DAKLINZA

Main information

  • Trade name:
  • DAKLINZA daclatasvir (as dihydrochloride) 30 mg tablet blister
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DAKLINZA daclatasvir (as dihydrochloride) 30 mg tablet blister
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222743
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222743

DAKLINZA daclatasvir (as dihydrochloride) 30 mg tablet 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

25/06/2015

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. DAKLINZA daclatasvir (as dihydrochloride) 30 mg tablet blister

Product Type

Single Medicine Product

Effective date

2/03/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

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

36 Months

Store below 30

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

7 tablets

(S4) Prescription Only Medicine

28 tablets

(S4) Prescription Only Medicine

Components

1. DAKLINZA daclatasvir (as dihydrochloride) 30 mg tablet blister

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

A green, biconvex, pentagonal film-coated tablet with "BMS" debossed on

one side and "213" debossed on the other side

Active Ingredients

daclatasvir dihydrochloride

33 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 10:54:33 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

DAKLINZA

®

Tablets

Daclatasvir (dak lat as vir)

Consumer Medicine Information

What is in this leaflet

Read this leaflet carefully before

taking DAKLINZA. This leaflet

answers some common questions

about DAKLINZA.

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 DAKLINZA

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 DAKLINZA is

used for

DAKLINZA is a trade name

(manufacturer's name) for the

medicine, daclatasvir. DAKLINZA is

a direct acting antiviral agent (DAA)

against the hepatitis C virus (HCV).

DAKLINZA is an inhibitor of NS5A,

which is a protein that is required to

form new HCV particles.

You should not take DAKLINZA

alone to treat chronic (lasting a long

time) hepatitis C infection in adults.

DAKLINZA should only be used

together with other antiviral

medicines such as sofosbuvir, or

asunaprevir (SUNVEPRA), or

together with SUNVEPRA,

peginterferon alfa, and ribavirin.

How DAKLINZA Works

DAKLINZA (in combination with

other medicines) works by stopping

the HCV from multiplying and

infecting liver cells. After you stop

taking DAKLINZA, 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 DAKLINZA is safe

and effective in children under 18

years of age.

Ask your doctor if you have any

questions about why DAKLINZA

has been prescribed for you.

DAKLINZA is not addictive. This

medicine is available only with a

doctor's prescription.

Before you take

DAKLINZA

It is important that you check the

information below before you take

DAKLINZA.

When you must not take

DAKLINZA

DAKLINZA 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.

Do not take DAKLINZA 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 DAKLINZA if you are

currently taking any of these

medicines:

carbamazepine

dexamethasone (when

administered by injection or taken

by mouth)

oxcarbazepine

phenobarbital

phenytoin

rifabutin

rifampicin

DAKLINZA

TABLETS

St. John's wort (Hypericum

perforatum) or a product that

contains St. John's wort

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 DAKLINZA 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 DAKLINZA if the

packaging is torn or shows signs of

tampering.

Before you start to take

DAKLINZA

Tell your doctor if you:

have a current or previous

infection with the hepatitis B

virus

have liver problems other than

hepatitis C infection

have had, or are intending to

have, a liver transplant

have any other medical condition

DAKLINZA should not be used

during pregnancy.

Tell your doctor if you are

pregnant or intend to become

pregnant.

It is not known if DAKLINZA will

harm your unborn baby.

If you can become pregnant,

continue the use of effective

contraception for 5 weeks after the

end of your treatment with

DAKLINZA.

If you are also taking ribavirin, you

must follow the contraception

instructions under "When you must

not take DAKLINZA" 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

DAKLINZA. It is not known if

DAKLINZA passes into breast milk.

If you have not told your doctor

about any of the above, tell them

before you use DAKLINZA.

As DAKLINZA should only be used

together with other antiviral

medicines such as sofosbuvir, or

SUNVEPRA, or together with

SUNVEPRA, peginterferon alfa, and

ribavirin, please read the Consumer

Medicine Information for the other

products prescribed by your doctor

before starting DAKLINZA.

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.

DAKLINZA and other medicines

may affect each other. This can cause

you to have too much or not enough

DAKLINZA or other medicines in

your body, which may affect the way

DAKLINZA or your other medicines

work, or may cause side effects.

Medicines for other conditions:

Tell your doctor if you are taking or

starting to take medicines that

contain:

amiodarone

atazanavir. You may need a lower

dose of DAKLINZA (30 mg).

boceprevir or telaprevir. You may

need a lower dose of DAKLINZA

(30 mg).

clarithromycin, erythromycin.

