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 GLYPRESSIN?
GLYPRESSIN is used to treat Bleeding Oesophageal Varices (BOV) bleeding veins in the
lower end of the food pipe in people with serious liver disease. GLYPRESSIN is also
used to treat hepatorenal syndrome, type 1 (HRS-1) when a patient with HRS-1 is being
considered for a liver transplant. HRS-1 is a life- threatening complication in which
the kidneys suddenly fail to work in a person with severe liver disease. GLYPRESSIN
contains the active ingredient terlipressin, which is similar to the hormone vasopressin.
2. What should I know before being given GLYPRESSIN?
Do not use GLYPRESSIN if you have ever had an allergic reaction to terlipressin, or
to any of the ingredients listed at the end of the CMI. (see Section
7. Product details in the full 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.
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.
4. How will I be given GLYPRESSIN?
GLYPRESSIN is a medicine that is used in hospital and should only be administered
by your doctor or nurse.
Your doctor will give you the correct amount of GLYPRESSIN. Your doctor may adjust
the dose depending on how you are responding to the treatment.
Instructions for proper use of the drug intended for your doctor or nurse are included
in the package insert.
5. What should I know while being given GLYPRESSIN?
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Things you should do
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Tell any doctor, dentist or pharmacist you visit that you are being given GLYPRESSIN.
Be sure to keep all your doctor's appointments. Your doctor will want to do blood
and other tests regularly to check on your progress and detect any unwanted side effects.
If you become pregnant while you are being given this medicine, stop taking/using
it and tell your doctor, nurse or pharmacist immediately.
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6. Are there any side effects?
All medicines can have side effects. Most of them are minor and temporary but some
may need medical attention.
Tell your doctor if you experience any side effects including rash, itching or hives
on the skin, swelling of the face, lips, tongue or other parts of the body, shortness
of breath, wheezing or difficulty breathing, abnormal heart rhythm and fatigue which
may result in developing serious life-threatening conditions (e.g. heart attack).
These are very serious side effects. You may need urgent medical attention.
Active ingredient:
terlipressin (as terlipressin acetate)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using GLYPRESSIN. 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 GLYPRESSIN.
Where to find information in this leaflet:
1. Why am I being given GLYPRESSIN?
GLYPRESSIN is used in the treatment of Bleeding Oesophageal Varices (BOV) and in the
treatment of hepatorenal syndrome, type 1 (HRS-1) when a patient with HRS-1 is being
considered for a liver transplant.
GLYPRESSIN contains the active ingredient terlipressin, which is similar to a natural
human hormone vasopressin.
GLYPRESSIN is used to treat Bleeding Oesophageal Varices (BOV), bleeding veins in
the lower end of the food pipe in people with serious liver disease. When the liver
is diseased, there is less blood flowing through it. This causes the blood to 'back
up' in the veins in the lower end of the food pipe (and upper part of the stomach).
The veins in the lining of the food pipe (and stomach) then become very large and
stretched, much like varicose veins. Because the veins are also very fragile, they
can rupture and then bleed severely into the stomach. GLYPRESSIN acts to stop the
bleeding by lowering the blood pressure in the veins of the food-pipe.
GLYPRESSIN is also given when a patient with hepatorenal syndrome, type 1 (HRS-1)
is being considered for a liver transplant. HRS-1 is a life- threatening complication
in which the kidneys suddenly fail to work in a person with severe liver disease.
The cause of HRS-1 is not fully understood. It is thought to be due to the kidneys
drastically reducing their own blood flow, in response to large changes in blood flow
in other parts of the body caused by severe liver disease. GLYPRESSIN works in HRS-1
by improving the blood flow in the kidneys.
2. What should I know before being given GLYPRESSIN?
Warnings
GLYPRESSIN should not be used if:
you are allergic to terlipressin, 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 are pregnant or breastfeeding.
you currently have heart disease or have recently had heart disease.
Tell your doctor if you:
have or have had any other medical conditions, especially the following:
heart disease, including previous heart attack
high blood pressure
irregular heartbeat
blood circulation problems, including diseases affecting the blood vessels in the
brain or limbs
obesity
severe asthma or chronic obstructive pulmonary disease (COPD)
kidney problems
you are on a controlled sodium diet (this medicine contains 1.33 mmol (or 30.7 mg)
of sodium per ampoule).
take any medicines for any other condition.
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
Do not use GLYPRESSIN if you are pregnant or breastfeeding.
It may affect you and your developing baby if you use it during pregnancy. Talk to
your doctor immediately if you become pregnant while using GLYPRESSIN.
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.
Some medicines may interfere with GLYPRESSIN and affect how it works.
Medicines that have their heart rate lowering effect
increased
when taken with GLYPRESSIN include:
some beta blockers used to treat high blood pressure and certain heart conditions.
other medicines which slow your heart rate such as propofol, a short-acting anaesthetic.
sufentanil, a powerful opioid painkiller (not available in Australia).
