Medication info
Bempedoic Acid Tablets (Tenofovir Alafenamide Hemitartrate)

Bempedoic Acid Tablets (Tenofovir Alafenamide Hemitartrate)

Prescription medicationTabletOral
Ingredient · strength
Tenofovir Alafenamide Hemitartrate›28.94mg / 1 tablet
Manufacturer / importer
Daewoong Pharmaceutical Co., Ltd.
Appearance
Yellow round film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202300226 · Approved 2023.01.12 · Insurance code 641607790

Summary

Main use
Treatment of chronic hepatitis B in adults
Who takes it
Adults
Adult dose
Administer 1 tablet once daily, with or without food. No dose adjustment is required for patients with mild, moderate, or severe renal impairment. Patients receiving chronic hemodialysis should take this medicine after dialysis on dialysis days. [See 'Precautions for Use,' '9. Administration to Patients with Renal Impairment.'] No dose adjustment is required for patients with hepatic impairment. [See 'Precautions for Use,' '3. Adverse Reactions' and '10. Administration to Patients with Hepatic Impairment.']

Ingredients

Manufacturer
Daewoong Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of chronic hepatitis B in adults

  • Chronic hepatitis B
View approved original text

This medication is used for the treatment of chronic hepatitis B in adults.

How to take

Adult dose

Administer 1 tablet once daily, with or without food. No dose adjustment is required for patients with mild, moderate, or severe renal impairment. Patients receiving chronic hemodialysis should take this medicine after dialysis on dialysis days. [See 'Precautions for Use,' '9. Administration to Patients with Renal Impairment.'] No dose adjustment is required for patients with hepatic impairment. [See 'Precautions for Use,' '3. Adverse Reactions' and '10. Administration to Patients with Hepatic Impairment.']

Precautions

There is a risk of severe exacerbation of hepatitis upon discontinuation of this medication, so when stopping treatment, the patient's condition should be closely monitored according to the doctor's instructions for at least several months. Patients with a history of allergy to this medication or with genetic disorders affecting lactose metabolism should not take it. During the use of this medication, symptoms such as headache, abdominal pain, cough, low back pain, fatigue, nausea, joint pain, diarrhea, and dyspepsia may occur, so if any unusual symptoms appear, patients should inform their healthcare provider. This medication may affect kidney function, so patients with impaired kidney function should undergo regular blood and urine tests, and the medication may be discontinued if kidney function worsens. Since there may be a decrease in bone density, attention to bone health is needed, and long-term users should consult their doctors about bone density testing. This medication may interact with certain drugs, so patients should inform their healthcare provider of any other medications they are currently taking. During pregnancy, the risks and benefits to the fetus should be carefully considered, and for breastfeeding mothers, caution is advised as this medication may pass into breast milk and affect the baby. The safety and efficacy in children under 18 years of age have not been established, so it is not recommended for use in this age group. Elderly patients over 65 can take this medication without special dosage adjustments, but it is advisable to periodically check their health status, including kidney function. In case of overdose, patients should immediately visit a medical facility for monitoring of vital signs and condition, and if necessary, the medication can be removed via blood dialysis. This medication should be stored in a tightly closed container, avoiding direct sunlight, and at a temperature between 1 to 30 degrees Celsius.

Side effects

  • headache
  • abdominal pain
  • cough
  • back pain
  • fatigue
  • nausea
  • joint pain
  • diarrhea
  • indigestion
  • vomiting
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  • rash
  • intestinal pneumatosis
  • elevated amylase
  • elevated lipase
  • nausea
  • back pain
  • abdominal tenderness
  • abdominal pain
  • abdominal distension
  • vascular edema
  • urticaria
  • acute renal failure
  • acute tubular necrosis
  • proximal tubular dysfunction
  • Fanconi syndrome
  • abdominal discomfort
  • constipation
  • discomfort in the upper abdomen
  • scallop-shaped stool
  • weakness
  • peripheral edema
  • chest discomfort
  • chills
  • cholelithiasis
  • cystitis
  • sinusitis
  • dizziness
  • muscle cramps
  • decreased blood insulin
  • hair loss
  • eczema
  • splenomegaly
  • eosinophilia
  • macular degeneration
  • hypercholesterolemia
  • depression
  • palpitations
  • benign paroxysmal positional vertigo

Not everyone experiences these, and they can vary from person to person.

Storage

This medication is sensitive to air and moisture, so it must be stored in a properly sealed container. It is important to maintain a room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.