LUCRIN

Main information

  • Trade name:
  • LUCRIN DEPOT leuprorelin acetate 45mg powder for suspension prefilled dual-chamber syringe injection
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • LUCRIN DEPOT leuprorelin acetate 45mg powder for suspension prefilled dual-chamber syringe injection
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222375
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222375

LUCRIN DEPOT leuprorelin acetate 45mg powder for suspension prefilled dual-chamber syringe injection

ARTG entry for

Medicine Registered

Sponsor

Abbvie Pty Ltd

Postal Address

Locked Bag 5029,BOTANY, NSW, 1455

Australia

ARTG Start Date

12/05/2015

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. LUCRIN DEPOT leuprorelin acetate 45mg powder for suspension prefilled dual-chamber syringe injection

Product Type

Single Medicine Product

Effective date

20/09/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Lucrin Depot is indicated for the palliative treatment of metastatic or locally advanced prostate cancer.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Syringe

Glass

3 Years

Store below 25

degrees Celsius

Not recorded

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

1 prefilled dual chamber syringe

(S4) Prescription Only Medicine

Components

1. Lucrin Depot leuprorelin acetate

Dosage Form

Injection

Route of Administration

Intramuscular

Visual Identification

White, lyophilised powder which, when reconstituted, becomes a milky

suspension

Active Ingredients

leuprorelin acetate

45 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 11:28:15 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

Lucrin

®

Injection

Leuprorelin acetate

Consumer Medicine Information (CMI)

What is in this leaflet

This leaflet answers some common

questions about Lucrin Injection.

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 being given this

medicine against the benefits they

expect it will have for you.

If you have any concerns about

being given this medicine, ask your

doctor or pharmacist.

Keep this leaflet.

You may need to read it again.

What Lucrin is used

for

Lucrin is used to treat prostate

cancer.

It belongs to a group of medicines

called gonadotropin releasing

hormone agonists.

It works by blocking the secretion of

hormones from testes. In some types

of cancer, these hormones help the

cancer cells to grow. By blocking

these hormones, Lucrin may slow or

stop the growth of prostate cancer.

Ask your doctor or pharmacist if

you have any questions about why

it has been prescribed for you.

Your doctor may have prescribed it

for another purpose.

Lucrin is available only with a

doctor's prescription.

Lucrin should not be given to

children.

Before you are given

Lucrin

When you must not be given

it

Do not receive Lucrin if you have

an allergy to:

any medicine similar to Lucrin

any of the ingredients listed at

the end of this leaflet

Some symptoms of an allergic

reaction include skin rash, itching,

shortness of breath or swelling of the

face, lips or tongue, which may cause

difficulty in swallowing or breathing.

Pregnancy and Breastfeeding

Although not relevant to prostate

cancer patients, Lucrin should not be

used during pregnancy or while

breastfeeding.

Do not receive it after the expiry

date printed on the pack or if the

packaging is damaged or shows

signs of tampering.

If it has expired or is damaged return

it to your pharmacist for disposal.

Before are given Lucrin

Tell your doctor if you have any

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you have or

have had any of the following

medical conditions:

if your cancer has spread to your

spine

difficulty or pain when passing

urine

history of convulsions, fits or

seizures

history of diabetes

history of heart problems

Fertility

Lucrin may impair fertility in men.

Use of this medicine for a short time

has shown a full return to fertility

after stopping the medicine. Fertility

suppression may or may not be

permanent when the medicine is

given for a long time.

Children

Certain strengths of Lucrin have not

been tested in children so the safety

and effectiveness in children is not

fully known.

If you have not told your doctor

about any of the above, tell them

before you are given Lucrin.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including any

that you buy without a

prescription from your pharmacy,

supermarket or health food store.

Lucrin has not been found to interact

with other commonly used

medicines. If you have any questions

or concerns, discuss them with your

doctor or pharmacist.

Tell your doctor or pharmacist if

you are taking any of the following

medicines:

medicines used to treat abnormal

heart rhythms, e.g. quinidine,

disopyramide, procainamide,

amiodarone, sotalol, dofetilide or

ibutilide

LUCRIN

INJECTION

methadone, a medicine used to

reduce withdrawal symptoms

associated with drug addiction

certain antibiotics such as

moxifloxacin, a medicine used to

treat infections caused by certain

bacteria

antipsychotic medicines

Taking these medicines together with

Lucrin may increase the risk of

abnormal heart rhythms.

