Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I being given INTEGRILIN?
INTEGRILIN contains the active ingredient eptifibatide and works by helping to prevent
blood clots by stopping the platelets in the blood from sticking together.
INTEGRILIN is used in people with unstable angina (chest pain) to help prevent heart
attack and possible death as well as to prevent the formation of blood clots when
people have a surgical procedure (percutaneous coronary intervention) to open an artery
and insert a tube (stent).
For more information, see Section
1. Why am I being given INTEGRILIN? in the full CMI.
2. What should I know before I am given INTEGRILIN?
Do not use if you have ever had an allergic reaction to eptifibatide or any of the
ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section
2. What should I know before I am given INTEGRILIN? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with INTEGRILIN and affect how it works. A list of these
medicines is in Section
3. What if I am taking other medicines? in the full CMI.
Tell your doctor if you are taking any medicines to thin your blood, to prevent blood
clots, or to dissolve clots.
4. How is INTEGRILIN given?
INTEGRILIN is given in hospital by an injection into a vein followed by an intravenous
drip (infusion). The infusion usually lasts for up to 3 or 4 days.
The dose given is based on your weight. Your doctor or hospital pharmacist will work
out the correct dose for you.
You may also be given aspirin and heparin.
5. What should I know while being given INTEGRILIN?
|
Looking after your medicine
|
INTEGRILIN is stored in a hospital.
Keep INTEGRILIN refrigerated at 2°C to 8°C. Do not freeze INTEGRILIN.
INTEGRILIN should be protected from light until it is administered.
|
6. Are there any side effects?
The most common side effect experienced by people using this medicine is bleeding.
During the administration of INTEGRILIN, the following effects have also occurred
in some patients: low blood pressure, abnormal fast heartbeat, congestive heart failure
(disease of the heart with shortness of breath or swelling of the feet or legs due
to build-up of fluid), heart attack, shock, swelling and tenderness around a vein,
low number of platelets in blood, decreased blood flow to brain, nausea, headache,
fever, general body pain, stomach pain and chest pain.
Active ingredient:
eptifibatide
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using INTEGRILIN. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using INTEGRILIN.
Where to find information in this leaflet:
1. Why am I being given INTEGRILIN?
INTEGRILIN contains the active ingredient eptifibatide.
INTEGRILIN works by helping to prevent blood clots by stopping the platelets in the
blood from sticking together.
INTEGRILIN is used in people with unstable angina (chest pain) to help prevent heart
attack and possible death.
Angina is a pain or uncomfortable feeling in the chest, often spreading to the arms
or neck and sometimes to the shoulders and back. This may be caused by too little
blood and oxygen getting to the heart.
INTEGRILIN is also used to prevent the formation of blood clots when people have a
surgical procedure (percutaneous coronary intervention) to open an artery and insert
a tube (stent).
Your doctor, however, may prescribe INTEGRILIN for another purpose.
Ask your doctor if you have any questions about why INTEGRILIN has been prescribed
for you.
2. What should I know before I am given INTEGRILIN?
Warnings
Do not use INTEGRILIN if:
you are allergic to eptifibatide, or any of the ingredients listed at the end of this
leaflet. Always check the ingredients to make sure you can use this medicine.
you have any of these medical conditions:
a blood clotting disorder or a very low platelet count
a bleeding disorder or you tend to bleed easily
very high blood pressure
severe liver problems or you require dialysis
you have had any of these medical conditions:
any internal bleeding (except for menstrual bleeding) in the last month, such as from
an ulcer or blood in the urine or bowel motions
a stroke as a result of bleeding in the brain
any other stroke in the last month
surgery or severe injury in the last six weeks
any brain tumour or a condition that affects the blood vessels around the brain
your doctor is going to use either of the following types of medicines:
another injection of the same type as INTEGRILIN
medicines used to destroy or dissolve blood clots
Check with your doctor if you:
you have any other medical conditions including liver or kidney problems or problems
with bleeding or blood clots.
You are pregnant or planning to become pregnant.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Do not use INTEGRILIN if you are pregnant unless you and your doctor have discussed
the risks and benefits involved.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
If you are breastfeeding, stop breastfeeding while you are being treated with INTEGRILIN.
Children
INTEGRILIN should not be used in children.
Addiction
There is no evidence that INTEGRILIN is addictive.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Tell your doctor if you are taking any medicines to thin your blood, to prevent blood
clots or to dissolve clots.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect INTEGRILIN.
4. How is INTEGRILIN given?
How is it given
INTEGRILIN is given in hospital by an injection into a vein followed by an intravenous
drip (infusion). The infusion usually lasts for up to 3 or 4 days.
The dose given is based on your weight. Your doctor or hospital pharmacist will work
out the correct dose for you.
You may also be given aspirin and heparin.
If you are given too much INTEGRILIN
If you get too much INTEGRILIN, it could cause bleeding. If this happens the intravenous
drip may need to be stopped. Usually, this will be enough to handle the overdose.
However, if necessary, a blood transfusion may be given.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while being given INTEGRILIN?
Looking after your medicine
INTEGRILIN is typically stored in a hospital.
Keep INTEGRILIN refrigerated at 2°C to 8°C. Do not freeze INTEGRILIN.
INTEGRILIN should be protected from light until it is administered.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
Tell your doctor, nurse or hospital pharmacist as soon as possible if you do not feel
well while you are being given INTEGRILIN.
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
While INTEGRILIN is being used, you will be checked for any signs of unusual or unexpected
bleeding.
INTEGRILIN may also cause stinging or redness at the site of injection.
Most common side effects
Other Undesirable Side Effects
It is not possible to know whether these effects are related to INTEGRILIN or to the
condition INTEGRILIN is used to treat. However, these effects can occur in this condition
even without the use of INTEGRILIN.
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What INTEGRILIN contains
|
Active ingredient
(main ingredient)
|
eptifibatide (as eptifibatide acetate)
|
|
Other ingredients
(inactive ingredients)
|
citric acid
sodium hydroxide
water for injections
|
Do not take this medicine if you are allergic to any of these ingredients.
What INTEGRILIN looks like
INTEGRILIN is a clear colourless liquid for injection. It comes in vials in two strengths:
INTEGRILIN (eptifibatide 20mg in 10mL) Injection (AUST R 71540)
INTEGRILIN (eptifibatide 75mg in 100mL) Infusion (AUST R 71541)
Who distributes INTEGRILIN
Merck Sharp & Dohme (Australia) Pty Limited
Level 1, Building A, 26 Talavera Road,
Macquarie Park NSW 2113, Australia
This leaflet was prepared in February 2022.
RCN: 000022580
Copyright © (2021) Merck & Co., Inc., Kenilworth, NJ, USA, and its affiliates. All
rights reserved.