Description of Hepcfix - 12 weeks
Product Index: Trade name: HepCfix Active component: Daclatasvir Strength: 60mg Mfg: Dr. Reddyâ€™s Pack: 28 tablets in a container Category: Anti-viral Description of HepCfix 12 weeks HepCfix is an anti-viral medication, which is available in tablet form. HepCfix exhibits its action by prohibiting the non structural 5A protein region of hepatitis C virus HepCfix is not monotherapy medicine; it should be combined with other anti-viral drugs for treating chronic hepatitis C infection caused by virus HepCfix is available in the strength of 60mg
Pharmacology of Hepcfix - 12 weeks
HepCfix mechanism of action for 12 weeks therapy: HepCfix 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 HepCfix will disrupt hyperphosphorylated NS5A protein and mediated with newly formed RNA viral HepCfix involved in blockade of intercellular viral RNA synthesis and colony of virion Pharmacokinetic: HepCfix 12 weeks Absorption: The peak plasma concentration of HepCfix occurs within 2 hours. The mean bioavailability of HepCfix is 67% The steady state level reached in 4 days after administration of single dose Distribution: The volume of distribution occurs at 47L. The human plasma protein bound with HepCfix with the range of 99% Metabolism: HepCfix a CYP3A substrates, it is dominantly metabolized by CYP3A4 isoenzymes High portion of HepCfix 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 HepCfix occurs from the range of almost 12 to 15 hours
Indication of Hepcfix - 12 weeks
Generally Hepcfix tablets are used in combination with sofosbuvir for the condition like chronic hepatitis C viral infection by combining with or without ribavirin.
Hepcfix used for treated genotype I or III induced HCV infection.
The major limitation of use of Hepcfix;
Loss of virological responses happens in the patients suffered with genotype III infection associated HCV treated with Hepcfix & sofosbuvir for 12 weeks.
Dose & Dosage's of Hepcfix - 12 weeks
Before initiating the therapy; NS5A resistance testing in HCV genotype 1a infected patients with cirrhosis has been evaluated The usual dose of HepCfix is 60mg as a single dose Recommended dosage regimens: Genotype III: Without cirrhosis: HepCfix with Sofosbuvir for 12 weeks Compensated or decompensated cirrhosis: HepCfix with Sofosbuvir + ribavirin for 12 weeks Genotype I: Without cirrhosis: HepCfix + Sofosbuvir for 12 weeks Compensated cirrhosis (child Pugh A): HepCfix + Sofosbuvir for 12 weeks Decompensated cirrhosis (child Pugh B or C): HepCfix + Sofosbuvir + ribavirin for 12 weeks Dose adjustments: While concomitant with strong CYP3A inhibitors: 30mg of HepCfix once a day Concomitant with moderate CYP3A inducers & nevirapine: 90mg of HepCfix as single dose With strong CYP3A inducers: contraindicated HepCfix should be administered with or without food. HepCfix 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 HepCfix 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 Hepcfix - 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: CVS: Bradycardia, heart block, cardiac arrhythmias Liver: Increased AST & ALT, Hyperbilirubinaemia, hepatitis B reactivation Genitourinary: Urinary tract infection Ocular: Dry eye GIT: Abdominal pain, gastro esophageal reflux, vomiting, elevated lipase, flatulence Muscle: Myalgia, arthralgia, back pain 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 Metabolic: Loss of appetite
Contraindication of Hepcfix - 12 weeks
HepCfix with ribavirin contraindicated to pregnancy condition Hypersensitivity reaction occur Concurrent use of CYP3A inducers strong with HepCfix, contraindicated to the patients
Drug Interaction of Hepcfix - 12 weeks
Concurrent use of HepCfix with some drugs likes; HepCfix is an inhibitor of P-glycoprotein transporter, organic anion transporting polypeptide and breast cancer resistance protein; taking HepCfix, may elevate exposure to these drugs, which prolong the therapeutic effect Proteases inhibitors: increase effect of concentration of HepCfix Efavirenz, etravirine & nevirapine: decrease the effect of concentration of HepCfix Amiodarone: serious bradycardia occurs Aprepitant: increase the serum concentration of CYP3A4 substrates Strong inducers of CYP3A causes decreased therapeutic effect of HepCfix Strong CYP3A inhibitors: increase the effect of concentration of HepCfix HMG CoA reductase: increase the effect of concentration of these lipid lowering drugs
Precaution of Hepcfix - 12 weeks
There is a risk of adverse effects due to concurrent use of HepCfix 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 Hepcfix - 12 weeks Pregnancy & Lactation
During monotherapy: pregnancy category of HepCfix -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 Hepcfix - 12 weeks
HepCfix tablets containers are stored at 25oC (77oF); excursion between 15oC and 30oC (59oF and 86oF) Keep away from heat, moisture and heat