Daclavir Special Precautions



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Special Precautions
Daclavir must not be administered as monotherapy. Daclavir must be administered in combination with other medicinal products for the treatment of chronic HCV infection (see Indications/Uses and Dosage & Administration).
Warnings and precautions for other agents in the regimen also apply when coadministered with Daclavir.
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 Daclavir 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 Daclavir 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 Daclavir in combination with sofosbuvir.
All patients receiving Daclavir 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: Concerning recommended regimens with different HCV genotypes, see Dosage & Administration. Concerning genotype-specific virological and clinical activity, see Pharmacology: Pharmacodynamics under Actions.
Data to support the treatment of genotype 2 infection with Daclatasvir and sofosbuvir are limited.
Data from study ALLY-3 (AI444218) support a 12-week treatment duration of Daclatasvir + sofosbuvir for treatment-naive and -experienced patients with genotype 3 infection without cirrhosis. Lower rates of SVR were observed for patients with cirrhosis (see Pharmacology: Pharmacodynamics under Actions).
The clinical data to support the use of Daclatasvir and sofosbuvir in patients infected with HCV genotypes 4 and 6 are limited. There are no clinical data in patients with genotype 5 (see Pharmacology: Pharmacodynamics under Actions).
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 ALLY-1 (AI444215, Daclatasvir + sofosbuvir + ribavirin for 12 weeks); however, SVR rates were lower than in patients with Child-Pugh A and B.
Ribavirin may be added based on clinical assessment of an individual patient.
HCV/HBV (hepatitis B virus) co-infection: Cases of hepatitis B virus (HBV) reactivation, some of them fatal, have been reported during or after treatment with direct-acting antiviral agents. HBV screening should be performed in all patients before initiation of treatment. HBV/HCV co-infected patients are at risk of HBV reactivation, and should therefore be monitored and managed according to current clinical guidelines.
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.
Interactions with medicinal products: Coadministration of Daclavir 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 Daclavir 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 Daclavir: Daclavir contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Effects on ability to drive and use machines: Dizziness has been reported during treatment with Daclavir in combination with sofosbuvir, and dizziness, disturbance in attention, blurred vision and reduced visual acuity have been reported during treatment with Daclavir in combination with peginterferon alfa and ribavirin.
Use in Pregnancy: Pregnancy and contraception requirements: Daclavir 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 Daclavir therapy (see Use in Pregnancy & Lactation).
Use in Children: Daclavir 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.
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