IRINOTECAN

Main information

  • Trade name:
  • IRINOTECAN ACCORD irinotecan hydrochloride trihydrate 100 mg/5 mL concentrated injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • IRINOTECAN ACCORD irinotecan hydrochloride trihydrate 100 mg/5 mL concentrated injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 209857
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

209857

IRINOTECAN ACCORD irinotecan hydrochloride trihydrate 100 mg/5 mL concentrated injection vial

ARTG entry for

Medicine Registered

Sponsor

Accord Healthcare Pty Ltd

Postal Address

Level 24 570 Bourke Street,Melbourne, VIC, 3000

Australia

ARTG Start Date

12/06/2014

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. IRINOTECAN ACCORD irinotecan hydrochloride trihydrate 100 mg/5 mL concentrated injection vial

Product Type

Single Medicine Product

Effective date

10/10/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Irinotecan hydrochloride is indicated as a component of first-line therapy for patients with metastatic carcinoma of the colon or rectum. Irinotecan

hydrochloride is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial

therapy.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Coloured 24 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Protect from Light

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

1 vial

(S4) Prescription Only Medicine

Components

1. IRINOTECAN ACCORD irinotecan hydrochloride trihydrate 100 mg/5 mL concentrated injection vial

Dosage Form

Injection, concentrated

Route of Administration

Intravenous Infusion

Visual Identification

A pale yellow clear solution

Active Ingredients

irinotecan hydrochloride trihydrate

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 27.11.2017 at 10:09:01 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

v 2.0

IRINOTECAN ACCORD

Irinotecan Hydrochloride Concentrated Injection 40 mg/2mL and 100 mg/5 mL

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Irinotecan Accord. 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 Irinotecan Accord against

the benefits they expect it will have

for you.

Ask your doctor if you have any

concerns about being treated with

this medicine.

Keep this leaflet.

You may need to read it again.

What Irinotecan

Accord is used for

Irinotecan Accord is used to treat

bowel cancer, which has spread to

other parts of the body. Cancer, which

has spread, cannot be treated by

surgery alone and one of the options in

this situation is treatment with an

anticancer medicine, known as

chemotherapy.

Irinotecan Accord may be used once

spread of cancer beyond the bowel is

first diagnosed. At this time Irinotecan

Accord will be given in combination

with other anticancer medicines.

Alternatively, Irinotecan Accord is

used alone when the cancer has not

responded or has returned after initial

treatment.

Ask your doctor if you have any

questions about why Irinotecan

Accord has been prescribed for you.

Your doctor may have prescribed it

for another purpose.

Use in children

It is not known if Irinotecan Accord is

safe and effective in the treatment of

children.

Before you are given

Irinotecan Accord

When Irinotecan Accord

must not be given

Irinotecan Accord must not be given if

you:

are allergic to irinotecan

hydrochloride or any of the

ingredients listed at the end of this

leaflet

are or may become pregnant

are breastfeeding or intend to

breastfeed

Before treatment with

Irinotecan Accord

You should only be treated with

Irinotecan Accord by a doctor who is

experienced in treating patients with

cancer. Treatment will normally take

place in a hospital because of the need

for hospital facilities and skilled

personnel.

It is likely that your doctor will give

you one or more medicines before

administering Irinotecan Accord to

help stop you vomiting or feeling sick

after the treatment. You will probably

also have a blood test before each

treatment.

You should tell your doctor if:

you are 65 years of age or older

you have or have had liver disease,

kidney disease or heart disease

you have previously been treated

with radiation therapy

you have diabetes or asthma

you have constipation or difficulty

urinating

you have hereditary fructose

intolerance

you have Crigler-Najjar syndrome

or Gilbert's syndrome

you are going to be vaccinated (have

an injection to prevent a certain

disease

If you have not told your doctor

about any of the above, tell your

doctor before you are given

Irinotecan Accord.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including

medicines that you buy without a

prescription from a pharmacy,

supermarket or health food shop.

Some medicines and Irinotecan

Accord may interfere with each other.