GLYPRESSIN may
trigger
irregular beating of the heart when taken with:
quinidine, procainamide, disopyramide (known as Class 1A anti-arrhythmic medicines)
amiodarone, sotalol, ibutilide, dofetilide (known as Class III anti-arrhythmic medicines)
erythromycin, an antibiotic
medicines used to treat allergies and may also be found in certain cough and cold
remedies (known as antihistamines)
some anti-depressants (known as tricyclic antidepressants)
medicines that may change the level of salt or electrolytes in your blood, such as
diuretics or "fluid" medicines (medicines used to treat high blood pressure and heart
failure).
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect or are affected by GLYPRESSIN.
4. How will I be given GLYPRESSIN?
How much you will be given
GLYPRESSIN is a medicine that is used in hospital and should only be administered
intravenously by your doctor or nurse
Your doctor will give you the correct amount of GLYPRESSIN
Your doctor may adjust the dose depending on how you are responding to the treatment
Instructions for proper use of the drug intended for your doctor or nurse are included
in the package insert.
When you will be given GLYPRESSIN
When treating BOV, GLYPRESSIN should not continue for more than 48 hours in total.
When treating HRS-1, GLYPRESSIN is usually used for 7-10 days (10 days on average).
How GLYPRESSIN is given
GLYPRESSIN will be given to you by injection in one of your veins.
If you are given too much GLYPRESSIN
As GLYPRESSIN is given to you by a nurse and under the supervision of your doctor,
it is very unlikely that you will receive too much.
However, if you experience any side effects after you are discharged, 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.
If you are given too much GLYPRESSIN, you may experience any of the following:
increased blood pressure
faster heart beats
headache
pale skin
blue lips and fingernails
stomach pain or discomfort
nausea
diarrhoea.
5. What should I know while being given GLYPRESSIN?
Things you should do
Call your doctor straight away if you:
Be sure to keep all your doctor's appointments. Your doctor will want to do blood and other tests regularly to check on your progress
and detect any unwanted side effects.
If you become pregnant while you are being given this medicine, tell your doctor,
nurse or pharmacist immediately.
Remind any doctor, dentist or pharmacist you visit that you have been given GLYPRESSIN.
6. Are there any side effects?
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.
Side effects*
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Side effects
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What to do
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Very common side effects (affect more than 1 in 10 users):
difficulty breathing**
stomach (abdominal) pain or discomfort
Common side effects (affect at least 1 in 100 and less than 1 in 10 users):
low blood sodium concentration
headache
chest pain
slow or fast heartbeat
constriction of blood vessels
pale skin
increased blood pressure
blueish colouration of skin and lips
difficulty breathing***
diarrhoea
nausea or vomiting
Uncommon side effects (affect at least 1 in 1000 and less than 1 in 100 users):
abnormal heart rhythm
hot flushes
Side effect with unknown frequency:
uterine constriction (constriction of the womb)
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Speak to your doctor if you have any of these side effects and they worry you.
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Serious side effects*
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Serious side effects
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What to do
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Allergic reaction:
rash, itching or hives on the skin
swelling of the face, lips, tongue or other parts of the body
shortness of breath, wheezing or difficulty breathing
Myocardial infarction, also known as a heart attack, is a condition when your heart
muscle begins to die because it isn't getting enough blood flow (uncommon)
Heart failure (uncommon)
Respiratory failure is a condition when your lungs are not able to get enough oxygen
into your blood (very common)**(uncommon)***
Intestinal ischaemia is a condition when there is reduced blood flow to the intestines
(uncommon)
Uterine ischaemia is a condition where there is decreased blood flow to the uterus
(frequency unknown)
Sepsis/Septic shock is a condition when the body's immune response to an infection
causes damage to its own tissue and organs (common)**
Skin necrosis and injection site necrosis are conditions when skin tissue begins to
die (uncommon)
Severe and persistent irregular heart rhythm, including Torsade de Pointes (uncommon)
Pulmonary oedema is a condition where there is excess fluid in the lungs (common)**
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Call your doctor straight away or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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*Side effects and how often they occur can depend on what you are being given GLYPRESSIN
for.
** Applicable to HRS-1
***Applicable to BOV
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 GLYPRESSIN contains
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Active ingredient
(main ingredient)
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terlipressin (as terlipressin acetate)
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Other ingredients
(inactive ingredients)
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sodium chloride
acetic acid
sodium acetate trihydrate
water for Injections
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Do not take this medicine if you are allergic to any of these ingredients.
What GLYPRESSIN looks like
GLYPRESSIN is given as intravenous injection.
GLYPRESSIN is a clear and colourless solution in an ampoule, containing 8.5mL of GLYPRESSIN
solution. It is supplied in a box containing 5 ampoules (AUST R 177708).
Who distributes GLYPRESSIN
GLYPRESSIN is distributed in Australia by:
Ferring Pharmaceuticals Pty Ltd
Suite 2, Level 1, Building 1
20 Bridge Street, Pymble, NSW 2073
GLYPRESSIN is a registered trademark of Ferring.
This leaflet was prepared in November 2023.
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