Gonapeptyl Injection 5ml

Introduction About GONAPEPTYL INJECTION

GONAPEPTYL INJECTION contains Triptorelin which belongs to the group of
medicines called Gonadotropin-releasing hormone (GnRH) agonists. It is used for
the downregulation and management of premature luteinizing hormone (LH) surges
(a rapid increase of a hormone called luteinizing hormone in women’s bloodstream
prior to the release of ova or egg cells from the ovary) in women undergoing
controlled ovarian hyperstimulation (techniques that involve the use of
medicines for induction of ovulation) used for assisted reproductive
technologies (to manage infertility).

GONAPEPTYL INJECTION is not recommended for use if you have severe allergic
conditions. GONAPEPTYL INJECTION should be used with caution in patients with
mild to severe liver disease, mood changes and depression. Consult your doctor
before receiving it.

GONAPEPTYL INJECTION is not recommended for use in pregnant and breastfeeding
women. The most common side effects of receiving GONAPEPTYL INJECTION are
headache, vaginal bleeding or spotting, and inflammation at the site of
injection. Contact your doctor if any of the symptoms worsen.

Uses Of GONAPEPTYL INJECTION

• For downregulation and management of premature luteinizing hormone (LH) surges

How GONAPEPTYL INJECTION Works

GONAPEPTYL INJECTION is a synthetic analogue of the natural
gonadotrophin-releasing hormone (GnRH). GnRH regulates the release of
gonadotrophins (sex hormones: luteinising hormone (LH) and follicle-stimulating
hormone (FSH)).

GONAPEPTYL INJECTION blocks GnRH action, thereby reducing the levels of LH and
FSH (so-called downregulation). This results in the management of the release of
egg cells (premature ovulation).

How to use GONAPEPTYL INJECTION

GONAPEPTYL INJECTION will be given to you only by a doctor or a nurse as a
subcutaneous injection under the skin of your lower abdomen. Your doctor will
decide the correct dose and duration for you depending on your age, body weight
and disease condition.

Do not stop using GONAPEPTYL INJECTION unless your doctor advised you to stop.
Otherwise, if you stop this medicine too quickly it will decrease your chances
on getting pregnant.

Side Effects Of GONAPEPTYL INJECTION

Common

• headache
• vaginal bleeding/spotting
• inflammation at the injection site
• infection of the upper respiratory tract, pharyngitis (sore throat)
• hot flushes
• flu-symptoms
• dizziness
• back pain
• abortion
• overstimulation of the ovaries
• pelvic pain
• ovarian cysts
• pain during menstruation
• pain or other reactions at the injection site
• tiredness

Uncommon

• mood changes, depression

Rare

Stop receiving GONAPEPTYL INJECTION and contact your doctor immediately if you
experience any of the following side effects:

• symptoms of brain bleeding (pituitary apoplexy) such as sudden headache, vomiting or visual disturbances
• abdominal pain or swelling in the abdomen, nausea, vomiting, diarrhoea
• weight gain
• difficulty breathing
• decreased urination

How To Manage Side Effects

Headache:

Rest and relax. Drink plenty of fluids such as water or ORS (Oral Rehydrating
Solution) and apply a pain-relieving balm on the head if necessary. Contact your
doctor if your headache did not improve.

Nausea and vomiting:

Receive GONAPEPTYL INJECTION, with or just after a meal. Stick to simple meals.
Avoid eating oily or spicy food. Contact your doctor if your nausea and vomiting
did not improve.

Stomach pain:

Try to have smaller meals but take them frequently. Keep a heating pad on your
stomach. Do not self-manage and contact your doctor if the stomach pain did not
improve.

Dizziness:

Try to rest and relax. Get enough sleep. Avoid driving or operating any machines
while you are feeling dizzy. Do not drink alcohol, as it can aggravate your
dizziness. Contact your doctor if your dizziness did not improve.

Diarrhoea:

Drink lots of fluids, such as water or fruit juices to keep yourself hydrated.
Do not take any medicine on your own for managing diarrhoea. Contact your doctor
if your diarrhoea did not improve.

Warning & Precautions

!### Pregnancy

GONAPEPTYL INJECTION is not recommended for use in pregnant women. If you become
pregnant during management, do not receive this medicine and consult your doctor
for advice.

Non-hormonal contrace
during management with GONAPEPTYL INJECTION and until menses resume.

