Common Use

The active ingredient present is daclatasvir - 60 mg. Daclatasvir 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.

Daclatasvir 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 Daclatasvir and sofosbuvir with ribavirin for 6 months after completion of treatment.

Dosage and Direction

The recommended dosage of Daclatasvir is 60 mg, taken orally, once daily, with or without food.

Recommended Treatment Regimen and Duration for Daclatasvir

Genotype 1:

• Without cirrhosis - Daclatasvir + sofosbuvir for 12 weeks
• Compensated (Child-Pugh A) cirrhosis - Daclatasvir + sofosbuvir for 12 weeks
• Decompensated (Child-Pugh B or C) cirrhosis - Daclatasvir + sofosbuvir + ribavirin for 12 weeks
• Post-transplant - Daclatasvir + sofosbuvir + ribavirin for 12 weeks

Genotype 3:

• Without cirrhosis - Daclatasvir + sofosbuvir for 12 weeks
• Compensated (Child-Pugh A) or decompensated (Child-Pugh B or C) cirrhosis - Daclatasvir + sofosbuvir + ribavirin for 12 weeks
• Post-transplant - Daclatasvir + sofosbuvir + ribavirin for 12 weeks

For specific dosage recommendations for sofosbuvir, refer to the prescribing information.

Precautions

The concomitant use of Daclatasvir and other drugs may result in known or potentially significant drug interactions, which may lead to:

• Loss of therapeutic effect of Daclatasvir and possible development of resistance
• Need for dosage adjustments of concomitant medications or Daclatasvir
• Clinically significant adverse reactions from greater exposures of concomitant drugs or Daclatasvir

Postmarketing cases of symptomatic bradycardia requiring pacemaker intervention have been reported when amiodarone is coadministered with sofosbuvir in combination with Daclatasvir. A fatal cardiac arrest was reported in a patient receiving a sofosbuvir-containing regimen.

For patients taking amiodarone:

• Cardiac monitoring is required for the first 48 hours of coadministration
• Daily outpatient or self-monitoring should continue for at least the first 2 weeks of treatment

Contraindications

Drugs that are Contraindicated with Daclatasvir:

• Anticonvulsants: phenytoin, carbamazepine
• Antimycobacterial agents: rifampin
• Herbal products: St. John's wort (Hypericum perforatum)

Possible Side Effects

Most common side effects during clinical trials included:

• Fatigue, headache, pruritus, insomnia
• Influenza-like illness, dry skin, nausea
• Decreased appetite, alopecia, rash
• Asthenia, irritability, myalgia
• Anemia, pyrexia, cough
• Dyspnea, neutropenia, diarrhea
• Arthralgia, thrombocytopenia, lymphopenia

Important warning: Taking Daclatasvir with sofosbuvir and amiodarone can cause dangerous heart-related side effects.

Drug Interaction

Potential for Other Drugs to Affect Daclatasvir (increase in concentration):

• HIV antiviral agents: Atazanavir with ritonavir, Indinavir, Nelfinavir, Saquinavir
• Cobicistat-containing antiretroviral regimens
• Anticoagulants: Dabigatran etexilate mesylate
• Strong inhibitors of CYP3A (clarithromycin, itraconazole, ketoconazole, ritonavir)

Potential for Daclatasvir to Affect Other Drugs (decrease in concentration):

• Non-nucleoside reverse transcriptase inhibitors (NNRTI)
• Moderate CYP3A inducers (bosentan, dexamethasone, modafinil, etc.)

Daclatasvir may increase systemic exposure to medicinal products that are substrates of certain transporters.

Missed Dose

Take Daclatasvir every day at the regularly scheduled time with or without food. Do not miss or skip doses and complete the full treatment course as recommended by your physician.

Overdose

There is no known antidote for Daclatasvir overdose. Treatment consists of general supportive measures, including monitoring of vital signs. Dialysis is unlikely to be effective due to high protein binding.

Storage

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

Disclaimer

This information provides general details about medications and does not cover all possible directions, interactions, or precautions. The content should not be used for self-treatment or self-diagnosis. Always consult your healthcare provider for specific instructions regarding your treatment. We cannot guarantee the accuracy or completeness of this information and disclaim any liability for its use.