Meyervir AF 25mg Meyer-BPC Treatment of chronic hepatitis B (3 blisters x 10 tablets)

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

Ingredient

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Composition information	Content
Tenofovir alafenamide	25mg

Uses

indications

Meyervir AF is indicated in the following cases:

Treatment of chronic hepatitis B in adults and adults aged 12 and older weighing at least 35kg.

ATC code: J05AF13.

Active mechanism:

Tenofovir Alafenamid is the premature phosphonamidate of Tenofovir (similar to 2'-dosoxyadenosin monophosphate). Tenofovir alafenamid goes into primary liver cells by passive diffusion and by the absorption of the liver in OATP1B1 and OATP1B3. Tenofovir alafenamid is mainly hydrolyzed to form Tenofovir by carboxyxyx. The intracellular tenofovir was then phosphoryl turned into an active metabolic substance as tenofovir diphosphate. Tenofovir Diphosphate inhibits the copy of HBV through the merger of the virus by the virus by the enzyme copy of HBV, the result of the DNA sequence.

Tenofovir has a specific activity with hepatitis B virus and immunodeficiency virus in humans (HIV-1 and HIV-2). Tenofovir Diphosphate is a weak inhibitor of the mammalic polymerase DNA, including mitochondrial polymerase DNA gamma and there is no evidence in vitro in toxicity on the mitochondria.

Dynamic pharmacokinetics

absorption

After taking Tenofovir Alafenamid in an empty abdominal condition in adult patients with chronic hepatitis B, observing the concentration of Tenofovir Alafenamid in plasma peaks after drinking about 0.48 hours.

distribution

Tenofovir Alafenamid is attached to plasma proteins about 80%. Links of Tenofovir with plasma protein below 0.7% and regardless of concentration.

transformation

Metabolic is the main elimination line of Tenofovir Alafenamid in humans, accounting for more than 80% of oral doses. In vitro studies have shown that Tenofovir Alafenamid is converted into Tenofovir (main metabolites) thanks to carboxxy-1 carboxy-cells in liver cells; and by cathepsin A in peripheral mononeries (PBMC) and macrophages. In Vivo, Tenofovir Alafenamid is hydrolyzed in cells to form Tenofovir (main metabolites), which are phosphoryl turned into metabolic metabolites with tenofovir diphosphate. CYP2D6. Tenofovir Alafenamid is metabolized very little by CYP3A4.

Tenofovir alafenamid is excreted through the kidneys, less than 1% of the dose is eliminated through the urine. Tenofovir Alafenamid is mainly eliminated after converting Tenofovir. Tenofovir Alafenamid and Tenofovir have an average selling time in plasma of 0.51 and 32.37 hours, respectively. Tenofovir is eliminated from the body through the kidneys by both the glomerular filtration and excretion in the renal tubules.

pharmacokinetics in special subjects

Age, gender and race: There is no clinical difference in pharmacokinetics by age or race. The gender dynamic difference is considered to be unrelated to clinical. Strong and patients with severe renal impairment (CrCl> 15 but

Before taking Meyervir AF 25mg Meyer-BPC Treatment of chronic hepatitis B (3 blisters x 10 tablets)

How to use

oral tablets. Should take medicine during or immediately after meals.

Dosage

Take 1 capsule a day.

Stop treatment: consider stopping treatment when:

HBeAg positive patients but not cirrhosis, so treatment for at least 6-12 months after the HBE serum conversion (no HBeAg and HBV DNA are accompanied by the appearance of anti-HBE antibodies) or until HBS serum conversion. Should regularly re -evaluate after stopping treatment to detect recurrent viruses. When treatment lasts more than 2 years, it should be re -evaluated to confirm the continuation of the selected therapy is still suitable for patients.

Special subjects:

Elderly: No need to adjust the dose for patients aged 65 and older. On the days of hemorrhage, the medication should be taken after the hemorrhage. Italian: 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 Alafenamid overdose treatment includes measures to support systemic, monitor signs of survival as well as monitor the patient's clinical status.

Tenofovir is effectively removed by hemorrhage.

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

What to do when forgetting a dose? If you have forgotten to take more than 18 hours from the time when the medication is used, the patient should not take the forgotten dose and just need to continue the normal medication schedule.

If the patient has vomiting within 1 hour after taking the medication, the patient should take another tablet. If the patient has vomiting after taking medicine for more than 1 hour, the patient does not need to take another tablet.

Side Effects

When using Meyervir AF you can experience unwanted effects (ADR):

The following unwanted effects have been determined with Tenofovir Alafenamid in chronic hepatitis B patients:

Very common, ADR ≥1/10

Neurological: headache.

Common, 1/100 ≤ ADR Neurological: Dizziness. 1/1,000 ≤ ADR

Skin and subcutaneous tissue: Evaluation, urticaria.

Instructions on how to handle ADR:

Notify the physician with 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

Meyervir AF drug is contraindicated in the following cases:

Patients with hypersensitivity to Tenofovir Alafenamid Fumarat or any excipients of the drug.

