Consumer Medicine Information
ANGIOMAX®
Bivalirudin (Bye-val-eh-roo-din)
What is in this leaflet
This leaflet answers some common questions about ANGIOMAX®.
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 having ANGIOMAX® against the benefits they expect it will have for you.
If you have any concerns about this medicine, ask your doctor, nurse or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What ANGIOMAX® is used for
ANGIOMAX® (bivalirudin) is a medicine that stops blood clotting (an anticoagulant). It helps prevent unwanted blood clotting during an "angioplasty."
"Angioplasty" is the name of the medical procedure in which blocked blood vessels in the heart are unblocked. Angioplasty is also called "percutaneous coronary intervention (PCI)." Angioplasty improves blood flow in the heart. Angioplasty helps heart problems such as angina. Your doctor unblocks the blood vessels in the heart using a fine tube inserted through a blood vessel in the skin.
You need an anticoagulant during an angioplasty/PCI, to stop unwanted blood clotting.
Angiomax® may also be given to you in hospital before angioplasty/PCI.
Ask your doctor if you have any questions about why ANGIOMAX® has been prescribed for you.
There is no information from clinical studies on the safety and effectiveness of ANGIOMAX® in children.
ANGIOMAX® is a 'PRESCRIPTION ONLY MEDICINE'. Use only for the person for whom it has been prescribed.
How ANGIOMAX® works
A protein, called "thrombin", starts blood clotting.
ANGIOMAX® is an anticoagulant. It prevents blood clotting by stopping thrombin from working.
Before you use ANGIOMAX®
When you must not be given ANGIOMAX®
Your doctor should not use ANGIOMAX® if you are:
- allergic to ANGIOMAX®
- allergic to other ingredients in ANGIOMAX® (mannitol and sodium hydroxide)
- pregnant
- experiencing an active bleed
Symptoms of an allergic reaction may include:
- shortness of breath, tightness of the chest, wheezing or difficulty breathing
- swelling of the face, lips, tongue or other parts of the body
- skin rash, itching or hives
Before ANGIOMAX® is used
Before you are given ANGIOMAX®, it is important for your doctor to know if you have medical problems other than the one ANGIOMAX® is being used for.
Tell your doctor if you:
- tend to bleed or bruise easily
- have kidney or liver disease
- have uncontrolled high blood pressure
- have any other heart condition
- are breastfeeding
- are pregnant, or planning to become pregnant.
Your risk of bleeding may increase:
- if you have recently given birth or if you are pregnant
- if you are already taking medicines, especially blood-thinners/anticoagulants.
If you wish to become pregnant and you are having treatment with ANGIOMAX®, please first discuss this with your doctor.
Tell your doctor if you are using any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop.
What other products influence the effect of ANGIOMAX®
Before treatment with ANGIOMAX® is started, tell your doctor about any other medicines that you are using.
It may be necessary to change the dose or stop using one of the medicines. This applies to both prescription and non-prescription medicines, especially:
- other medicines used to stop blood clotting (anticoagulants), such as warfarin, or heparin (examples are Coumadin™, Clexane™, Fragmin™ or Heparin Injection BP)
- medicines which affect platelets. (Platelets are blood particles involved in clotting). Examples are aspirin (eg Disprin™), Ticlid™ (ticlopidine) or Plavix™ (clopidogrel)
- self-administered non-prescription medicines, such as St John's Wort, ginseng and ginkgo biloba.
What do you have to consider during pregnancy or while breast feeding
Generally, you should not be given ANGIOMAX® if you are pregnant because it might cause harm to your baby. However, if in your doctor's judgement, potential benefits outweigh possible risks, you may still be given ANGIOMAX®.
Because ANGIOMAX® could be excreted into breast milk, you should tell your doctor if you are breast feeding. If you are of child-bearing age, a pregnancy test may be done by your doctor to determine whether or not you are pregnant.
How will ANGIOMAX® be used
Your doctor will give you ANGIOMAX® into a vein as an injection and/or as a continuous infusion.
