Ducklinza - Instructions For Use, Indications, Doses, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Ducklin's

Instructions for use:

1. Release form and composition
2. Indications for use
3. Contraindications
4. Method of application and dosage
5. Side effects
6. Special instructions
7. Drug interactions
8. Analogs
9. Terms and conditions of storage
10. Terms of dispensing from pharmacies

Prices in online pharmacies:

from 43,000 rubles.

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Ducklinza is an antiviral drug used in the treatment of chronic viral hepatitis C.

Release form and composition

Daklinza's dosage form is film-coated tablets: biconvex, pentagonal, with "BMS" engraved on one side; 30 mg each - green, engraving on the second side - "213"; 60 mg each - light green, engraving on the second side - "215" (14 pieces in blisters, in a cardboard box 2 blisters).

Composition of 1 tablet:

active substance: daclatasvir - 30 or 60 mg (daclatasvir dihydrochloride - 33 or 66 mg);
auxiliary components (30/60 mg): magnesium stearate - 2.4 / 4.8 mg; lactose - 57.75 / 115.5 mg; silicon dioxide - 1.5 / 3 mg; microcrystalline cellulose - 47.85 / 95.7 mg; croscarmellose sodium - 7.5 / 15 mg; Opadry green (hypromellose - 3.6 / 8.9625 mg; titanium dioxide - 1.698 / 4.2825 mg; macrogol-400 - 0.48 / 1.35 mg; indigo carmine-based aluminum varnish - 0.12 / 0.255 mg; yellow iron oxide - 0.102 / 0.15 mg) - 6/15 mg.

Indications for use

Daklinza is prescribed for the treatment of chronic hepatitis C in patients with compensated liver disease (including cirrhosis) as part of a combination therapy with the following drugs (depending on the genotype of the virus):

genotype 1b: asunaprevir;
genotype 1: asunaprevir, ribavirin, and alpha peginterferon.

Contraindications

Absolute:

lactose intolerance, lactase deficiency, glucose-galactose malabsorption;
the use of Daklinza in the form of monotherapy;
the presence of contraindications to the use of drugs that are part of the combined regimen;
combined use with moderate inducers of the CYP3A4 isoenzyme when using regimens that include asunaprevir;
combined use with strong inducers of the isoenzyme CYP3A4: drugs with antiepileptic (phenytoin, phenobarbital, carbamazepine, oxcarbazepine) and antibacterial (rifabutin, rifampicin, rifapentin) action; herbal remedies (preparations based on St. John's wort); systemic glucocorticosteroids (dexamethasone);
pregnancy and the period of breastfeeding;
age up to 18 years (for this group of patients, the effectiveness / safety of the drug has not been studied);
individual intolerance to the components of the drug.

In the presence of relative contraindications to the use of drugs included in the treatment regimen, Ducklinza should be prescribed with caution.

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

It should be taken into account that combined use with other drugs can lead to a mutual change in the concentration of active substances.

Method of administration and dosage

Daklinza is taken orally, regardless of food intake.

The recommended daily dose is 60 mg in 1 dose.

The drug is taken in a course of 24 weeks in combination with asunaprevir (genotype 1b) or with asunaprevir, alpha peginterferon and ribavirin (genotype 1).

The therapy is recommended both for patients who have not previously received treatment for chronic hepatitis C, and for patients in whom previous therapy was ineffective.

The full course of combination therapy should be followed. If, for any reason, one of the drugs is canceled, Ducklinza should not be taken as monotherapy.

During the treatment course, it is necessary to monitor the viral load (the number of RHK of the hepatitis C virus in the blood). In patients with an inadequate virological response, the likelihood of achieving a sustained virological response during therapy is low, and this group also has a risk of resistance. Discontinuation of therapy is recommended in patients with a virological breakthrough - an increase in the level of RNA of the hepatitis C virus by more than 1 log ₁₀ from the previous level.

If a single dose was accidentally missed, it should be taken as soon as possible. In the future, you should not change the dosage regimen. If you skip taking the drug for more than 20 hours, it is recommended to skip the dose without doubling the next one.

The efficacy and safety profile of Daklinza in patients with decompensated liver failure has not been studied.

If it is necessary to carry out combination therapy with powerful inhibitors of the CYP3A4 isoenzyme, the daily dose should be reduced to 30 mg (you cannot break the 60 mg tablet, you must use a tablet with the appropriate dosage). Combined use with potent and moderate inhibitors of the CYP3A4 isoenzyme, including regimens with Sunvepra, is contraindicated.

When used in combination with moderate inducers of the CYP3A4 isoenzyme, the daily dose of Daklinza should be increased to 90 mg. It is contraindicated to use the drug with moderate inducers of the CYP3A4 isoenzyme in cases of using the regimens with Sunvepra.

Side effects

Daklinza is used only simultaneously with other combination therapy drugs, therefore, before starting the course, you need to familiarize yourself with their adverse reactions.

The most common disorders (more than 10% of cases) with therapy in combination with asunaprevir are headache and fatigue. In most cases, they were mild / moderate and rarely resulted in discontinuation of therapy. The most common disorders, due to the development of which the drug was discontinued, was an increase in the activity of alanine aminotransferase and aspartate aminotransferase.

Possible disorders in the treatment of genotype 1b hepatitis (≥ 1/10 - very often; ≥ 1/100 and <1/10 - often):

digestive system: often - nausea, diarrhea;
nervous system: very often - headache;
instrumental and laboratory data: often - an increase in alanine aminotransferase and aspartate aminotransferase;
general disorders: very often - fatigue.

