Generic Daklinza (Daclatasvir )

Description

Common use
The active ingredient present in is daclatasvir – 60 mg.
Daklinza is a drug for the treatment of hepatitis C (HCV). Daclatasvir inhibits the HCV nonstructural protein NS5A. Recent research suggests that it targets two steps of the viral replication process, enabling rapid decline of HCV RNA. Daklinza is indicated for use with sofosbuvir, with or without ribavirin, for the treatment of patients with chronic hepatitis C virus (HCV) genotype 1 or genotype 3 infections.
It is advised to avoid pregnancy during combination treatment with Daklinza and sofosbuvir with ribavirin for 6 months after completion of treatment.

Dosage and direction
The recommended dosage of Daklinza is 60 mg, taken orally, once daily, with or without food.
Recommended Treatment Regimen and Duration for Daklinza
Genotype 1:
Without cirrhosis – Daklinza + sofosbuvir for 12 weeks
Compensated (Child-Pugh A) cirrhosis – Daklinza + sofosbuvir for 12 weeks
Decompensated (Child-Pugh B or C) cirrhosis – Daklinza + sofosbuvir + ribavirin for 12 weeks
Post-transplant – Daklinza + sofosbuvir + ribavirin for 12 weeks
Genotype 3:
Without cirrhosis – Daklinza + sofosbuvir for 12 weeks
Compensated (Child-Pugh A) or decompensated (Child-Pugh B or C) cirrhosis – Daklinza + sofosbuvir + ribavirin for 12 weeks
Post-transplant – Daklinza + sofosbuvir + ribavirin for 12 weeks
For specific dosage recommendations for sofosbuvir, refer to the prescribing information.

Precautions
The concomitant use of Daklinza and other drugs may result in known or potentially significant drug interactions, some of which may lead to loss of therapeutic effect of Daklinza and possible development of resistance, dosage adjustments of concomitant medications or Daklinza, possible clinically significant adverse reactions from greater exposures of concomitant drugs or Daklinza.
Postmarketing cases of symptomatic bradycardia and cases requiring pacemaker intervention have been reported when amiodarone is coadministered with sofosbuvir in combination with another HCV direct-acting antiviral, including Daklinza. A fatal cardiac arrest was reported in a patient receiving a sofosbuvir-containing regimen (ledipasvir/sofosbuvir). Bradycardia generally resolved after discontinuation of HCV treatment. The mechanism for this bradycardia effect is unknown.
For patients taking amiodarone who have no alternative treatment options and who will be coadministered Daklinza and sofosbuvir need cardiac monitoring for the first 48 hours of coadministration, after which outpatient or self-monitoring of the heart rate should occur on a daily basis through at least the first 2 weeks of treatment.

Contraindications
Drugs that are Contraindicated with Daklinza:
Anticonvulsants – phenytoin, carbamazepine
Antimycobacterial agents – rifampin
Herbal products – St. John’s wort (Hypericum perforatum)

Possible side effect
Most common side effects occurred during the trials in combination with sofosbuvir (with or without ribavirin), with peginterferon alfa/ribavirin, with asunaprevir, or with asunaprevir/peginterferon alfa/ribavirin are such: fatigue, headache, pruritus, insomnia, influenza-like illness, dry skin, nausea, decreased appetite, alopecia, rash, asthenia, irritability, myalgia, anemia, pyrexia, cough, dyspnea, neutropenia, diarrhea, arthralgia, neutropenia, anemia, thrombocytopenia, and lymphopenia.
If you take Daklinza with sofosbuvir and you also take a heart rhythm medicine called amiodarone: This combination of medicines can cause dangerous side effects on your heart.

Drug interaction
Potential for Other Drugs to Affect Daklinza (clinically relevant increase in concentration):
HIV antiviral agents – Atazanavir with ritonavirb; Indinavir; Nelfinavir; Saquinavir
Other antiretrovirals – Cobicistat-containing antiretroviral regimens e.g. atazanavir/cobicistat,
elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate
Anticoagulants – Dabigatran etexilate mesylate
Strong inhibitors of CYP3A (eg, clarithromycin, itraconazole, ketoconazole, ritonavir) may increase the plasma levels of daclatasvir.
Potential for Daklinza to Affect Other Drugs (clinically relevant decrease in concentration):
Non-nucleoside reverse transcriptase inhibitors (NNRTI) – Efavirenzb; Etravirine; Nevirapine
Moderate CYP3A inducers (see also HIV antiviral agents) – Examples: bosentan, dexamethasone, modafinil,
nafcillin, rifapentine.
Daclatasvir is an inhibitor of P-glycoprotein transporter (P-gp), organic anion transporting polypeptide (OATP) 1B1 and 1B3, and breast cancer resistance protein (BCRP). Administration of Daklinza may increase systemic exposure to medicinal products that are substrates of P-gp, OATP 1B1 or 1B3, or BCRP, which could increase or prolong their therapeutic effect or adverse reactions.

Missed dose
Take Daklinza every day at the regularly scheduled time with or without food. It is important not to miss or skip doses and to take Daklinza for the duration that is recommended by the physician. For instructions for missed doses of other agents in the regimen, refer to the respective prescribing information.

Overdose
There is no known antidote for overdose of Daklinza. Treatment of overdose with Daklinza should consist of general supportive measures, including monitoring of vital signs and observation of the patient’s clinical status. Because daclatasvir is highly protein bound (>99%), dialysis is unlikely to significantly reduce plasma concentrations of the drug.

Storage
Store Daklinza tablets at 25°C (77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F). Store away from moisture and heat. Keep all drugs out of the reach children and pets.

Disclaimer
We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information at the site cannot be used for self-treatment and self-diagnosis. Any specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.