Mydekla (Daclatasvir)

DESCRIPTION

A virus which causes severe life threatening conditions is known as Hepatitis C virus that is a RNA virus, Chronic hepatitis Cirrhosis Hepatocellular carcinoma Mydekla  is an anti-viral medication, which is available in tablet form. Mydekla  perform its action by inhibiting the non structural 5A protein region of hepatitis C virus Mydekla  is not monotherapy medicine; it should be combined with other anti-viral drugs for treating chronic hepatitis C infection caused by virus Mydekla  is available in the strength of 30mg, 60mg, and 90mg

INDICATION

Mydekla  is indicated for the treatment of chronic hepatitis C viral infection by inhibiting the replication of hepatitis C virus. Mydekla  is indicated for the treatment of genotype III advanced hepatitis C virus in adults without cirrhosis. Normally Mydekla  tablets are not used as single agent, it may combined with other anti-viral medicines like Sofosbuvir, interferon and ribavirin

MECHANISM OF ACTION

Mydekla  is a NS5A inhibitors, NS5A protein is required for viral multiplication This NS5A inhibitor has efficiency to incorporate with HCV RNA. There are two essential mechanism in RNA proliferation 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 Mydekla  will disrupt hyperphosphorylated NS5A protein and mediated with newly formed RNA viral Mydekla  involved in blockade of intercellular viral RNA synthesis and colony of virion

ADME PROPERTIES

ABSORPTION

The peak plasma concentration of Mydekla  occurs within 2 hours. The mean bioavailability of Mydekla  is 67%

DISTRIBUTION

The volume of distribution occurs at 47L. The human plasma protein bound with Mydekla  with the range of 99%

METABOLISM

Mydekla  a CYP3A substrates, it is dominantly metabolized by CYP3A4 isoenzymes High portion of drug in plasma is in unchanged mode nearly 97%

ELIMINATION

The route of elimination of metabolites; Elimination of drug via Bile: 88%; feces 53% (unchanged form) and 6.6% in unchanged form through urine The mean terminal half life period of Mydekla  occurs from the range of almost 12 to 15 hours

DOSAGE MANAGEMENT

DOSAGE AND ADMINISTRATION OF DACLAHEP

Before initiating the therapy; NS5A resistance testing in HCV genotype 1a infected patients with cirrhosis has been evaluated The usual dose of Mydekla  is 60mg as a single dose Recommended dosage regimens:

GENOTYPE I

Without cirrhosis: Mydekla  + Sofosbuvir for 12 weeks Compensated cirrhosis (child Pugh A): Mydekla  + Sofosbuvir for 12 weeks Decompensated cirrhosis (child Pugh B or C): Mydekla  + Sofosbuvir + ribavirin for 12 weeks

GENOTYPE III

Without cirrhosis: Mydekla  with Sofosbuvir for 12 weeks Compensated or decompensated cirrhosis: Mydekla  with Sofosbuvir + ribavirin for 12 weeks

DOSE ADJUSTMENTS

While concomitant with strong CYP3A inhibitors: 30mg of Mydekla  once a day Concomitant with moderate CYP3A inducers & nevirapine: 90mg of Mydekla  as single dose With strong CYP3A inducers: contraindicated Mydekla  should be administered with or without food

SIDE EFFECTS

SIDE EFFECTS OF DACLAHEP

While using the drug Some common side effects occurred as follows:: Chest pain, dizziness Irregular heart beat Unusual tiredness More common: Headache, nausea Pharmacological effects:

OTHER

Pyrexia , hot flush, loss of weight, Fatigue, asthenia, influenza like symptoms

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

GIT

Gastro esophageal reflux, vomiting, Abdominal pain, 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

PRECAUTION & WARNING

There is a risk of adverse effects due to concurrent use of Mydekla  with some other drugs may causes; loss of therapeutic effect serious life threatening conditions symptomatic bradycardia while using with amiodarone risk related to ribavirin during combination hepatitis b reactivation

DRUG INTERACTION

Concurrent use of Mydekla  with some drugs likes; Amiodarone: serious bradycardia occurs Aprepitant: increase the serum concentration of CYP3A4 substrates Strong inducers of CYP3A causes decreased therapeutic effect of Mydekla  Mydekla  is an inhibitor of P-glycoprotein transporter, organic anion transporting polypeptide and breast cancer resistance protein; taking Mydekla  , may elevate exposure to these drugs, which prolong the therapeutic effect Proteases inhibitors: increase effect of concentration of Mydekla  Efavirenz, etravirine & nevirapine: decrease the effect of concentration of Mydekla  Strong CYP3A inhibitors: increase the effect of concentration of Mydekla  Interaction with HMG CoA reductase will increase the effect of concentration of these lipid lowering drugs.

CONTRAINDICATION

Concurrent use of CYP3A inducers strong with Mydekla  , contraindicated to the patients Mydekla  with ribavirin contraindicated to pregnancy condition Hypersensitivity reaction occur

PREGNANCY & LACTATION

During monotherapy: pregnancy category of Mydekla  B; it is safe while using alone but under supervision of medical practitioner advice While ribavirin combination, the pregnancy categories with ribavirin X; causes severe ill effects like fetal harm even to death During monotherapy Breast feeding is safe but in combination with ribavirin breast feeding is not recommended

STORAGE 

Mydekla  tablets are stored at 25°C (77°F); excursion between 15°C and 30°C (59°F and 86°F) Keep away from heat, moisture and heat

MISSED DOSE

Mydekla  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 Mydekla  tablet, must consult with physician and take the missed dose within the time Or the missed dose should be leave and continue the regular dosing schedule Do not take overdose.