ng 50 mcg/mL tirofiban. It is supplied in lntraVia*** containers (PL 2408 plastic). To open the lntraVia container, first tear off its foil overpouch. The plastic may be somewhat opaque because of moisture absorption during sterilization; the opacity will diminish gradually. Check for leaks by squeezing the inner bag firmly; if any leaks are found, the sterility is suspect and the solution should be discarded. Do not use unless the solution is clear and the seal is intact. Suspend the container from its eyelet support, remove the plastic protector from the outlet port, and attach a conventional administration set.
AGGRASTAT may be administered in the same intravenous line as dopamine, lidocaine, potassium chloride, and PEPCID* (famotidine) Injection. AGGRASTAT should not be administered in the same intravenous line as diazepam.
Recommended Dosage
In most patients, AGGRASTAT should be administered intravenously, at an initial rate of 0.4 mcg/kg/min for 30 minutes and then continued at 0.1 mcg/kg/min.
Patients with severe renal insufficiency (creatinine clearance <30 mL/min) should receive half the usual rate of infusion (see PRECAUTIONS, Severe Renal Insufficiency and CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations, Renal Insufficiency). The table below is provided as a guide to dosage adjustment by weight.
No dosage adjustment is recommended for elderly or female patients (see PRECAUTIONS, Geriatric Use). In PRISM-PLUS, AGGRASTAT was administered in combination with heparin for 48 to 108 hours. The infusion should be continued through angiography and for 12 to 24 hours after angioplasty or atherectomy.
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HOW SUPPLIED
FOR INTRAVENOUS USE ONLY
AGGRASTAT Injection 12.5mg per 50mL(250mcg per mL) is a non-preserved, clear, colorless concentrated sterile solution for intravenous infusion after dilution and is supplied as follows:
NDC 25208-001-01, 50mL vials.
AGGRASTAT Injection Premixed 5mg tirofiban per 100mL(50mcg per mL) and 12.5mg tirofiban per 250mL(50 mcg per mL) are clear, non-preserved, sterile solutions premixed in a vehicle made iso-osmotic with sodium chloride, and are supplied as follows:
NDC 25208-002-01, 100mL single-dose IntraVia containers (PL 2408 Plastic).
NDC 25208-002-02, 250mL single-dose IntraVia containers (PL 2408 Plastic).
Storage
AGGRASTAT Injection
Store at 25°C(see USP Controlled Room Temperature). Do not freeze. Protect from light during storage.
AGGRASTAT Injection Premixed
Store at 25°C(see USP Controlled Room Temperature). Do not freeze. Protect from light during storage. US Patent Nos: 5,292,756, 5,439,454, 5,849,843, and 5,998,019
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SIDE EFFECTS
In clinical trials, 1946 patients received AGGRASTAT in combination with heparin and 2002 patients received AGGRASTAT alone. Duration of exposure was up to 116 hours. 43% of the population was >65 years of age and approximately 30% of patients were female.
Bleeding
The most common drug-related adverse event reported during therapy with AGGRASTAT when used concomitantly with heparin and aspirin, was bleeding (usually reported by the investigators as oozing or mild). The incidences of major and minor bleeding using the TIMI criteria in the PRISM-PLUS and RESTORE studies are shown below.
There were no reports of intracranial bleeding in the PRISM-PLUS study for AGGRAS |
