Decapeptyl

Solution for injection

Triptorelin acetate

Consumer Medicine Information

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.

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.

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.

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.

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.

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.

This medicine contains a solution of triptorelin providedin 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.

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.

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.

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.

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.

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).

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 of:

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).

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.

Decapeptyl should not normally interfere with your ability to drive or operate machinery.

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.

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

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.

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.

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.

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.

Each 1 mL pre-filled syringe of Decapeptyl contains, as the activeingredient, 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.

Decapeptyl is distributed in Australia by:

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