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Daklataswir - instructions for use, reviews, analogs and formulations (30 mg and 60 mg tablets) of the drug for the treatment of chronic hepatitis C in adults, children and pregnancy. Composition of antiviral and therapy regimens

Daklataswir - instructions for use, reviews, analogs and formulations (30 mg and 60 mg tablets) of the drug for the treatment of chronic hepatitis C in adults, children and pregnancy. Composition of antiviral and therapy regimens

In this article, you can read the instructions for using the drug Daklataswir. Presented are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Daklataswir in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Daklatasvir in the presence of existing structural analogues.Use for the treatment of chronic hepatitis C in adults, children, as well as in pregnancy and lactation. Composition of antiviral drug and therapy regimen.

 

⇒ Where to buy Daklataswir in Moscow and St. Petersburg

 

Daklatasvir - is a highly specific direct action against hepatitis C virus (HCV) and does not have a pronounced activity against other RNA and DNA containing viruses, including human immunodeficiency virus (HIV). Daklatasvir is an inhibitor of the non-structural protein 5A (NS5A), a multifunctional protein required for HCV replication, and thus suppresses the two stages of the viral life cycle-viral RNA replication and virion assembly. Based on in vitro data and computer simulation data, it has been shown that daklataswir interacts with the N-terminus within domain 1 of the protein, which can cause structural distortions that interfere with the function of the NS5A protein. It was found that the preparation is a potent panthenotypic inhibitor of HCV replication of genotypes 1a, 1b, 2a, 3a, 4a, 5a and 6a with effective concentration values ​​(50% reduction, EC50) from picomolar to low nanomolar.In cell quantitative replicon assays, EC50 values ​​of daklataswir vary from 0.001 to 1.25 nM in genotypes 1a, 1b, 3a, 4a, 5a and 6a and from 0.034 to 19 nM in genotype 2a. In addition, daklataswir inhibits hepatitis C virus of genotype 2a (JFH-1) at an EC50 value of 0.020 nM. In genotype 1a in infected patients who had not received previous treatment, a single dose of daklatasvira 60 mg resulted in an average decrease in viral load, measured after 24 hours, by 3.2 log10 IU / ml.

 

Cell culture studies also showed an increase in the antiviral effect of the drug when combined with Interferon alpha and NS3 protease inhibitors, non-nucleoside HCV NS5B inhibitors, and NS5B nucleoside analogues. With all these groups of drugs, antagonism of the antiviral effect was not observed.

 

Resistance in cell culture

 

Amino acid substitutions causing resistance to daklatasvir in genotypes of HCV 1-6 were isolated in the replicon cell system and were observed in the N-terminal region of the 100 amino acid residue of NS5A. L31V and Y93H were frequently observed in genotype 1b, and the substitutions of M28T, L31V / M, Q30E / H / R and Y93C / H / N were often observed in genotype 1a.Single amino acid substitutions in general cause a low level of resistance (EC50 less than 1 nM for L31V, Y93H) for genotype 1b and higher resistance levels for genotype 1a (up to 350 nM for Y93N).

 

Resistance in clinical trials

 

The effect of the initial polymorphism of HCV in response to therapy

 

In the course of the study, the relationship between the naturally occurring initial substitutions of NS5A (polymorphism) and the outcome of the treatment revealed that the effect of NS5A polymorphism depends on the therapy regimen.

 

Therapy with a combination of drugs Daklatasvir + Asunaprevir

 

In clinical trials of 2-3 phases, the efficacy of the combination of daklatasvir + asunaprevir was reduced in patients infected with HCV genotype 1b with original NS5A L31 and / or Y93M substitutions. 40% (48/119) of patients with NS5A L31 and / or Y93H substitutions achieved a sustained virologic response (SVR12) compared with 93% (686/742) patients without these polymorphisms. The initial prevalence of NS5A L3 I and Y93H substitutions was 14%; 4% for L31 separately, 10% for Y93H separately and 0.5% for L31 + Y93H. Of the 127 virological inefficiencies in the initial NS5A substitution, 16% had only L31, 38% had only Y93H and 2% had L31 + Y93H.

