Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Tirofiban Hydrochloride Injection is supplied as a clear, non-preserved, colorless, isosmotic, sterile premixed solution with sodium chloride for tonicity adjustment. Table 8 Tirofiban Hydrochloride Injection Product Details Strength Total Amount Packaging NDC # 50 mcg/mL 12.5 mg/250 mL bag, single pack 14789-102-05 50 mcg/mL 12.5 mg/250 mL bag, two pack 14789-102-10 50 mcg/mL 5 mg/100 mL bag, single pack 14789-101-01 FOR INTRAVENOUS USE ONLY Store Tirofiban Hydrochloride Injection at controlled room temperature, 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.; Principal Display Panel – 100 mL Carton Label NDC 14789-101-02 PROTECT FROM LIGHT DURING STORAGE RECOMMENDED FOR USE WITH CALIBRATED INFUSION DEVICE PREMIXED INJECTION Tirofiban Hydrochloride Injection 5 mg per 100 mL (50 mcg per mL) 100 mL Single-dose Container Rx Only Iso-osmotic Sterile Nonpyrogenic Each 100mL contains: Tirofiban hydrochloride equivalent to 5 mg tirofiban, 0.9 g sodium chloride, 54 mg sodium citrate dihydrate, 3.5 mg citric acid monohydrate, Water for Injection. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Usual Dosage: Intravenously as directed by a physican. See package insert. Cautions: Do not add supplementary medication. Check for minute leaks by squeezing bag firmly. If leaks are found discard bag as sterility may be impaired. Do not use in series connections. Do not use unless solution is clear. Recommended Storage: Store at 25°C (77°F) with excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light during storage. TFB0.05-100CTNR001 Manufactured in the UK for: Nexus Pharmaceuticals, Inc. 400 Knightsbridge Parkway Lincolnshire, IL 60069 NEXUS PHARMACEUTICALS Principal Display Panel – 100 mL Carton Label; Principal Display Panel – 100 mL Bag Label RECOMMENDED FOR USE WITH CALIBRATED INFUSION DEVICE 100 mL Single-dose Container Rx ONLY NDC 14789-101-01 Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL) Pre-mixed Iso-osmotic Sterile; Non-pyrogenic Each 100 mL contains: Tirofiban hydrochloride equivalent to 5 mg tirofiban, 0.9 g sodium chloride, 54 mg sodium citrate dihydrate, 3.5 mg citric acid monohydrate, Water for Injection. pH may be adjusted with hydrochloric acid and/or sodium hydroxide. Usual Dosage: Intravenously as directed by a physician. See package insert. Cautions: Do not add supplementary medication. Check for minute leaks by squeezing bag firmly. If leaks are found discard bag as sterility may be impaired. Do not use in series connections. Do not use unless solution is clear. Recommended storage: Store at 25°C (77°F) with excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]. Do not freeze. Protect from light during storage. Manufactured in the UK for: Nexus Pharmaceutical, Inc. Lincolnshire, IL 60069 USA TFB0.05-100LBL-BR001 NE083v1 Lot: Exp: Principal Display Panel – 100 mL Bag Label; Principal Display Panel – 250 mL Carton Label NDC 14789-102-05 PROTECT FROM LIGHT DURING STORAGE RECOMMENDED FOR USE WITH CALIBRATED INFUSION DEVICE PREMIXED INJECTION Tirofiban Hydrochloride Injection 12.5 mg per 250 mL (50 mcg per mL) 250 mL Single-dose Container Rx Only Iso-osmotic Sterile Nonpyrogenic Each 250mL contains: Tirofiban hydrochloride equivalent to 12.5 mg Tirofiban, 2.25 g sodium chloride, 135 mg sodium citrate dihydrate, 8.75 mg citric acid monohydrate , Water for Injection. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Usual Dosage: Intravenously as directed by a physican. See package insert. Cautions: Do not add supplementary medication. Check for minute leaks by squeezing bag firmly. If leaks are found discard bag as sterility may be impaired. Do not use in series connections. Do not use unless solution is clear. Recommended Storage: Store at 25°C (77°F) with excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light during storage. Manufactured in the UK for: Nexus Pharmaceuticals, Inc. 400 Knightsbridge Parkway Lincolnshire, IL 60069 TFBCT01GBR02 NEXUS PHARMACEUTICALS Principal Display Panel – 250 mL Carton Label; Principal Display Panel – 250 mL Bag Label RECOMMENDED FOR USE WITH CALIBRATED INFUSION DEVICE 250 mL Single-dose Container Rx ONLY NDC 14789-102-02 Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL) Pre-mixed Iso-osmotic Sterile; Non-pyrogenic Each 250 mL contains: Tirofiban hydrochloride equivalent to 12.5 mg Tirofiban, 2.25 g sodium chloride, 135 mg sodium citrate dihydrate, 8.75 mg citric acid monohydrate, Water for Injection. pH may be adjusted with hydrochloric acid and/or sodium hydroxide. Usual