Teravir-AF NATCO 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

Teravir - AF 25 mg is indicated in the case of chronic hepatitis B treatment in adults and adolescents (from 12 years old, weighing at least 35 kg).

Pharmacokological

Tenofovir alafenamide is the precursor of tenofovir phosphonamidate (similar to 2 ' - Deoxyadenosine monophosphate). Tenofovir Alafenamide penetrates into primary liver cells due to passive diffusion and absorption in the liver by OatP1B1 and OATP1B3 transport channels.

Tenofovir Alafenamide is mainly hydrolyzed to form Tenofovir with carboxyxic cars in primary liver cells. Tenofovir intracellular was then phosphoryl turned into metabolites with pharmacological activity Tenofovir diphosphate. Tenofovir Diphosphate inhibits the multiplication of HBV through the combination of DNA virus by copying HBV backwards, resulting in the end of the DNA chain.

Tenofovir has a specific activity for hepatitis B and viruses that cause immunodeficiency in humans (HIV - 1 and HIV - 2). Tenofovir Diphosphate is a inhibitor of mammal polymerase DNA including DNA polymerase γ mitochondria and has no evidence of toxicity for mitochondria In vitro.

pharmacokinetic

absorption

After taking Tenofovir in an empty stomach in patients with adult hepatitis B, the drug reaches the peak concentration after taking 0.48 hours. The average stability AUC0-24 of Tenofovir Alafenamide is 0.22 μg. Rice/ml and of Tenofovir are 0.32 μg. The stable state of CMAX of Tenofovir Alafenamide and Tenofovir are 0.18 and 0.02 μg, respectively. When taking pills with a fat -rich meal, Tenofovir Alafenamide contact increased by 65%.

Distribution

Tenofovir Alafenamide binds to plasma proteins approximately 80%. Tenofovir's connection is lower than 0.7% and independent of concentrations of 0.01 - 25 μg/ml.

Metabolism

Metabolism is the main excretion path of Tenofovir Alafenamide in the body, accounting for over 80% of oral dose. In vitro, Tenofovir Alafenamide converts mainly into tenofovir by carboxyxic cars 1 in liver cells and by cathepsin A in pbmcs and macrophages. In Vivo, Tenofovir Alafenamide is hydrolyzed in cells to form Tenofovir and then phosphoryl turned into an active metabolic substance as tenofovir diphosphate.

In vitro, Tenofovir Alafenamide is not metabolized by CYP1A2, 2C8, 2C9, 2C19, 2D6. Tenofovir Alafenamide is minimized by CYP3A4.

Elimination

less than 1% of Tenofovir Alafenamide intact excreted through the kidneys (urine). Tenofovir Alafenamide and Tenofovir have an average selling time in plasma of 0.51 and 32.37 hours respectively. Tenofovir is discharged through the kidneys both by glomerular filtration and excretion in the renal tubules.

Before taking Teravir-AF NATCO treatment for chronic hepatitis B (30 tablets)

How to use

Should take medicine at the same meal.

Dosage

Adults and adolescents (from 12 years old, weighing at least 35 kg):

Take 1 capsule/day.

kidney failure:

No dose adjustment in adults and adolescents (from 12 years of age, weighs at least 35 kg) has CrCl ≥ 15 ml/minute or patients with dialysis with CrCL

Do not recommend used in patients with CrCl

Hepatic failure:

No dose adjustment.

Children:

Do not recommend for children under 12 years old or weighs less than 35 kg.

Stop treatment may be considered when:

In patients positive for HBeAg without cirrhosis, so treatment for at least 6-12 months after conversion of HBE serum results (HBeAg and HBV DNA with HBE detection) are confirmed or until HBS serum transformation or until ineffective. Need to evaluate regularly after stopping treatment to detect virus recurrence.

In negative patients with HBeAg without cirrhosis, so the treatment should be at least until the conversion of serum results or until signs of loss are ineffective. With more than 2 years of treatment, it is necessary to re -evaluate regularly to confirm that continuing to choose the therapy is still suitable for patients.

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?

How to handle: General auxiliary measures include monitoring vital signs, observing the patient's clinical status.

