Daclatasvir- Daklinza -@-(July 2015) - Antiviral
Drug Name:Daclatasvir- Daklinza -@-(July 2015) - Antiviral
List Of Brands:
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
Drug Interactions: Coadministration of DAKLINZA can alter the
concentration of other drugs and other drugs may alter the concentration of
daclatasvir. Consult the full prescribing information before use for
contraindicated drugs and other potential drug-drug interactions.
DRUG INTERACTIONS
Hepatotoxic Drugs: Evaluate potential for increased risk of hepatotoxicity
with concomitant use
Indication:
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
DAKLINZA safely and effectively. See full prescribing information for DAKLINZA. DAKLINZA? (daclatasvir) tablets, for oral use
Initial U.S. Approval: 2015
WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV
See full prescribing information for complete boxed warning. Hepatitis B virus (HBV) reactivation has been reported, in some cases resulting in fulminant hepatitis, hepatic failure, and death
NEW MOLECULAR ENTITY AND NEW THERAPEUTIC BIOLOGICAL
PRODUCTS APPROVED FOR 2015
Certain drugs are classified as New molecular Emtities- NME- for FDA review
Many of these products contain active moieties that have not been approved
by FDA previously, either as a single ingredient or as part of a combination
products; these products frequently provide important new therapies for the
patients.
Some drugs are characterized as NMEs for administrative purposes ,but
nonetheless contain certain active moieties in products that have been
previously approved by FDA. For example, CDER classifies biological
products submitted in an application under section 351(a) of the Public
Service Act as NME for purposes of FDA review, regardless of whether
the agency previously approved a related active moiety in a different
product.
FDAs classification of a drug as an -NME- for review purposes is distinct
from FDAs determination of whether a drug is a - New Chemical Entity or - NCE-
within the meaning of the Federal Food,Drug, and Cosmetic Act
No.20
Drug Name - Daclatasvir- Daklinza
Active Ingredient- Daklinza
Date of approval - 7/24/2015
FDA-approved use - To treat chronic Hepatitis C virus (HCV)
genotype 3 infections
Approved by US FDA on 7/24/2015- (Ref- FDA approved List- 2015)
INDICATIONS AND USAGE
DAKLINZA is a hepatitis C virus (HCV) NS5A inhibitor indicated for use
with sofosbuvir for the treatment of chronic HCV genotype 3 infection.
Limitations of Use:
Sustained virologic response (SVR) rates are reduced in patients with
cirrhosis.
LIST OF APPROVED DRUG FROM 01-01-2015 To 31-12-2015
ISSUED BY NEW DRUG DIVISION - DRUG CONTROLLER GENERAL- INDIA
Sr.No Name of Drug Indication Date of Issue
16. Daclatasvir Dihydrochloride Bulk 14-12-2015
& Tablet 30mg/60mg
For use with Sofosbuvir for the treatment of
patient with chronic hepatitis C virus(HCV)
genotype 3 infection
Approved by DCG INDIA (Ref- DCGI approved List- 01-01-2015 To 31-12-3015)
Adverse Reaction:
Most common adverse reactions (.10%) observed with DAKLINZA in
combination with sofosbuvir were headache and fatigue.
ADVERSE REACTIONS
The most common adverse reactions (incidence =5% and =2% higher
incidence than comparator) reported for ZINBRYTA were nasopharyngitis,
upper respiratory tract infection, rash, influenza, dermatitis, oropharyngeal
pain, bronchitis, eczema and lymphadenopathy compared with AVONEX; and
upper respiratory tract infection, depression, rash, pharyngitis, and increased
alanine aminotransferase (ALT) compared with placebo.
Contra-Indications:
CONTRAINDICATIONS
Strong inducers of CYP3A, including phenytoin, carbamazepine, rifampin,
and St. John’s wort.
