Tafsafe 25mg ATA treatment of chronic hepatitis B (30 tablets)

Dosage form Box of 30 tablets
Specifications Tenofovir alafenamide

Ingredient

Composition information	Content
Tenofovir alafenamide	25mg

Uses

indications

Tafsafe 25mg drugs are indicated in the following cases:

Indications for the treatment of chronic hepatitis B virus (HBV) on adults without compensation.

In patients positive for HBeAg without cirrhosis, so treatment for at least 6-12 months after the HBE serum conversion (loss of HBeAg and Losing DNA HBV when detecting HBE resistance) or until HBS serum conversion or until the negative loss. Effectiveness. After entering the body it is transported or diffused passively into liver cells. Taf was then hydrolyzed into tenofovir, then phosphoryl turned into a activity form as tenofovir diphosphate.

Tenofovir diphosphate inhibits the copy of HBV (hepatitis B virus) through inhibition of HBV polymerase reverse copy enzymes that leads to the end of the DNA chain of the virus.

Dynamic pharmacokinetics

After taking Tenofovir Alafenamide in the condition of fasting in patients with adults with chronic hepatitis B, the top concentration of plasma of Tenofovir Alafenamide is observed after about 0.48 hours. Compared to fasting, the use of a single dose of Tenofovir Alafenamide with a high -fat meal increases 65% of Tenofovir Alafenamide in contact with the body.

The cohesion of Tenofovir Alafenamide with plasma proteins in samples collected in clinical studies is about 80%. The link of tenofovir with plasma proteins is less than 0.7%.

Metabolic is the main excretion path of tenofovir alafenamide in humans, accounting for> 80% of oral dose. In vitro studies have shown that Tenofovir Alafenamide is converted into Tenofovir (main metabolites) by carboxy aconem in liver cells; and by cathepsin A in peripheral mononeries (PBMC) and macrophages.

Tenofovir alafenamide excretion is not significant with

Before taking Tafsafe 25mg ATA treatment of chronic hepatitis B (30 tablets)

How to use

Tafsafe 25mg oral drugs.

Should take medicine at the same time during the day, should take medicine with food.

If the patient vomits within 1 hour after taking Tafsafe, the patient should take another tablet. If the patient vomits more than 1 hour after taking Tafsafe, the patient does not need to take another tablet.

Dosage

Adults and adolescents (aged 12 years and older with weight ≥ 35 kg): 1 capsule/time x 1 time/day.

In patients positive with HBeAg without cirrhosis, so treatment for at least 6-12 months after the HBE serum transformation (loss of HBeAg and DNA HBV loss when detecting HBE resistance) or until HBS serum conversion or until the loss.

Reassessment is regularly recommended after stopping treatment to detect virus recurrence.

In patients negative with HBeAg without cirrhosis, so treatment should be at least until the HBS serum conversion or until there is evidence of effective loss.

With more than 2 years of treatment, it is advisable to re -evaluate regularly to confirm that continuing treatment is still suitable for patients.

Elderly: No need to adjust the dose in patients aged 65 and over.

Patients with renal impairment: No need to adjust the tafsafe dose in adults or adolescents (at least 12 years old and at least 35 kg of body weight) with estimated creatinine clearance (CrCl) ≥ 15 ml / minute or in patients with CrCl

It is impossible to make recommendations on the dosage for patients with CrCl

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

Children: Safety and effectiveness of children under 12 years old or weighs

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?

Tenofovir is effectively removed by dialysis with an extract coefficient of approximately 54%. It is not known whether Tenofovir can be removed by peritoneal fertilizer.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

If a dose is missed and less than 18 hours after normal use. Patients should take Tafsafe as soon as possible and then continue the normal drug schedule.

If it has been over 18 hours since normal use. Patients should not use the forgotten dose and should only continue the normal drug schedule.

Side Effects

When using Tafsafe 25mg ATA, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Neurology: headache, dizziness.

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

Liver: Increase ALT.

Skin and subcutaneous tissue: itching, rash.

musculoskeletal: muscle pain.

Body: tired.

less common, 1

Skin and subcutaneous tissue: 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

Tafsafe 25mg ATA anti -contraindications in the following cases:

Hypersensitivity to any ingredients of the drug.

