Pharmavir 25mg Pharbaco treatment for chronic hepatitis B (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Tenofovir alafenamide

Ingredient

Composition information	Content
Tenofovir alafenamide	25mg

Uses

Indications

Phacavir 25mg is indicated in the following cases:

Indications for the treatment of chronic hepatitis B in adults and adolescents (aged 12 years and older with weight ≥ 35 kg). 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 Pharmavir 25mg Pharbaco treatment for chronic hepatitis B (3 blisters x 10 tablets)

How to use

Phacavir 25mg oral drugs, should be used with food.

Should take medicine at a time of the day.

If the patient has vomiting within an hour after taking the medication, the patient needs to take another pill. If the patient has vomiting for more than 1 hour after taking the medication, no other tablet is needed.

Dosage

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

In patients with positive, non-cirrhosis: treatment should be conducted at least 6-12 months after determining the serum conversion of HBE (HBeAg negative, no DNA DNA of hepatitis B virus and HBE antibodies) or until HBS conversion serum or when the drug is inactive. Recommendations to re -evaluate regularly after stopping treatment to detect virus recurrence.

In patients with negative, non -cirrhosis: treatment must last until the serum converts HBS or until the drug is no longer effective. With more than 2 years of treatment, it is advisable to re -evaluate regularly to make sure that continuing to choose therapy is still suitable for patients.

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

Patients with renal impairment: No dose adjustments in adults and adolescents (aged 12 and older with weight ≥ 35 kg) and have creatinine clearance ≥ 15 ml/min or in patients with blood apart and have creatinine clearance

Hepatic failure: No need to adjust the pharmavir in patients with liver failure.

Children: The safety and effectiveness of pharmavir in 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 the patient forgets a dose of oral right after remembering (if the time is less than 18 hours) and take the next dose as usual. If the time exceeds 18 hours, do not take the forgotten dose and take the next dose as usual.

Side Effects

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

Common, ADR> 1/100

Neurological: headache, dizziness.

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

Liver: Increase ALT.

Skin and subcutaneous tissue: itching, rash.

musculoskeletal: muscle pain.

all body: tired.

Uncommon, 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

Phacavir 25mg contraindications in the following cases:

Hypersensitivity to Tenofovir Alafenamid Fumarat or 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 ... Pharcavir can increase the concentration of these drugs in plasma.

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

Cladribine: Tenofovir alafenamide reduces the treatment effect of Cladribine.

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

Storage

Store no more than 30 ° C.

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