Simeprevir -Olysio- @- (Nov 2013)- Anti-Viral
Drug Name:Simeprevir -Olysio- @- (Nov 2013)- Anti-Viral
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:
Co-administration of OLYSIO with drugs that are moderate or strong inducers
or inhibitors of CYP3A may significantly affect the plasma concentrations
of simeprevir. The potential for drug-drug interactions must be considered
prior to and during treatment.
Indication:
OLYSIO (simeprevir) capsules, for oral use
Initial U.S. Approval 2013
Drug Name- Olysio
Active Ingredient - Simeprevir
To treat chronic hepatitis C virus (HCV) infection
Indication-
To treat Chronic Hepatitis C virus (HCV) Infection
Approved by FDA on 22-11-2013 (Ref- FDA Approved List- 2013)
Adverse Reaction:
The most common reported adverse reactions (greater than 20% of subjects)
in subjects receiving the combination of OLYSIO with peginterferon and
ribavirin and occurring with at least 3% higher frequency compared to subjects
receiving placebo in combination with peginterferon alfa and ribavirin during
the first 12 weeks of treatment were: rash (including photosensitivity),
pruritus and nausea
Contra-Indications:
CONTRAINDICATIONS
All contraindications to peginterferon alfa and ribavirin also apply to OLYSIO
combination treatment with peginterferon alfa and ribavirin.
Because ribavirin may cause birth defects and fetal death, OLYSIO in combination
with peginterferon alfa and ribavirin is contraindicated in pregnant women
and in men whose female partners are pregnant.
WARNINGS AND PRECAUTIONS
Embryofetal Toxicity (Use with Ribavirin and Peginterferon Alfa):
Ribavirin may cause birth defects and fetal death and animal studies have
shown interferons have abortifacient effects; avoid pregnancy in female
patients and female partners of male patients.
Patients must have a negative pregnancy test prior to initiating therapy, use at least
two effective methods of contraception during treatment, and undergo monthly
pregnancy tests.
Photosensitivity: Serious photosensitivity reactions have been observed during
combination therapy with OLYSIO, peginterferon alfa and ribavirin.
Use sun protection measures and limit sun exposure.
Consider discontinuation if a photosensitivity reaction occurs.
Rash: Rash has been observed during combination therapy with OLYSIO,
peginterferon alfa and ribavirin. Discontinue OLYSIO if severe rash occurs.
Dosages/ Overdosage Etc:
Indication-
To treat Chronic Hepatitis C virus (HCV) Infection
INDICATIONS AND USAGE
OLYSIO is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated for the
treatment of chronic hepatitis C (CHC) infection as a component of a combination
antiviral treatment regimen.
OLYSIO efficacy has been established in combination with peginterferon
alfa and ribavirin in HCV genotype 1 infected subjects with compensated
liver disease (including cirrhosis).
OLYSIO must not be used as monotherapy.
Screening patients with HCV genotype 1a infection for the presence of
virus with the NS3 Q80K polymorphism at baseline is strongly recommended.
Alternative therapy should be considered for patients infected with HCV
genotype 1a containing the Q80K polymorphism.
DOSAGE AND ADMINISTRATION
One 150 mg capsule taken once daily with food.
OLYSIO should be administered with both peginterferon alfa and ribavirin.
The recommended treatment duration of OLYSIO with peginterferon alfa
and ribavirin is 12 weeks, followed by either 12 or 36 additional weeks
of peginterferon alfa and ribavirin depending on prior response status.
For specific dosage instructions for peginterferon alfa and ribavirin,
see their respective prescribing information.
A dose recommendation cannot be made for patients of East Asian
ancestry.
A dose recommendation cannot be made for patients with moderate
to severe hepatic impairment.
DOSAGE FORMS AND STRENGTHS
Capsule: 150 mg
Patient Information:
PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
OLYSIO should be used in combination with peginterferon alfa and ribavirin,
and thus contraindications and warnings for peginterferon alfa and ribavirin
also apply to OLYSIO combination treatment.
Pregnancy
Ribavirin must not be used by female patients who are pregnant or by men
whose female partners are pregnant. Ribavirin therapy should not be initiated until
a report of a negative pregnancy test has been obtained immediately before
starting therapy.
