SUNVEPRA

Main information

  • Trade name:
  • SUNVEPRA asunaprevir 100 mg capsule blister
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • SUNVEPRA asunaprevir 100 mg capsule blister
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222744
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222744

SUNVEPRA asunaprevir 100 mg capsule blister

ARTG entry for

Medicine Registered

Sponsor

Bristol-Myers Squibb Australia Pty Ltd

Postal Address

PO Box 1080,MOUNT WAVERLEY, VIC, 3149

Australia

ARTG Start Date

25/05/2015

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. SUNVEPRA asunaprevir 100 mg capsule blister

Product Type

Single Medicine Product

Effective date

3/05/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

SUNVEPRA (asunaprevir) is indicated in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults

with compensated liver disease (including cirrhosis) [see CLINICAL TRIALS and DOSAGE AND ADMINISTRATION].

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PCTFE (Aclar)/Al

30 Months

Store below 25

degrees Celsius

Child resistant closure

Protect from Light

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

14 capsules

(S4) Prescription Only Medicine

56 capsules

(S4) Prescription Only Medicine

Components

1. SUNVEPRA asunaprevir 100 mg capsule blister

Dosage Form

Capsule, soft

Route of Administration

Oral

Visual Identification

Opaque, white to pale yellow, oval, soft gelatin capsule imprinted with BMS

in black on one line and 711 in black on second line, filled with clear

solution

Active Ingredients

asunaprevir

100 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 10:54:09 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

SUNVEPRA

®

Capsules

Asunaprevir (a soo na pre veer)

Consumer Medicine Information

Warnings and

Precautions

While you are are taking

SUNVEPRA, your doctor will

frequently monitor you for signs of

how well your liver is working.

This will be done with regular

blood tests.

If the results of these tests show a

decline in how well your liver is

working, a decision will be made to

stop your treatment with

SUNVEPRA.

What is in this leaflet

Read this leaflet carefully before

taking SUNVEPRA. This leaflet

answers some common questions

about SUNVEPRA.

It does not contain all the available

information.

It does not take the place of talking to

your doctor or pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking SUNVEPRA

against the benefits they expect it

will have for you.

If you have any concerns about

taking this medicine, ask your doctor

or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What SUNVEPRA is

used for

SUNVEPRA is a trade name

(manufacturer's name) for the

medicine, asunaprevir. SUNVEPRA

is a direct acting antiviral agent

(DAA) against the hepatitis C virus

(HCV). SUNVEPRA is an inhibitor

of the HCV protein 3/4A (NS3/4A),

a protease that is required to form

new HCV particles.

You should not take Sunvepra alone

to treat chronic (lasting a long time)

hepatitis C infection in adults.

SUNVEPRA should only be used

together with another antiviral

medicine, daclatasvir (DAKLINZA),

or together with DAKLINZA,

peginterferon alfa, and ribavirin.

How SUNVEPRA Works

SUNVEPRA (in combination with

other medicines) works by stopping

the HCV from multiplying and

infecting liver cells. After you stop

taking SUNVEPRA, your doctor will

monitor your blood for HCV. If HCV

is still not detected in your blood at

least 12 weeks after stopping

treatment, you have what is called a

sustained virologic response (SVR),

also referred to as virologic cure.

It is not known if SUNVEPRA is

safe and effective in children under

18 years of age.

Ask your doctor if you have any

questions about why SUNVEPRA

has been prescribed for you.

SUNVEPRA is not addictive. This

medicine is available only with a

doctor's prescription.

Before you take

SUNVEPRA

It is important that you check the

information below before you take

SUNVEPRA.

When you must not take

SUNVEPRA

SUNVEPRA is sometimes used with

peginterferon alfa and ribavirin.

Peginterferon alfa and ribavirin may

cause birth defects or death of your

unborn baby. If you are pregnant or

planning to become pregnant, or your

sexual partner is pregnant or plans to

become pregnant, do not take these

medicines. You or your sexual

partner should not become pregnant

while taking peginterferon alfa and

ribavirin, and for 6 months after

treatment ends.

Two effective forms of birth

control must be used, one by

each partner, male and female,

during treatment and for the 6

months after treatment with

peginterferon alfa and

ribavirin. Talk with your

doctor about forms of birth

control that may be used during

this time.

Females must have a negative

pregnancy test before starting

treatment with peginterferon alfa

and ribavirin, every month while

being treated, and every month

for 6 months after your treatment

ends.

If you or your female sexual partner

becomes pregnant while taking, or

within 6 months after you stop

taking, peginterferon alfa and

ribavirin, tell your doctor right away.

SUNVEPRA

V2.0 31 OCTOBER 2015

Tell your doctor if you have or have

had:

have a current or previous

infection with the hepatitis B

virus.

liver problems other than

hepatitis C. Your doctor may tell

you not to take SUNVEPRA if

you have certain liver problems.

