Medication info
Tenofovir Alafenamide Tablet (Tenofovir Alafenamide Fumarate)

Tenofovir Alafenamide Tablet (Tenofovir Alafenamide Fumarate)

Prescription medicationTabletOral
Ingredient · strength
Tenofovir Alafenamide Succinate›31.2mg / 1 tablet
Manufacturer / importer
Jongkundang Co., Ltd.
Appearance
Yellow, round, film-coated tablet with "CKD" on one side and "25" embossed on the other side.
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202300190 · Approved 2023.01.10 · Insurance code 643309280

Summary

Main use
Treatment of chronic hepatitis B in adults
Who takes it
Adults
Adult dose
1. Recommended dose for adults Administer 1 tablet once daily, with or without food. 2. Dose adjustment in patients with renal impairment No dose adjustment of this medicine is necessary in patients with mild, moderate, or severe renal impairment. Patients receiving chronic hemodialysis should take this medicine after dialysis is completed on dialysis days. [See '9. Administration to patients with renal impairment' under 'Precautions for use'.] 3. Dose adjustment in patients with hepatic impairment No dose adjustment of this medicine is necessary in patients with hepatic impairment. [See '3. Adverse reactions' and '10. Administration to patients with hepatic impairment' under 'Precautions for use'.]

Ingredients

Manufacturer
Jongkundang 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

1. Recommended dose for adults Administer 1 tablet once daily, with or without food. 2. Dose adjustment in patients with renal impairment No dose adjustment of this medicine is necessary in patients with mild, moderate, or severe renal impairment. Patients receiving chronic hemodialysis should take this medicine after dialysis is completed on dialysis days. [See '9. Administration to patients with renal impairment' under 'Precautions for use'.] 3. Dose adjustment in patients with hepatic impairment No dose adjustment of this medicine is necessary in patients with hepatic impairment. [See '3. Adverse reactions' and '10. Administration to patients with hepatic impairment' under 'Precautions for use'.]

Precautions

This medication can lead to rapid deterioration of liver function if hepatitis B treatment is stopped, so the patient's condition should be closely monitored for at least several months under medical supervision even after stopping treatment. Patients who are allergic to this medication or its ingredients should not take it, and those with hereditary lactose intolerance or galactose metabolism disorders should also refrain from using it. While taking this medication, side effects such as headache, abdominal pain, cough, back pain, fatigue, nausea, joint pain, diarrhea, and dyspepsia may occur; any abnormal symptoms should be reported to healthcare professionals. As this medication may affect renal function, patients with kidney disease or those taking other medications that may impact the kidneys should have regular kidney function tests. Long-term use may reduce bone density, so individuals at risk of osteoporosis should check their bone health status. This medication may affect liver function; therefore, patients with liver diseases also need regular liver function tests. Women who are pregnant or planning to become pregnant should carefully consider the potential risks and benefits of this medication, and breastfeeding women should consult a doctor before taking it. The safety and efficacy of this medication in pediatric patients under 18 years of age have not been established, so it should be administered cautiously to children. Elderly patients aged 65 and older can use it without special dosage adjustments, but renal function and overall health should be considered. Due to potential interactions with other medications, patients should inform healthcare providers of any currently taken medications, especially when used in conjunction with certain anticonvulsants, antituberculosis medications, or herbal medicines. In cases of overdose, immediate medical attention should be sought to monitor vital signs and clinical status, and blood dialysis may be used to remove the medication if necessary. This medication should be stored in a tightly closed container at a temperature between 1 and 30 degrees Celsius, avoiding direct sunlight.

Side effects

  • Headache
  • abdominal pain
  • cough
  • back pain
  • fatigue
  • nausea
  • joint pain
  • diarrhea
  • indigestion
  • vomiting
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  • rash
  • intestinal gas retention
  • angioedema
  • urticaria
  • acute renal failure
  • acute tubular necrosis
  • proximal tubular disease
  • Fanconi syndrome
  • abdominal discomfort
  • constipation
  • upper abdominal discomfort
  • scallop-shaped stool
  • asthenia
  • peripheral edema
  • chest discomfort
  • chills
  • cholelithiasis
  • cystitis
  • sinusitis
  • dizziness
  • muscle spasms
  • hair loss
  • eczema
  • splenomegaly
  • eosinophilia
  • macular degeneration
  • hypercholesterolemia
  • depression
  • palpitations
  • vertigo
  • nausea
  • abdominal tenderness
  • abdominal distension
  • obstructive pancreatitis
  • elevated amylase
  • elevated lipase

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

Storage

This medication should be stored in a tightly closed container to avoid exposure to air or light, preferably at room temperature between 1 and 30 degrees Celsius. Storing in this manner helps maintain the efficacy of the medication and prevent deterioration.

Appearance and packaging

Appearance

Yellow, round, film-coated tablet with "CKD" on one side and "25" embossed on the other side.

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.