In particular, tell your doctor if you

are taking:

laxatives (e.g. for constipation)

diuretics (medicines which make

you pass urine more frequently e.g.

for heart disease)

v 2.0

any medicine for nausea or

diarrhoea

dexamethasone (may be used to

treat skin diseases, asthma or other

allergic disorders)

anticonvulsants used to treat

seizures

St John’s Wort, a herbal medicine

used to treat depression

ketoconazole used to treat fungal

infections.

Ask your doctor or other health

care professional if you are not sure

about this list of medicines.

You may need to take different

amounts of your medicines or you

may need to use different medicines.

Your doctor will advise you.

How Irinotecan Accord

is given

Irinotecan Accord will be given to

you by your doctor. It is diluted and

given by slow infusion into a vein

over a period of 90 minutes.

It is recommended that Irinotecan

Accord be given in different treatment

courses depending on whether

Irinotecan Accord is given alone or in

combination with other anticancer

medicines.

When Irinotecan Accord is given in

combination, treatment courses are of

6 weeks duration given either weekly

or fortnightly. Rest periods of 1 or 2

weeks are incorporated into the 6

week courses.

When Irinotecan Accord is given

alone, treatment courses include

Irinotecan Accord being given weekly

for 4 weeks followed by a 2 week rest

period and Irinotecan Accord being

given once every 3 weeks.

Depending on your response,

treatment courses may be repeated

more than once.

It is recommended that treatment with

Irinotecan Accord should be

interrupted if you get severe diarrhoea

or other intolerable side effects.

Dose

The recommended dose for Irinotecan

Accord varies between 125 mg/m

and 350mg/m

(based on body

surface area), depending on the dosing

schedule.

Your doctor will decide the dose of

Irinotecan Accord to be given.

Ask your doctor if you want more

information about the dose of

Irinotecan Accord and the other

medicines you will be receiving and

how they are given.

After your first treatment course, the

dose of Irinotecan Accord may be

increased by your doctor if you have

not had too many side effects.

Your doctor will lower the dose or

stop treatment if you have serious side

effects, particularly diarrhoea or

changes appearing in your blood tests.

In case of overdose

Overdose is unlikely as treatment will

be given in hospital under the

supervision of a doctor. The possible

effects of overdose are the same as

those listed below under Side effects.

Tell your doctor immediately if you

do not feel well while being given

Irinotecan Accord

While you are using

Irinotecan Accord

Things you must do

Keep all appointments with your

doctor and always discuss with your

doctor any problems during or

after treatment with Irinotecan

Accord.

Tell your doctor as soon as possible

if diarrhoea occurs.

Diarrhoea is a common side effect of

Irinotecan Accord. If untreated, severe

diarrhoea can be life-threatening.

Your doctor will prescribe loperamide

(a medicine to treat diarrhoea) for you

to take in case you get diarrhoea after

treatment. You should start taking

loperamide, when you first have

poorly formed or loose stools or

bowel movements more frequent than

you would normally expect.

You must tell your doctor if you

cannot get diarrhoea under control

within 24 hours after taking

loperamide.

You should not take loperamide for

more than 48 hours.

Also tell your doctor if you develop

a fever in addition to the diarrhoea.

In these cases, your doctor may give

you antibiotics. If the diarrhoea or

fever persists you may become

dehydrated and need to go to hospital

for treatment.

You may need to take antibiotics if

there are changes in your blood tests

indicating a lack of white blood cells.

Symptoms of this may include

frequent infections such as fever,

severe chills, sore throat or mouth

ulcers. If this persists, you may need

to go to hospital for treatment. If you

have severe stomach cramps, you may

need to be treated with antibiotics.

You must use a reliable method of

contraception (birth control) while

being treated with Irinotecan

Accord.

If pregnancy occurs, consult your

doctor.

Things you must not do

Because of the risk of diarrhoea, do

not take laxatives during treatment

courses with Irinotecan Accord.

Talk to your doctor if you need more

information about this.

v 2.0

Do not start taking any other

medicines, prescription or not,

without first telling your doctor or

pharmacist.

Side effects

Irinotecan Accord, like all other

medicines, may cause unwanted side

effects. Side effects are very common

with anti-cancer medicines such as

Irinotecan Accord and they may be

severe. Deaths have occurred which,

in some cases, may have been related

to treatment.

Tell your doctor immediately if you

get any of the following side effects:

diarrhoea

start to vomit

develop a fever or any type of

infection

fainting, light-headedness or

dizziness

bloody or black stools

cannot eat or drink due to nausea or

vomiting.

