• Patients undergoing percutaneous coronary intervention (PCI), including those with heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis syndrome (HITTS).

Contraindicated in:

• Active major bleeding
• Hypersensitivity.

Use Cautiously in:

• Any disease state associated with an ↑ risk of bleeding
• Heparin-induced thrombocytopenia or heparin-induced thrombocytopenia-thrombosis syndrome
• Patients with unstable angina not undergoing PCI
• Patients with other acute coronary syndromes
• Concurrent use with other platelet aggregation inhibitors (safety not established)
• Renal impairment (↓ infusion rate if CCr <30 mL/min)
• OB: Safety not established in pregnancy
• Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant
• Pedi: Safety and effectiveness not established in children.

CV: hypotension, ACUTE STENT THROMBOSIS (ESPECIALLY IN PATIENTS WITH ST-SEGMENT ELEVATION MI UNDERGOING PCI), bradycardia, hypertension.

GI: nausea, abdominal pain, dyspepsia, vomiting.

Hemat: BLEEDING.

Local: injection site pain.

MS: pain.

Neuro: headache, anxiety, insomnia, nervousness.

Misc: fever.

Drug-Drug:

• Risk of bleeding may be ↑ by concurrent use of heparin, low molecular weight heparins, clopidogrel, thrombolytics, or any other drugs that inhibit coagulation.

Drug-Natural Products:

• ↑ risk of bleeding with arnica, chamomile, clove, dong quai, feverfew, garlic, ginger, gingko, Panax ginseng, and others.

(Generic available)

• Lyophilized powder for injection: 250 mg/vial;
• Premixed infusion: 250 mg/50 mL (as ready-to-use vial);

• IV (Adults): 0.75 mg/kg as a bolus injection, followed by an infusion at a rate of 1.75 mg/kg/hr for the duration of the PCI procedure. An activated clotting time (ACT) should be performed 5 min after bolus dose and an additional bolus dose of 0.3 mg/kg may be administered if needed. Continuation of the infusion (at a rate of 1.75 mg/kg/hr) for up to 4 hr post-procedure is optional (should be considered in patients with ST-segment elevation MI). Therapy should be initiated prior to the procedure and given in conjunction with aspirin.

Angiomax

• Specifically and reversibly inhibits thrombin by binding to its receptor sites. Inhibition of thrombin prevents activation of factors V, VIII, and XII; the conversion of fibrinogen to fibrin; platelet adhesion and aggregation.

• Decreased acute ischemic complications in patients with unstable angina (death, MI, or the urgent need for revascularization procedures).

Therapeutic Classification: anticoagulants

Pharmacologic Classification: thrombin inhibitors

Absorption: IV administration results in complete bioavailability.

Distribution: Unknown.

Metabolism/Excretion: Cleared from plasma by a combination of renal mechanisms and proteolytic breakdown.

Half-life: 25 min (↑ in renal impairment).

(anticoagulant effect)

• Inform patient of the purpose of bivalirudin.
• Instruct patient to notify health care professional immediately if any bleeding or bruising is noted.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
• Rep: May cause fetal harm. Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or of breastfeeding.

bi-val-i-ROO-din

NDC Code^*

• 0409- Hospira, Inc.
  • 0409-8300- Bivalirudin
    • 0409-8300-15- 10 VIAL, PATENT DELIVERY SYSTEM in 1 BOX (0409-8300-15) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM (0409-8300-25)

• 0409- Hospira, Inc.
  • 0409-8300- Bivalirudin
    • 0409-8300-10- 10 VIAL, SINGLE-DOSE in 1 TRAY (0409-8300-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0409-8300-20)

• 0781- Sandoz Inc
  • 0781-3158- bivalirudin
    • 0781-3158-95- 10 VIAL, SINGLE-USE in 1 CARTON (0781-3158-95) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (0781-3158-94)

• 0781- Sandoz Inc
  • 0781-3447- Angiomax
    • 0781-3447-95- 10 VIAL, SINGLE-USE in 1 CARTON (0781-3447-95) > 1 INJECTION in 1 VIAL, SINGLE-USE

• 0781- Sandoz Inc
  • 0781-9158- bivalirudin
    • 0781-9158-95- 10 VIAL, SINGLE-USE in 1 CARTON (0781-9158-95) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (0781-9158-94)

• 16729- Accord Healthcare, Inc.
  • 16729-275- Bivalirudin
    • 16729-275-67- 10 VIAL, SINGLE-USE in 1 CARTON (16729-275-67) > 5 mL in 1 VIAL, SINGLE-USE (16729-275-03)

• 52958- Hainan Shuangcheng Pharmaceuticals Co., Ltd.
  • 52958-034- Bivalirudin
    • 52958-034-01- 10 VIAL, SINGLE-USE in 1 CARTON (52958-034-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE

• 55111- Dr. Reddy's Laboratories Limited
  • 55111-652- Bivalirudin
    • 55111-652-37- 10 VIAL, SINGLE-DOSE in 1 CARTON (55111-652-37) > 1 INJECTION in 1 VIAL, SINGLE-DOSE (55111-652-07)

• 55150- AuroMedics Pharma LLC
  • 55150-210- BIVALIRUDIN
    • 55150-210-10- 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-210-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

• 60505- Apotex corp
  • 60505-6101- Bivalirudin
    • 60505-6101-4- 10 VIAL, SINGLE-DOSE in 1 CARTON (60505-6101-4) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

• 63323- Fresenius Kabi USA, LLC
  • 63323-562- Bivalirudin
    • 63323-562-15- 10 VIAL, SINGLE-USE in 1 CARTON (63323-562-15) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (63323-562-41)

• 63323- Fresenius Kabi USA, LLC
  • 63323-562- Bivalirudin
    • 63323-562-10- 10 VIAL, SINGLE-USE in 1 CARTON (63323-562-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE

• 65293- The Medicines Company
  • 65293-001- Angiomax
    • 65293-001-01- 10 VIAL, SINGLE-USE in 1 CARTON (65293-001-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE

• 67457- Mylan Institutional LLC
  • 67457-256- Bivalirudin
    • 67457-256-10- 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-256-10) > 5 mL in 1 VIAL, SINGLE-DOSE (67457-256-00)

• 69097- Cipla USA Inc.
  • 69097-601- bivalirudin
    • 69097-601-37- 1 VIAL, SINGLE-USE in 1 CARTON (69097-601-37) > 1 INJECTION in 1 VIAL, SINGLE-USE

• 69097- Cipla USA Inc.
  • 69097-601- bivalirudin
    • 69097-601-96- 10 VIAL, SINGLE-USE in 1 CARTON (69097-601-96) > 1 INJECTION in 1 VIAL, SINGLE-USE

• 70860- Athenex Pharmaceutical Division, LLC.
  • 70860-402- Bivalirudin
    • 70860-402-10- 10 VIAL, SINGLE-DOSE in 1 CARTON (70860-402-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (70860-402-41)