 

Therapy with a combination of drugs Daklatasvir + Asunaprevir + Peginterferon alfa + Ribavirin

 

Of the 373 patients who underwent sequencing, 42 patients had initial substitutions associated with resistance to daklatasvir in the study of this combination. Of the 42 patients, 38 achieved SVR12, 1 had non-vascular inefficiency, and 3 patients had virological inefficiency (1 patient with genotype 1a had NS5A-L31M substitutions and 1 had NS5A-Y93F at baseline, 1 patient with genotype 1b there was a replacement of NS5A-L31M at the initial level).

 

Composition

 

Daklutasvira dihydrochloride + excipients.

 

Pharmacokinetics

 

The pharmacokinetic properties of daklataswir were evaluated in adult healthy volunteers and in patients with chronic hepatitis C virus infection. After repeated oral daklataswir intake of 60 mg once daily in combination with peginterferon alfa and ribavirin, the mean (variability factor,%) of C max daklataswir was 1534 ( 58) ng / ml, the area under the concentration-time curve (AUC0-24h) was 14122 (70) ng × h / ml and Cmin was 232 (83) ng / ml.

 

Suction

 

Absorption is fast. C max daklatasvira is observed 1-2 h after oral administration. AUC, Cmax, Cmin in the blood are dose-dependent, a stable level of daklatasvira in the blood plasma is observed on the 4th day of application of the drug for ingestion once a day.Studies have not revealed differences in the pharmacokinetics of the drug in patients with hepatitis C and healthy volunteers. Studies with human Caco-2 cells have shown that daklataswir is a substrate for P-glycoprotein (P-gp). Absolute bioavailability of the drug is 67%.

 

In studies on healthy volunteers, it was found that a single dose of 60 mg daklataswir 30 minutes after a high-fat meal (about 1000 kcal with a fat content of about 50%) reduces the Cmax of the drug in the blood by 28% and the AUC by 23%. Taking the drug after a light meal (275 kcal with a fat content of about 15%) did not change the concentration of the drug in the blood.

 

Metabolism

 

In studies, it has been established that daklataswir is a substrate of the CYP3A isoenzyme, with CYP3A4 being the main isoform of CYP responsible for the metabolism of the drug. Metabolites with more than 5% of the initial substance concentration are absent.

 

Excretion

 

After oral administration of single doses of daklataswir labeled with radioactive carbon C14 ([14C] -diclatasvir) by healthy volunteers, 88% of all radioactivity was excreted with feces (53% unchanged), 6.6% excreted in the urine (mostly unchanged).

 

After repeated daklataswir reception by HCV-infected patients, T1 / 2 daklatasvir varied from 12 to 15 hours. In patients who took daklatasvir in tablets of 60 mg followed by intravenous administration of 100 μg of [13C, 15N] -diclatasvir, the total clearance was 4.24 l / h.

 

Patients with impaired renal function

 

Comparison of the AUC value in patients with HCV infection and normal kidney function (CK 90 ml / min) and patients with HCV infection with impaired renal function (QC 60, 30 and 15 ml / min) showed an AUC increase of 26%, 60% and 80 % (unrelated AUC - 18%, 39%, 51%), respectively. In patients with end-stage renal disease requiring hemodialysis, an AUC increase of 27% (associated -20%) was observed compared to patients with normal renal function. Statistical population analysis of patients with HCV infection showed an increase in AUC in patients with mild to moderate renal failure, but the magnitude of this increase is not clinically significant for the pharmacokinetics of daklataswir. Due to the high degree of binding of daklatasvir to proteins, hemodialysis does not affect its concentration in the blood. Changes in the dose of the drug in patients with renal failure are not required.

 

Patients with impaired hepatic function

 

Daklataswir pharmacokinetics studies at a dose of 30 mg were performed in patients with hepatitis C with mild, moderate and severe hepatic insufficiency (classes A-C on the Child-Pugh scale) in comparison with patients without impaired liver function. The values ​​of Cmax and AUC of daklataswir (free and protein-bound) were lower in the presence of hepatic insufficiency compared to the values ​​of these parameters in healthy volunteers, but this decrease in concentration was not clinically significant. There is no need to change the dose of the drug in patients with impaired liver function.

 

Elderly patients

 

In clinical trials, elderly patients were involved (310 people were 65 years of age or older, and 20 were aged 75 years and older). Changes in pharmacokinetics, as well as profiles of efficacy and safety of the drug in elderly patients were not observed.

