MyDekla Special Precautions

Daclatasvir must not be administered as monotherapy. Daclatasvir must be administered in combination with other medicinal products for the treatment of chronic HCV infection (see Indications/Uses and Dosage & Administration).
General: The safety and efficacy of the combination of Daclatasvir and sofosbuvir have been evaluated in a number of patients with cirrhosis in clinical studies. Further clinical studies with the combination are ongoing.
Severe bradycardia and heart block: Cases of severe bradycardia and heart block have been observed when Daclatasvir is used in combination with sofosbuvir and concomitant amiodarone with or without other drugs that lower heart rate. The mechanism is not established. The concomitant use of amiodarone was limited through the clinical development of sofosbuvir plus direct-acting antivirals (DAAs). Cases are potentially life threatening, therefore amiodarone should only be used in patients on Daclatasvir and sofosbuvir when other alternative antiarrhythmic treatments are not tolerated or are contraindicated.
Should concomitant use of amiodarone be considered necessary it is recommended that patients are closely monitored when initiating Daclatasvir in combination with sofosbuvir. Patients who are identified as being at high risk of bradyarrhythmia should be continuously monitored for 48 hours in an appropriate clinical setting. Due to the long half-life of amiodarone, appropriate monitoring should also be carried out for patients who have discontinued amiodarone within the past few months and are to be initiated on Daclatasvir in combination with sofosbuvir. All patients receiving Daclatasvir and sofosbuvir in combination with amiodarone with or without other drugs that lower heart rate should also be warned of the symptoms of bradycardia and heart block and should be advised to seek medical advice urgently should they experience them.
Genotype-specific activity: The clinical data to support the use of daclatasvir and sofosbuvir in patients infected with HCV genotype 2, 4, 5, and 6 are limited.
Hepatitis B Virus (HBV) Reactivation: Cases of hepatitis B virus (HCV) reactivation, including fatal cases, have been reported during and after treatment of HCV with direct-acting anti viral agent in HCV/HBV co-infected patients. Screening for current or past HBV infection, including testing for HBV surface antigen (HBsAg) and HBV core antibody (anti-HBc), should be performed in all patients before initiation of treatment with DACLATASVIR. Patients with serologic evidence of current or past HBV infection should be monitored and treated according to current clinical practice guideline to manage potential HBV reactivation. Consider initiation of HBV antiviral therapy, if indicated.
Patients with Child-Pugh C liver disease: The safety and efficacy of Daclatasvir in the treatment of HCV infection in patients with Child-Pugh C liver disease have been established in the clinical study ALL Y-1 (AI444215, Daclatasvir + sofosbuvir + ribavirin for 12 weeks); however, SVR rates were lower than in patients with Child-Pugh A and B. Therefore, a conservative treatment regimen of Daclatasvir + sofosbuvir +/- ribavirin for 24 weeks is proposed for patients with Child-Pugh C (see Pharmacology: Pharmacodynamics under Actions and Dosage & Administration). Ribavirin may be added based on clinical assessment of an individual patient.
Retreatment with daclatasvir: The efficacy of Daclatasvir as part of a retreatment regimen in patients with prior exposure to a NS5A inhibitor has not been established.
HCV/HBV (hepatitis B virus) co-infection: The safety and efficacy of Daclatasvir in the treatment of HCV infection in patients who are co-infected with HBV have not been investigated.
Interactions with medicinal products: Co-administration of Daclatasvir can alter the concentration of other medicinal products and other medicinal products may alter the concentration of daclatasvir. Refer to Contraindications for a listing of medicinal products that are contraindicated for use with Daclatasvir due to potential loss of therapeutic effect. Refer to Interactions for established and other potentially significant drug-drug interactions.
Important information about some of the ingredients in Daclatasvir: Daclatasvir contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Effect on Ability to Drive and Use Machines: Dizziness has been reported during treatment with Daclatasvir in combination with sofosbuvir, and dizziness, disturbance in attention, blurred vision and reduced visual acuity have been reported during treatment with Daclatasvir in combination with peginterferon alfa and ribavirin.
Pregnancy and contraception requirements: Daclatasvir should not be used during pregnancy or in women of childbearing potential not using contraception. Use of highly effective contraception should be continued for 5 weeks after completion of Daclatasvir therapy.
When Daclatasvir is used in combination with ribavirin, the contraindications and warnings for that medicinal product are applicable. Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin; therefore, extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients (see the Summary of Product Characteristics for ribavirin).
Paediatric population: Daclatasvir is not recommended for use in children and adolescents aged below 18 years because the safety and efficacy have not been established in this population.