The above side effects may be serious.

You may need urgent medical

attention.

Very common side effects (occurring

in over 50% of patients) are:

diarrhoea or stomach cramps; may

occur early (during or shortly after a

treatment) or late (usually more

than 24 hours after treatment)

nausea, vomiting, loss of appetite

anaemia which may make you weak

and light-headed or may cause you

to faint

increased risk of infections

including severe infections

weakness

hair loss.

Common side effects (occurring in

10-50% of patients) are:

constipation, flatulence (passing

wind), sore mouth, heartburn

fever (increased body temperature),

chills, headache, back pain or other

types of pain, infection, fluid

retention which results in swelling

weight loss, dehydration

runny nose or eyes, increased saliva,

sweating or flushing

skin rash

coughing, difficulty breathing

difficulty sleeping or dizziness.

Less common side effects (occurring

in less than 10% of patients) are:

increased risk of bleeding

severe fever associated with a

reduction in white blood cell

numbers

bleeding from the bowel

jaundice (yellowing of skin and

eyes)

severe breathing difficulties

generally feeling unwell

abnormal manner of walking

fungal infections (e.g. thrush)

kidney problems.

Problems speaking

In addition to the above side effects

the following have also been reported:

allergic reactions; some of the

symptoms of an allergic reaction

may include: rash, itching or hives

on the skin. In more severe cases

symptoms may also include

shortness of breath, wheezing or

difficulty breathing, swelling of the

face, lips, tongue or other parts of

the body

pins and needles

bloating or pain in upper stomach

chest pains

hiccups.

Other side effects not listed above

may happen in some people. Some of

these side effects can only be found

when your doctor does tests to check

your progress.

Rare side effects of Irinotecan Accord

have also been reported. These

include effects on the heart and blood

vessels such as:

slowed heart beat

fainting

blackouts

blood clots

swelling and redness along a vein,

which is extremely tender when

touched

chest pains

heart attack

stroke.

Your doctor has information on

monitoring for such side effects and

their treatment. A very small number

of patients have died suddenly while

on Irinotecan Accord.

Tell your doctor as soon as possible

if you experience any side effects,

including any effects not listed

above.

Storage

Stored below 25°C. Do not Freeze.

Protect from Light.

Product description

What it looks like

Irinotecan Accord is a sterile, pale

yellow, clear, aqueous solution with

pH 3.0 – 3.8. It is available in 2 sizes:

40 mg/2 mL and 100 mg/5 mL Each

vial is for single use in one patient

only and is contained in an outer

carton.

Ingredients

The active ingredient in Irinotecan

Accord is irinotecan hydrochloride

trihydrate. There is 20 mg of

irinotecan hydrochloride trihydrate in

each 1 mL of Irinotecan Accord.

v 2.0

Irinotecan Accord also contains:

Sorbitol,

Lactic acid

Water for injections.

It might also contain sodium

hydroxide or hydrochloric acid.

Name and Address of the

Sponsor

Accord Healthcare Pty Ltd

Lvl 24, 570 Bourke Street

Melbourne, VIC, 3000

Australia

Australian Registration Numbers

40 mg/2 mL: AUST R 209856

100 mg/5 mL: AUST R 209857

Date of Preparation

This leaflet was prepared on 10

October 2016.

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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

21-5-2018

EU/3/14/1421 (Incyte Biosciences Distribution B.V.)

EU/3/14/1421 (Incyte Biosciences Distribution B.V.)

EU/3/14/1421 (Active substance: Ponatinib hydrochloride) - Transfer of orphan designation - Commission Decision (2018)3141 of Mon, 21 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/212/14/T/02

Europe -DG Health and Food Safety

15-5-2018

Votrient (Novartis Europharm Limited)

Votrient (Novartis Europharm Limited)

Votrient (Active substance: Pazopanib hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3062 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1141/T/46

Europe -DG Health and Food Safety

21-3-2018

EU/3/11/919 (Monopar Therapeutics SARL)

EU/3/11/919 (Monopar Therapeutics SARL)

EU/3/11/919 (Active substance: Clonidine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)1817 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/11/T/02

Europe -DG Health and Food Safety