OLYSIO in combination treatment with peginterferon alfa and ribavirin is
contraindicated in women who are pregnant and in men whose female partners
are pregnant
Female patients of childbearing potential and male patients with female partners
of childbearing potential must be advised of the teratogenic/embryocidal risks
of ribavirin and should be advised that extreme care must be taken to avoid
pregnancy in female patients and in female partners of male patients -both
during treatment and for 6 months after the completion of all treatment.
Women of childbearing potential and men must use at least two forms of effective
contraception during treatment and for 6 months post-treatment.
Women of childbearing potential and men must be counseled about use of
effective contraception (two methods) prior to initiating treatment.
Patients (both male and female) should be advised to notify their healthcare
provider immediately in the event of a pregnancy
Photosensitivity
Patients should be advised of the risk of photosensitivity reactions related to
the use of OLYSIO in combination with peginterferon and ribavirin and that these
reactions may be severe.
Patients should be advised to contact their healthcare provider immediately
if they develop a photosensitivity reaction. Patients should not stop OLYSIO
due to photosensitivity reactions unless instructed by their healthcare provider
.
Patients should be advised to use sun protection measures (such as a hat,
sunglasses, protective clothing, sunscreen) during treatment with OLYSIO.
Patients should limit exposure to natural sunlight and avoid artificial sunlight
(tanning beds or phototherapy) during treatment with OLYSIO.
Rash
Patients should be advised of the risk of rash related to the use of OLYSIO
in combination with peginterferon and ribavirin and that rash may become
severe.
Patients should be advised to contact their healthcare provider immediately if
they develop a rash. Patients should not stop OLYSIO due to rash unless
instructed by their healthcare provider .
Administration
Patients should be advised that OLYSIO should be administered in combination
with both peginterferon alfa and ribavirin. If peginterferon alfa and/or ribavirin
is discontinued for any reason, OLYSIO must also be discontinued.
Patients should be advised that the dose of OLYSIO must not be reduced
or interrupted, as it may increase the possibility of treatment failure.
If the patient misses a dose of OLYSIO and remembers within 12 hours
of the usual dosing time, the patient should take the missed dose of OLYSIO
with food as soon as possible and then take the next dose of OLYSIO
at the regularly scheduled time.
If a patient misses a dose of OLYSIO by more than 12 hours after the usual
dosing time, the patient should not take the missed dose of OLYSIO,
but resume the usual dosing of OLYSIO with food at the regularly scheduled time.
Inform the patient that he or she should not take more or less than the prescribed
dose of OLYSIO at any one time.
Hepatitis C Virus Transmission
Patients should be informed 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 should be taken
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of Action
Simeprevir is a direct-acting antiviral (DAA) agent against the hepatitis C virus
2. Pharmacokinetics
The pharmacokinetic properties of simeprevir have been evaluated in healthy adult
subjects and in adult HCV-infected subjects. Plasma Cmax and the area under
the plasma concentration time curve (AUC) increased more than dose-proportionally
after multiple doses between 75 mg and 200 mg once daily, with accumulation
occurring following repeated dosing.
Steady-state was reached after 7 days of once daily dosing.
Plasma exposure (AUC) of simeprevir in HCV-infected subjects was about
2-to 3-fold higher compared to that observed in HCV-uninfected subjects
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy
Pregnancy Category X: Use with Ribavirin and Peginterferon Alfa
Extreme caution must be taken to avoid pregnancy in female patients and female
partners of male patients while taking this combination.
Women of childbearing potential and their male partners should not receive ribavirin
unless they are using effective contraception (two reliable forms) during treatment
with ribavirin and for 6 months after treatment
2. Nursing Mothers
It is not known whether simeprevir or its metabolites are excreted in human
breast milk. When administered to lactating rats, simeprevir was detected in
plasma of suckling rats likely due to excretion of simeprevir via milk.
Because of the potential for adverse reactions from the drug in nursing infants,
a decision must be made whether to discontinue nursing or discontinue treatment
with OLYSIO, taking into account the importance of the therapy to the mother.
3. Pediatric Use
The safety and efficacy of OLYSIO in children and adolescents less than
18 years of age have not been established.
4. Geriatric Use
Clinical studies of OLYSIO did not include sufficient numbers of patients
older than 65 years to determine whether they respond differently from
younger patients. No dose adjustment of OLYSIO is required in geriatric
patients .