Dosage : Intravenously as directed by a physician. See package insert. Cautions: Do not add supplementary medication. Check for minute leaks by squeezing bag firmly. If leaks are found discard bag as sterility may be impaired. Do not use in series connections. Do not use unless solution is clear. Recommended storage: Store at 25°C (77°F) with excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]. Do not freeze. Protect from light during storage. Manufactured in the UK for: Nexus Pharmaceuticals, LLC. Lincolnshire, IL 60069 USA TFBLB01GBR02 NE084v1 Lot: Exp: Principal Display Panel – 250 mL Bag Label; Principal Display Panel – 250 mL Carton Label 2 Pack NDC 14789-102-10 PROTECT FROM LIGHT DURING STORAGE RECOMMENDED FOR USE WITH CALIBRATED INFUSION DEVICE PREMIXED INJECTION Tirofiban Hydrochloride Injection 12.5 mg per 250 mL (50 mcg per mL) 250 mL 2 Count Single-dose Container Rx Only Iso-osmotic Sterile Nonpyrogenic Each 250mL contains:Tirofiban hydrochloride equivalent to 12.5 mg Tirofiban, 2.25 g sodium chloride, 135 mg sodium citrate dihydrate, 8.75 mg citric acid monohydrate , Water for Injection. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Usual Dosage:Intravenously as directed by a physican. See package insert. Cautions:Do not add supplementary medication. Check for minute leaks by squeezing bag firmly. If leaks are found discard bag as sterility may be impaired. Do not use in series connections. Do not use unless solution is clear. Recommended Storage:Store at 25°C (77°F) with excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light during storage. Manufactured in the UK for: Nexus Pharmaceuticals, LLC 400 Knightsbridge Parkway Lincolnshire, IL 60069 TFBCT02GBR01 NEXUS PHARMACEUTICALS Principal Display Panel – 250 mL Carton Label 2 Pack
- 16 HOW SUPPLIED/STORAGE AND HANDLING Tirofiban Hydrochloride Injection is supplied as a clear, non-preserved, colorless, isosmotic, sterile premixed solution with sodium chloride for tonicity adjustment. Table 8 Tirofiban Hydrochloride Injection Product Details Strength Total Amount Packaging NDC # 50 mcg/mL 12.5 mg/250 mL bag, single pack 14789-102-05 50 mcg/mL 12.5 mg/250 mL bag, two pack 14789-102-10 50 mcg/mL 5 mg/100 mL bag, single pack 14789-101-01 FOR INTRAVENOUS USE ONLY Store Tirofiban Hydrochloride Injection at controlled room temperature, 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.
- Principal Display Panel – 100 mL Carton Label NDC 14789-101-02 PROTECT FROM LIGHT DURING STORAGE RECOMMENDED FOR USE WITH CALIBRATED INFUSION DEVICE PREMIXED INJECTION Tirofiban Hydrochloride Injection 5 mg per 100 mL (50 mcg per mL) 100 mL Single-dose Container Rx Only Iso-osmotic Sterile Nonpyrogenic Each 100mL contains: Tirofiban hydrochloride equivalent to 5 mg tirofiban, 0.9 g sodium chloride, 54 mg sodium citrate dihydrate, 3.5 mg citric acid monohydrate, Water for Injection. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Usual Dosage: Intravenously as directed by a physican. See package insert. Cautions: Do not add supplementary medication. Check for minute leaks by squeezing bag firmly. If leaks are found discard bag as sterility may be impaired. Do not use in series connections. Do not use unless solution is clear. Recommended Storage: Store at 25°C (77°F) with excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light during storage. TFB0.05-100CTNR001 Manufactured in the UK for: Nexus Pharmaceuticals, Inc. 400 Knightsbridge Parkway Lincolnshire, IL 60069 NEXUS PHARMACEUTICALS Principal Display Panel – 100 mL Carton Label
- Principal Display Panel – 100 mL Bag Label RECOMMENDED FOR USE WITH CALIBRATED INFUSION DEVICE 100 mL Single-dose Container Rx ONLY NDC 14789-101-01 Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL) Pre-mixed Iso-osmotic Sterile; Non-pyrogenic Each 100 mL contains: Tirofiban hydrochloride equivalent to 5 mg tirofiban, 0.9 g sodium chloride, 54 mg sodium citrate dihydrate, 3.5 mg citric acid monohydrate, Water for Injection. pH may be adjusted with hydrochloric acid and/or sodium hydroxide. Usual Dosage: Intravenously as directed by a physician. See package insert. Cautions: Do not add supplementary medication. Check for minute leaks by squeezing bag firmly. If leaks are found discard bag as sterility may be impaired. Do not use in series connections. Do not use unless solution is clear. Recommended storage: Store at 25°C (77°F) with excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]. Do not freeze. Protect from light during storage. Manufactured in the UK for: Nexus Pharmaceutical, Inc. Lincolnshire, IL 60069 USA TFB0.05-100LBL-BR001 NE083v1 Lot: Exp: Principal Display Panel – 100 mL Bag Label