During percutaneous coronary intervention (PCI, angioplasty), ANGIOMAX® should be given with aspirin.
Your doctor will decide how much Angiomax® to give you.
If you have a kidney disease the doctor may change the usual dose.
Things you must not do
Do not give ANGIOMAX® to anyone else, even if they appear to have the same condition as you.
Side effects
Like all medicines, ANGIOMAX® can cause some side effects. Side effects not listed in this leaflet may occur in some patients.
Tell your doctor or pharmacist if you have any unpleasant effects while you are taking ANGIOMAX® even if you do not think the effect is connected with the medicine or it is not listed in this leaflet.
Ask your doctor or pharmacist to answer any questions you may have.
If any of the following happen, tell your medical or nursing staff immediately. (If you have been discharged from hospital, go to accident and emergency at your nearest hospital)
- swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing
- tightness of the chest, wheezing
- itchiness or hives.
These are very serious side effects. If you have them, you may have had a serious allergic reaction to ANGIOMAX®. You may need urgent medical attention or hospitalisation.
It is not known whether all of the following side effects are related to your general health, to ANGIOMAX® or to a combination of both.
ANGIOMAX® (like other anticoagulants), may have unwanted or excessive bleeding as a side effect.
The following unwanted effects have been observed with ANGIOMAX®:
Frequent
- Bleeding, for example at needle puncture wounds, into the urine, or bruising where the intravenous catheter was inserted.
Less frequent
- Bleeding from other parts of the body
- nausea
- headache
- vomiting
- trouble falling asleep
- low blood pressure
- high blood pressure
- fever
- pain, at injection site, chest or back
- heart beat too slow, or too fast
- shortness of breath, difficulty breathing
- skin rash
- anaemia, decreased platelets, blood vessel disorders
Very Rare
- Allergic reaction and shock (anaphylaxis)
- non-specified hypersensitivity.
If you notice any unwanted effects not mentioned in this leaflet, please inform your doctor, or pharmacist.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Product Description
ANGIOMAX® is a white sterile powder in single-use, glass vials.
- 100 mg Angiomax® Powder is in a 5mL vial. It is prepared for use by dissolving in 2mL of sterile Water for Injections. This provides a 50 mg/mL solution.
- 250 mg Angiomax® Powder is in a 10 mL vial. It is prepared for use by dissolving in 5mL of sterile Water for Injections. This provides a 50 mg/mL solution.
Ingredients
Active ingredients:
- 100mg or 250 mg of bivalirudin.
Other ingredients:
- Mannitol, Sodium hydroxide
ANGIOMAX® does not contain:
- Lactose
- Gluten
- preservative
Storing ANGIOMAX®
ANGIOMAX® is usually stored in the doctor's surgery or clinic.
Store below 25°C.
Keep ANGIOMAX® out of reach of children.
After ANGIOMAX® powder has been dissolved, use the solution as soon as possible.
NOTE: the dissolved ANGIOMAX® solution can be stored for up to 24 hours at between 2° and 8°C (the temperature of most standard refrigerators).
DO NOT FREEZE. Do not place in a freezer or freezing compartment of a refrigerator.
Note the expiry date on the pack. Do not use after this expiry date.
Further information
You can obtain more information from your doctor or pharmacist.
Australian Registration Numbers:
Angiomax® 100mg vial AUST R 102154
Angiomax® 250mg vial AUST R 102155
Angiomax® is distributed in Australia by:
CSL Limited
ABN 99 051 588 348
45 Poplar Road
Parkville 3052
Victoria
Australia
Angiomax® is distributed in New Zealand by:
CSL Biotherapies (New Zealand) Ltd
666 Great South Road
Penrose
Auckland
Telephone: 09 579 8105
Angiomax® is supplied by:
The Medicines Company
Parsippany, NJ 07054
United States of America
This leaflet was prepared in November 2008
® ANGIOMAX is a registered trademark of The Medicines Company.