AKYNZEO

Main information

  • Trade name:
  • AKYNZEO netupitant/palonosetron (as hydrochloride) 300 mg/500 mcg capsule blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AKYNZEO netupitant/palonosetron (as hydrochloride) 300 mg/500 mcg capsule blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222237
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222237

AKYNZEO netupitant/palonosetron (as hydrochloride) 300 mg/500 mcg capsule blister pack

ARTG entry for

Medicine Registered

Sponsor

Mundipharma Pty Ltd

Postal Address

GPO Box 5214,SYDNEY, NSW, 2001

Australia

ARTG Start Date

6/05/2015

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. AKYNZEO netupitant/palonosetron (as hydrochloride) 300 mg/500 mcg capsule blister pack

Product Type

Single Medicine Product

Effective date

27/09/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

AKYNZEO is indicated in adult patients for:

Prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy.

Prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

36 Months

Store below 30

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

1 capsule

(S4) Prescription Only Medicine

Components

1. AKYNZEO netupitant/palonosetron (as hydrochloride) 300 mg/500 mcg capsule blister pack

Dosage Form

Capsule

Route of Administration

Oral

Visual Identification

AKYNZEO is supplied as a hard, opaque, gelatin capsule with white body

and caramel cap with HE1 printed on the body

Active Ingredients

netupitant

300 mg

Palonosetron hydrochloride

.56 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 11:48:26 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

AKYNZEO

®

Netupitant (ne-TU-pi-tant) 300mg and Palonosetron (pa-lo-NOS-etron) 500 mcg capsules

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Akynzeo. 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 this medicine

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.

You may need to read it again.

What Akynzeo is used

for

This medicine is used to prevent

nausea (feeling sick) and vomiting

caused by cancer chemotherapy in

adult patients.

It is a combination medicine which

contains two active ingredients. The

active ingredients ae called netupitant

and palonosetron.

Netupitant belongs to a group of

medicines 'neurokinin-1 (NK1)

receptor antagonists'.

Palonosetron belongs to a group of

medicines called 'serotonin (5-HT3)

receptor antagonists'.

Akynzeo works by blocking the

actions of substances in your body

and brain that are thought to cause

nausea and vomiting.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

Your doctor may have prescribed it

for another reason.

This medicine is not addictive.

This medicine is available only with

a doctor's prescription.

There is not enough information to

recommend the use for children

under the age of 18 years.

Before you take it

When you must not take it

Do not take this medicine if you

are allergic to:

any medicine containing

palonosetron or netupitant

any of the ingredients listed at the

end of this leaflet.

Some of the symptoms of an allergic

reaction may include:

shortness of breath

wheezing or difficulty breathing

or a tight feeling in your chest

swelling of the face, lips, tongue

or other parts of the body

rash, itching or hives on the skin

Do not take it after the expiry date

printed on the pack or if the

packaging is torn or shows signs of

tampering.

If it has expired or is damaged, return

it to your pharmacist for disposal.

Before you start to take it

Your doctor must know about all of

the following before you are given

this medicine.

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you have or

have had any of the following

medical conditions:

constipation

bowel obstruction

alterations in heart rhythm also

known as QT prolongation

other heart problems

taking any medicines that may

induce an abnormal heart rhythm

such as amiodarone, nicardipine,

quinidine, moxifloxacin,

erythromycin, haloperidol,

chlorpromazine, quetiapine,

thioridazine, domperidone

liver disease

imbalance of certain minerals in

your blood such as potassium and

magnesium

an intolerance to fructose

peanut or soya allergy.

Tell your doctor if you are

pregnant or plan to become

pregnant.

Your doctor can discuss with you the

risks and benefits involved.

Tell your doctor if you are breast-

feeding or plan breast-feed.

It is not known whether Akynzeo

passes into breast milk.

If you have not told your doctor

about any of the above, tell him/

her before you start taking

Akynzeo.

AKYNZEO

It is not recommended to take

Akynzeo in the days following

chemotherapy unless you are

receiving another chemotherapy

cycle.

Taking or being given other

medicines

Tell your doctor if you are taking

any other medicines, including any

that you get without a prescription

from your pharmacy, supermarket

or health food shop.

Akynzeo can affect other medicines

both during and after treatment.

These include:

dexamethasone, a steroid used for

a variety of conditions

certain cancer chemotherapy

medicines such as docetaxel,

etoposide or cyclophosphamide

certain antibiotics such as

erythromycin or moxifloxacin

midazolam, used as a sedative

and to relieve anxiety

ketoconazole, used to treat fungal

infections

rifampin, an antibiotic used to

treat tuberculosis and other

infections

heart medications such as

amiodarone, quinidine and

nicardipine

medicines normally used to treat

certain mental and emotional

conditions (antipsychotics) such

as haloperidol, chlorpromazine,

quetiapine and thioridazine

domperidone, a medicine

normally used to treat nausea and

vomiting, or certain other gastric

problems

SSRIs (selective serotonin

reuptake inhibitors) used to treat

depression and/or anxiety

including fluoxetine, paroxetine,

sertraline, fluvoxamine,

citalopram, escitalopram

SNRIs (serotonin noradrenaline

reuptake inhibitors) used to treat

depression and/or anxiety

including venlafaxine, duloxetine.