Do not take SUNVEPRA if you have

an allergy to it or to any other

ingredients in the formulation listed

at the end of this leaflet.

Do not take SUNVEPRA if you are

currently taking any of these

medicines:

atazanavir

bosentan

carbamazepine

clarithromycin

cobicistat

cyclosporin

darunavir/ritonavir

dexamethasone (when

administered by injection or taken

by mouth)

diltiazem

efavirenz

erythromycin

etravirine

fluconazole

fosamprenavir

gemfibrozil

indinavir

itraconazole

ketoconazole

lopinavir/ritonavir

modafinil

nevirapine

oxcarbazepine

phenobarbital

phenytoin

posaconazole

rifabutin

rifampicin

ritonavir

saquinavir

St. John's wort (Hypericum

perforatum) or a product that

contains St John's wort

thioridazine

verapamil

voriconazole

If you are not sure if any of these

medicines are in the products you

are taking, talk to your doctor or

pharmacist.

Do not use SUNVEPRA after the

expiry date printed on the back of the

pack. If this medicine is taken after

the expiry date has passed, it may not

work as well.

Do not take SUNVEPRA if the

packaging is torn or shows signs of

tampering.

Before you start to take

SUNVEPRA

Tell your doctor if you:

had a liver transplant

have kidney problems

have any other medical condition

SUNVEPRA, when used with

DAKLINZA, should not be used

during pregnancy.

Tell your doctor if you are

pregnant or intend to become

pregnant.

It is not known if SUNVEPRA will

harm your unborn baby.

If you can become pregnant and

use oral contraception, use a

"high-dose" contraceptive that

includes at least 30 mcg of ethinyl

estradiol combined with

norethindrone acetate/

norethindrone.

A lower dose contraceptive may not

work with SUNVEPRA.

If you are also taking ribavirin, you

must follow the contraception

instructions under "When you must

not take SUNVEPRA" above.

Tell your doctor or pharmacist if

you are breast-feeding or plan to

breast-feed.

It is recommended that you do not

breast-feed while taking

SUNVEPRA. It is not known if

SUNVEPRA passes into breast milk.

If you have not told your doctor

about any of the above, tell them

before you use SUNVEPRA.

As SUNVEPRA should only be used

together with another antiviral

medicine such as DAKLINZA, or

together with DAKLINZA,

peginterferon alfa, and ribavirin,

please read the Consumer Medicine

Information for the other products

prescribed by your doctor before

starting SUNVEPRA.

Taking other medicines

Be sure to inform your doctor of all

medications you are taking including

prescribed drugs, over the counter

products, natural therapies, vitamin

supplements and recreational drugs.

SUNVEPRA and other medicines

may affect each other. This can cause

you to have too much or not enough

SUNVEPRA or other medicines in

your body, which may affect the way

SUNVEPRA or your other medicines

work, or may cause side effects.

Medicines for other conditions:

Do not take SUNVEPRA if you are

currently taking any of the medicines

listed under "When you must not

take SUNVEPRA" above.

Tell your doctor if you are taking or

starting to take medicines that

contain:

amitriptyline, imipramine, or

nortriptyline

dabigatran

dextromethorphan (a cough

suppressant that is an ingredient

in many over-the counter cold

medicines)

digoxin

flecainide

hormonal contraceptive

midazolam rosuvastatin,

atorvastatin, fluvastatin,

simvastatin, pitavastatin, or

pravastatin

Your doctor will be able to advise

you about the most appropriate

SUNVEPRA

V2.0 31 OCTOBER 2015

medications to treat your

condition. It is important that you

tell your doctor or pharmacist

about the medicines you are

taking, even if they are not listed in

this leaflet.

They will be able to provide you

with more information than is

contained within this leaflet on the

medicines you need to be careful

with, or should avoid while taking

SUNVEPRA.

How to take

SUNVEPRA

SUNVEPRA should be given only

when prescribed by your doctor.

Follow all directions given to you by

your doctor or pharmacist carefully.

They may differ from the

information contained in this leaflet.

How much to take

Take SUNVEPRA exactly as your

doctor tells you to take it. Do not

change your dose unless your doctor

tells you to.

Do not stop taking SUNVEPRA

without first talking with your doctor.

If you think there is a reason to stop

taking SUNVEPRA, talk with your

doctor before doing so.

How to take it

Swallow the capsule whole with a

drink such as a glass of water.

When to take SUNVEPRA

Take SUNVEPRA two times each

day with or without food.

How long to take it

Continue taking SUNVEPRA for as

long as your doctor tells you to.

Do not stop taking SUNVEPRA

unless your doctor tells you to - even

if you feel better.