- Principal Display Panel – 250 mL Carton Label NDC 14789-102-05 PROTECT FROM LIGHT DURING STORAGE RECOMMENDED FOR USE WITH CALIBRATED INFUSION DEVICE PREMIXED INJECTION Tirofiban Hydrochloride Injection 12.5 mg per 250 mL (50 mcg per mL) 250 mL Single-dose Container Rx Only Iso-osmotic Sterile Nonpyrogenic Each 250mL contains: Tirofiban hydrochloride equivalent to 12.5 mg Tirofiban, 2.25 g sodium chloride, 135 mg sodium citrate dihydrate, 8.75 mg citric acid monohydrate , Water for Injection. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Usual Dosage: Intravenously as directed by a physican. See package insert. Cautions: Do not add supplementary medication. Check for minute leaks by squeezing bag firmly. If leaks are found discard bag as sterility may be impaired. Do not use in series connections. Do not use unless solution is clear. Recommended Storage: Store at 25°C (77°F) with excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light during storage. Manufactured in the UK for: Nexus Pharmaceuticals, Inc. 400 Knightsbridge Parkway Lincolnshire, IL 60069 TFBCT01GBR02 NEXUS PHARMACEUTICALS Principal Display Panel – 250 mL Carton Label
- Principal Display Panel – 250 mL Bag Label RECOMMENDED FOR USE WITH CALIBRATED INFUSION DEVICE 250 mL Single-dose Container Rx ONLY NDC 14789-102-02 Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL) Pre-mixed Iso-osmotic Sterile; Non-pyrogenic Each 250 mL contains: Tirofiban hydrochloride equivalent to 12.5 mg Tirofiban, 2.25 g sodium chloride, 135 mg sodium citrate dihydrate, 8.75 mg citric acid monohydrate, Water for Injection. pH may be adjusted with hydrochloric acid and/or sodium hydroxide. Usual Dosage : Intravenously as directed by a physician. See package insert. Cautions: Do not add supplementary medication. Check for minute leaks by squeezing bag firmly. If leaks are found discard bag as sterility may be impaired. Do not use in series connections. Do not use unless solution is clear. Recommended storage: Store at 25°C (77°F) with excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]. Do not freeze. Protect from light during storage. Manufactured in the UK for: Nexus Pharmaceuticals, LLC. Lincolnshire, IL 60069 USA TFBLB01GBR02 NE084v1 Lot: Exp: Principal Display Panel – 250 mL Bag Label
- Principal Display Panel – 250 mL Carton Label 2 Pack NDC 14789-102-10 PROTECT FROM LIGHT DURING STORAGE RECOMMENDED FOR USE WITH CALIBRATED INFUSION DEVICE PREMIXED INJECTION Tirofiban Hydrochloride Injection 12.5 mg per 250 mL (50 mcg per mL) 250 mL 2 Count Single-dose Container Rx Only Iso-osmotic Sterile Nonpyrogenic Each 250mL contains:Tirofiban hydrochloride equivalent to 12.5 mg Tirofiban, 2.25 g sodium chloride, 135 mg sodium citrate dihydrate, 8.75 mg citric acid monohydrate , Water for Injection. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Usual Dosage:Intravenously as directed by a physican. See package insert. Cautions:Do not add supplementary medication. Check for minute leaks by squeezing bag firmly. If leaks are found discard bag as sterility may be impaired. Do not use in series connections. Do not use unless solution is clear. Recommended Storage:Store at 25°C (77°F) with excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light during storage. Manufactured in the UK for: Nexus Pharmaceuticals, LLC 400 Knightsbridge Parkway Lincolnshire, IL 60069 TFBCT02GBR01 NEXUS PHARMACEUTICALS Principal Display Panel – 250 mL Carton Label 2 Pack
Overview
Tirofiban Hydrochloride Injection contains tirofiban hydrochloride, a non-peptide antagonist of the platelet GP IIb/IIIa receptor, which inhibits platelet aggregation. Tirofiban hydrochloride monohydrate is chemically described as N- (butylsulfonyl)- O -[4-(4-piperidinyl)butyl]-L-tyrosine monohydrochloride monohydrate. Its molecular formula is C 22 H 36 N 2 O 5 S•HCl•H 2 O and its structural formula is: Tirofiban hydrochloride monohydrate is a white to off-white, non-hygroscopic, free-flowing powder, with a molecular weight of 495.08. It is very slightly soluble in water. Tirofiban Hydrochloride Injection Premixed is supplied as a sterile solution in water for injection, for intravenous use. The pH of the solution ranges from 5.5 to 6.5 adjusted with hydrochloric acid and/or sodium hydroxide. Each 100 mL of the premixed, isosmotic intravenous injection contains 5.618 mg tirofiban hydrochloride monohydrate equivalent to 5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 0.9 g sodium chloride, 54 mg sodium citrate dihydrate, and 3.5 mg citric acid monohydrate. Each 250 mL of the premixed, isosmotic intravenous injection contains 14.045 mg tirofiban hydrochloride monohydrate equivalent to 12.5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 2.25 g sodium chloride, 135 mg sodium citrate dihydrate, and 8.75 mg citric acid monohydrate. Structural Formula