 

Floor

 

There are differences in the overall clearance (CL / F) of daklataswir, with CL / F in women being lower, but this difference is not clinically significant.

 

Indications

 

Treatment of chronic hepatitis C in patients with compensated liver disease (including cirrhosis) in the following combinations of daklatasvir:

  • with the drug asunaprevir for patients with the hepatitis virus of genotype 1b;
  • with drugs asunaprevir, peginterferon alfa and ribavirin - for patients with the hepatitis virus of genotype 1.

 

Forms of release

 

Tablets coated with 30 mg and 60 mg.

 

Instructions for use and reception schemes

 

Recommended dosing regimen

 

The recommended dose of Daklatasvir is 60 mg once a day, regardless of the intake of the food. The drug should be used in combination with other medicines. Recommendations for doses of other drug regimens are given in the relevant instructions for medical use. Therapy is recommended both for patients who have not previously received treatment for chronic hepatitis C, and for patients with previous ineffectiveness of therapy.

 

Recommended regimens of therapy of the drug Daklatasvir when used at a dose of 60 mg once a day as part of a combination therapy:

  • Genotype 1b - drugs: daklatasvir + asunaprevir - duration of therapy: 24 weeks.
  • Genotype 1 - drugs: daklatasvir + asunaprevir + peginterferon alfa and ribavirin - duration of therapy: 24 weeks.

 

Possible schemes and duration of treatment with antiviral drugs of chronic hepatitis, depending on the genotype:

 

Daklataswir - instructions for use, reviews, analogs and formulations (30 mg and 60 mg tablets) of the drug for the treatment of chronic hepatitis C in adults, children and pregnancy. Composition of antiviral and therapy regimens

Dose change and suspension of therapy

 

After the initiation of therapy, a change in the dose of Daklatasvir is not recommended. To change the dose of other drugs of the regimen, it is necessary to familiarize yourself with the relevant instructions for medical use. Interruption of treatment should be avoided; However, in the event that the interruption of treatment with any preparation of the scheme is necessary because of the adverse reactions that have arisen, use of the drug Daklataswir in the form of monotherapy should not be used.

 

During treatment, it is necessary to monitor the viral load (the amount of PNK HCV in the patient's blood). Patients with an inadequate virologic response during treatment with a low degree of probability have achieved SVR, and this group is also likely to develop resistance. Discontinuation of treatment is recommended in patients with a virologic breakthrough - an increase in the level of HCV RNA by more than 1 log10 from the previous level.

 

Dose skip

 

If you miss a dose of another dose of Daklatasvir for up to 20 hours, the patient should take the drug as soon as possible and then adhere to the original therapy regimen.If a dose has passed more than 20 hours from the planned time of taking the drug, the patient should skip this dose, the next dose of the drug should be taken in accordance with the initial scheme of therapy.

 

Patients with renal insufficiency

 

Dose changes in patients with renal failure of any degree are not required.

 

Patients with hepatic insufficiency

 

Dose changes in patients with mild liver failure (class A on the Child-Pugh scale) are not required. In studies with mild (class A on the Child-Pugh scale), moderate (class B on the Child-Pugh scale), and severe (class C on the Child-Pugh scale), hepatic insufficiency did not reveal significant changes in the pharmacokinetics of the drug. Efficacy and safety of use in decompensated liver failure is not established.

 

Concomitant therapy

 

Strong inhibitors of the 3A4 isoenzyme of the cytochrome P450 system (CYP3A4)

 

The dose of Daklatasvir should be reduced to 30 mg once a day in case of simultaneous use with potent inhibitors of the isoenzyme CYP3A4 (use a tablet of 30 mg, do not break a 60 mg tablet).Simultaneous use of potent and moderate inhibitors of the isoenzyme CYP3A4 is contraindicated in the use of schemes involving the preparation of Sunvepra.

 

Moderate inducers of the isoenzyme CYP3A4

 

The dose of Daklatasvir should be increased to 90 mg once a day (3 tablets 30 mg or 1 tablet 60 mg and 1 tablet 30 mg), while using moderate inducers of the isoenzyme CYP3A4. Simultaneous use of moderate inducers of the CYP3A4 isoenzyme is contraindicated in the use of schemes involving the preparation of Sunvepra.

