HEPA-TAF 25mg BRV treatment for chronic hepatitis B (30 tablets)

Dosage form Box of 30 tablets
Specifications Tenofovir alafenamide

Ingredient

Composition information	Content
Tenofovir alafenamide	25mg

Uses

indications

HEPA - TAF drugs are indicated to treat chronic hepatitis B in adults and adolescents (from 12 years old and older with at least 35 kg body weight).

Pharmacology

ATC code: J05A F13.

Drug group: Systemic antiviral drugs, nucleosid and nucleotid -reverse enzyme inhibitors.

Tenofovir alafenamide is a phosphonamid chemical precursor of tenofovir (similar to 2'-dosoxyadenosine monophosphate). Tenofovir alafenamide enters the original liver cells by passive diffusion and by the drug transportation into the OATP1B1 and OATP1B3 liver. Tenofovir Alafenamide is first hydrolyzed by carboxy aconemis 1 in the primitive liver cells into tenofovir. The intracellular tenofovir was then phosphoryl turned into metabolites with the Tenofovir Diphosphate activity. Tenofovir diphosphate inhibits HBV's multiplication by connecting the virus DNA by the HBV reverse transcription enzymes, leading to the end of the DNA chain.

Tenofovir has a special activity with hepatitis B virus and immunodeficiency virus (HIV-1 and HIV-2).

Tenofovir Diphosphate is a weak inhibitor of DNA polymerase enzyme in mammals including mitochondrial DNA and has no toxic evidence with mitochondria in In vitro tests including mitochondrial DNA analysis.

pharmacokinetics

No data.

Before taking HEPA-TAF 25mg BRV treatment for chronic hepatitis B (30 tablets)

How to use

oral medication with food.

Dosage

Drugs need to be instructed by a doctor with experience in chronic hepatitis B.

Adults and teenagers (aged 12 years and older have a minimum body weight of 35 kg): One, once a day.

Stop treatment:

Discontinuation of treatment may be considered as follows:

In patients with HBeAg positive, there is no cirrhosis, should take the drug for at least 6-12 months after converting blood into HBE (loss of HBeAg and the loss of HBV DNA whose anti -HBE - HBE) is determined or until HBS serum conversion or inefficient. Regular monitoring should be monitored after treatment to detect recurrent cases.

In patients with negative hbeag without cirrhosis, the drug should be used at least until the serum transformation or there is evidence that is ineffective.

When treatment lasts more than 2 years, it is necessary to re -evaluate regularly to confirm that continuing treatment is still suitable for patients.

Elderly: No need to adjust the dose for the elderly aged 65 and older.

Renal failure: No dose adjustment for adults or adolescents (ages 12 years and older and body weight at least 35 kg) suffers from kidney failure with creatinine clearance (CrCl) ≥ 15 ml/min or in patients with CrCl

During the hemorrhage days, the drug should be used after completing the appraisal.

Do not recommend medication for patients with CrCl

Hepatic failure: No dose adjustment for patients with liver failure.

Children: Safety and effectiveness when taking drugs for children under 12 years old or body weight - 35 kg has not been set up.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose?

Management: Overdose by applying basic support measures including monitoring of survival signs as well as observing the patient's clinical conditions.

Tenofovir can be effectively eliminated by hemorrhage with a separation coefficient of about 54%. Unknown, Tenofovir can be excluded by peritoneal fertilizer.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when forgetting 1 dose?

If more than 18 hours after taking the normal medication, the patient does not need to take compensation and just take the next tablets on time.

If the patient is vomiting within 1 hour after taking the medication, it must be taken in return for another tablet, if vomiting after 1 hour of taking the medicine, there is no need to take another tablet.

Side Effects

When using the drug, there are common unwanted effects (ADR) such as:

Nervous system:

Very common: headache.

Common: Dizziness.

Common: diarrhea, nausea, vomiting, abdominal pain, bloating, flatulence.

Common: Increase Alt.

Skin and subcutaneous tissue:

Common: rash, itching.

Common: joint pain.

General:

Common: fatigue.

Instructions on how to handle ADR:

Notify the physician the unwanted effects when using the drug.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

HEPA - TAF contraindicated in the following cases:

Hypersensitivity to Tenofovir Alafenamide or any ingredient of the drug.

Caution when using

HBV infection

Patients should be notified that this drug does not prevent the risk of HBV infection to others through sexual contact or blood infection. It is necessary to continue using appropriate preventive measures.

Patients with liver failure

There is no data on the safety and effectiveness of the drug in HBV infected patients with loss of liver failure and having a PUGH Turcotte child (CPT)> 9 (i.e. type C).

These patients are at higher risk of serious side effects in the liver or kidneys. Therefore, the parameters of liver and kidney should be closely monitored in this group of patients,

Heavenly hepatitis

Outbreaks at treatment:

Chronic spontaneous thriving hepatitis B is relatively common and distinguished by the temporary increase in alanine aminotransferase serum (ALT). After starting treatment with antiviral drugs, serum alt may increase in some patients.

