AGGRASTAT, in combination with heparin, is indicated for the treatment of acute coronary syndrome, including patients who are to be managed medically and those undergoing PTCA or atherectomy. In this setting, AGGRASTAT has been shown to decrease the rate of a combined endpoint of death, new myocardial infarction or refractory ischemia/repeat cardiac procedure (for discussion of trial results and for definition of acute coronary syndrome see CLINICAL PHARMACOLOGY, Clinical Trials).

AGGRASTAT has been studied in a setting, as described in Clinical Trials, that included aspirin and heparin.

Use with Aspirin and Heparin

In the clinical studies, patients received aspirin, unless it was contraindicated, and heparin. AGGRASTAT and heparin can be administered through the same intravenous catheter.

Precautions

AGGRASTAT is intended for intravenous delivery using sterile equipment and technique. Do not add other drugs or remove solution directly from the bag with a syringe. Do not use plastic containers in series connections; such use can result in air embolism by drawing air from the first container if it is empty of solution. Any unused solution should be discarded.

Directions for Use

AGGRASTAT Injection Premixed is supplied as 100 mL or 250 mL of 0.9% sodium chloride containing 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 atropine sulfate, dobutamine, dopamine, epinephrine HCl, famotidine injection, furosemide, lidocaine, midazolam HCl, morphine sulfate, nitroglycerin, potassium chloride, and propranolol HCl. 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.

For Intravenous Use Only

AGGRASTAT Injection Premixed 5 mg tirofiban per 100 mL (50 mcg per mL) and 12.5 mg tirofiban per 250 mL (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, 100 mL single-dose lNTRAVIA containers (PL 2408 Plastic).

NDC 25208-002-02, 250 mL single-dose lNTRAVIA containers (PL 2408 Plastic).

Storage

AGGRASTAT Injection Premixed

Store at 25°C (77°F) with excursions permitted between 15-30°C (59-86°F) (see USP Controlled Room Temperature). Do not freeze. Protect from light during storage.

Patent: www.medicure.com/aggrastat/patents

AGGRASTAT (Tirofiban Hydrochloride Injection Premixed) is manufactured for: Medicure International, Inc. by: Baxter Healthcare Corporation Deerfield, Illinois 60015 USA Distributed by: Medicure International, Inc. Somerset, NJ 08873 USA. Issued May 2010.

Last reviewed on RxList: 6/13/2012
This monograph has been modified to include the generic and brand name in many instances.