These medicines may be affected by

Akynzeo or may affect how well it

works. You may need different

amounts of your medicines, or you

may need to take different medicines.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while taking

this medicine.

How to take it

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ from the

information contained in this leaflet.

If you do not understand the

instructions on the box, ask your

doctor or pharmacist for help.

How much to take

The recommended dose is one

capsule by mouth, one hour before

you start your chemotherapy cycle.

How to take it

Swallow the capsule whole with a

drink of water.

If you have trouble swallowing

your capsule, tell your doctor.

When to take it

Take Akynzeo approximately one

hour prior to starting your

chemotherapy cycle.

Take it with or without food.

How long to take it

Akynzeo is a single dose given only

on the day of chemotherapy

treatment.

It is not recommended to take

Akynzeo in the days following

chemotherapy unless you are

receiving another chemotherapy

cycle.

If you forget to take it

If you forget to take your capsule,

contact your doctor for

instructions.

If you take too much

(overdose)

Immediately telephone your doctor

or the Poisons Information Centre

(telephone 13 11 26) for advice, or

go to Accident and Emergency at

the nearest hospital, if you think

that you or anyone else may have

taken too much Akynzeo.

Do this even if there are no signs of

discomfort or poisoning.

While you are taking it

Things you must do

Tell your doctor if, for any reason,

you have not taken your medicine

exactly as directed.

Tell your doctor if you feel the

medicine is not helping to prevent

the nausea and vomiting.

If the medicine starts to upset you,

tell your doctor.

Things you must not do

Do not give this medicine to anyone

else, even if their symptoms seem

similar to yours.

Do not take it to treat any other

complaints unless your doctor tells

you to.

Things to be careful of

Be careful driving or operating

machinery until you know how

Akynzeo affects you.

Akynzeo may induce dizziness,

somnolence or fatigue in some

people. If you have any of these

symptoms, do not drive, operate

machinery or do anything else that

could be dangerous.

AKYNZEO

Side effects

Tell your doctor, nurse or

pharmacist as soon as possible if

you do not feel well while you are

taking Akynzeo.

This medicine helps most people

with control of nausea and vomiting

associated with chemotherapy

treatment, but it may have unwanted

side effects in a few people. All

medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical attention if you get some of

the side effects.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor, nurse or

pharmacist if you notice any of the

following and they worry you:

Headache

Constipation

General weakness

The above list includes the more

common side effects of your

medicine.

Tell your doctor or pharmacist if

you notice anything else that is

making you feel unwell.

Other side effects not listed above

may also occur in some people.

After taking it

Storage

Keep the capsule in the blister

pack until it is time to take it.

If you take the capsule out of the

blister it may not keep well.

Keep your medicine in a cool dry

place where the temperature stays

below 25°C.

Do not store Akynzeo or any other

medicine in the bathroom or near a

sink. Do not leave it on a window

sill or in the car.

Heat and dampness can destroy some

medicines.

Keep it where children cannot

reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

Ask your pharmacist what to do

with any medicine that is left over

or if the expiry date has passed.

Product description

What it looks like

The Akynzeo capsule is opaque with

a white body and a caramel cap with

"HE1" printed on the body.

Akynzeo capsule is supplied in an

aluminium blister containing 1

capsule.

Ingredients

Active ingredient:

Akynzeo 300/500 - 300mg netupitant

and 500 mcg palonosetron (as the

hydrochloride) per capsule.

Inactive ingredients

microcrystalline cellulose

sucrose laurate

povidone

croscarmellose sodium

silicon dioxide

sodium stearylfumarate

magnesium stearate

glyceryl caprylate / caprate

glycerol

polyglyceryl-3-dioleate

purified water

butylated hydroxyanisole

Gelatin

sorbitol special glycerin blend

A-810

titanium dioxide (E171)

iron oxide yellow, iron oxide red

(E172) and iron oxide black

(E172)

shellac

propylene glycol (E1520)

ammonium hydroxide (E527).

Each Akynzeo hard capsule contains

7 mg of sorbitol.

Akynzeo contains sucrose. It may

contain traces of lecithin derived

from soya.

Akynzeo does not contain gluten,

tartrazine or any other azo dyes.

Supplier

Akynzeo is supplied in Australia by:

Mundipharma Pty Limited

88 Phillip Street

Sydney NSW 2000

Akynzeo is a registered trade mark

of Helsinn Healthcare SA,

Switzerland.

This leaflet was prepared in April

2016.

Australian Registration Number

Akynzeo 300mg/500mcg capsule

AUST R 222237

Orbis AU-3273

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EU/3/14/1353 (Lupin Europe GmbH)

EU/3/14/1353 (Lupin Europe GmbH)

EU/3/14/1353 (Active substance: Mexiletine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)3134 of Mon, 21 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/074/14/T/03

Europe -DG Health and Food Safety