WARNINGS AND PRECAUTIONS
Bradycardia When Coadministered with Sofosbuvir and Amiodarone:
Serious symptomatic bradycardia may occur in patients taking amiodarone
with sofosbuvir in combination with another HCV direct-acting agent,
including DAKLINZA, particularly in patients also receiving beta blockers
or those with underlying cardiac comorbidities and/or advanced liver
disease. Coadministration of amiodarone with DAKLINZA in combination
with sofosbuvir is not recommended. In patients with no alternative
treatment options, cardiac monitoring is recommended.
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
DAKLINZA is a hepatitis C virus (HCV) NS5A inhibitor indicated for use
with sofosbuvir for the treatment of chronic HCV genotype 3 infection.
Limitations of Use:
Sustained virologic response (SVR) rates are reduced in patients with
cirrhosis.
DOSAGE AND ADMINISTRATION
60 mg taken orally once daily with or without food in combination with
sofosbuvir.
Recommended treatment duration: 12 weeks.
Dose modification: Reduce dosage to 30 mg once daily with strong
CYP3A inhibitors and increase dosage to 90 mg once daily with moderate
CYP3A inducers.
DOSAGE FORMS AND STRENGTHS
Tablet: 60 mg and 30 mg
Patient Information:
PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Drug Interactions
Inform patients of the potential for drug interactions with DAKLINZA, and that some
drugs should not be taken with DAKLINZA
.
Symptomatic Bradycardia When Used in Combination with Sofosbuvir and Amiodarone
Advise patients to seek medical evaluation immediately for symptoms of bradycardia,
such as near-fainting or fainting, dizziness or lightheadedness, malaise, weakness,
excessive tiredness,shortness of breath, chest pain, confusion or memory problems .
Combination Therapy with Sofosbuvir
Inform patients that DAKLINZA should not be used alone to treat genotype 3 chronic
hepatitis C infection. DAKLINZA should be used in combination with sofosbuvir for the
treatment of genotype 3 HCV infection
Missed Doses
Instruct patients that if they miss a dose of DAKLINZA, the dose should be taken as
soon as possible if remembered within the same day. However, if the missed dose
is not remembered within the same day, the dose should be skipped and the next
dose taken at the appropriate time.
Hepatitis C Virus Transmission
Inform patients that the effect of treatment of hepatitis C infection on transmission is
not known,and that appropriate precautions to prevent transmission of the hepatitis C
virus during treatment should be taken.
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of Action
Daclatasvir is a direct-acting antiviral agent (DAA) against the hepatitis C virus
2. Pharmacokinetics
The pharmacokinetic properties of daclatasvir were evaluated in healthy adult subjects
and in subjects with chronic HCV. Administration of daclatasvir tablets in HCV-infected
subjects resulted in approximately dose-proportional increases in Cmax, AUC, and
Cmin up to 60 mg once daily.
Steady state is anticipated after approximately 4 days of once-daily daclatasvir
administration. Exposure of daclatasvir was similar between healthy and HCV-infected
subjects.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1 Pregnancy
Risk Summary
No data with DAKLINZA in pregnant women are available to inform a
drug-associated risk.
In animal reproduction studies in rats and rabbits, no evidence of fetal harm
was observed with oral administration of daclatasvir during organogenesis
at doses that produced exposures up to 6 and 22 times, respectively,
the recommended human dose (RHD) of 60 mg.
Consider the benefits and risks of DAKLINZA when prescribing DAKLINZA to a pregnant
woman
2 Lactation
Risk Summary
No information regarding the presence of daclatasvir in human milk, the effects
on the breastfed infant, or the effects on milk production is available. Daclatasvir
is present in the milk of lactating rats
Breastfeeding should be considered along with the mother’s clinical need for
DAKLINZA and any potential adverse effects on the breastfed infant from DAKLINZA
or from the underlying maternal condition.
3. Pediatric Use
Safety and effectiveness of DAKLINZA in pediatric patients younger than 18 years of
age have not been established.
4. Geriatric Use
Safety was similar across older and younger subjects and there were no safety findings
unique to subjects 65 years and older. Sustained virologic response (SVR) rates
were comparable among older and younger subjects. No dosage adjustment of
DAKLINZA is required for elderly patients
