Description of MyHep - 12 weeks
Trade name: Myhep Generic name: Sofosbuvir Strength: 400mg Pack: 28 tablets in a container Mfg: Mylan Classification: Anti-viral Myhep description: 12 weeks Myhep contains an active components Sofosbuvir, is a nucleotide prodrug analogue; it is a NS5B polymerase inhibitor with HCV prohibiting activity. Sofosbuvir is an active chemical ingredient which is applicable in various brands. Myhep is not monotherapy; it should be combined with other retroviral medicines. Sofosbuvir is generally available in tablet form (film coated) Myhep is available in the strength of 400mg
Pharmacology of MyHep - 12 weeks
Myhep mechanism of action Myhep, an anti-viral medicine has nucleotide prodrug that prevents the replication of hepatitis C virus by prohibiting the effect of HCV NS5B RNA polymerase. This enzyme undergoes intercellular metabolism to produce GS-461203, it is a pharmacologically active uridine analog triphosphate. Hepatitis C virus NS5B RNA polymerase inserted this metabolite into viral DNA, it acts as chain terminator. GS-461203, it is not prohibits human DNA or RNA polymerase, nor it blocks mitochondrial RNA polymerase. Pharmacokinetic: Absorption: The Myhep is absorbed well after oral administration The peak concentration of Myhep tablets (Sofosbuvir and GS-331007) in the blood plasma was approximately occurred at 0.5-2 hours and 2-4 hours respectively, after the drug intake. Effect of Food: While taking Myhep with high fat meals, it leads to deplete the absorption rate of the drug Sofosbuvir when compared with fasting. High fat meal, creates no effect when exposed to the metabolite GS-331007, so it is not take to consider while drug taken with meals. Distribution: The Myhep is highly bound to blood plasma protein approximately 61-65%. The GS-331007 binding to plasma proteins is minimal. Metabolism: Myhep is highly metabolized in liver and to form active triphosphate a nucleoside analogue (GS-461203). The metabolic route of activation associates sequential hydrolysis of a carboxylic acid ester molecule with cathepsin A or carboxyl esterase 1. The metabolite GS-331007 by Dephosphorylation, is cannot be completely rephosphorylated and has no activity against HCV Elimination: The route of elimination of metabolites occurs through Kidneys, intestines, and lungs The drug around 78% excreted as inactive metabolite, 3.5% was excreted as Sofosbuvir The half life time of both Sofosbuvir and GS-331007 is 0.4 and 27 hours respectively.
Indication of MyHep - 12 weeks
Myhep exhibits anti viral activity, to treats chronic hepatitis C viral infection. It is effective against hepatitis C of I, II, III and IV genotypes.
Dose & Dosage's of MyHep - 12 weeks
The prescribed dose of Myhep is 400mg should be taken as a single dose, disregarding of food intake. In the treatment of chronic hepatitis C infection; Myhep should be combined with ribavirin or pegylated interferon and ribavirin. Combinational therapy: Genotypes Hepatitis type Dosage regimen Duration HCG (genotype I and IV) Myhep + peg interferon alpha + ribavirin For 12 weeks HCG (genotype II) Myhep + ribavirin For 12 weeks HCG (genotype III) Myhep + ribavirin For 24 weeks Ribavirin dose should be recommended on the basis of weight of the patient. It is administered orally with food. In the condition of renal failure, ribavirin should be discontinued. There is a chance to get re-infection of HCV after transplantation; in this condition Myhep with ribavirin is recommended it is not more than 48 weeks. Peg interferon dosage regimen: Peg interferon alpha 2a: 180 mcg SC weekly Peg interferon alpha 2b: 1.5mcg/kg/week SC, not exceed to 150mcg/week Ribavirin dosage regimen: For prevention of post transplant HCV re-infection: Myhep + ribavirin for 48 weeks or until liver transplant. It should be taken with food <75 kg: 500mg PO twice daily â‰¥75 kg: 600mg PO twice daily Pediatric dose: For hepatitis C viral infection: <12 years or <35 kg: the safety and efficacy of the drug has not been established â‰¥12 years or weight â‰¥35 kg: 400mg PO qDay with weight based ribavirin During combination with ribavirin, it must be taken with food. Myhep should be taken with or without food Missed dose: Once patient fail to administer the dose of Myhep, must consult with medical practitioner and take the missed dose. Otherwise it should be skipped and follow the next drug schedule. Do not double the dose.
Side Effects of MyHep - 12 weeks
Myhep plus ribavirin for 24 weeks; Fatigue Headache Nausea Insomnia Pruritus Asthenia Diarrhea >10% of the patient may have chance to get adverse effects while taking Myhep and ribavirin (12 weeks) like; Fatigue Headache Nausea Insomnia Pruritus Myhep with ribavirin plus peg interferon for 12 weeks; Fatigue Headache Nausea Insomnia Pruritus Anemia Rash Loss of appetite Chills Influenza like syndrome Pyrexia Diarrhea Neutropenia Myalgia Irritability Myhep with peg interferon and ribavirin for 24 weeks; Fatigue Headache Nausea Insomnia Pruritus Anemia Rash Decreased appetite Chills Influenza-like illness Pyrexia Diarrhea Neutropenia Myalgia Irritability <1% has chances to get; Neutropenia Pancytopenia Severe depression Bradycardia
Contraindication of MyHep - 12 weeks
While using combinational therapy there is a possibilities of contraindication; Myhep with When combined with ribavirin; Hypersensitivity Pregnant women or become pregnant Pancreatitis Thalassemia major, sickle cell anemia Concomitant with Didanosine Autoimmune hepatitis, decompensated liver disease For neonates and infants With peg-interferon; Autoimmune hepatitis, decompensated liver disease For neonates and infants
Drug Interaction of MyHep - 12 weeks
Amiodarone: symptomatic bradycardia occurs while taking Myhep with amiodarone. This combination causes serious cardiac arrest. Atazanavir; cobicistat: cobicistat is an inhibitor of transporters P-glycoprotein inducers and BCRP. In combination with Myhep leads to increase its concentration; adverse affects may produce. Apalutamide: Apalutamide is a P-glycoprotein inducers and BCRP. It should not be combined with Myhep, these concomitant can cause reduction of plasma concentration of Sofosbuvir and loss of anti-viral efficacy. Some other drugs like; Atropine, hyoscyamine, Phenobarbital, scopolamine, carbamazepine, carvedilol, elvitegravir, Emtricitabine, tenofovir, rifabutin, rifampin, St Johnâ€™s wort, tipranavir, ritonavir
Precaution of MyHep - 12 weeks
Drugs like rifampin and st. John s wort are potent P-gp inducers leads to reduce plasma concentration of Myhep. It should not be used as monotherapy Peg interferon: Caution in renal impairment patient Liver transplantation Cause Myelosuppression Flu like symptoms Hepatic impairment Ribavirin: While combined with ribavirin care should be taken, because it causes fetal harm or death. Ribavirin not recommended in pregnancy period. Hemolytic anemia Anemia Ocular disorders Carcinogenic effects Bone marrow suppression
Usage & Safety profile of MyHep - 12 weeks Pregnancy & Lactation
Generally Myhep is comes under the pregnancy category: B But when combined with ribavirin category should be X Ribavirin causes fetal death Concomitant with ribavirin and peg interferon, it is not recommended in breastfeeding mothers.
Storage of MyHep - 12 weeks
Myhep is generally stored at room temperature below 30oc (86oF) It should be keep away from moisture, heat, and light Keep reach out from children and pets.