In patients with compensation liver failure, the increase in serum ALT is often not accompanied by increased serum bilirubin concentration or loss of liver failure. Patients with cirrhosis may have a high risk of liver failure after getting worse of hepatitis and therefore should be closely monitored during treatment.

Outbreak after treatment:

The worse hepatitis has been reported in patients who have stopped treating hepatitis B, often combined with increased DNA HBV concentration in plasma. Most cases are self -recovered but the disease gets worse, including death results, which may occur after stopping the treatment of hepatitis B. It is necessary to monitor liver function both clinically and subclinical in the repeated period for at least 6 months after the hepatitis B treatment.

If appropriate, can ensure the continued treatment of hepatitis b.

It is not recommended to stop treating hepatitis in patients with progressive liver disease or cirrhosis, because hepatitis is worse after treatment can lead to loss of liver failure. The liver pain is particularly serious and sometimes fatal in patients with liver failure.

kidney failure

Patients with creatinine clearance

There is no safe data on the use of this drug to treat HBV infected patients with CRCI

Do not recommend this medication for patients with CRCI

Kidney toxicity

It is impossible to rule out the potential risk of kidney toxicity due to long -term contact with low concentration Tenofovir due to the use of tenofovir alafenamide.

Patients with HBV and hepatitis C or D

There is no data on the safety and effectiveness of this drug in patients with the co -infection with hepatitis C virus or D. It is necessary to follow the instructions in the treatment of hepatitis C.

co -infection with hepatitis B and HIV

It is necessary to test HIV antibodies for all HBV infected patients without knowing HIV -1 infection before starting treatment with this drug. In HBV and HIV -infected patients. Other drugs need to be combined with other antacids to ensure patients have appropriate HIV treatment regimen.

Use in combination with other drugs

Do not use this drug with other drugs containing tenofovir disoproxil fumarate, tenofovir alafenamide or adefovir dipivoxil.

It is not recommended to use this drug at the same time with some anticonvulsants (such as carbamazepin, oxcarbazepin, phenobarbital and phenytoin), tuberculosis anti -bacterial drugs (such as rifampicin, rifabutin and rifapentin) or ST. Johns Wort, all of which are P-Glycoprotein (P-GP) induction that can reduce the concentration of Tenofovir Alafenamide in plasma.

It is not recommended to use this combination of drugs with strong P-GP inhibitors (such as: otraconazole and ketoconazole) that can increase the concentration of tenofovir alafenamide in plasma.

Lactose intolerance

This drug contains lactose monohydrate. Therefore, this medication should not be used for patients with rare genetic problems in tolerance of galactose, lactase deficiency or malposure - Galactose.

Use drugs for women during pregnancy and lactation

Pregnant women

No or very little data (less than 300 pregnancy results) from the use of Tenofovir Alafenamide in pregnant women.

However, a large amount of data on pregnant women (more than 1,000 exposure results) shows no deformity or toxic to the fetus/infant related to the use of Tenofovir disoproxil fumarate. Animal studies show that there is no reproductive toxicity. The use of this drug can be considered during pregnancy, if necessary.

breastfeeding

It is not known whether Tenofovir Alafenamide is excreted through breast milk or not. However, in animal studies, Tenofovir has been excreted in milk.

Not enough information about the effects of tenofovir in infants/children. It is not possible to rule out the risks for breastfeeding children: Therefore, this medication should not be used during breastfeeding.

The effect of the drug on the ability to drive and operate machinery

The drug does not have or have a significant impact on the ability to drive and operate machinery. It is necessary to notify the patient about the ability to cause dizziness when treating with this drug.

Interactive drug

Interactive studies have only been conducted in adults.

Do not use this drug with drugs containing tenofovir disoproxil fumarate, tenofovir alafenamide or adefovir dipivoxil.

Medications can affect Tenofovir Alafenamide

Tenofovir Alafenamide is transported by P-GP protein and/or anti-anti-cancer protein (BCRP).

P-GP induction drugs (such as: Rifampicin, Rifabutin, Carbamazepin, Phenobarbital or St. John's Wort) can reduce the plasma concentration of Tenofovir Alafenamide, which can lead to loss of drug effectiveness. Do not use such drugs at the same time with this drug.

Use this combination of drugs with P-GP and/or BCRP inhibitors that may increase the plasma concentration of Tenofovir Alafenamide. Do not use a combination of strong P-GP inhibitors with this drug.

Tenofovir Alafenamide is the substrate of Oatpibi and CATPTB3 Invitro. The distribution of Alafenamide Tenofovir in the body can be affected by the activity of OATP1B1 and/or CATP1B3.

The effect of tenofovir alafenamide on other drugs

Tenofovir Alafenamide is not inhibitor CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 or CYP2D6 in In vitro. It is not an inhibitor үрза in in vivo.

Tenofoviralafenamide is not an uricine diphosphate glucuronosyltransferase (UGT) 1A1 1A1 in vitro. It is unknown whether Tenofovir Alafenamide is an inhibitor of other UGT enzymes.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

Other drugs

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