Aggrastat (Cipher Pharmaceuticals): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

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 important nonmedicinal 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 forms 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.

In case of drug overdose, contact a health care practitioner or hospital emergency department immediately, even if there are no symptoms.

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.

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 IT

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

  (http://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

Last revised: July 24, 2018