How Lucrin is given

Lucrin should only be given by a

doctor or nurse.

Your doctor will tell you which

formulation of Lucrin will be given

and for how long. This may differ

from the information contained in

this leaflet

How often Lucrin is given

Lucrin Injection

Recommended dose is 1mg (0.2mL)

injected daily under the skin.

Lucrin Depot 7.5mg, 22.5mg, 30mg

and 45mg PDS injection should be

mixed with the diluent before use

according to the manufacturer's

instructions provided.

Lucrin Depot 7.5mg PDS is injected

into a muscle once every 4 weeks.

Lucrin Depot 22.5mg PDS is injected

into a muscle once every 12 weeks.

Lucrin Depot 30mg PDS is injected

into a muscle once every 16 weeks.

Lucrin Depot 45mg PDS is injected

into a muscle once every 24 weeks.

The site of injection should be varied

from time to time.

If the microspheres are not in

suspension, the injection must not be

administered.

How to take it

This medicine is given as an

injection, usually into your muscle by

a doctor or trained nurse with

experienced in the administration of

such injections.

How long to take it

Continue taking your medicine for

as long as your doctor tells you.

The medicine helps control your

condition, but it does not cure it. It is

important to keep taking your

medicine even if you feel well.

If you forget to have your

injection

If you missed your injection or are

not sure what to do, check with your

doctor or pharmacist.

Overdose

As Lucrin is given to you under the

supervision of your doctor, it is very

unlikely that you will receive too

much. However, if you experience

any side effects after being given this

medicine, telephone your doctor, or

the Poisons Information Centre

(telephone Australia 13 11 26), or go

to Accident and Emergency at your

nearest hospital.

There have not been any unwanted

side effects seen with the overdosage

of Lucrin.

While you are being

given Lucrin

Things you must do

When Lucrin is first started, there

may be a temporary increase in some

hormones. This may cause an

increase in pain or other symptoms of

the cancer in the first weeks. If this

happens, see your doctor.

If symptoms include difficulty

urinating, a feeling of weakness or

numbness in the lower limbs, you

should notify your doctor

immediately.

These symptoms usually only happen

with the first treatment with this

medicine; you should not experience

them with future treatments.

Your doctor may continue to monitor

your testosterone levels to ensure that

acceptable suppression of the

secretion of hormones from the testes

is maintained throughout your course

of treatment.

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking Lucrin.

Tell any other doctors, dentists and

pharmacists who treat you that

you are taking this medicine.

If you are going to have surgery,

tell the surgeon that you are taking

this medicine.

If you are about to have any blood

tests, tell your doctor that you are

taking this medicine.

It may interfere with the results of

some tests.

Keep all of your doctor's

appointments so that your progress

can be checked.

If you do not feel well or your

condition worsens, tell your doctor.

Things you must not do

Do not use this medicine to treat

any other complaints unless your

doctor or pharmacist tells you to.

Do not give this medicine to anyone

else, even if they have the same

condition as you.

Do not use fractional doses or

combinations of doses to substitute

any depot formulations.

Due to different release

characteristics of each presentation of

Lucrin Depot, a fractional dose of the

3-month depot, 4-month depot or 6-

month depot formulation is not

equivalent to the same dose of the

monthly formulation (Lucrin Depot

7.5 mg PDS) and should not be

given. Similarly, fractional doses of

the 30 mg or 45 mg formulations

should not be used as a substitute for

the 30 mg or 22.5 mg and multiples

of the 7.5 mg presentation should not

be used as a substitute for the 22.5

mg, 30 mg or 45 mg formulations.

LUCRIN

INJECTION

Things to be careful of

Be careful driving or operating

machinery until you know how

Lucrin affects you.

If you feel light-headed, dizzy or

faint when getting out of bed or

standing up, get up slowly.

Standing up slowly, especially when

you get up from bed or chairs, will

help your body get used to the

change in position and blood

pressure. If this problem continues or

gets worse, talk to your doctor.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking Lucrin.

It helps most people with prostate

cancer, but it may have unwanted

side effects in a few people. All

medicines have some unwanted side

effects. Sometimes they are serious,

but 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 or pharmacist if

you notice any of the following and

they worry you:

pain, swelling or redness at the

injection site

cough

unusual tiredness or weakness

tiredness, sleepiness or

drowsiness

difficulty sleeping

mild muscle, back or joint pain

changes in testicular size

change in your sexual drive

inability to get or maintain an

erection

sweating and body odour

hot flushes

general pain

nausea/vomiting

buzzing, hissing, whistling,

ringing or other persistent noise

in the ear

mild skin problems such as rash,

itching, hives, dry skin or acne

headache

dizziness or light-headedness

diarrhoea

constipation

The above list includes the more

common side effects of your

medicine. They are usually mild and

short-lived.

