DECAPEPTYL

Main information

  • Trade name:
  • DECAPEPTYL triptorelin acetate 100 micrograms/1 mL solution for injection in 1mL pre-filled syringe with integrated needle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DECAPEPTYL triptorelin acetate 100 micrograms/1 mL solution for injection in 1mL pre-filled syringe with integrated needle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219857
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219857

DECAPEPTYL triptorelin acetate 100 micrograms/1 mL solution for injection in 1mL pre-filled syringe with

integrated needle

ARTG entry for

Medicine Registered

Sponsor

Ferring Pharmaceuticals Pty Ltd

Postal Address

PO Box 315,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

4/03/2015

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. DECAPEPTYL triptorelin acetate 100 micrograms/1 mL solution for injection in 1mL pre-filled syringe with

integrated needle

Product Type

Single Medicine Product

Effective date

13/06/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

DECAPEPTYL 100 micrograms/1 mL is indicated for down-regulation and prevention of premature luteinising hormone (LH) surges in women

undergoing controlled ovarian hyperstimulation for assisted reproductive technologies (ART).,In clinical trials DECAPEPTYL 100 micrograms/1 mL has

been used in cycles where urinary and recombinant human follicle stimulating hormone (FSH) as well as human menopausal gonadotrophin (HMG) were

used for stimulation.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Syringe

Glass Type I Clear

36 Months

Store at 2 to 8

degrees Celsius

Not recorded

Store in Original

Container

Protect from Light

Refrigerate

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

28 x 1 mL prefilled syringes

(S4) Prescription Only Medicine

7 x 1 mL prefilled syringes

(S4) Prescription Only Medicine

Components

1. DECAPEPTYL triptorelin acetate 100 micrograms/1 mL solution for injection in 1mL pre-filled syringe with integrated needle

Dosage Form

Injection, solution

Route of Administration

Subcutaneous

Visual Identification

Clear, colourless solution in a 1 mL pre-filled glass type I syringe with

integrated needle.

Active Ingredients

triptorelin acetate

100 microgram

© 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 03:22:17 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

DECAPEPTYL

®

Solution for injection

Triptorelin acetate

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Decapeptyl.

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

Decapeptyl against the benefits she/

he expects it will have for you.

If you have any concerns about

being given this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Decapeptyl is

used for

Decapeptyl contains triptorelin,

which is a synthetic version of the

natural gonadotropin releasing

hormone (GnRH). GnRH regulates

the release of two gonadotropins that

are involved in the development of

follicles and release of eggs from the

ovaries: follicle-stimulating hormone

(FSH) and luteinising hormone (LH).

Assisted Reproductive Technology

(ART) include gonadotropins that

replace the activities of naturally

produced FSH and LH. Occasionally,

in response to ART treatment, the

release of eggs may occur too early

due to an early surge in LH levels

and this may lead to that ART cycle

being cancelled, without retrieval of

any eggs. Decapeptyl blocks the

action of GnRH and is therefore

intended to prevent an LH surge,

thereby lessening the chances of

premature ovulation and a cancelled

ART cycle.

Ask your doctor if you have any

questions about why it 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.

This medicine is not expected to

affect your ability to drive a car or

operate machinery.

Before you use

Decapeptyl

When you must not use it

Do not use Decapeptyl if you are

allergic to:

triptorelin acetate, the active

ingredient in Decapeptyl

any of the other ingredients listed

at the end of this leaflet

GnRH or synthetic versions of

GnRH (medicines similar to

Decapeptyl).

Some of the symptoms of an allergic

reaction may include shortness of

breath, wheezing or difficulty

breathing; swelling of the face, lips,

tongue or other parts of the body;

rash, itching or hives on the skin.

Do not use Decapeptyl if:

you are pregnant

you are breast feeding

you are prone to allergies.

Do not use Decapeptyl after the

expiry date printed on the pack.

Do not use Decapeptyl if the

packaging is torn or shows signs of

tampering.

If you are not sure whether you

should have this medicine, talk to

your doctor.

Before you use it

Tell your doctor if you have

allergies to:

any other medicines

any other substances such as

foods, preservatives or dyes.

Tell your doctor if you have or

have had any medical conditions,

especially the following:

if you are possibly pregnant

if you have a mild to severe liver

disease

if you have an active allergic

condition or if you are prone to

allergic reactions

if you administer Decapeptyl

yourself. You should be aware of

possible allergic reactions (e.g.

itching, skin rash, fever).