Caution when using

HBV infection

Patients must be notified that Tenofovir Alafenamide tablets do not prevent the risk of HBV transmission to others through sex or blood sugar. Must continue using appropriate preventive measures.

Patients with liver disease are lost

There is no safe and effective data of Tenofovir Alafenamide tablets in patients with HBV infected with loss of liver disease and a Pugh Turcotte child (CPTP9 (meaning CPTP9). These patients are at high risk of unwanted effects on the liver and kidneys. Therefore, the parameters of liver and kidney should be closely monitored in this patient group.

The more serious of hepatitis

Outbreaks in treatment:

The spontaneous increase in chronic hepatitis B is relatively common and characterized by an open increase in alanine aminotransferase (ALT) in serum. After starting treatment with antiviral drugs, serum alt can increase in some patients.

In patients with compensation liver disease, the increase in serum alt generals is not accompanied by increased serum bilirubin concentration or liver loss. Patients with cirrhosis are at higher risk of liver loss after hepatitis worse, and thus should be closely monitored during treatment.

Outbreaks after stopping treatment:

The acute drama of hepatitis has been reported in patients who have stopped treating hepatitis B, often associated with an increase in the concentration of HBV DNA in plasma. Most cases are self -limited but serious drama, including death, may occur after stopping treatment with hepatitis b.

Liver function must be monitored for a clinical repetition and test for at least 6 months after the treatment of hepatitis B. If appropriate, the continued treatment of hepatitis B can be guaranteed.

In patients with progressive liver disease or cirrhosis, discontinuated treatment is not recommended because after the hepatitis's drama treatment can lead to liver loss. The outbreak of the liver is particularly serious, and sometimes death in patients with liver disease.

kidney failure

Patients with creatinine clearance

The use of Tenofovir Alafenamide tablets at a time in patients with CrCl2 15 ml/minute but

Using Tenofovir Alafenamide tablets is not recommended in patients with CrCl

Single

Potential risks of single chronic exposure at a low tenofovir due to the use of Tenofovir Alafenamide cannot be excluded.

Patients infected at the same time HBV and hepatitis C or D

There is no safe and effective data of Tenofovir Alafenamide tablets in infected patients simultaneously with hepatitis C or D. Should monitor the instructions for use for inflammation treatment.

Hepatitis B and at the same time HIV

HIV antibodies should be proposed to all HBV infected patients in people with HIV-1 infection unknown before starting treatment with Tenofovir Alafenamide tablets. In infected patients at the same time HBV and HIV, Tenofovir Alafenamide tablets should be used simultaneously with other anti -Tetrovirus resistant agents to ensure that the patient receives the appropriate regimen for HIV treatment.

The ability to drive and operate machinery

without or negligible effects on the ability to drive and use machinery. Patients should be informed that dizziness has been reported during treatment with Tenofovir Alafenamide.

pregnancy

without or limited amount of data (less than 300 results) on the use of tenofovir alafenamide in pregnant women. However, a large amount of data on pregnant women (more than 1,000 exposures) shows no defects and toxicity to the fetus / infant related to the use of Tenofovir disoproxil.

Animal studies do not indicate direct or indirect harm to reproductive toxicity.

The use of Tenofovir Alafenamide may be considered during pregnancy, if necessary.

The period of breastfeeding

It is not known whether Tenofovir Alafenamide will be secreted into breast milk or not. However, in animal studies, it has been shown that Tenofovir is secreted into milk. There is no enough information about the effects of tenofovir in infants / children.

Can not rule out risks for infants / infants breastfeeding; Therefore, Tenofovir Alafenamide should not be used during breastfeeding.

Drug interaction

Acyclovir - Valacyclovir, Adefovir, Aminoglycoside, Cabozantinib, Cidofovir, Ganciclovir - Valganciclovir ...: Tenofovir can increase the concentration of these drugs in plasma.

Carbamazepine, Fosphenytoin - Phenytoin, Orlistat, Oxcarbazepine Phenobarbital, Primidone, Rifabutin, Rifampin, Rifapentine, Tipranavir ...: Reducing Tenofovir Alafenamide concentration in plasma.

Cladribine: Tenofovir alafenamide reduces the treatment effect of Cladribine.

anti -inflammatory steroids (NSAIDs): enhance the renal detoxification effect of Tenofovir Alafenamide.

Storage

Store no more than 30 ° C.

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