Glycosuria (at least 3+)

Tenofovir DF:

-Common (1% to 10%): Hematuria, glycosuria

-Frequency not reported: Decreased urine volume

-Postmarketing reports: Proteinuria, polyuria^[Ref]

Hypersensitivity

Tenofovir DF:

-Postmarketing reports: Allergic reaction (including angioedema)^[Ref]

Immunologic

Tenofovir DF:

-Frequency not reported: Immune reconstitution syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome, autoimmune hepatitis)

Endocrine

Tenofovir DF:

-Frequency not reported: Higher serum parathyroid hormone levels