Description of Daclahep - 12 weeks
Trade name: Daclahep Active component: Daclatasvir Strength: 60mg Mfg: Hetero healthcare Pack: 28 tablets in a container Category: Anti-viral Description of Daclahep 12 weeks Hepatitis C virus is a RNA virus, which causes severe life threatening conditions like; â€¢ Chronic hepatitis â€¢ Cirrhosis â€¢ Hepatocellular carcinoma Daclahep is an anti-viral medication, which is available in tablet form. Daclatasvir exhibits its action by prohibiting the non structural 5A protein region of hepatitis C virus. Daclahep is not monotherapy medicine; it should be combined with other anti-viral drugs for treating chronic hepatitis C infection caused by virus Daclahep is available in the strength of 60mg
Pharmacology of Daclahep - 12 weeks
Daclahep mechanism of action for 12 weeks therapy: Daclahep is a NS5A inhibitors, NS5A protein is required for viral multiplication This NS5A has capability to merge with HCV RNA. There are two specific functions in RNA multiplication which is based on phosphorylated state Cis acting function of phosphorylated NS5A: interfering HCV replication complex Trans acting function: regulate HCV assembly and infectious particle production Daclahep will disrupt hyperphosphorylated NS5A protein and mediated with newly formed RNA viral Daclahep involved in blockade of intercellular viral RNA synthesis and colony of virion Pharmacokinetic: 12 weeks Absorption: The steady state level reached in 4 days after administration of single dose The peak plasma concentration of Daclahep occurs within 2 hours. The mean bioavailability of Daclahep is 67% Distribution: The human plasma protein bound with Daclahep with the range of 99% The volume of distribution occurs at 47L. Metabolism: Daclahep a CYP3A substrates, it is dominantly metabolized by CYP3A4 isoenzymes High portion of Daclahep in plasma is in unchanged form nearly 97% Elimination: The route of elimination of metabolites; Bile: 88%; feces 53% (unchanged form) and 6.6% in unchanged form through urine The mean terminal half life period of Daclahep occurs from the range of almost 12 to 15 hours
Indication of Daclahep - 12 weeks
Generally Daclahep tablets are used in combination with sofosbuvir for the condition like chronic hepatitis C viral infection by combining with or without ribavirin.
Daclahep used for treated genotype I or III induced HCV infection.
The major limitation of use of Daclahep;
Loss of virological responses happens in the patients suffered with genotype III infection associated HCV treated with Daclahep & sofosbuvir for 12 weeks.
Dose & Dosage's of Daclahep - 12 weeks
Before initiating the therapy; NS5A resistance testing in HCV genotype 1a infected patients with cirrhosis has been evaluated The usual dose of Daclahep is 60mg as a single dose Recommended dosage regimens: Genotype I: Without cirrhosis: Daclahep + Sofosbuvir for 12 weeks Compensated cirrhosis (child Pugh A): Daclahep + Sofosbuvir for 12 weeks Decompensated cirrhosis (child Pugh B or C): Daclahep + Sofosbuvir + ribavirin for 12 weeks Genotype III: Without cirrhosis: Daclahep with Sofosbuvir for 12 weeks Compensated or decompensated cirrhosis: Daclahep with Sofosbuvir + ribavirin for 12 weeks Dose adjustments: While concomitant with strong CYP3A inhibitors: 30mg of Daclahep once a day Concomitant with moderate CYP3A inducers & nevirapine: 90mg of Daclahep as single dose With strong CYP3A inducers: contraindicated Daclahep should be administered with or without food. Missed dose: Daclahep is a prescription medicine; it should be used only under the guaindance of doctor Do not self medicate If patient fail to take the dose of Daclahep tablet, must consult with physician and take the missed dose within the time Otherwise the missed dose should be skipped and follow the regular dosing schedule Do not take overdose
Side Effects of Daclahep - 12 weeks
Some common side effects occurred in 12 weeks therapy; Chest pain, dizziness Irregular heart beat Unusual tiredness More common: Headache, nausea Pharmacological effects: GIT: Abdominal pain, gastro esophageal reflux, vomiting, elevated lipase, flatulence Muscle: Myalgia, arthralgia, back pain Metabolic: Loss of appetite CVS: Bradycardia, heart block, cardiac arrhythmias Liver: Increased AST & ALT, Hyperbilirubinaemia, hepatitis B reactivation Genitourinary: Urinary tract infection Ocular: Dry eye Other: Fatigue, asthenia, influenza like symptoms, pyrexia, hot flush, loss of weight Nerve: Headache, migraine, somnolence Dermatological: Rashes, Pruritus, dry skin, alopecia, and Erythema multiforme Psychiatric: Insomnia, irritability, depression, anxiety Blood: Anemia, neutropenia, thrombocytopenia, esinophillia Respiratory: Cough, Nasopharyngitis, dyspnea, nasal congestion, upper respiratory infection
Contraindication of Daclahep - 12 weeks
Daclahep with ribavirin contraindicated to pregnancy condition Hypersensitivity reaction occur Concurrent use of CYP3A inducers strong with Daclahep, contraindicated to the patients
Drug Interaction of Daclahep - 12 weeks
Concurrent use of Daclahep with some drugs likes; Daclahep is an inhibitor of P-glycoprotein transporter, organic anion transporting polypeptide and breast cancer resistance protein; taking Daclahep, may elevate exposure to these drugs, which prolong the therapeutic effect Proteases inhibitors: increase effect of concentration of Daclahep Efavirenz, etravirine & nevirapine: decrease the effect of concentration of Daclahep Amiodarone: serious bradycardia occurs Aprepitant: increase the serum concentration of CYP3A4 substrates Strong inducers of CYP3A causes decreased therapeutic effect of Daclahep Strong CYP3A inhibitors: increase the effect of concentration of Daclahep HMG CoA reductase: increase the effect of concentration of these lipid lowering drugs
Precaution of Daclahep - 12 weeks
There is a risk of adverse effects due to concurrent use of Daclahep with some other drugs causes; Loss of therapeutic effect Serious life threatening conditions Symptomatic bradycardia while using with amiodarone Risk related to ribavirin during combination Hepatitis B reactivation
Usage & Safety profile of Daclahep - 12 weeks Pregnancy & Lactation
During monotherapy: pregnancy category of Daclahep-B; it is safe while using alone but under supervision of medical practitioner advice During combination: pregnancy categories with ribavirin-X; causes severe ill effects like fetal harm even to death Breast feeding is safe during monotherapy but in combination with ribavirin breast feeding is not recommended
Storage of Daclahep - 12 weeks
Daclahep tablets containers are stored at 25oC (77oF); excursion between 15oC and 30oC (59oF and 86oF) Keep away from heat, moisture and heat