If you have not told your doctor

about any of the above, tell him/

her before you are given

Decapeptyl.

Taking 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.

DECAPEPTYL

There are some medicines which

may interfere with the action of

Decapeptyl. These include medicines

affecting secretion of gonadotropins.

Your doctor or pharmacist has more

information on medicines to be

careful with or avoid while you are

receiving this medicine.

How to use

Decapeptyl

This medicine contains a solution of

triptorelin provided in a pre-filled

disposable syringe for single use. It is

given as an injection under the skin

(subcutaneous) of the lower

abdomen.

If your doctor or nurse decides you

can give the injections to yourself,

they will train you appropriately on

the injection technique.

Do not self-inject Decapeptyl until

you are sure of how to do it.

The first injection of Decapeptyl

should be under medical supervision.

Follow all instructions given to you

by your doctor carefully.

An instruction leaflet is supplied with

your medicine and the following

information is included:

Injecting your medicine

Remove the protective foil and

take the syringe out of the blister

packaging

Keep the syringe upright with the

grey protective cap facing up

Remove the grey protective cap

Gently push the plunger until the

first drops of liquid appear at the

needle tip

The medicine is to be injected

under the skin of the lower

abdomen. Clean the injection site

with an antiseptic swab

immediately prior to injection

Lift up a fold of skin between the

thumb and forefinger. With your

free hand hold the syringe at a

right angle to the skin like a dart

and quickly insert the needle all

the way into the skin fold. Press

down slowly on the plunger to

inject the contents of the syringe

Remove the syringe and needle

from the skin and discard this

immediately into a sharps

disposal unit

For each dose, choose a different

injection site along the lower

abdomen.

Other important information

Each pre-filled syringe is for

single-use only

Tell your doctor immediately or

go to Accident and Emergency at

your nearest hospital if you

experience sign/symptoms of an

allergic reaction (e.g. difficulty in

breathing or swelling of the lips)

The first injection of this

medicine should be supervised by

your doctor or nurse

The syringe should be disposed

into a sharps disposal unit.

How much to use

Always use this medicine exactly as

your doctor has told you. You

should check with your doctor if

you are not sure.

The usual dosage of Decapeptyl is

one injection under the skin of your

lower abdomen once-daily.

Treatment can be started on day 2 or

3, or on day 21 to 23, of the

menstrual cycle.

After 2 to 4 weeks of Decapeptyl

treatment, other hormones

(gonadotropins) will be given in

order to stimulate follicle growth.

In general, Decapeptyl treatment will

continue until follicles have reached

a suitable size, usually 4 to 7 weeks.

If enough follicles are present,

Decapeptyl treatment will be stopped

and you will be given a medicine to

induce ovulation.

Your doctor will closely monitor

your progress for at least another 2

weeks.

How long to use it

Usually one dose of Decapeptyl is

used each day. The length of

Decapeptyl treatment is usually from

4-7 weeks. However, your doctor

will be able to answer this question

more precisely.

If you forget to use it

It is important that you do not miss a

dose of Decapeptyl.

If you do miss a dose, contact your

doctor or nurse. Do not take a

double dose to make up for the

dose that you missed.

If you use too much

(overdose)

As your treatment will be closely

monitored it is unlikely you will be

prescribed too large a dose of

Decapeptyl. However, Decapeptyl

can be associated with some

symptoms (see Side Effects). If you

use more than the prescribed dose

contact a doctor immediately.

While you are using

Decapeptyl

In case you suffer from a reaction

after injecting Decapeptyl you

should contact your doctor

immediately. Symptoms of a

reaction can include:

pain in the abdomen

swelling in the abdomen

nausea

vomiting

diarrhoea

weight gain

difficulty breathing

decreased urination.

Tell your doctor straight away, even

if the symptoms develop some days

after the last injection has been

given. These can be signs of high

levels of activity in the ovaries which

might become severe (see also

section Side effects).

DECAPEPTYL

If these symptoms become severe,

the infertility treatment should be

stopped and you should receive

treatment in hospital.

Undergoing infertility treatment with

hormones, like this medicine, has

been associated with increased risk

ectopic pregnancy (pregnancy

outside of the womb) if you have

a history of fallopian tube disease

miscarriage

multiple pregnancy (twins,

triplets, etc.)

congenital malformations

(physical defects present in baby

at birth).

Things you must do

Tell your doctor immediately if

you become pregnant while using

Decapeptyl.

Tell your doctor if you have

abnormal vaginal bleeding while

using Decapeptyl.