 

Side effect

 

The drug Daklatasvir is used only as part of combined therapy regimens. It is necessary to get acquainted with the side effect of the medications included in the treatment regimen before the initiation of therapy. Unwanted drug reactions (NLR) associated with the use of asunaprevir, peginterferon alfa and Ribavirin are described in the instructions for the medical use of these drugs.

 

The safety of daklataswir was evaluated in 5 clinical studies in patients with chronic hepatitis C who received 60 mg of the drug Daklataswir 1 time per day in combination with asunaprevir and / or peginterferon alfa and ribavirin.The safety data are presented below for treatment regimens.

 

Daklatasvir + Asunaprevir:

  • headache;
  • diarrhea, constipation;
  • nausea, vomiting;
  • fatigue;
  • increased ALT;
  • increased ACT;
  • skin rash;
  • itching;
  • alopecia (baldness);
  • eosinophilia, thrombocytopenia, anemia;
  • increased body temperature;
  • malaise;
  • chills;
  • insomnia;
  • decreased appetite;
  • discomfort in the abdomen;
  • pain in the upper abdomen;
  • stomatitis;
  • bloating;
  • increased blood pressure;
  • joint pain;
  • stiff muscles;
  • nasopharyngitis;
  • pain in the oropharynx;
  • increased activity of gamma globulin transferase, alkaline phosphatase, lipase, hypoalbuminemia.

 

Daklatasvir in combination with asunaprevir, peginterferon alfa and ribavirin:

  • increased fatigue;
  • headache;
  • itching;
  • asthenia;
  • influenza-like condition;
  • insomnia;
  • anemia;
  • rash;
  • alopecia;
  • irritability;
  • nausea;
  • dry skin;
  • decreased appetite;
  • muscle pain;
  • fever;
  • cough;
  • dyspnea;
  • neutropenia, lymphopenia;
  • diarrhea;
  • joint pain.

 

If any of the specified in the NLR instruction is aggravated or you notice any other side effects not indicated in the instructions, inform the doctor about it.

 

Contraindications

  • the drug should not be used as a monotherapy;
  • hypersensitivity to daklatasvir and / or any of the auxiliary components of the drug;
  • in combination with strong inducers of the isoenzyme CYP3A4 (due to a decrease in the concentration of daklatasvir in the blood and a decrease in efficacy), such as: antiepileptic drugs (phenytoin, carbamazepine, phenobarbital, oxcarbazepine), antibacterial agents (rifampicin, rifabutin, rifapentium), systemic glucocorticosteroids dexamethasone), herbal remedies (preparations based on Hypericum perforatum);
  • simultaneous application of moderate inducers of the isoenzyme CYP3A4 is contraindicated in the use of regimens that include asunaprevir;
  • in the presence of contraindications to the use of drugs of the combined scheme (asunaprevir and / or peginterferon alfa + ribavirin);
  • deficiency of lactase, lactose intolerance, glucose-galactose malabsorption;
  • pregnancy and lactation;
  • age to 18 years (efficacy and safety not studied).

 

Carefully

 

Since the drug is used as a combined regimen, combined therapy should be used with caution under conditions,described in the instructions for the use of each preparation included in the scheme (asunaprevir and / or peginterferon alfa and ribavirin).

 

The safety of the use of combination therapy has not been studied in patients with decompensated liver diseases, as well as in patients after liver transplantation.

 

The combined use of the drug, daklatasvir with other drugs, can lead to a change in the concentration of both daklatasvir and other drugs.

 

Application in pregnancy and lactation

 

Daklatasvir + Asunaprevir

 

There are no adequate and well-controlled studies involving pregnant women. In animal studies, when daklataswir was administered at doses exceeding the recommended therapeutic ratios (4.6 times (rats) and 16 times (rabbits)), there was no adverse effect on intrauterine fetal development, while still higher drug concentrations (in 25 times (rats) and 72 times (rabbits)) revealed negative effects for both the mother and the fetus. Women of childbearing age should use effective methods of contraception during treatment with drug Daklatasvir and within five weeks after its completion.

 

The use of the combination of daklutasvir + Asunaprevir in pregnancy is contraindicated. It is not known whether daklataswir penetrates breast milk. Daklataswir penetrated the breast milk of lactating rats at concentrations exceeding the plasma maternal concentrations by a factor of 1.7-2, and therefore, breastfeeding should be discontinued for the duration of treatment with Daklatasvir.

