Tirofiban

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tirofiban increases your risk of bleeding, which can be severe or life-threatening. Call your doctor or seek emergency medical attention if you have:

• easy bruising or bleeding (nosebleeds, bleeding gums);
• bleeding around your IV or catheter; or
• any bleeding that will not stop.

You may also have bleeding on the inside of your body, such as in your stomach or intestines. Call your doctor at once if you have bloody or tarry stools, or if you cough up blood or vomit that looks like coffee grounds. These could be signs of bleeding in your digestive tract.

Common side effects may include:

• dizziness;
• slow heart rate;
• leg pain, pelvic pain; or
• swelling, increased sweating.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• antiplatelets (a type of blood thinner) such as clopidogrel (Plavix), aspirin, prasugrel (Effient), ticagrelor (Brilinta), ticlopidine (Ticlid), abciximab (ReoPro), eptifibatide (Integrilin), tirofiban (Aggrastat), and cilostazol (Pletal)
• anticoagulant (blood thinner) medications such as warfarin (Coumadin, Jantoven), heparin, enoxaparin (Lovenox), fondaparinux (Arixtra), rivaroxaban (Xarelto), and apixaban (Eliquis) 
• Heparin
• Aspirin
• Thromolytic agesnts such as Alteplase (activase), Defibrotide, Reteplase (retavase) and Tenecteplase (TNKase).

This is not a complete list of tirofiban drug interactions. Ask your doctor or pharmacist for more information.

The dose your doctor recommends will be based on your weight and how well your kidneys work. 

In most patients, tirofiban should be injected into the vein at an initial rate of 0.4 µg/kg/min for 30 minutes and then continued at 0.1 µg/kg/min.

Non-ST-Segment-Elevation Acute Coronary Syndromes

Adjunct to anticoagulant therapy (e.g., heparin [referring throughout this monograph to unfractionated heparin], low molecular weight heparin), aspirin, and a P2Y12-receptor antagonist (e.g., clopidogrel, prasugrel, ticagrelor) to reduce risk of acute cardiac ischemic events (death and/or MI) in patients with non-ST-segment-elevation acute coronary syndromes (NSTE ACS) (i.e., unstable angina or non-ST-segment-elevation MI [NSTEMI]), including those who are to receive medical management or to undergo PCI.1 5 6 21 91 994 995 1100

Adjunctive therapy with a GP IIb/IIIa-receptor inhibitor can reduce the incidence of cardiac ischemic events, including subsequent MI and death, in patients with NSTE ACS.5 6 11 35 36 42 46 51 71 72 73 80 83 84 85 91

The American College of Cardiology Foundation (ACCF) and AHA recommend either clopidogrel or IV administration of a GP IIb/IIIa-receptor inhibitor in addition to aspirin therapy prior to diagnostic angiography (“upstream”) in patients in whom an initial invasive management strategy is planned; eptifibatide or tirofiban is the preferred GP IIb/IIIa-receptor inhibitor for this use.991

The American College of Chest Physicians (ACCP) states that a clear risk-benefit profile has not been established for the use of GP IIb/IIIa-receptor inhibitors in patients with ACS who are not routinely scheduled for early revascularization.1016

In patients undergoing PCI, ACCF, AHA, and the Society for Cardiovascular Angiography and Intervention (SCAI) state that administration of a GP IIb/IIIa-receptor inhibitor at the time of PCI may be used as an adjunct to heparin in those with high-risk features (e.g., elevated troponin) who are not receiving bivalirudin and are not adequately pretreated with clopidogrel.994

Regarding choice of GP IIb/IIIa-receptor inhibitor in patients undergoing PCI, IV abciximab, “double-bolus” IV eptifibatide, and high-dose tirofiban by direct IV injection all produce a high degree of platelet inhibition and reduce ischemic complications.994

Tirofiban and eptifibatide not recommended by AHA in women with NSTE ACS who are at lower risk for adverse events and are managed with a conservative strategy, because of little demonstrated benefit and possible detrimental effects.109

ACCF, AHA, SCAI, and other experts currently do not recommend routine use of GP IIb/IIIa-receptor inhibitors in patients with ST-segment-elevation MI (STEMI) undergoing PCI; however, selective use of these drugs as an adjunct to heparin may be reasonable in certain high-risk patients (e.g., those with large anterior MI and/or large thrombus).994 1016

• It is used during a heart treatment to protect the arteries.
• It is used to lower the chance of heart attack, the need for some heart treatments, or blockage of a stent after a stent is placed in the heart.
• It may be given to you for other reasons. Talk with the doctor.

• If you have an allergy to tirofiban or any other part of tirofiban.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have active bleeding or you are at risk for very bad bleeding.
• If you have had bleeding problems, an injury, or surgery in the last month.
• If you have ever had a low platelet count during past use of this medicine or another drug like this one.
• If you are breast-feeding. Do not breast-feed while you take tirofiban.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take tirofiban with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• If you fall or hurt yourself, or if you hit your head, call your doctor right away. Talk with your doctor even if you feel fine.
• If you are 65 or older, use tirofiban with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.

Use tirofiban as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Concentrate, Intravenous:

Aggrastat: 3.75 mg/15 mL (15 mL)

Solution, Intravenous:

Aggrastat: 5 mg/100 mL in NaCl 0.9% (100 mL); 12.5 mg/250 mL in NaCl 0.9% (250 mL)

Refer to adult dosing.

Concerns related to adverse effects:

• Bleeding: The most common complication is bleeding, including retroperitoneal, pulmonary, and spontaneous GI and/or GU bleeding; watch closely for bleeding, especially the arterial access site for the cardiac catheterization. Fatal bleeding has been reported. Use with extreme caution in patients with platelet counts <150,000/mm3, patients with hemorrhagic retinopathy, previous history of GI disease, recent thrombolytic therapy and in chronic dialysis patients. Use caution with administration of other drugs affecting hemostasis. Minimize other procedures including arterial and venous punctures, IM injections, nasogastric tubes, etc.

• Thrombocytopenia: Profound thrombocytopenia has been reported with use of tirofiban. If during therapy platelet count decreases to <90,000/mm3, monitor platelet counts to exclude pseudothrombocytopenia. If thrombocytopenia is confirmed, discontinue tirofiban and heparin if administered concurrently. Platelet counts should recover rapidly (within 1 to 5 days) after discontinuation. Previous exposure to a glycoprotein IIb/IIIa inhibitor may increase the risk of thrombocytopenia. Use is contraindicated in patients with a history of thrombocytopenia following exposure to tirofiban. Specific management guidelines for GP IIb/IIIa induced thrombocytopenia have been published (Huxtable 2006; Llevadot 2000).

Disease-related concerns:

• Renal impairment: Dosage reduction of the maintenance infusion rate is necessary in patients with CrCl ≤60 mL/minute.

Other warnings/precautions:

• Percutaneous coronary intervention: Sheath removal: Prior to pulling the sheath, ACT should be <180 seconds or aPTT <50 seconds (ACCF/AHA/SCAI [Levine, 2011]). Use standard compression techniques after sheath removal. Watch the site closely afterwards for further bleeding.

• Surgery: Discontinue at least 2 to 4 hours prior to coronary artery bypass graft surgery (ACC/AHA [Amsterdam 2014]; ACCF/AHA [Hillis, 2011]).

Data not available

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.