Aggrastat Special Precautions

Aggrastat should be used with caution in the following patients: recent (<1 year) bleeding, including a history of gastrointestinal bleeding, or genitourinary bleeding of clinical significance; known coagulopathy, platelet disorder, or history of thrombocytopenia; platelet count <150,000 cells/mm³; history of cerebrovascular disease within 1 year; major surgical procedure or severe physical trauma within 1 month; recent epidural procedure; history, symptoms, or findings suggestive of aortic dissection; severe uncontrolled hypertension (systolic blood pressure >180 mmHg and/or diastolic blood pressure >110 mmHg); acute pericarditis; hemorrhagic retinopathy.
Bleeding Precautions: Because Aggrastat inhibits platelet aggregation, caution should be employed when it is used with other drugs that affect hemostasis. The safety of Aggrastat when used in combination with thrombolytic agents has not been established.
During therapy with Aggrastat, patients should be monitored for potential bleeding. When treatment of bleeding is required, discontinuation of the drug should be considered. Consideration may also be given to transfusions.
Fatal bleedings have been reported (see Side Effects).
Femoral artery access site: Aggrastat is associated with minor increases in bleeding rates particularly at the site of arterial access for femoral sheath placement. Care should be taken when attempting vascular access that only the anterior wall of the femoral artery is punctured, avoiding a Seldinger (through and through) technique for obtaining sheath access. Care should be taken to obtain proper hemostasis after removal of the sheaths followed by close observation.
Laboratory Monitoring: Platelet counts, and hemoglobin and hematocrit should be monitored prior to treatment, within 6 hours following the bolus or loading infusion, and at least daily thereafter during therapy with Aggrastat (or more frequently if there is evidence of significant decline). In patients who have previously received GP IIb/IIIa receptor antagonists, consideration should be given to earlier monitoring of platelet count. If the patient experiences a platelet count decrease to <90,000 cells/mm³, additional platelet counts should be performed to exclude pseudothrombocytopenia. If thrombocytopenia is confirmed, Aggrastat and heparin should be discontinued and the condition appropriately monitored and treated.
In addition, the activated partial thromboplastin time (APTT) should be determined before treatment and the anticoagulant effects of heparin should be carefully monitored by repeated determinations of APTT and the dose should be adjusted accordingly (see also Dosage & Administration). Potentially life-threatening bleeding may occur especially when heparin is administered with other products affecting hemostasis, such as GP IIb/IIIa receptor antagonists.
Severe Renal Insufficiency: In clinical studies, patients with severe renal insufficiency (creatinine clearance <30 mL/min) demonstrated decreased plasma clearance of Aggrastat. The dosage of Aggrastat should be reduced in these patients (see Dosage & Administration).
Use in Children: Safety and effectiveness in children have not been established.
Use in the Elderly: In clinical studies the efficacy of Aggrastat in the elderly (≥65 years) was comparable to that seen in younger patients (<65 years). Elderly patients receiving Aggrastat with heparin or heparin alone had a higher incidence of bleeding complications than younger patients. The incremental risk of bleeding in patients treated with Aggrastat in combination with heparin over the risk in patients treated with heparin alone was comparable regardless of age. The overall incidence of non-bleeding adverse events was higher in older patients (compared to younger patients); however, the incidence of non-bleeding adverse events in these patients was comparable between the Aggrastat with heparin and the heparin alone groups. No dose adjustment is recommended (see Other Patient Populations under Dosage & Administration).