Be sure to keep all your doctor's

appointments so your progress can

be checked.

Your doctor will normally arrange

for you to have ultrasound scans and

sometimes blood tests to monitor

your response to treatment.

Tell any other doctors, dentists,

and pharmacists who are treating

you that you are using Decapeptyl.

If you are about to be started on

any new medicine, tell your doctor,

dentist or pharmacist that you are

using Decapeptyl.

If you are going to have surgery,

tell the surgeon or anaesthetist that

you are using Decapeptyl.

Things to be careful of

Decapeptyl should not normally

interfere with your ability to drive or

operate machinery.

Take special care with

Decapeptyl

Decapeptyl can lead to mood

changes (including depression).

Long-term use (over many months or

years) of Decapeptyl for other

conditions can lead to thinning of

bones, which may increase risk of

bone fracture.

If you are at additional risk of

thinning of the bones (osteoporosis)

you should tell you doctor before

taking Decapeptyl.

Side effects

Tell your doctor or nurse or

pharmacist as soon as possible if

you do not feel well after you use

Decapeptyl.

This medicine may have unwanted

side effects in some 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 experience

side effects.

Do not be alarmed by the following

list of side effects. You may not

experience any of them.

Ask your doctor or nurse or

pharmacist to answer any

questions you may have.

Tell your doctor if you notice any

of the following and they worry

you:

headache

abdominal pain

vaginal bleeding/spotting

nausea

inflammation at the injection site.

These are mild side effects and are

usually short-lived.

Tell your doctor as soon as possible

if you notice any of the following:

cold

sore throat

flu-like symptoms

pharyngitis

mood alterations

dizziness

hot flushes

vomiting

abdominal bloating

back pain

abortion

pelvic pain

overstimulation of the ovaries

ovarian-cysts (at the beginning of

the Decapeptyl treatment)

pain during menstruation

heavy, prolonged and /or irregular

periods

vulvovaginal dryness

painful sexual intercourse

decreased libido

breast pain

joint pain

pain or other reactions at the

injection site

tiredness.

The above list includes serious side

effects which may require medical

attention.

Contact your doctor immediately if

you experience sudden headache,

vomiting or visual disturbances

while using Decapeptyl.

Medicines like Decapeptyl can

uncover a rare pituitary condition

that a person may not be aware of

and use of the medicine in this case

may lead to these symptoms.

Tell your doctor immediately or go

to Accident and Emergency at

your nearest hospital if any of the

following happen.

allergic reactions

angioedema (swelling of the face,

lips, mouth, tongue or throat,

which may cause difficulty in

swallowing or breathing)

abdominal discomfort

swelling in the abdomen

blurred eye vision

visual impairment

diarrhoea

excessive sweating

weight gain

difficulty breathing, shortness of

breath

DECAPEPTYL

decreased urination.

These are very serious side effects.

You may need urgent medical

attention or hospitalisation.

Tell your doctor or pharmacist if

you notice anything that is making

you feel unwell.

Other side effects not listed above

may also occur in some people.

After using

Decapeptyl

Storage

Keep Decapeptyl where children

cannot reach it.

Keep Decapeptyl in the original pack

until it is time for it to be used.

Store Decapeptyl in a refrigerator

(2°C to 8°C). Do not freeze.

Disposal

If you are self-injecting, you should

discard all sharps into a disposal unit.

If you have any Decapeptyl that has

expired or is left over from your

treatment refer this to your clinic.

Product description

What it looks like

This medicine is supplied as a

colourless solution in a glass syringe

of 1 mL to which a needle is

connected. The syringe and needle

are closed with a rubber stopper and

a needle shield. This product is

supplied as a pack of 7 or 28 pre-

filled syringes.

Not all pack sizes may be marketed

in Australia.

Ingredients

Each 1 mL pre-filled syringe of

Decapeptyl contains, as the active

ingredient, 100 micrograms

triptorelin acetate (equivalent to 95.6

micrograms triptorelin).

The other ingredients are:

sodium chloride

glacial acetic acid

Water for injections.

This medicine does not contain

sucrose, gluten, tartrazine or any

other azo dyes.

Sponsor:

Decapeptyl is distributed in Australia

Ferring Pharmaceuticals Pty Ltd

Suite 2, Level 1, Building 1,

20 Bridge Street, Pymble NSW 2073

This leaflet was prepared in August

2015.

#36096-v2A

Australian Register Number:

AUST R 219857

Decapeptyl 100 micrograms/1 mL

solution for injection

DECAPEPTYL

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