 

Daklatasvir + Asunaprevir + Peginterferon alfa + Ribavirin

 

The use of ribavirin can cause fetal malformations, fetal death and abortions, so careful care should be taken when applying a therapy regimen including ribavirin. It is necessary to prevent the onset of pregnancy both in the patients themselves and in women whose sexual partners receive this therapy. Ribavirin therapy should not begin until patients capable of childbearing and their male sexual partners will not use at least 2 effective methods of contraception, which is necessary both throughout the therapy and for at least 6 months after it completion. During this period, it is necessary to perform standard pregnancy tests.When using oral contraceptives as one of the ways to prevent pregnancy, it is recommended to use high doses of oral contraceptives (containing at least 30 micrograms of ethinylestradiol in combination with norethindrone acetate / norethindrone).

 

Investigation of interferons in animal experiments was associated with abortive effects, the possibility of development of which in humans can not be ruled out. Therefore, when using therapy, both patients and their partners should use adequate contraception.

 

Use in children

 

The drug is contraindicated in children and adolescents under the age of 18 (efficacy and safety not studied).

 

special instructions

 

Daklutasvir should not be used as a monotherapy.

 

Of the more than 2,000 patients enrolled in clinical trials of combination therapy with daklatasvir, 372 patients had compensated cirrhosis (class A on the Child-Pugh scale). Differences in the safety and efficacy of therapy among patients with compensated cirrhosis and patients without cirrhosis were not observed.The safety and efficacy of Daklatasvir in patients with decompensated cirrhosis has not been established. It is not necessary to change the dose of Daklatasvir in patients with a weak (class A on the Child-Pugh scale), moderate (class B on the Child-Pugh scale) or severe (class C on the Child-Pugh scale), a violation of liver function.

 

The safety and effectiveness of combination therapy with the drug Daklatasvir in patients with transplanted liver is not established. There is limited experience with the use of the drug Daklatasvir after liver transplantation.

 

The effect of daclataswir on the QTc interval was evaluated in a randomized, placebo-controlled study in healthy volunteers. Single dose daklatasvira 60 mg and 180 mg had no clinically significant effect on the QTc interval, corrected according to Frederick's formula (QTcF). There was no significant relationship between elevated daklataswir concentrations in plasma and changes in QTc. In this case, a single dose of daklatasvira 180 mg corresponds to the maximum expected concentration of the drug in the blood plasma for clinical use.

 

The use of the drug for the treatment of chronic hepatitis C in patients with concomitant infection with the hepatitis B virus or human immunodeficiency virus has not been studied.The drug Daklatasvir contains lactose: 1 tablet of 60 mg (daily dose) contains 115.50 mg of lactose.

 

Appropriate contraceptive methods should be used within 5 weeks after completion of therapy with daklatasvir.

 

It is worth noting active development and introduction of generic drugs Daklatasvir Chinese, Egyptian and Indian production to increase the affordability of this drug, as the original drugs based on Daklatasvira have a very high cost of course treatment.

 

A combination of daklatasvir and sophosbuvir was performed: cofosbuvir 400 mg, daklatasvir 60 mg, once a day for 12 or 24 weeks. In some groups, patients also took ribavirin. In some groups there was an introductory phase of taking sophosbuvira, 7 days.

 

Patient groups:

  • Patients with genotypes 1a and 1b who had not previously received therapy;
  • Patients with genotypes 2 and 3 who had not previously received therapy;
  • Patients with genotype 1 who failed on triple therapy (telaprevir or boceprevir in combination with pegylated interferons and ribavirin) 24 weeks.

 

Results for effectiveness:

  • Patients with genotype 1 - a response of 100%.
  • Patients with genotypes 2 and 3 - from 86% to 100%.
  • 100% of patients from the group of non-responders to triple therapy responded to daklatasvir + sophosbuvir therapy.

 

Influence on ability to drive vehicles, mechanisms

 

Studies of the possible effect of the use of the drug on the ability to drive vehicles and work with mechanisms have not been carried out. If the patient experiences dizziness, attention disturbance, blurred vision, or reduced visual acuity, these adverse events have been observed with a peginterferon alfa treatment regimen) that may affect the ability to concentrate, he should refrain from managing the vehicles and mechanisms.

