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 5 mg/100 mL bag 55150-429-01 50 mcg/mL 12.5 mg/250 mL bag 55150-430-01 FOR INTRAVENOUS USE ONLY Store tirofiban hydrochloride injection at controlled room temperature, 25°C (77°F) with excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light during storage. Discard Unused Portion.; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 5 mg per 100 mL (50 mcg/mL) - Infusion Bag Label Recommended for Use With Calibrated Infusion Device Rx only NDC 55150-429-01 Tirofiban Hydrochloride Injection 5 mg per 100 mL (50 mcg/mL) For Intravenous Infusion Premixed Iso-osmotic Sterile, Nonpyrogenic 100 mL Single-Dose Container PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 5 mg per 100 mL (50 mcg/mL) - Infusion Bag Label; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 5 mg per 100 mL (50 mcg/mL) - Pouch Label TO OPEN: TEAR AT NOTCH Rx only NDC 55150-429-01 Protect From Light During Storage Recommended for Use With Calibrated Infusion Device Premixed Injection Tirofiban Hydrochloride Injection 5 mg per 100 mL (50 mcg/mL) For Intravenous Infusion Sterile, Nonpyrogenic Iso-osmotic 100 mL Single-Dose Container Each 100 mL contains: Tirofiban hydrochloride equivalent to 5 mg tirofiban, 900 mg sodium chloride, 54 mg sodium citrate dihydrate, 3.2 mg citric acid anhydrous, Water for Injection. pH may have been 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° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Discard unused portion. Do not freeze. Protect from light during storage. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 5 mg per 100 mL (50 mcg/mL) - Pouch Label; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 5 mg per 100 mL (50 mcg/mL) - Container Carton Rx only NDC 55150-429-01 Protect From Light During Storage Recommended for Use With Calibrated Infusion Device Premixed Injection Tirofiban Hydrochloride Injection 5 mg per 100 mL (50 mcg/mL) For Intravenous Infusion Sterile, Nonpyrogenic Iso-osmotic 100 mL Single-Dose Container eugia PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 5 mg per 100 mL (50 mcg/mL) - Container Carton; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 12.5 mg per 250 mL (50 mcg/mL) - Infusion Bag Label Recommended for Use With Calibrated Infusion Device Rx only NDC 55150-430-01 Tirofiban Hydrochloride Injection 12.5 mg per 250 mL (50 mcg/mL) For Intravenous Infusion Premixed Iso-osmotic Sterile, Nonpyrogenic 250 mL Single-Dose Container Each 250 mL contains: Tirofiban hydrochloride equivalent to 12.5 mg tirofiban, 2.25 g sodium chloride, 135 mg sodium citrate dihydrate, 8 mg citric acid anhydrous, water for injection. pH may have been 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° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Discard unused portion. Do not freeze. Protect from light during storage. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 12.5 mg per 250 mL (50 mcg/mL) - Infusion Bag Label; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 12.5 mg per 250 mL (50 mcg/mL) - Pouch Label TO OPEN: TEAR AT NOTCH Rx only NDC 55150-430-01 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/mL) For Intravenous Infusion Sterile, Nonpyrogenic Iso-osmotic 250 mL Single-Dose Container Each 250 mL contains: Tirofiban hydrochloride equivalent to 12.5 mg tirofiban, 2.25 g sodium chloride, 135 mg sodium citrate dihydrate, 8 mg citric acid anhydrous, water for injection. pH may have been 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° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Discard unused portion. Do not freeze. Protect from light during storage. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 12.5 mg per 250 mL (50 mcg/mL) - Pouch Label; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 12.5 mg per 250 mL (50 mcg/mL) - Container Carton Rx only NDC 55150-430-01 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/mL) For Intravenous Infusion Sterile, Nonpyrogenic Iso-osmotic 250 mL Single-Dose Container eugia PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 12.5 mg per 250 mL (50 mcg/mL) - Container Carton
- 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 5 mg/100 mL bag 55150-429-01 50 mcg/mL 12.5 mg/250 mL bag 55150-430-01 FOR INTRAVENOUS USE ONLY Store tirofiban hydrochloride injection at controlled room temperature, 25°C (77°F) with excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light during storage. Discard Unused Portion.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 5 mg per 100 mL (50 mcg/mL) - Infusion Bag Label Recommended for Use With Calibrated Infusion Device Rx only NDC 55150-429-01 Tirofiban Hydrochloride Injection 5 mg per 100 mL (50 mcg/mL) For Intravenous Infusion Premixed Iso-osmotic Sterile, Nonpyrogenic 100 mL Single-Dose Container PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 5 mg per 100 mL (50 mcg/mL) - Infusion Bag Label
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 5 mg per 100 mL (50 mcg/mL) - Pouch Label TO OPEN: TEAR AT NOTCH Rx only NDC 55150-429-01 Protect From Light During Storage Recommended for Use With Calibrated Infusion Device Premixed Injection Tirofiban Hydrochloride Injection 5 mg per 100 mL (50 mcg/mL) For Intravenous Infusion Sterile, Nonpyrogenic Iso-osmotic 100 mL Single-Dose Container Each 100 mL contains: Tirofiban hydrochloride equivalent to 5 mg tirofiban, 900 mg sodium chloride, 54 mg sodium citrate dihydrate, 3.2 mg citric acid anhydrous, Water for Injection. pH may have been 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° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Discard unused portion. Do not freeze. Protect from light during storage. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 5 mg per 100 mL (50 mcg/mL) - Pouch Label
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 5 mg per 100 mL (50 mcg/mL) - Container Carton Rx only NDC 55150-429-01 Protect From Light During Storage Recommended for Use With Calibrated Infusion Device Premixed Injection Tirofiban Hydrochloride Injection 5 mg per 100 mL (50 mcg/mL) For Intravenous Infusion Sterile, Nonpyrogenic Iso-osmotic 100 mL Single-Dose Container eugia PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 5 mg per 100 mL (50 mcg/mL) - Container Carton