You may need a lower dose of

DAKLINZA (30 mg).

dabigatran

digoxin

diltiazem, verapamil

efavirenz, etravirine, or

nevirapine. You may need a

higher dose of DAKLINZA (90

mg).

elvitegravir, cobicistat,

emtricitabine, or tenofovir

disoproxil fumarate. You may

need a lower dose of DAKLINZA

(30 mg).

fluconazole, ketoconazole,

itraconazole, posaconazole, or

voriconazole. You may need a

lower dose of DAKLINZA (30

mg).

rosuvastatin, atorvastatin,

fluvastatin, simvastatin,

pitavastatin, or pravastatin

Your doctor will be able to advise

you about the most appropriate

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

DAKLINZA.

How to take

DAKLINZA

DAKLINZA 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 DAKLINZA exactly as your

doctor tells you to take it. Do not

change your dose unless your doctor

tells you to.

Do not stop taking DAKLINZA

without first talking with your doctor.

If you think there is a reason to stop

taking DAKLINZA, talk with your

doctor before doing so.

How to take it

Swallow the tablet whole with a

drink such as a glass of water.

When to take DAKLINZA

Take DAKLINZA once each day

with or without food.

DAKLINZA

TABLETS

How long to take it

Continue taking DAKLINZA for as

long as your doctor tells you to.

Do not stop taking DAKLINZA

unless your doctor tells you to - even

if you feel better.

If you forget to take it

If you miss a dose of DAKLINZA

and less than 20 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 DAKLINZA

and more than 20 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 2 doses of DAKLINZA

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

DAKLINZA.

Do this even if there are no signs of

discomfort or poisoning.

While you are using

DAKLINZA

Things you must do

If you become pregnant while

taking DAKLINZA, tell your

doctor immediately.

If you are about to start taking

any new medicines, tell your

doctor and pharmacist that you

are taking DAKLINZA.

DAKLINZA and the other

medicine may interfere with each

other.

If you are taking DAKLINZA

together with SUNVEPRA, your

doctor may perform additional

tests that will determine how well

your liver is working. Please read

the Consumer Medicine

Information for SUNVEPRA.

Things you must not do

Do not give DAKLINZA to

anyone else, even if they have the

same condition as you.

Do not use DAKLINZA to treat

any other complaints unless your

doctor tells you to.

Do not stop taking DAKLINZA

without checking with your

doctor.

Things to be careful of

Be careful driving or operating

machinery until you know how

DAKLINZA affects you.

Make sure that you visit your doctor

regularly throughout your entire

course of treatment with

DAKLINZA.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

DAKLINZA. 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

DAKLINZA is taken in combination

with SUNVEPRA include:

headache

tiredness

diarrhoea

nasal congestion (blocked nose)

nausea

The most common side effects when

DAKLINZA is taken in combination

with sofosbuvir (some patients in

studies of this regimen also received

ribavirin) include:

tiredness

headache

nausea

joint pain

diarrhoea

The most common side effects when

DAKLINZA is taken in combination

with SUNVEPRA, peginterferon

alfa, and ribavirin include:

tiredness

headache

itching

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

DAKLINZA. 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

DAKLINZA

TABLETS

experience any of them or only some

of them.

After using DAKLINZA

Storage

Store DAKLINZA tablets in a cool

dry place where the temperature

stays below 30°C.

Keep your tablets in the original

container until it is time to take them.

Do not store DAKLINZA 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 DAKLINZA tablets 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

DAKLINZA tablets, or the tablets

have passed their expiry date, ask

your pharmacist what to do with any

that are left over.

Product description

What it looks like

DAKLINZA tablets come in three

strengths:

DAKLINZA 60 mg tablets are

light green biconvex pentagonal

debossed with "BMS" on one side

and "215" on the other side.

Available in packs of 7 and 28

tablets.

DAKLINZA 30 mg tablets are

green biconvex pentagonal

debossed with "BMS" on one side

and "213" on the other side.

Available in packs of 7 and 28

tablets.

DAKLINZA 90 mg tablets are

light green biconvex round

embossed with "BMS" on one

side and "011" on the other side.

Available in packs of 7 and 28

tablets.

Ingredients

Each capsule contains:

Active ingredients:

DAKLINZA 60 mg tablets - 60

mg of daclatasvir as daclatasvir

dihydrochloride per tablet

DAKLINZA 30 mg tablets - 30

mg of daclatasvir as daclatasvir

dihydrochloride per tablet

DAKLINZA 90 mg tablets - 90

mg of daclatasvir as daclatasvir

dihydrochloride per tablet

Other ingredients:

anhydrous lactose, microcrystalline

cellulose, croscarmellose sodium,

silicon dioxide, magnesium stearate,

and OPADRY Green.

Opadry Green contains

hypromellose, titanium dioxide,

Macrogol 400, indigo carmine

aluminum lake, and iron oxide

yellow.

DAKLINZA tablets do not contain

gluten or sucrose.

Registration Numbers

DAKLINZA 60 mg - AUST R

222742

DAKLINZA 30 mg - AUST R

222743

DAKLINZA 90mg - AUST R

273048 (Not marketed)

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: December 2016

V4.0 22 December 2016

DAKLINZA

TABLETS

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