!### Breastfeeding

GONAPEPTYL INJECTION is not recommended for use in breastfeeding women. Consult
your doctor before receiving it.

!### Driving and Using Machines

Do not drive or operate any machines if you experience dizziness, sleepiness or
visual disturbances after receiving GONAPEPTYL INJECTION.

!### Alcohol

Inform your doctor if you drink large amount of alcohol since it increases the
risk of osteoporosis (weak and brittle bones).

!### Kidney

GONAPEPTYL INJECTION can be used safely in patients with kidney disease with no
dose adjustment. Consult your doctor before receiving it.

!### Liver

GONAPEPTYL INJECTION should be used with caution in patients with mild to severe
liver disease. Consult your doctor before receiving it.

!### Allergy

Do not receive GONAPEPTYL INJECTION if you are allergic to Triptorelin or GnRH
or its analogues or any of the other ingredients of this medicine.

Others

GONAPEPTYL INJECTION is not recommended for you, if you:

• have severe allergic conditions

Before receiving GONAPEPTYL INJECTION inform your doctor if you:

• suffer from mood changes or depression
• have increased risk of osteoporosis such as family history of osteoporosis
• suffer from malnutrition Ex. anorexia nervosa
• are a heavy smoker
• have allergic reactions in the past

Use in pediatrics:

There is no information of GONAPEPTYL INJECTION in children.

Interactions

A. Drug - Drug interactions:

Before receiving GONAPEPTYL INJECTION, inform your doctor if you are taking any
of the following medicines:

• anticonvulsants Ex. lamotrigine (used to manage fits)
• corticosteroids Ex. hydrocortisone (used to manage inflammatory conditions)
• medicines affecting pituitary secretion of gonadotrophins Ex. Goserelin (used to manage breast and prostate cancer)

Overdosage:

GONAPEPTYL INJECTION will be administered to you only by a doctor or a nurse in
a hospital and so it is unlikely to receive an overdose. However, consult your
doctor or nurse if you experience any unusual symptoms.

Synopsis

Drug	:	Triptorelin
Pharmacological Category	:	Gonadotropin-releasing hormone (GnRH) agonists
Therapeutic Indication	:	Downregulation and management of premature LH surges
Dosage Forms	:	Injection

More Information

• Keep GONAPEPTYL INJECTION out of reach of children
• Store GONAPEPTYL INJECTION in a refrigerator 2-8°C

FAQs About GONAPEPTYL INJECTION

Does GONAPEPTYL INJECTION cause depression?

There have been reports of depression in patients receiving GONAPEPTYL INJECTION
which may be severe. If you are receiving GONAPEPTYL INJECTION and develop
depressed mood, inform your doctor.

Is GONAPEPTYL INJECTION safe and effective?

Undergoing infertility management with hormones like this medicine can increase
the risk of ectopic pregnancy (pregnancy outside of the womb) if you have a
history of fallopian tube disease, miscarriage, multiple pregnancies (twins,
triplets, etc.), congenital malformations (physical defects present in a baby at
birth). Contact your doctor before receiving it.

Does GONAPEPTYL INJECTION cause ovarian cysts?

Ovarian cysts may occur during the initial phase of management with GnRH
agonist. They are usually asymptomatic and non-functional. Contact your doctor
before receiving it.

Can GONAPEPTYL INJECTION be used in pregnancy?

GONAPEPTYL INJECTION is not recommended for use in women who are pregnant or
think they might be pregnant. A pregnancy should be first checked by your
doctor. If you find out that you are pregnant during management, do not continue
the management and contact your doctor for advice. During management with
GONAPEPTYL INJECTION, use non-hormonal contrace
diaphragm and until menses return.

Can GONAPEPTYL INJECTION cause a headache?

Yes. Headache is a common side effect of GONAPEPTYL INJECTION. Rest and relax.
Drink plenty of fluids such as water or ORS (Oral Rehydrating Solution) and
apply a pain-relieving balm on the head if necessary. Contact your doctor if
your headache did not improve.

Can I stop receiving GONAPEPTYL INJECTION?

Do not stop receiving GONAPEPTYL INJECTION without consulting your doctor. If
you suddenly stop, it will lower your chances on getting pregnant. If you have
any more doubts regarding the use of this medicine, ask your doctor.

Useful Diagnostic Tests

• Ultrasound scan
• Complete blood count