Tenoqkay drug 25mg Oriental treatment of 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
Tenoqkay drug is indicated in the following cases:
Pharmacokinus
ATC code: J05AF13. Pharmacological group: antiviral.
Active mechanism: Tenofovir alafenamide is a precursor of tenofovir phosphonamidafe (2'-dosoxyadenosine monophosphate analogue). Tenofovir Alafenamide penetrates primary liver cells by passive diffusion and by the absorption protein in the liver such as OATP1B1 and OATP1B3.
Tenofovir Alafenamide is mainly hydrolyzed into fenofovir due to carboxylesferase 1 in primary liver cells. Tenofovir intracellular was then phosphoryl turned into tenofovir diphosphate metabolites. Tenofovir diphosphate inhibits the multiplication of HBV through the combination of DNA of the virus with HBV's reverse copy enzyme, leading to the end of the DNA chain. Tenofovir has a specific activity for hepatitis B virus and human immunodeficiency virus (HIV-1 and HIV-2), Tenofovir Diphosphate is a weak Australian substance of DNA polymerases enzymes in mammals including DNA polymerase Y FI fi and no Ti toxic evidence in Vitro Including DNA analysis.
Antivirus activity: The antiviral activity of Fenofovir Alanamide has been evaluated in HEPG2 cells for a clinical HBV isolation representing the A-H genotypes. EC50 concentration (50% of concentration is effective) for tenofovir alafenamide ranges from 34.7 to 134.4 Nm, with an average EC50 of 86.6Nm. CC50 (50%cytotoxic concentration) in HEPG2 cells is> 44400Nm.
Drug resistance: In an analysis of patients using drugs, the analysis of the sequence has been performed in the original isolated HBV strains and is being treated for patients who undergo a virus outbreak (2 continuous contact with HBV DNA> 69 IU/ mL after HBV DNA 69 IU / ml at early or 24 weeks. There is no replacement of amino acids related to resistance to Fenofovir Alafenamide has been identified in 20 pairs of isolation.
Diagonal resistance: The antiviral activity of Fenofovir Alafenamide is evaluated on a isolated board containing mutations inhibiting the reverse copy enamel nucleos (F) IDE in HEPG2 cells. The HBV strains are about to represent the replacement segments of RV173L, HL180M and RM204V/ I related to resistance to Lamivudine sensitive to fenofovir alafenamide (
HBV strains are about to represent RL180M, HM204V replacement segments plus RT184G, HS202G, or RMM50V replacement segments related to resistance to Enfecavir sensitive to Fenofovir Alafenamide. The isolated HBV strains show the only replacement of HA181T, HA181V, or HN236T related to resistance to adefovir sensitive to Fenofovir Alafenamide; However, the HBV isolated the expression of 181V with HN236T showing a decrease in sensitivity to Fenofovir Alafenamide (3.7 times changing EC50). The clinical relevance of these alternatives is not known.
Dynamic pharmacokinetics
absorption
After taking Tenofovir Alafenamide in the condition of fasting in adults with hepatitis B, the peak concentration of plasma of Fenofovir Alafenamide has been observed about 0.48 hours after the dose. Based on pharmacokinetics analysis in stages 3 patients with CHB, AUC0-24 average in the stable state of Fenofovir Alafenamide (n = 698) is 0.22 PG*hour/ml and fenofovir (n = 856) is 0.32 PG/h/ml. Regarding fasting conditions, absorbing the single dose of Fenofovir Alafenamide with a fat -rich meal, resulting in an increase of 65% in contact with Fenofovir Alafenamide.
distribution
Fenofovir Alafenamide's bonding with plasma proteins in humans in samples collected in clinical trials is about 80%. Fenofovir bonds with plasma proteins in humans is less than 0.7% and independent of concentrations of 0.01 - 25 PG/ml.
transformation
Metabolic is the main elimination process of Fenofovir Alafenamide in humans, based on> 80% of oral dose. In vitro studies have shown that fenofovir alafenamide is converted into fenofovir (main metabolites) by carboxyxyxy-chesting enzymes in primary liver cells; And by Cathepsin A in PBMC cells and macrophages. In In Vivo study, Fenofovir Alafenamide was hydrolyzed in the cell to form fenofovir (main metabolites), then phosphoryl turned into active metabolites, fenofovir diphosphate.
In In vitro study, Fenofovir Alafenamide is not metabolized by enzymes CYP1A2, CYP2C8, CYP2C9, CYP2C19 or CYP2D6. Tenofovir Alafenamide is less metabolized by CYP3A4.
Elimination
The intact excretory excretion of Fenofovir Alafenamide is an extra process with
Tenofovir Alafenamide and Fenofovir have an average time for selling plasma discharges of 0.51 and 32.37 hours. Tenofovir is discharged from the body through the kidneys with both glomerular filtration and active excretion in the renal tubules.
linear/non -linear
Tenofovir Alafenamide has the corresponding ratio in the dose range from 8 to 125 mg.
