TIROFIBAN HYDROCHLORIDE- tirofiban injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TIROFIBAN HYDROCHLORIDE (UNII: 6H925F8O5J) (TIROFIBAN - UNII:GGX234SI5H)

Available from:

Gland Pharma Limited

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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)]. Risk Summary While published data cannot definitively establish the absence of risk, available published case reports have not established an association with tirofiban use during pregnancy and major birth defects, miscarriage, or adverse maternal or

Product summary:

Tirofiban hydrochloride injection 12.5 mg/250 mL (50 mcg/mL) is supplied as a clear, non-preserved, colorless, isosmotic, sterile premixed solution with sodium chloride for tonicity adjustment and is supplied as follows: NDC 68083-145-01, 250 mL single-dose bag  FOR INTRAVENOUS USE ONLY Store tirofiban hydrochloride injection 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TIROFIBAN HYDROCHLORIDE - TIROFIBAN INJECTION, SOLUTION
GLAND PHARMA LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TIROFIBAN
HYDROCHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
TIROFIBAN HYDROCHLORIDE INJECTION.
TIROFIBAN HYDROCHLORIDE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
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 AND 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)
DOSAGE FORMS AND STRENGTHS
Injection: 12.5 mg/250 mL (50 mcg/mL) in 250 mL bag. (3) (3)
CONTRAINDICATIONS
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)
WARNINGS AND 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)
ADVERSE REACTIONS
Bleeding is the most commonly reported adverse reaction. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLAND PHARMA AT
864-879-9994 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Coadministration of fibrinolytics, anticoagulants and antiplatelet
agents, increases the risk of bleeding.
(7)
USE IN SPECIFIC POPULATIONS
Renal Insufficiency: Reduce the