 

Drug Interactions

 

In view of the fact that the drug Daklatasvir is used as part of combined treatment regimens, you should familiarize yourself with possible interactions with each of the drugs of the scheme. When prescribing concomitant therapy, the most conservative recommendations should be observed.

 

Daklatasvir is a substrate for the isoenzyme CYP3A4, so the moderate and strong inducers of the CYP3A4 isoenzyme may reduce the level of daklatasvir in the plasma and the therapeutic effect of daklatasvir.Strong inhibitors of the isoenzyme CYP3A4 can increase the serum concentration of daklatasvir. Daklatasvir is also a substrate for transport P-glycoprotein (P-gp), but the combined use of agents that affect only P-gp properties (without simultaneous effect on the CYP3A isoenzyme) is not sufficient to produce a clinically significant effect on daklatasvir plasma concentration.

 

Daklatasvir is an inhibitor of P-gp, the Transport Polypeptide of Organic Anions (TPAA) 1B1 and 1B3 and the Breast Cancer Resistance (BCRP) protein. The use of the drug may increase the systemic effect of drugs that are substrates of the P-glycoprotein or transport polypeptide of organic anions 1B1 / 1B3 or BCRP, which may increase or prolong their therapeutic effect and enhance undesirable phenomena. Caution should be exercised in the joint use of daklatasvir and substrates of these isoenzymes / vectors, especially in the case of a narrow therapeutic range of the latter.

 

Drugs, the use of which in conjunction with the drug Daklatasvir is contraindicated:

  • Antiepileptic agents (carbamazepine, oxcarbazepine, phenobarbital, phenytoin)
  • Antibacterial agents (Rifampicin, Rifabutin, Rifapentin)
  • Glucocorticosteroids (Dexamethasone)
  • Herbal remedies (preparations of St. John's wort (Hypericum perforatum)).

 

Changes in the dose of asunaprevir are not required.

 

Changes in the dose of daklatasvira, peginterferon alfa or ribavirin are not required.

 

Changes in the dose of daklataswir and simeprevir are not required.

 

Changes in the dose of daklatasvir and sophosbuvir are not required.

 

The dose of daklataswir should be reduced to 30 mg once daily with the concomitant use of atazanavir / ritonavir or other strong inhibitors of the isoenzyme CYP3A4.

 

The dose of daklatasvir should be reduced to 30 mg once daily with the concomitant use of bocetrevir or other strong inhibitors of the isoenzyme CYP3A4.

 

A change in the dose of daklataswir and nucleoside reverse transcriptase inhibitors (NRTIs) is not required.

 

The dose of daklataswir should be increased to 90 mg once a day with the concomitant use of efavirenz or other moderate inducers of the isoenzyme CYP3A4.

 

Due to the lack of data, the combined use of daklatasvir and etravirine or nevirapine is not recommended.

 

A change in the dose of daklatasvir and rilpivirin is not required.

 

A change in the dose of daklatasvir and integrase inhibitors is not required.

 

A change in the dose of daklatasvir and enfuvirtide is not required.

 

A change in the dose of daklatasvira and maraviroc is not required.

 

The dose of daklatasvir should be reduced to 30 mg once daily with the concomitant use of a co-bicystate or other strong inhibitors of the CYP3A4 isoenzyme.

 

The dose of daklatasvir should probably be reduced to 30 mg once daily with the concomitant use of clarithromycin, telithromycin, or other strong inhibitors of the CYP3A4 isoenzyme.

 

Joint use of the drug Daklatasvir and Erythromycin may lead to an increase in the concentration of daklatasvir.

 

Changes in the dose of daklatasvira and Azithromycin or Ciprofloxacin are not required.

 

It is recommended that the safety of the application be carefully monitored at the beginning of the application of the Daklataswir regimens in patients taking dabigatran etexilate or other P-gp substrates with a narrow therapeutic range.

 

Doklataswir and Warfarin dose changes are not required.

 

Doklatasvir and Escitalopram dose changes are not required.

 

The dose of daklatasvir should be reduced to 30 mg once daily with the concomitant use of Ketoconazole or other strong inhibitors of the CYP3A4 isoenzyme.

 

Suppression of P-gp from the side of daklatasvir Digoxin and other P-gp substrates with a narrow therapeutic range should be used with caution when applied together with daklatasvir. It should be given the smallest dose of digoxin and monitor the level of digoxin in the blood plasma. To achieve the desired therapeutic effect, dose titration should be used.

