Aggrastat Side Effects
Generic name: tirofiban
Note: This document contains side effect information about tirofiban. Some of the dosage forms listed on this page may not apply to the brand name Aggrastat.
Some side effects of Aggrastat may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to tirofiban: intravenous powder for injection, intravenous solution
Get emergency medical help if you have any of these signs of an allergic reaction while taking tirofiban (the active ingredient contained in Aggrastat) 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.
For Healthcare Professionals
Applies to tirofiban: intravenous powder for injection, intravenous solution
Prior to approval by the FDA the efficacy and safety of tirofiban (the active ingredient contained in Aggrastat) was evaluated in 1,946 patients who received both tirofiban and heparin and 2,002 patients who received tirofiban alone. The average duration of exposure was 116 hours. Forty-three percent of the patients were greater than 65 years old and approximately 30% of the patients were female. In clinical studies, the incidences of side effects were generally similar among different races, and were not more prevalent among patients with hypertension or diabetes or hypercholesterolemia. The most common and potentially significant side effect was bleeding; non-bleeding side effects occurred in up to approximately 6% of patients. The overall incidence of non-bleeding side effects was higher in female and older patients compared with male or younger patients. However, the incidence of non-bleeding side effects was similar among all patients who received tirofiban + heparin versus heparin alone.
Hematologic lab changes in patients who received tirofiban (the active ingredient contained in Aggrastat) + heparin versus heparin alone have included decreases in hemoglobin in 2.1% and 3.1% and hematocrit in 2.2% and 2.6%, increases in microhematuria in 10.7% and 7.8%, and increases in fecal occult blood in 18.3% and 12.2% of patients, respectively.
The incidence of thrombocytopenia (less than 100,000 cells/mcL) associated with tirofiban is 1.1% to 1.9%, while severe thrombocytopenia (less than 50,000 cells/mcL) has been reported in 0.2% to 0.5% of patients in clinical trials.
Decreases in platelet concentrations have been associated with the use of heparin alone. The incidences of reversible decreases in platelet concentrations among patients treated the tirofiban + heparin versus heparin alone in controlled trials were 1.5% and 0.6% (platelet counts less than 90,000/mm3) and 0.3% and 0.1% (platelet counts less than 50,000/mm3) of patients, respectively.
Risk factors for bleeding events in patients treated with glycoprotein (GP) IIb/IIIa inhibitors undergoing percutaneous coronary intervention have been identified and include advanced age, renal dysfunction, female gender, peripheral vascular disease, lower body weight, duration of GP IIb/IIIa inhibitor infusion, baseline platelet count, lower baseline hemoglobin, diabetes, and elevated peak activated clotting time. According to one study (CRUSADE trial) involving patients with non-ST-segment elevation acute coronary syndrome treated with a GP IIb/IIIa inhibitor, women are at a greater risk of bleeding than men, primarily because of excessive dosing.
The most common and potentially serious side effect associated with the use of tirofiban (and heparin and aspirin) has been bleeding. The incidences of major and minor bleeding in the PRISM-PLUS trial were 1.4% and 10.5%, respectively, and the incidence of transfusions was 4.0%. The incidences of these events in the RESTORE trial were 2.2%, 12.0%, and 4.3%. All incidences were greater than those observed among patients who were given heparin alone. There were no reports of intracranial hemorrhage (ICH) in the PRISM-PLUS trial, but the incidences of ICH associated with the use of tirofiban + heparin and heparin alone in the RESTORE trial were 0.1% and 0.3%. For patients who received tirofiban + heparin versus heparin alone, the following incidences were observed: retroperitoneal bleeding, 0% and 0.1% (PRISM-PLUS) and 0.6% and 0.3% (RESTORE), respectively; and gastrointestinal or genitourinary bleeding, 0.1% and 0.1% (PRISM-PLUS) and 0.2% and 0.0%, respectively. The incidences of major bleeding in patients undergoing PTCA in PRISM-PLUS among patients who were given tirofiban + heparin versus heparin alone were 0.3% and 0.1% (pre-PTCA), 1.3% and 0.7% (following angiography), and 2.5% and 2.2% (following PTCA), respectively. Female and elderly patients in either group had a higher incidence of bleeding compared with male or younger patients. Concomitant use of heparin did not confer significant additional risk of bleeding in any group.
Cardiovascular side effects in patients who received tirofiban (the active ingredient contained in Aggrastat) + heparin versus heparin alone have included edema or swelling in 2% and 1%, bradycardia in 4% and 3%, and coronary artery dissection in 5% and 4% of patients, respectively. Many side effects may in fact be attributed to underlying disease or the risks of procedures patients were undergoing.
Analysis of one study (TARGET trial) indicates that patients with renal dysfunction undergoing PCI and receiving a GP IIb/IIIa inhibitor (i.e., tirofiban, abciximab) are at a higher risk of developing ischemic complications (30-day death, myocardial infarction,urgent revascularization) than patients with normal creatinine clearance.
Musculoskeletal side effects in patients who received tirofiban (the active ingredient contained in Aggrastat) + heparin versus heparin alone have included pelvic pain in 6% and 5% and general leg pain in 3% and 2% of patients, respectively. These side effects may in fact be attributed to complications associated with femoral artery access associated with angiography.
Nervous system side effects in patients who received tirofiban (the active ingredient contained in Aggrastat) + heparin versus heparin alone have included vasovagal reactions in 2% and 1%, dizziness in 3% and 2%, and sweating in 2% and 1% of patients, respectively. Headache has been associated with the use of tirofiban + heparin in approximately 1% of patients (and in a similar fraction of patients treated with heparin alone).
The only gastrointestinal side effect noted among patients in controlled trials was nausea, observed in approximately 1% of patients.
Hypersensitivity reactions were remarkably absent in clinical studies prior to FDA approval. There were no recorded instances of anaphylaxis or hives. There are no data regarding the development of anti-tirofiban (the active ingredient contained in Aggrastat) antibodies; very few patients have received this drug twice.
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