Tenofovir is removed by dialysis with an extract coefficient of approximately 54%. It is unknown whether the drug can be removed by peritoneal fertilizer.

What to do when forgetting a dose? If more than 18 hours after taking the drug, the patient skip the forgotten dose and take the next dose as the normal schedule.

Side Effects

When using Teravir - AF 25 mg, you may experience unwanted effects (ADR).

Very common, ADR> 1/10

Neurological: headache.

Common, ADR> 1/100

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

all body: tired. Neurological: dizziness.

Liver: Increase ALT.

musculoskeletal: joint pain.

Uncommon, 1/1000

Skin: Evana, urticaria.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

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

Contraindicated

Teravir - AF 25 mg is contraindicated in case of hypersensitivity to any component of the drug.

Precautions when using

Tenofovir does not prevent the risk of HBV transmission to others through sex or blood sugar. Must continue using appropriate preventive measures.

There is no safe and effective data when taking drugs in HBV infected patients with compensated liver disease and Child Pugh Turcotte> 9 (Grade C). These patients are at high risk of side effects on the liver and kidneys should be closely monitored.

When treated with antiviral drugs, serum alt can be increased in some patients. In patients with liver disease, the increase in serum alt is not accompanied by an increase in serum bilirubin concentration or liver loss. Patients with cirrhosis are at higher risk of liver loss when hepatitis is worse, closely monitoring this object.

The acute drama of hepatitis has been reported in patients who have stopped treating hepatitis B, often due to increased plasma HBVs of plasma DNA. Periodic liver function monitoring with clinical research and tests for at least 6 months after the drug stops. If necessary, it is necessary to continue treating hepatitis b.

In patients with progressive liver disease or cirrhosis, it is not recommended to stop treating because after the hepatitis's drama treatment can lead to liver compensation, especially serious and sometimes fatal outbreaks.

Cannot rule out the risk of kidney toxicity due to chronic exposure at low tenofovir.

Should check HIV antibodies in HBV and HIV -1 -infected patients and in combination with resistant retrovirus anti -Retrovirus medications according to the HIV regimen.

Do not share Teravir - AF with drugs containing Tenofovir Alafenamide, Tenofovir Disoproxil Fumarate, Adenovir Dipivoxil.

The ability to drive and operate machinery

The drug does not affect or negatively affect the ability to drive and operate machinery. Patients should be cautious if dizzy when taking the drug.

Pregnancy

Restricted data on drug use for pregnant women. However, a large amount of data on pregnant women shows no expression of malformations and toxicity in newborns when taking the drug. In Vivo, no direct and indirect impact on reproduction.

Can consider using tenofovir when pregnant if necessary.

Breastfeeding period

It is not known whether Tenofovir will excrete in breast milk. In Vivo, the drug can be breast milk. There is no sufficient information about the effect of the drug on babies. Can not rule out the risk in breastfeeding, so do not take the drug while breastfeeding.

Drug interaction

Tenofovir Alafenamide is the substrate of P - Glycoprotein (P - GP) and BCRP. The induction drugs of P - GP work reduce the absorption and reduce the concentration of Tenofovir in the blood. Active inhibitors P - GP and BCRP increases the concentration of tenofovir in the blood.

It is not recommended to simultaneously use tenofovir with anti -epileptic drugs (carbamazepine, oxcarbazepine, phenobarbital, phenytoin), antiviral drugs (rifampicin, rifapentine, rifabutin), ST. John’s Wort due to the ability to reduce the level of tenofovir in the blood, reduce the effectiveness of treatment.

It is not recommended to simultaneously use Tenofovir with strong inhibitors P - GP such as antifungal drugs (Itraconazole, ketoconazole) due to the ability to increase the level of Tenofovir in blood, increase toxicity.

Tenofovir is excreted mainly through the kidneys (through glomerular filtration and positive excretion in the renal tubules). Used in combination with drugs that reduce the activity of the kidneys or the positive excretion competition in the renal tubules (Acyclovir, Cidofovir, Ganciclovir, Valacyclovir, Valganciclovir, Aminoglycoside, high doses of NSAIDs ...) can increase the level of tenofovir in blood, leading to increased toxicity.

Storage

Storage in the original packaging, no more than 30 ° C.

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