Brand name : Daclahep
Active substance : Daclatasvir
Strength : 60mg
Manufactured by : Hetero drugs Ltd
Pack : 28 tablets in a container
Category : Anti-viral drug
Daclahep is an anti-viral medication which is used for preventing the disease progression of hepatitis C viral infection by reduces the multiplication of virus in the body. Daclahep is used by combining with other anti-virals for treating the HCV infection in chronic stage majorly in adults. Daclahep is usually combined with Sofosbuvir, with or without ribavirin.
Daclahep is belongs to class like;
HCV NS5A protein inhibitor
Daclahep is a NS5A protein inhibitor, NS5A is a HCV non structural phosphoprotein that is responsible for replicating function of charge of viral RNA augmentation on endoplasmic reticulum membranes. Daclahep has ability to merge to viral RNA. There are two pathway involved in the mechanism of Daclahep; Cis acting function of basally phosphorylated NS5A is responsible for maintaining the HCV replication complex. HCV assembly & infectious particle formation is altered by Trans acting function of hyperphosphorylated NS5A. Daclahep is used to confuse the hyperphosphorylated NS5A proteins thus concludes as interceding with activity of newly produced HCV. Daclahep works as blockade of; Intercellular viral RNA synthesis Virion assembly/ secretion in-vivo
Before starting the treatment; Patient’s HBsAg & anti-HBc levels should be monitored. Hepatic function test should be performed
Without cirrhosis or Compensated cirrhosis: One Daclahep with sofosbuvir or 12 weeks. Decompensated cirrhosis: One Daclahep with sofosbuvir combined with ribavirin for 12 weeks Post transplant: One Daclahep + sofosbuvir combined with ribavirin for 12 weeks. Genotype III; Without cirrhosis: One Daclahep tablet should be combined with sofosbuvir for 12 weeks. Compensated or decompensated cirrhosis: One Daclahep with sofosbuvir combined with ribavirin for 12 weeks
WARNING & PRECAUTION
HBV reactivation :
In HBV/HCV co infected patients, HBV reoccurrence occurs after completion of HCV anti-viral agents but not getting the HBV anti-viral agents. This fatal case causes hepatic failure & finally leads to death. Overcome the problem by measuring HBsAg & anti-HBc before starting the treatment. Initiate the patient management for HBV infection. Hepatic function test should be performed.
Increased exposure of loss of virological responses :
The concurrent use of Daclahep with other drugs may leads to loss of therapeutic effect of Daclatasvir & possible advancement of resistance. Dosage modification should be involved during combinational treatment. The adverse reactions related to the concomitant use should be monitored.
Risk due to ribavirin :
The combination of Daclahep & sofosbuvir with ribavirin should produce fetal harm during pregnancy period.
This lethal case should be occurred during the concomitant use of Daclahep with amiodarone. This should be prevented by avoiding this combination. Monitor the ECG during the treatment. Initiate the alternative therapy for reducing the cardiac disorders. Counsel the patient before starting the treatment about the risk related to this combinational therapy.
Daclahep combined with the strong inducers of CYP3A causes depletion of plasma evels of Daclatasvir which concludes as loss of therapeutic activity of Daclahep. Daclahep tablet combined with P-gp or BCRP substrates causes increased systemic exposure of these substrates & elevates the adverse effects related to this substrates. Daclahep combined with warfarin causes bleeding effects by altering the prothrombin time & INR values. Daclahep with protease inhibitors causes increased Daclatasvir effect of concentration, to prevent this problem by reducing the dose of Daclahep to 30mg as once daily. Daclahep combined with NNRTI, causes decreased Daclatasvir concentration, overcome the problem by increasing the dose of Daclahep to 90mg. Daclahep with strong CYP3A inhibitors causes increased Daclatasvir concentration. Daclahep with moderate CYP3A inducers causes reduced concentration of Daclatasvir. Daclahep with amiodarone causes serious bradycardia Daclahep with lipid lowering drugs causes increased concentration of these drugs.
The combination of Daclahep & sofosbuvir with ribavirin is contraindicated to pregnancy & lactating period. Hypersensitivity reactions are produced during the therapy while patients are contraindicated to component of Daclahep.
No specific anti-toxin is required for treating the over dosage of Daclahep. Patient should be provided with general supportive measures. The signs & symptoms of Daclahep over dosage should be monitored. Hemodialysis should not be applicable; it is difficult to remove from the body because it is highly bounds to human plasma protein.
If patients missed a dose then should be consult with medical practitioner & follow the instructions. On the other hand missed dose should be skipped. Avoid self medication Maintain the regular dosing schedule.
Pregnancy category of Daclahep is B Daclahep with sofosbuvir pregnancy category is B Ribavirin pregnancy category is X Ribavirin should not be used in pregnancy condition.
Breast feeding should not be suggested.
The safety & effectivity of Daclahep in pediatric patients below 18 years should not be evaluated.
No dosage adjustment should be recommended
Chest pain or discomfort, Dizziness, Irregular heartbeat, Tiredness, Head ache , Nausea, Diarrhea, Insomnia, Dry skin, Influenza like syndrome, Dyspnea, Neutropenia, Pruritus, Thrombocytopenia, Bradycardia , Increased AST, ALT, Increased bilirubin, Hepatitis B reactivation .
RENAL & LIVER IMPAIRMENT
Dosage modification should not be recommended in both renal & hepatic impaired patients.
Store the container at temperature 25℃ (77℉). Keep the container away from moisture, heat & light.