Pharmacokinetics for special populations
Age, gender, ethnicity
There is no clinical difference in pharmacokinetics by age or ethnicity. The difference in pharmacokinetics by gender is not considered to be clinically related.
Hepatic failure
In patients with severe liver failure, the sum of the sum of Fenofovir Alafenamide and Fenofovir is lower than those with normal liver function. When corrected the bonding protein, Tenofovir Alafenamide and Fenofovir serum is not cohesive in patients with liver failure and has the same normal liver function.
Fenofovir alafenamide serum concentration in serum does not decline and normal liver function is similar.
kidney failure
There is no clinical difference in pharmacokinetics between Fenofovir Alafenamide and Fenofovir observed between healthy people and patients with severe renal impairment (CrCL estimated> 15 ml/minute but
Children
The pharmacokinetics of Fenofovir Alafenamide and Fenofovir have been evaluated among HIV-1 teenagers who have never been treated for Fenofovir Alafenamide (10 mg) along with Elvitegravir, Cobicistal and Emtricitabine with a combination dose (E/C/F/TAF; There is no clinical difference to pharmacokinetics of Fenofovir Alafenamide and Fenofovir observed between adolescents and adults infected HIV-1.Clinical studies
Clinical research in patients with chronic hepatitis B and cirrhosis is still compensated
The safety and effectiveness of Fenofovir Alafenamide in patients with chronic hepatitis B is also assessed in two double -blind, controlled random studies for 48 weeks, which are 108 (n = 425) and 110 (n = 873). Patients in patient research are used other than drugs that are evaluated as nucleoside, nucleotides or interferon drugs.
In the 108 study, patients with untreated hepatitis or failed treatment with negative hbea Fenofovir Disproxil Fumarate 300mg (n = 140) 1 time/day for 48 weeks. The average age is 46, 61% in male, 72% Asia, 25% white, 2% black and 1% of other groups. 24% Genotype B, 38% Genotype C and 31% Genotype D. 21% have failed treatment (previously treated with oral antiviral drugs, Entecavir (n = 41), lamivudine (n = 42) fenofovir disoproxil fumarate (n = 21), other drugs (n = 18)). At the initial level, the average concentration of HBV plasma HBV is 5.8 log IU/ml, the average serum is 94 U/L, and 9% has a history of cirrhosis. In the study of 110 patients with HBeAg patients who have not been treated or failed to be randomly divided at a ratio of 2: 1 in the group using fenofovir alafenamide (n = 581) 25mg/ 1 time/ day or fenofovir disoproxil fumarate 300 mg (n = 292) 1 time/ day for 48 weeks. Average age 38.64% male, 82% Asian, 17% white skin 1% black skin or other groups. 17% Genotype B, 52% Genotype C, 23% Genotype D. 26% have failed treatment (with oral antiviral drugs ADefovir N = 42), Entecavir (N = 117), Lamivudine (N = 84). Telbivudine (n = 25), fenofovir disoproxil fumarate (n = 70), or other drugs (n = 17)). At the beginning, the average plasma DNA HBV is 7.6 Log10 IU/ml. The average serum is 120 U/L and 7% has a history of cirrhosis.
Before randomly dividing the patient is stratified based on the history of treatment, the initial HBV level of DNA ( 7 to 8 log10 IU/ mL in the 108 study; and 8 log10 IU/ mL in study 110). The results of the effectiveness of the study based on the proportion of patients with plasma DNA HBV 29 IU/ml at 4%week. Other evaluation agents include the ratio including the recovery of the ALT, HBsAg and HBeAg in research 110.
Please see more information about drugs in the instructions for the use of drugs attached.
Before taking Tenoqkay drug 25mg Oriental treatment of chronic hepatitis B (3 blisters x 10 tablets)
How to use
oral tablets, used with food. Dosage
Adults and children aged 12 and older with at least 35 kg body weight:
Stop treatment:
Older people: No need to adjust the dose for people over 65 years old.
kidney failure:
Children: The safety and effectiveness of drugs 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? What to do when you forget 1 dose? If it is more than 18 hours after taking the previous dose, patients should not use the forgotten dose and should only continue the normal drug schedule.
Side Effects
When using Tenoqkay you can experience unwanted effects (ADR):
Unwanted frequency: common, ADR> 1/100, rarely, 1/1000 Nervous system disorders General disorder 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
Tenoqkay drugs are contraindicated in the following cases:
Be cautious when using
need to be very careful when taking the drug for patients in the following cases:
HBV transmission
Patients must be notified that the drug does not prevent the risk of HBV transmission to others through sex or blood contact. The appropriate preventive measures must be used.