Indications & Usage
Tirofiban Hydrochloride Injection is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS). Tirofiban Hydrochloride Injection is a platelet aggregation inhibitor indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS). ( 1 )
Dosage & Administration
Administer intravenously 25 mcg/kg within 5 minutes and then 0.15 mcg/kg/min for up to 18 hours. In patients with creatinine clearance ≤ 60 mL/min, give 25 mcg/kg within 5 minutes and then 0.075 mcg/kg/min. ( 2 ) 2.1 Recommended Dosage The recommended dosage is 25 mcg/kg administered intravenously within 5 minutes and then 0.15 mcg/kg/min for up to 18 hours. 2.2 Administration For intravenous use only. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. To open the 100 mL or the 250 mL premixed bag, first tear off its foil overpouch and remove inner overwrap. 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 or sterility is suspect then the solution should be discarded. Do not use unless the solution is clear and the seal is intact. Administration Instructions Withdraw the bolus dose of Tirofiban Hydrochloride Injection from the 100 mL or 250 mL premixed bag into a syringe. Do not dilute. Administer the bolus dose within 5 minutes via a syringe or IV pump. Immediately following the bolus dose administration, administer the maintenance infusion from the 100 mL or 250 mL premixed bag via an IV pump. Discard any unused portion left in the bag. The recommended bolus volume using the 100 mL or 250 mL premixed bag can be calculated using the following equation: The recommended infusion rate for patients with CrCl (Creatinine Clearance) > 60 mL/min using the 100 mL or 250 mL premixed bag can be calculated using the following equation: Example calculation of infusion rate for 60 kg patient with CrCl > 60 mL/min using the 100 mL or 250 mL premixed bag: Bolus Volume Equation Infusion Rate Equation Example Calculation Drug Compatibilities Tirofiban Hydrochloride Injection can be administered in the same intravenous line as heparin, atropine sulfate, dobutamine, dopamine, epinephrine hydrochloride (HCl), famotidine injection, furosemide, lidocaine, midazolam HCl, morphine sulfate, nitroglycerin, potassium chloride, and propranolol HCl. Do not administer Tirofiban Hydrochloride Injection through the same IV line as diazepam. Do not add other drugs or remove solution directly from the bag with a syringe. 2.3 Dose Adjustment for Renal Impairment The recommended dosage in patients with CrCl ≤ 60 mL/min (calculated using the Cockcroft-Gault equation with actual body weight) is 25 mcg/kg intravenously within 5 minutes and then 0.075 mcg/kg/min, for up to 18 hours. The recommended infusion rate for patients with CrCl ≤ 60 mL/min using the 100 mL or 250 mL premixed bag can be calculated using the following equation: Recommended Infusion Rate
Warnings & Precautions
Tirofiban Hydrochloride Injection can cause serious bleeding. If bleeding cannot be controlled discontinue Tirofiban Hydrochloride Injection. ( 5.1 ) Thrombocytopenia: Discontinue Tirofiban Hydrochloride Injection and heparin. ( 5.2 ) 5.1 General Risk of Bleeding Bleeding is the most common complication encountered during therapy with Tirofiban Hydrochloride Injection. Most bleeding associated with Tirofiban Hydrochloride Injection occurs at the arterial access site for cardiac catheterization. Minimize the use of traumatic or potentially traumatic procedures such as arterial and venous punctures, intramuscular injections, nasotracheal intubation, etc. Concomitant use of fibrinolytics, anticoagulants and antiplatelet drugs increases the risk of bleeding. 5.2 Thrombocytopenia Profound thrombocytopenia has been reported with Tirofiban Hydrochloride Injection. Monitor platelet counts beginning about 6 hours after treatment initiation and daily thereafter. If the platelet count decreases to < 90,000/mm 3 , monitor platelet counts to exclude pseudothrombocytopenia. If thrombocytopenia is confirmed, discontinue Tirofiban Hydrochloride Injection and heparin. Previous exposure to a glycoprotein (GP) IIb/IIIa receptor antagonist may increase the risk of developing thrombocytopenia [see Adverse Reactions ( 6.1 )] .