 

The use of the drug Daklatasvir together with blockers of "slow" calcium channels can lead to an increase in the concentration of daklatasvir in the blood plasma. Such combinations must be used with caution.

 

The use of the drug Daklatasvir together with the drug Verapamil may lead to an increase in the concentration of daklatasvir in the blood plasma. Such combinations must be used with caution.

 

Doklatasvir and cyclosporine dose changes are not required.

 

Changes in the dose of daklatasvir and immunosuppressants are not required.

 

Caution should be exercised when using jointly the preparation of daklatasvir and Rosuvastatin or other substrates of OATP1B1, OATP1B3 and BCRP. An increase in the concentration of statins in plasma is expected due to inhibition of OATP1B1 and / or BCRP by daklatasvir.

 

Changes in the dose of daklatasvir and buprenorphine are not required.

 

Analogues of the medicament Daklatasvir

 

Structural analogs for the active substance:

  • Daklinsa (Daklinza);
  • Daxliver.

 

Analogues on the curative effect (drugs for the treatment of chronic hepatitis C):

  • Algeron;
  • Altevir;
  • Alfaron;
  • Asunaprevir;
  • Ingaron;
  • Intron A;
  • Layfferon;
  • Ladipasvir;
  • Moliksan;
  • Neovir;
  • Pegasys;
  • Peginterferon;
  • PegIntron;
  • Realdiron;
  • EU Reaferon;
  • Rebetol;
  • Ribavirin Meduna;
  • Ribamidyl;
  • Roferon A;
  • Sovriad;
  • Sofosbuvir;
  • Ferrovir;
  • Cycloferon.

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Reviews (7):
Visitors
georgia
Hello. Prompt, please, diclofenac and ketorol it is possible to accept with these preparations?
Administrators
admin
georgiaAt the moment there has been no negative interaction between Daklataswir and Diclofenac and Ketorol. Additional side effects when combined use of these drugs should not be.

And yet, Diclofenac and Ketorol belong to the same class of non-steroidal proinflammatory drugs, so in one treatment regimen they should not be used.Can be consistent, but not parallel.
Visitors
Prokofy
Hello. Tell me, please, I'm now on the course of therapy Sofosbuvir and Daklatasvir. What is better to drink with toothache (Pentalgin will go)?
Administrators
admin
Prokofy, I think you can. In the instructions, there are no special interactions with analgesics, but it is better to take a simple Analgin or Baralgin. How will behave in the therapy schemes with Sofosbuvir and Daklatasvir multicomponent drugs like Pentalgin, I'm afraid even the manufacturer does not yet know.
Administrators
admin
The visitor question of the Directory Valerie12 moved to the required section:
Hello. Tell me, what are they different about daklatasvir and lepidavir?
Valerie12, I can assume that the chemical formula. In any case, until the drug under patent protection, it will be general formulations and no specifics. And so in Daklatasvira, in comparison with Ladipasvir, more spectrum of therapeutic effect (in combination with Sofosbuvir additionally helps to fight with hepatitis C 2 and 3 genotype).
Visitors
Valery90
Good afternoon. I have several questions on the compatibility of drugs. First: Is it possible to drink NOT simultaneously Daklatasvir + Asunaprevir with Revalgin, Ibuprofen, Sanorin (drops in the nose), Pancreatin?
I read that alcohol and tobacco can not be treated with therapy. But I, as a man with a sinusitis, need inhalations nebulizer at home. I add Rotakan syrup with water 1: 1 to 5 mg (herbs + alcohol). Can I use this for steam inhalations?
In occasion of tobacco: my mother smokes, I come to her 1-2 times a week. Is passive smoking dangerous in therapy?
Administrators
admin
Valery90, New antiviral drugs for fighting hepatitis C have not been sufficiently studied, therefore we operate only with current knowledge and at the moment the drugs listed by you are not included in the list of banned to joint reception with Daklatasvir. Although Revalgin, I would replace it with another remedy, because it is multi-component, there are a lot of things in it, it's not known what kind of reaction your body will shoot this cocktail.

Alcohol and tobacco in relation to this drug are prohibited with active consumption, and not as you described in the question,in the form of inhalations or passive smoking.

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