Side effects occurring in less than 5% of patients: fever, skin rash / itching, alopecia, eosinophilia, anemia, thrombocytopenia, malaise, chills, insomnia, decreased appetite, constipation, abdominal discomfort, bloating, stomatitis, vomiting, pain in the upper abdomen, increased blood pressure, joint pain, muscle stiffness, pain in the oropharynx, nasopharyngitis, hypoalbuminemia, increased activity of gamma globulin transferase, lipase, alkaline phosphatase.

The most common disorders (more than 15% of cases) during therapy in combination with asunaprevir, alpha peginterferon and ribavirin are pruritus, headache, flu-like condition, asthenia, insomnia, anemia, alopecia, nausea, irritability, rash, and increased fatigue. In addition, disorders such as muscle and joint pain, decreased appetite, dry skin, fever, shortness of breath, cough, lymphopenia, neutropenia, and diarrhea were noted. Typically, adverse reactions were mild / moderate. The most common side effects that led to discontinuation of therapy are neutropenia, rash, dizziness, and malaise.

Also, during the treatment period, pathological deviations of laboratory parameters from the norm of 3-4 degrees may be observed (increased activity of alanine aminotransferase, aspartate aminotransferase and concentration of total bilirubin).

special instructions

The use of Daklinza in the treatment of chronic hepatitis C in patients with concomitant infection with hepatitis B virus or human immunodeficiency virus has not been studied.

It must be borne in mind that Ducklinza contains lactose.

After completion of therapy for 5 weeks, you need to use adequate methods of contraception.

In cases where during the treatment the patient experiences dizziness, impaired attention, decreased visual acuity / blurred vision, it is recommended to refuse to drive vehicles.

Drug interactions

Ducklinza is used as part of combination therapy regimens, therefore, before prescribing it, you need to become familiar with the possible interactions of each of the drugs used. When prescribing concomitant therapy, the most conservative recommendations should be followed.

Moderate and strong inducers of the isoenzyme CYP3A4 can reduce the plasma level of daclatasvir and, accordingly, its therapeutic effect. Potent inhibitors of the CYP3A4 isoenzyme can increase the serum concentration of daclatasvir.

Ducklinza can increase the systemic effect of drugs that are substrates of P-glycoprotein or transport polypeptide of organic anions 1B1 / 1B3 or BCRP, which can lead to an increase or prolongation of their therapeutic effect, as well as an increase in the severity of undesirable effects. In this regard, when using Daklinza together with the substrates of these isoenzymes / carriers, especially in cases of a narrow therapeutic range of the latter, care must be taken.

The use of Daklinza is contraindicated with strong inducers of the CYP3A4 isoenzyme:

drugs with antiepileptic action: phenytoin, phenobarbital, carbamazepine, oxcarbazepine;
drugs with antibacterial action: rifabutin, rifampicin, rifapentin;
herbal remedies: preparations based on St. John's wort;
systemic glucocorticosteroids: dexamethasone.

Other significant drug interactions:

telaprevir: an increase in the plasma concentration of daclatasvir;
atazanavir / ritonavir, boceprevir, cobicistat, clarithromycin, telithromycin: an increase in the plasma concentration of daclatasvir (it is recommended to reduce the daily dose of Daclinza to 30 mg when combined with these drugs or other strong inhibitors of the isoenzyme CYP3A4);
darunavir / ritonavir: the interaction has not been studied, and therefore the combination is not recommended (an increase in the plasma concentration of daclatasvir is possible);
efavirenz: a decrease in the plasma concentration of daclatasvir (it is recommended to increase the daily dose of Daclinza to 90 mg in cases of combined use with efavirenz or other moderate inducers of the CYP3A4 isoenzyme);
etravirine, nevirapine: the interaction has not been studied, and therefore the combination is not recommended (a decrease in the plasma concentration of daclatasvir is possible);
erythromycin: the interaction has not been studied, and therefore the combination should be used with caution (an increase in the plasma concentration of daclatasvir is possible);
dabigatran etexilate: the interaction has not been studied, and therefore it is recommended to carefully monitor the condition of patients taking dabigatran etexilate or other P-gp substrates with a narrow therapeutic range (an increase in its plasma concentration is possible);
ketoconazole (at a dose of 400 mg): an increase in the plasma concentration of daclatasvir (it is recommended to reduce the daily dose of Daklinza to 30 mg when used in combination with ketoconazole or other strong inhibitors of the CYP3A4 isoenzyme);
itraconazole, posaconazole: the interaction has not been studied (an increase in the plasma concentration of daclatasvir is possible; it is recommended to reduce the daily dose of Daklinza to 30 mg when used in combination with itraconazole, posaconazole or other strong inhibitors of the CYP3A4 isoenzyme);
digoxin: an increase in its plasma concentration (the drug and other P-gp substrates with a narrow therapeutic range should be used with caution; it is recommended to prescribe digoxin in a minimum dose and monitor its plasma level; in order to achieve the desired therapeutic effect, dose titration should be performed);
diltiazem, nifedipine, amlodipine, verapamil: the interaction has not been studied, and therefore the combination requires caution (an increase in the plasma level of daclatasvir is possible);
HMG-CoA reductase inhibitors, including rosuvastatin, atorvastatin, fluvastatin, simvastatin, pitavastatin, pravastatin: an increase in their plasma concentration (the combination requires caution).

Analogs

There is no information on analogues.

Terms and conditions of storage

Store at temperatures up to 30 ° C. Keep out of the reach of children.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Ducklinza: prices in online pharmacies

Drug name

Price

Pharmacy

Ducklinza 60 mg film-coated tablets 28 pcs.

RUB 43,000

Buy

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!