Tell your doctor as soon as possible

if you notice any of the following:

swelling in limbs

problems with your eyesight

difficulty breathing

thirst

frequent passing of urine

numbness or tingling of hands or

feet

blood in your urine

difficulty or pain when passing

urine

changes in breast size

chest pain

feeling of weakness in arms(s) or

leg(s)

speech problems

The above list includes serious side

effects that may require medical

attention. Serious side effects are

rare.

If any of the following happen, tell

your doctor immediately or go to

Accident and Emergency at your

nearest hospital:

swelling of the face, lips, mouth,

throat or neck which may cause

difficulty in swallowing or

breathing or sudden collapse

unsteadiness when walking

The above list includes very serious

side effects. You may need urgent

medical attention. These side effects

are rare.

Tell your doctor or pharmacist if

you notice anything else that is

making you feel unwell.

Other side effects not listed above

may occur in some people.

Storage

Lucrin injection should be stored

in a refrigerator (2°C to 8°C). Do

not freeze. Protect from light.

Lucrin PDS Injections should be

kept in a cool, dry place where the

temperature stays below 25°C.

Do not store it or any other

medicine in the bathroom, near a

sink, or on a windowsill. Do not

leave it 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

If your doctor or pharmacist tells

you to stop taking this medicine, or

the medicine has passed its expiry

date, ask your pharmacist what to

do with any medicine that is left

over.

Product description

What it looks like

MULTI-DOSE VIAL

Description:

Lucrin 5 mg/mL Injection is a clear

colourless liquid in a multidose glass

vial.

Lucrin 5 mg/mL Injection may also

be supplied as an injection kit, which

consists of a multidose glass vial

containing a clear colourless liquid,

LUCRIN

INJECTION

alcohol swabs and syringes with

needles.

PREFILLED DUAL-

CHAMBER SYRINGES

Description:

Lucrin Depot 7.5 mg PDS Injection,

Lucrin Depot - 3 Month PDS

Injection, Lucrin Depot - 4 Month

and Lucrin Depot - 6 Month PDS

Injection is a dual-chamber syringe

containing active ingredient (white

powder) in the front chamber and

diluent (colourless solution) in the

rear chamber.

Ingredients

Lucrin multidose vial contains

leuprorelin acetate 5 mg/mL as the

active ingredient.

It also contains sodium chloride,

sodium hydroxide, acetic acid, and

water for injections.

It also contains the preservative:

benzyl alcohol.

Lucrin Depot 7.5mg PDS contains

7.5mg leuprorelin acetate as the

active ingredient.

It also contains gelatine, mannitol

and polyglactin.

Lucrin Depot 22.5mg PDS contains

22mg leuprorelin acetate as the

active ingredient.

It also contains polylactic acid and

mannitol.

Lucrin Depot 30mg PDS contains

30mg leuprorelin acetate as the

active ingredient.

It also contains polylactic acid and

mannitol.

The diluent contains carmellose

sodium, mannitol, polysorbate 80 and

water for injections.

Lucrin Depot 45mg PDS contains

45mg leuprorelin acetate as the

active ingredient.

It also contains polylactic acid,

stearic acid and mannitol.

The diluent contains carmellose

sodium, mannitol, polysorbate 80,

glacial acetic acid and water for

injections.

Supplier

Lucrin multidose vial is made in

France.

Lucrin Depot PDS is made in Japan.

Lucrin is supplied in Australia by:

AbbVie Pty Ltd

241 O'Riordan Street

Mascot NSW 2020

1800 043 460

ABN: 48 156384262

This leaflet was prepared in May

2015.

Australian Registration Number(s)

Lucrin 5 mg/mL Injection:

AUST R 29658

Lucrin Depot 7.5mg 1 Month PDS

Injection: AUST R 114302

Lucrin Depot 22.5mg 3-Month PDS

Injection: AUST R 114303

Lucrin Depot 30mg 4-Month PDS

Injection: AUST R 114304

Lucrin Depot 45mg 6-Month PDS

Injection: AUST R 222375

Version 11

LUCRIN

INJECTION

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