Patients with liver disease are lost: There is no data on the safety and effectiveness of the drug in HBV infected patients with liver disease and there is PUGH Turcoffe (CPT)> 9 (ie C). These patients may be at high risk of serious adverse reactions on liver or kidneys. Therefore, it is necessary to closely monitor the parameters of the liver and kidneys for these patients
Severe hepatitis
Serious spontaneous phases in chronic hepatitis B are relatively common and are characterized by an open increase in alanine aminofransferase serum (ALD). After starting treatment with antiviral drugs, serum alt may increase in some patients. In patients with liver disease, the increase in serum ALT is often not accompanied by an increase in bilirubin levels or liver loss. Patients with cirrhosis may have a higher risk of liver loss when suffering from severe hepatitis, and thus should be closely monitored during treatment.
Acute hepatitis has been reported in patients who have stopped treating hepatitis B, often associated with increasing the concentration of HBV DNA in plasma. Most cases are self -adjustable but serious, including death, may occur after stopping treatment with hepatitis B. The liver function should be monitored including clinical and testing for at least 6 months after stopping the use of hepatitis B.
In patients with progressive liver disease or cirrhosis, the discontinuation of treatment is not recommended because after hepatitis after treatment can lead to liver loss. Liver disease is particularly serious and sometimes fatal in patients with liver disease.
kidney failure
Patients with Creatinine clearance 30 ml/minute:
Patients infected simultaneously with HBV and hepatitis C or D virus: There is no data on the safety and effectiveness of the drug in patients infected and the hepatitis C or D. need to follow the coordination instructions for the treatment of hepatitis C.
Simultaneously infected with hepatitis B and HIV: HIV antibodies should be performed for all HBV infected patients with HIV-1 infection before starting medical treatment. In patients infected with HBV and HIV, the drug should be used with other antacids to ensure the patient receives an appropriate treatment for HIV treatment.
Coordinate with other medicinal products
The drug should not be used with drug products that contain fenofovir alafenamid, fenofovir disoproxil or adefovir dipivoxil. Combination of drug treatment with certain anti -convulsions (eg carbamazepin, oxcarbazepin, phenobarbital and phenytoin), anti -bacterial drugs (eg rifampicin, rifabutin and rifapentin) or ST. Reducing fenofovir alafenamid levels, not recommended.
Combining drugs with strong P-GP inhibitors (for example ifraconazole and ketoconazole) may increase the concentration in Fenofovir Alafenamid plasma plasma. Therefore this combination is not recommended
Lacfose intolerance: The drug contains lactose monohydrate. Patients with rare genetic problems in tolerance Galactose, Lactase deficiency or Glucose-Galactose should not use this drug.
Colonel: This drug contains less than 1 mmol of sodium (23 mg) each tablet, meaning basically "no sodium".
The effect of the drug on the ability to drive and operate machinery
drugs do not have or have a significant effect on the ability to drive and use machinery. Patients should be notified that dizziness has been reported during treatment with Tenofovir Alafenamid.
Use drugs for women during pregnancy and lactation
Pregnancy
No or limited data from the use of Fenofovir Alafenamid in pregnant women. However, a large amount of data on pregnant women (more than 1,000 results) shows that there is no toxicity of defects related to the use of Fenofovir Disoproxil.
Animal studies do not indicate directly or indirectly harmful effects on reproductive toxicity. The use of fenofovir alafenamid may be considered during pregnancy, if necessary.
Breastfeeding period
It is unclear whether fenofovir will be in milk. However, in animal studies have shown that Fenofovir is secreted into milk.
Not enough information about the effects of fenofovir in infants, so Fenofovir Alafenamide should not be used during breastfeeding.
Drug interaction
Interactive research is only done in adults.
Drugs should not be used with drug products containing fenofovir disoproxil, tenofovir alafenamid or adefovir dipivoxil.
Products can affect Fenofovir Alafenamid
Tenofovir Alafenamid is transported by P-GP and breast cancer protein (BCRP). The drug products are P-GP induction (for example, Rifampicin, Rifabutin, Carbamazepin Phenobarbifal or St. John's Wort) is expected to reduce the concentration of fenofovir alafenamid in plasma, which can lead to loss of treatment effect of the drug. Do not simultaneously use these products with tenofovir alafenamid.
Combining Fenofovir Alafenamid with P-GP and BCRP inhibitors can increase fenofovir alafenamid levels in plasma. Do not simultaneously use strong P-GP inhibitors with fenofovir alafenamid.
Tenofovir Alafenamid is the substrate of OATP1B1 and OATP1B3 in the test tube.
Fenofovir alafenamid distribution in the body may be affected by the activity of OATP1B1 and/ or OatP1B3.
The effect of fenofovir alafenamide on other medicinal products
Tenofovir Alafenamid is not inhibitor CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 or CYP2D6 in the test tube. It is not inhibitor or CYP3A in vivo. Tenofovir alafenamid is not an uridine diphosphate glucuronosylfrransferase inhibitor (UGT) 1A1 in a test tube. It is not known whether Fenofovir Alafenamid is an inhibitor of 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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