Common Use

The active ingredient in Daklinza is daclatasvir - 60 mg. Daklinza is a medication used for treating hepatitis C (HCV). It works by inhibiting the HCV nonstructural protein NS5A. Recent studies suggest it targets two stages of viral replication, leading to a rapid decline in HCV RNA. Daklinza is prescribed in combination with sofosbuvir, with or without ribavirin, for treating chronic hepatitis C virus (HCV) genotype 1 or genotype 3 infections. It is advised to avoid pregnancy during and for 6 months after completing treatment with Daklinza, sofosbuvir, and ribavirin.

Dosage and Direction

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

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

Combining Daklinza with other drugs may lead to significant interactions, potentially reducing its effectiveness or causing adverse reactions. Postmarketing cases of bradycardia and pacemaker interventions have been reported when amiodarone is used with sofosbuvir and Daklinza. A fatal cardiac arrest was also reported. Patients on amiodarone without alternatives should undergo cardiac monitoring during the first 48 hours of treatment and daily self-monitoring for the first two weeks.

Contraindications

Drugs contraindicated with Daklinza include:

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

Possible Side Effects

Common side effects during trials with sofosbuvir (with or without ribavirin) or other combinations include 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, and lymphopenia. Combining Daklinza with sofosbuvir and amiodarone can lead to serious heart-related side effects.

Drug Interactions

Daklinza may interact with other drugs, affecting its concentration or the efficacy of other medications:

Drugs that increase Daklinza levels:

• HIV antiviral agents: Atazanavir with ritonavir, Indinavir, Nelfinavir, Saquinavir
• Anticoagulants: Dabigatran etexilate mesylate
• Strong CYP3A inhibitors: clarithromycin, itraconazole, ketoconazole, ritonavir

Drugs that decrease Daklinza levels:

• Non-nucleoside reverse transcriptase inhibitors (NNRTI): Efavirenz, Etravirine, Nevirapine
• Moderate CYP3A inducers: bosentan, dexamethasone, modafinil, nafcillin, rifapentine

Daklinza may also increase exposure to substrates of P-gp, OATP 1B1/1B3, or BCRP, affecting their efficacy or side effects.

Missed Dose

Take Daklinza daily at the scheduled time, with or without food. Avoid missing doses and complete the prescribed treatment duration. Refer to prescribing information for missed doses of other medications in the regimen.

Overdose

There is no known antidote for Daklinza overdose. Treatment involves supportive measures, monitoring vital signs, and observing clinical status. Due to high protein binding, dialysis is unlikely to reduce daclatasvir levels.

Storage

Store Daklinza tablets at 25°C (77°F), with temperature excursions permitted between 15°C and 30°C (59°F and 86°F). Keep away from moisture, heat, children, and pets.

Disclaimer

This information provides general guidance about medications and does not cover all directions, interactions, or precautions. It is not for self-treatment or self-diagnosis. Always consult your healthcare provider for personalized advice. We disclaim responsibility for any errors or damages resulting from the use of this information or self-treatment practices.