If you forget to take it

If you miss a dose of SUNVEPRA

and less than 8 hours have passed

since you were to take the missed

dose, take the missed dose as soon as

possible. Take the next dose at your

regular time.

If you miss a dose of SUNVEPRA

and more than 8 hours have passed

since you were to take the missed

dose, skip the missed dose. Take the

next dose at your regular time.

Do not take two doses of

SUNVEPRA at the same time to

make up for the missed dose.

If you take too much

(overdose)

Immediately call your doctor or

the Poisons Information Centre on

131126 in Australia, or go to the

Accident and Emergency Centre at

your nearest hospital if you or

anyone else takes too much

Sunvepra.

Do this even if there are no signs of

discomfort or poisoning.

While you are using

SUNVEPRA

Things you must do

If you become pregnant while

taking SUNVEPRA, tell your

doctor immediately.

If you are about to start taking

any new medicines, tell your

doctor and pharmacist that you

are taking SUNVEPRA.

SUNVEPRA or the other

medicine may interfere each

other.

Liver problems:

Some people taking SUNVEPRA

have had abnormal results on tests

that show how well the liver is

working, occasionally accompanied

by serious liver problems. Your

doctor will monitor these tests while

you take SUNVEPRA. If the results

show a decline in how well your liver

is working, your doctor may instruct

you to stop taking SUNVEPRA.

Things you must not do

Do not give SUNVEPRA to

anyone else, even if they have the

same condition as you.

Do not use SUNVEPRA to treat

any other complaints unless your

doctor tells you to.

Do not stop taking SUNVEPRA

without checking with your

doctor.

Things to be careful of

Be careful driving or operating

machinery until you know how

SUNVEPRA affects you.

Make sure that you visit your doctor

regularly throughout your entire

course of treatment with

SUNVEPRA.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

SUNVEPRA. All medicines can

have side effects. Sometimes they are

serious, most of the time they are not.

You may need medical treatment if

you get some of the side effects

Ask your doctor or pharmacist to

answer any questions you may have.

The most common side effects when

SUNVEPRA is taken in combination

with DAKLINZA include:

headache

tiredness

diarrhoea

nasal congestion (blocked nose)

nausea

The most common side effects when

SUNVEPRA is taken in combination

with DAKLINZA, peginterferon alfa,

and ribavirin include:

tiredness

headache

itching

SUNVEPRA

V2.0 31 OCTOBER 2015

unusual weakness

flu-like symptoms

insomnia

rash

anaemia

cough

dry skin

diarrhoea

nausea

hair loss

irritability

fever

muscle aches

If any of the following happen, tell

your doctor immediately, or go to

the Accident and Emergency

Centre at your nearest hospital:

allergic reaction - swelling of the

face, lips, or throat which makes

breathing difficult

If you have these side effects, you

may have had a serious reaction to

SUNVEPRA. You may need urgent

medical attention or hospitalisation.

This is not a complete list of side

effects, other side effects not listed

above may also occur in some

patients.

Tell your doctor if you notice

anything that is making you feel

unwell.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them or only some

of them.

After using

SUNVEPRA

Storage

Store SUNVEPRA Capsules in a

cool dry place where the temperature

stays below 25°C.

Keep your capsules in the original

container until it is time to take them.

Do not store SUNVEPRA or any

other medicine in the bathroom or

near the kitchen sink. Do not leave it

in the car. Heat and dampness can

destroy some medicines.

Keep SUNVEPRA capsules where

children cannot reach them. A locked

cupboard at least one-and-a-half

metres above the ground is a good

place to store medicines.

Disposal

If your doctor tells you to stop taking

SUNVEPRA capsules, or the

capsules have passed their expiry

date, ask your pharmacist what to do

with any that are left over.

Product description

What it looks like

SUNVEPRA 100 mg capsules are

available as oval, opaque white to

pale-yellow, soft-gelatin capsule

containing 100 mg asunaprevir

Capsules are imprinted with "BMS"

in black on one line and "711" in

black on a second line below "BMS."

Available in packs of 14 and 56

capsules.

Ingredients

Each capsule contains:

Active ingredients:

SUNVEPRA 100 mg capsules - 100

mg of asunaprevir per capsule

Other ingredients:

medium-chain triglycerides, caprylic/

capric glycerides, polysorbate 80,

and butylated hydroxytoluene (BHT).

The capsule shell contains gelatin,

partially dehydrated liquid sorbitol,

glycerol, titanium dioxide and

OPACODE Black (printing ink).

Registration Numbers

SUNVEPRA 100 mg - AUST R

222744

Sponsored by

Bristol-Myers Squibb Australia Pty

Ltd,

4 Nexus Court, Mulgrave,

Victoria 3170, Australia

This information in no way replaces

the advice of your doctor or

pharmacist.

Date of Preparation: 31 October 2016

SUNVEPRA

V2.0 31 OCTOBER 2015