Contraindications
Tirofiban Hydrochloride Injection is contraindicated in patients with: Severe hypersensitivity reaction to Tirofiban Hydrochloride Injection (i.e., anaphylactic reactions) [see Adverse Reactions ( 6.2 )] . A history of thrombocytopenia following prior exposure to Tirofiban Hydrochloride Injection [see Adverse Reactions ( 6.1 )] . Active internal bleeding or a history of bleeding diathesis, major surgical procedure or severe physical trauma within the previous month [see Adverse Reactions ( 6.1 )] . Known hypersensitivity to any component of Tirofiban Hydrochloride Injection. ( 4 ) History of thrombocytopenia with prior exposure to Tirofiban Hydrochloride Injection. ( 4 ) Active internal bleeding, or history of bleeding diathesis, major surgical procedure or severe physical trauma within the previous month. ( 4 )
Adverse Reactions
Bleeding is the most commonly reported adverse reaction. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lambda Therapeutics Limited at 1-855-642-2594 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 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 Tirofiban Hydrochloride Injection in combination with heparin and 2002 patients received Tirofiban Hydrochloride Injection 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), Tirofiban Hydrochloride Injection 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 * 0.4 mcg/kg/min initial infusion; 0.10 mcg/kg/min maintenance infusion. ‡ Major = Hemoglobin drop of > 5.0 g/dL with or without an identified site, intracranial hemorrhage, or cardiac tamponade. § Minor = Hemoglobin drop of > 3.0 g/dL 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. PRISM-PLUS (NSTE-ACS) Bleeding (TIMI Criteria)‡ § Tirofiban Hydrochloride * + Heparin (N=773) Heparin alone (N=797) Major Bleeding 1.4% 0.8% Minor Bleeding 10.5% 8.0% Transfusions 4.0% 2.8% Table 3 TIMI Major Bleeding Associated with Percutaneous Procedures in PRISM-PLUS Tirofiban Hydrochloride + 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 Tirofiban Hydrochloride Injection were 17% on Tirofiban Hydrochloride Injection 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 4 g/dL, bleeding requiring transfusion of ≥ 2 U 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 Tirofiban Hydrochloride Injection. There was a trend toward greater bleeding in ST segment elevation myocardial infarction (STEMI) patients treated with fibrinolytics prior to administration of Tirofiban Hydrochloride Injection 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 Tirofiban Hydrochloride + H eparin (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 Tirofiban Hydrochloride Injection plus heparin, were more likely to experience decreases in platelet counts than were those on heparin alone. These decreases were reversible upon discontinuation of Tirofiban Hydrochloride Injection. The percentage of patients with a decrease of platelets to < 90,000/mm 3 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/mm 3 was 0.3%, compared with 0.1% of the patients who received heparin alone. 6.2 Post-Marketing Experience The following additional adverse reactions have been identified during post-approval use of Tirofiban Hydrochloride Injection. 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 Tirofiban Hydrochloride Injection infusion, during initial treatment, and during re-administration of Tirofiban Hydrochloride Injection. Some cases have been associated with severe thrombocytopenia (platelet counts < 10,000/mm 3 ). No information is available on the formation of antibodies to tirofiban hydrochloride
Drug Interactions
Concomitant use of fibrinolytics, anticoagulants and antiplatelet drugs increases the risk of bleeding. Coadministration of fibrinolytics, anticoagulants and antiplatelet agents, increases the risk of bleeding. ( 7 )
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