Details for: AGGRASTAT
Company: CIPHER PHARMACEUTICALS INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02240706 | AGGRASTAT | TIROFIBAN (TIROFIBAN HYDROCHLORIDE) | 12.5 MG / 250 ML | SOLUTION | INTRAVENOUS |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
AGGRASTAT® is used to help assist the blood flow to your heart
and to help prevent chest pain and heart attacks.
This medicine may also be used in patients whose heart vessels are
dilated with a balloon (percutaneous coronary intervention or PCI).
This is a procedure, possibly with implantation of a small tube
(stent), to improve the blood flow to the heart.
AGGRASTAT® is intended for use with aspirin and heparin.
What it does
It works by preventing platelets, cells found in the blood, from forming blood clots.
When it should not be used
- if you are allergic (hypersensitive) to tirofiban or any of the other ingredients of AGGRASTAT® Solution for Infusion,
- if you are bleeding internally or have a history of bleeding internally within the last 30 days,
- if you have a history of bleeding in the brain, brain tumor or abnormal blood vessels in the brain,
- if you have severe uncontrolled high blood pressure (malignant hypertension),
- if you have a low blood platelet count (thrombocytopenia) or problems with blood clotting,
- if you developed thrombocytopenia if you had received treatment with AGGRASTAT® Solution for Infusion or another medicine in the same group of drugs previously,
- if you have a history of stroke within the last 30 days or any history of stroke with bleeding,
- if you have been seriously injured or had a major operation within the previous 6 weeks,
- if you have severe liver disease (cirrhosis),
- if you have a history or symptoms of splitting of the aorta (aortic dissection),
- if you have an inflammation of the lining around your heart (pericarditis),
- if you have had a recent spinal procedure, or had a special intravenous line inserted under your collar bone within the last 24 hours,
- if you have a treatment with another GP IIb/IIIa inhibitor such as abciximab,
- if you have chest pain caused by irregular heartbeat, low levels of red blood cells (anemia), excessive sweating or low blood pressure.
What the medicinal ingredient is
tirofiban hydrochloride
What the non-medicinal ingredients are
Citric acid anhydrous,
Sodium citrate dihydrate
Sodium chloride
For a full listing of nonmedicinal ingredients see Part 1 of the
product monograph.
What dosage form it comes in
Solution for Infusion
Warnings and precautions
Serious Warnings and Precautions
AGGRASTAT® is intended for use in combination with anticoagulants (e.g. heparin) and other antiplatelet therapies, including ASA. Caution should be employed when used with other drugs that affect bleeding.
BEFORE you use AGGRASTAT® Solution for Infusion, talk to your doctor or pharmacist if:
- You have an inflammation of the blood vessels (vasculitis),
- You have problems with the blood vessels in the back of your eye (retina),
- You have a treatment with medications that help to prevent or dissolve blood clots like warfarin,
- You have kidney problems,
- You have heart failure,
- You have very low blood pressure due to a failing heart (cardiogenic shock),
- You have a liver disorder,
- You have a low blood count or anemia,
- You have been seriously injured or had a major operation within the last 3 months,
- You have had cardiopulmonary resuscitation (CPR), a biopsy, or a procedure to break up kidney stones within the last 2 weeks,
- You have had an ulcer in the stomach or intestine (duodenum) within the last 3 months,
- You have had a recent bleeding disorder (within 1 year) such as bleeding in the stomach or intestine, or blood in your urine or stool,
- You have had a cerebrovascular disease like a stroke in the last year,
- You are being treated with non-thienopyridines P2Y12 inhibitors, adenosine, dipyridamole, sulfinpyrazone, and prostacyclin,
- You had been treated with balloon pump in your aorta, a vessel in your heart,
- You have clotting problems,
- You have a low blood platelet count,
- You are on chronic hemodialysis,
- You have had a puncture of a blood vessel within 24 hours and the bleeding cannot be stopped.
Interactions with this medication
Drugs that may interact with AGGRASTAT® Solution for Infusion include other medicines that help prevent your blood from clotting such as warfarin.
Proper use of this medication
Usual dose
Your doctor will decide on the appropriate dose, depending on your condition and your weight.
Overdose
The most frequently reported symptom of overdose is bleeding.
Side effects and what to do about them
The most common side effect of treatment with AGGRASTAT®
Solution for Infusion is bleeding which could occur anywhere in the
body. This can become serious and may, rarely, be fatal.
Very common side effects include bleeding after surgery, bleeding
under the skin at the site of an injection, or into a muscle, causing
swelling, small red bruises on the skin, invisible blood in urine or
stool, feeling sick, headache.
Common side effects include nose bleeds, bleeding in the gums and
mouth, bleeding from vessel puncture site, reduction in red blood
cells (reduced haematocrit and haemoglobin), decrease in platelet
count below 90,000/mm3, fever.
Uncommon side effects include bleeding in the stomach or
intestines, vomiting of blood, decrease in platelet count below
50,000/mm3.
Other side effects include haematoma in the spinal region, bleeding
in the abdomen of the internal organs, accumulation of blood around
the heart, bleeding in the lung, acute and/or severe decreases in
platelet counts below 20,000/mm3.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| - signs of internal bleeding / coughing up blood or blood in your urine or stool | ✔ | ||
| Not known frequency | |||
| - bleeding in the skull / pain in the head, sensory impairments (visual or hearing), difficulties in speech, numbness or problems with movement or balance | ✔ | ||
| - severe allergic reactions / tightness of chest, hives or nettle rash, including reactions that cause difficulty in breathing and dizziness | ✔ | ||
These are not all the possible side effects you may feel when taking AGGRASTAT® Solution for Infusion If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
Store between 15-30°C.
Do not freeze.
Keep container in foil overpouch to protect from light during
storage.
Keep out of reach and sight of children.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for
health professionals can be found at:
http://www.cipherpharma.com or by contacting the sponsor,
Cipher Pharmaceuticals Inc. at:
1-866-992-2749
This leaflet was prepared by Cipher Pharmaceuticals Inc.
Last revised: July 24, 2018