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 12.5 mg per 250 mL (50 mcg/mL) - Infusion Bag Label Recommended for Use With Calibrated Infusion Device Rx only NDC 55150-430-01 Tirofiban Hydrochloride Injection 12.5 mg per 250 mL (50 mcg/mL) For Intravenous Infusion Premixed Iso-osmotic Sterile, Nonpyrogenic 250 mL Single-Dose Container Each 250 mL contains: Tirofiban hydrochloride equivalent to 12.5 mg tirofiban, 2.25 g sodium chloride, 135 mg sodium citrate dihydrate, 8 mg citric acid anhydrous, water for injection. pH may have been 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° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Discard unused portion. Do not freeze. Protect from light during storage. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 12.5 mg per 250 mL (50 mcg/mL) - Infusion Bag Label
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 12.5 mg per 250 mL (50 mcg/mL) - Pouch Label TO OPEN: TEAR AT NOTCH Rx only NDC 55150-430-01 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/mL) For Intravenous Infusion Sterile, Nonpyrogenic Iso-osmotic 250 mL Single-Dose Container Each 250 mL contains: Tirofiban hydrochloride equivalent to 12.5 mg tirofiban, 2.25 g sodium chloride, 135 mg sodium citrate dihydrate, 8 mg citric acid anhydrous, water for injection. pH may have been 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° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Discard unused portion. Do not freeze. Protect from light during storage. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 12.5 mg per 250 mL (50 mcg/mL) - Pouch Label
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 12.5 mg per 250 mL (50 mcg/mL) - Container Carton Rx only NDC 55150-430-01 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/mL) For Intravenous Infusion Sterile, Nonpyrogenic Iso-osmotic 250 mL Single-Dose Container eugia PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 12.5 mg per 250 mL (50 mcg/mL) - Container Carton
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 hydrochloride 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 off-white, non-hygroscopic, free-flowing powder, with a molecular weight of 495.07. 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 3.2 mg citric acid anhydrous. 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 mg citric acid anhydrous. chemical-structure
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 250 mL premixed bag, 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 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 The bolus dose of tirofiban hydrochloride injection may be administered from the 100 mL or 250 mL premixed bag. Do not dilute. Administer the bolus dose within 5 minutes via IV pump. Immediately following the bolus dose administration, administer the maintenance infusion from the 100 mL premixed bag or the 250 mL premixed bag via an IV pump. Discard any unused portion left in the bag. The recommended bolus volume using the 100 mL premixed bag or 250 mL premixed bag can be calculated using the following equation: Bolus Volume = 25 mcg/kg x body weight (kg) (mL) 50 mcg/mL The recommended infusion rate for patients with CrCl (Creatinine Clearance) >60 mL/min using the 100 mL premixed bag or 250 mL premixed bag can be calculated using the following equation: Infusion Rate for CrCl > 60 mL/min = 0.15 mcg/kg/min × body weight (kg) × 60 min/h (mL/h) 50 mcg/mL Example calculation of infusion rate for 60 kg patient with CrCl >60 mL/min using the 100 mL premixed bag or 250 mL premixed bag: Infusion Rate for CrCl > 60 mL/min = 0.15 mcg/kg/min × 60 kg × 60 min/h = 10.8 mL/h (mL/h) 50 mcg/mL 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 premixed bag or 250 mL premixed bag can be calculated using the following equation: Infusion Rate for CrCl ≤ 60 mL/min = 0.075 mcg/kg/min × body weight (kg) × 60 min/h (mL/h) 50 mcg/mL
Warnings & Precautions
Tirofiban hydrochloride can cause serious bleeding. If bleeding cannot be controlled discontinue tirofiban hydrochloride. ( 5.1 ) Thrombocytopenia: Discontinue tirofiban hydrochloride and heparin. ( 5.2 ) 5.1 General Risk of Bleeding Bleeding is the most common complication encountered during therapy with tirofiban hydrochloride. Most bleeding associated with tirofiban hydrochloride 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. 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 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 (i.e., anaphylactic reactions) [see Adverse Reactions (6.2) ] . A history of thrombocytopenia following prior exposure to tirofiban hydrochloride [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. ( 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 Eugia US LLC at 1-866-850-2876 or 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 in combination with heparin and 2002 patients received tirofiban hydrochloride 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 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. Bleeding (TIMI Criteria) ‡§ PRISM-PLUS (NSTE-ACS) 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% The incidence rates of TIMI major bleeding in patients undergoing percutaneous procedures in PRISM- PLUS are shown below. 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 were 17% on tirofiban hydrochloride 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. There was a trend toward greater bleeding in ST segment elevation myocardial infarction (STEMI) patients treated with fibrinolytics prior to administration of tirofiban hydrochloride 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 + Heparin (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 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. 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. 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 infusion, during initial treatment, and during readministration of tirofiban hydrochloride. 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.
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 )
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.