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Aggrastat

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Aggrastat

Aggrastat Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Aggrastat (tirofiban hydrochloride) is used to prevent blood clots or heart attack in people with severe chest pain or other conditions, and in those who are undergoing an angioplasty procedure (to open blocked arteries). It keeps platelets in the blood from coagulating (clotting) to prevent blood clots. Common side effects include nausea, stomach pain, runny or stuffy nose, cough, sore throat, or mild headache or dizziness.

Aggrastat is administered intravenously in a clinical setting, at an initial rate of a 0.4 mcg/kg/min dose for 30 minutes and then continued at 0.1 mcg/kg/min. Aggrastat may interact with phenytoin, tamoxifen, tolbutamide, torsemide, fluvastatin, blood thinners, or other medications used to prevent blood clots. Tell your doctor all medications you use. Tell your doctor if you are pregnant or plan to become pregnant during treatment with Aggrastat and aspirin. Aggrastat is not expected to be harmful to a fetus. However, aspirin is sometimes given with Aggrastat, and aspirin can cause bleeding when taken during the last 3 months of pregnancy. Aspirin can also cause side effects in a newborn baby. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breast-feeding.

Our Aggrastat (tirofiban hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Aggrastat in Detail - Patient Information: Side Effects

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

Call your doctor at once if you have any of these serious side effects:

  • nosebleed or other bleeding that will not stop;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • fever, chills, body aches, flu symptoms; or
  • pale skin, easy bruising or bleeding, weakness, fever, and urinating more or less than usual.

Less serious side effects may also occur, such as:

  • nausea, stomach pain;
  • runny or stuffy nose, cough, sore throat; or
  • mild headache or dizziness.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Aggrastat (Tirofiban HCl) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Aggrastat Overview - Patient Information: Side Effects

SIDE EFFECTS: Consult your pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Aggrastat (Tirofiban HCl)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Aggrastat FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In the PRISM (Platelet Receptor Inhibition for Ischemic Syndrome Management), PRISM-PLUS (Platelet Receptor Inhibition for Ischemic Syndrome Management - Patients Limited by Unstable Signs and Symptoms) and RESTORE (Randomized Efficacy Study of Tirofiban for Outcomes and Restenosis) trials, 1946 patients received AGGRASTAT in combination with heparin and 2002 patients received AGGRASTAT alone for about 3 days. Forty-three percent of the population was > 65 years of age and approximately 30% of patients were female. In clinical studies with the recommended regimen (25 mcg/kg bolus followed by a 0.15 mcg/kg/min maintenance infusion), AGGRASTAT was administered in combination with aspirin, clopidogrel and heparin or bivalirudin to over 8000 patients for typically ≤ 24 hours. Approximately 30% of the population was > 65 years of age and approximately 25% were female.

Bleeding

PRISM-PLUS Regimen

The incidences of major and minor bleeding using the TIMI criteria in the PRISM-PLUS study are shown below.

Table 2 : TIMI Major and Minor Bleeding in PRISM-PLUS

Bleeding (TIMI Criteria)‡ § AGGRASTAT* + heparin
(N=773)
Heparin alone
(N=797)
Major Bleeding 1.4% 0.8%
Minor Bleeding 10.5% 8.0%
Transfusions 4.0% 2.8%
* 0.4 mcg/kg/min initial infusion; 0.10 mcg/kg/min maintenance infusion.
‡ Major = Hemoglobin drop of > 5.0 g/L with or without an identified site, intracranial hemorrhage, or cardiac tamponade.
§ Minor = Hemoglobin drop of > 3.0 g/L with bleeding from a known site, spontaneous gross hematuria, hematemesis or hemoptysis. The incidence rates of TIMI major bleeding in patients undergoing percutaneous procedures in PRISM-PLUS are shown below.

Table 3 : TIMI Major Bleeding Associated with Percutaneous Procedures in PRISM-PLUS

  AGGRASTAT+ heparin Heparin alone
N % N %
Prior to Procedures 773 0.3 797 0.1
Following Angiography 697 1.3 708 0.7
Following PTCA 239 2.5 236 2.2

The incidence rates of TIMI major bleeding in patients undergoing coronary artery bypass graft surgery (CABG) in PRISM-PLUS within one day of discontinuation of AGGRASTAT were 17% on AGGRASTAT plus heparin (N=29) and 35% on heparin alone (N=31).

Recommended (“High-Dose Bolus”) Regimen

Rates of major bleeds (including any intracranial, intraocular or retroperitoneal hemorrhage, clinically overt signs of hemorrhage associated with a drop in hemoglobin of > 3 g/dL or any drop in hemoglobin by 4g/dL, bleeding requiring transfusion of > 2U blood products, bleeding directly resulting in death within 7 days or hemodynamic compromise requiring intervention) were consistent with the rates observed in subjects administered the PRISM-PLUS regimen of AGGRASTAT. There was a trend toward greater bleeding in ST segment elevation myocardial infarction (STEMI) patients treated with fibrinolytics prior to administration of AGGRASTAT using the recommended regimen during rescue PCI.

Non-Bleeding

The incidences of non-bleeding adverse events that occurred at an incidence of > 1% and numerically higher than control, regardless of drug relationship, are shown below:

Table 4 : Non-bleeding Adverse Reactions in PRISM-PLUS

  AGGRASTAT + heparin
(N=1953)
%
Heparin alone
(N=1887)
%
Body as a Whole
  Edema/swelling 2 1
  Pain, pelvic 6 5
  Reaction, vasovagal 2 1
Cardiovascular System
  Bradycardia 4 3
  Dissection, coronary artery 5 4
Musculoskeletal System
  Pain, leg 3 2
Nervous System/Psychiatric
  Dizziness 3 2
Skin and Skin Appendage
  Sweating 2 1

Thrombocytopenia

Patients treated with AGGRASTAT plus heparin, were more likely to experience decreases in platelet counts than were those on heparin alone. These decreases were reversible upon discontinuation of AGGRASTAT. The percentage of patients with a decrease of platelets to < 90,000/mm³ was 1.5%, compared with 0.6% in the patients who received heparin alone. The percentage of patients with a decrease of platelets to < 50,000/mm³ was 0.3%, compared with 0.1% of the patients who received heparin alone.

Post-Marketing Experience

The following additional adverse reactions have been identified during post-approval use of AGGRASTAT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the drug exposure.

Hypersensitivity

Severe allergic reactions including anaphylactic reactions have occurred during the first day of AGGRASTAT infusion, during initial treatment, and during readministration of AGGRASTAT. Some cases have been associated with severe thrombocytopenia (platelet counts < 10,000/mm³). No information is available on the formation of antibodies to tirofiban.

Read the entire FDA prescribing information for Aggrastat (Tirofiban HCl) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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