Be cautious when using

need to be very careful when taking the drug for patients in the following cases:

HBV transmission: This drug does not prevent the risk of HBV transmission to others by sex or blood sugar. Appropriate preventive measures must be continued.

Patients with hepatitis are out of compensation: There is no data on the safety and effectiveness of the drug in patients with hepatitis B (HBV) and has a Child Pugh Turcotte (CPT)> 9 (type C). These patients may be at high risk of harmful reactions to the liver or kidneys. Therefore, bile and kidney parameters should be closely monitored in this patient group.

Execute of hepatitis:

Reactions when treated: Spontaneous acute phases of chronic hepatitis B are relatively common and characterized by an open increase in alanin aminotransferase serum (ALT). After starting treatment with antiviral drugs, serum alt may increase in some patients. Patients with hepatitis are still compensated, this serum hyperplation is usually not accompanied by an increase in serum or liver bilirubin levels. Patients with high risk of cirrhosis may be unsatisfactory in the liver after the hepatitis acidic period, so it should be closely monitored during treatment. Most cases of self -sufficient but severe cases, including deaths may occur after stopping the treatment of hepatitis B. It is necessary to monitor liver function (both clinical and testing) for at least 6 months after stopping hepatitis B. If appropriate, can continue to treat hepatitis B. The outbreaks in the liver are particularly serious, and sometimes death in patients with liver disease.

kidney failure:

Patients with CrCl 15 ml/minute but Kidney toxicity:

The potential risk of toxicity on the kidneys due to long -term use of Tenofovir Alafenamid is not excluded. Patients with significant kidney functional impairment, or evidence of close tubing, should consider stopping the use of Tenofovir Alafenamid.

Patients with HBV and hepatitis C or D virus: There is no data on safety and effectiveness of Tenofovir Alafenamid in infected patients with hepatitis C or D.

Hepatitis B and HIV co-infected: Before starting treatment with Tenofovir Alafenamid, HIV antibodies should be tested for all HBV-infected patients when HIV-1 is not known. Patients infected with HBV and HIV, should use a combination of Tenofovir Alafenamid with other antiviral drugs to ensure the appropriate HIV treatment regimen.

Simultaneous use with other drugs:

Do not simultaneously use Meyervir AF with other drugs containing Tenofovir Alafenamid, Tenofovir Disoproxil or Adefovir Dipivoxil. Bacteria (such as rifampicin, rifabutin and rifapentin) or St. John's Wort, all of which are P-Glycoprotein (P-GP) induction and can reduce the concentration of Tenofovir Alafenamid in plasma, so it is not recommended to use simultaneously. In plasma.

Precautions related to the excipients of the drug:

Due to the excipients of the drug containing lactose, patients with rare genetic diseases such as galactose tolerance, lactase deficiency, glucose-galactose absorption disorders. Do not use this medication. Should be cautious when taking the drug.

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

drugs are not or negligible effects on the ability to drive and use machinery. However, be cautious because there has been a dizziness during treatment with Tenofovir Alafenamid.

Use drugs for women during pregnancy and lactation

pregnancy:

Data on pregnant women using Tenofovir Alafenamid is not limited or limited. However, a large amount of data on pregnant women (more than 1,000 cases of exposure) shows no defects as well as toxicity on the fetus/ infant related to the use of Tenofovir Disoproxil.

Animal studies do not show direct or indirect toxicity on reproduction.

If necessary, it is possible to consider using Tenofovir Alafenamid during pregnancy.

breastfeeding period:

It is not known whether Tenofovir Alafenamid will be secreted into breast milk or not. However, animal studies have shown Tenofovir to be secreted into milk.

There is no enough information about the effect of tenofovir on infants/young children.

Can not rule out the risk for babies/ infant breastfeeding; Therefore, Tenofovir Alafenamid should not be used during breastfeeding.

reproductive ability:

There is no data on the effects of tenofovir alafenamid on human fertility. Animal studies do not indicate the harmful effects of Tenofovir Alafenamid on fertility.

Drug interaction

should not be used simultaneously Meyervir AF with drugs containing tenofovir disoproxil, tenofovir alafenamid or adefovir dipivoxil.

Medications can affect Tenofovir Alafenamid:

Tenofovir Alafenamid is transported by P-GP and BCRP. P-GP induction drugs (for example: Rifampicin, Rifabutin, Carbamazepin, Phenobarbital or St. John's Wort) are said to reduce the plasma concentration of Tenofovir Alafenamid, which can lead to reducing the treatment effect of Tenofovir Alafenamid. Do not simultaneously use the above drugs with tenofovir alafenamid. It is not recommended to simultaneously use strong P-GP inhibitors with Tenofovir Alafenamid. The distribution of Tenofovir Alafenamid may be affected by the activity of OATP1B1, OATP1B3.

The effect of tenofovir alafenamid on other drugs:

Tenofovir Alafenamid does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 or CYP2D6 In vitro. Tenofovir alafenamid does not inhibit or touch CYP3A in vivo. It is unknown whether Tenofovir Alafenamid has inhibit other UGT enzymes.

Please see more information about drugs in the instructions for the use of drugs attached.

Storage

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

To be out of reach of children, read the instructions carefully before use.

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