bivalirudin

ROUTE	ONSET	PEAK	DURATION
IV	immediate	unknown	1–2 hr

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.

Adv. Reactions/Side Effects ⬆ ⬇

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

Interactions ⬆ ⬇

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.

Route/Dosage ⬆ ⬇

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.

Renal Impairment

IV (Adults ): No ↓ in the bolus dose is needed in any patient with renal impairment. CCr <30 mL/min:↓ infusion rate to 1 mg/kg/hr; Hemodialysis:↓ infusion rate to 0.25 mg/kg/hr.

Availability ⬆ ⬇

(Generic available)

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

Assessment ⬆ ⬇

Assess for bleeding. Most common is oozing from the arterial access site for cardiac catheterization. Minimize use of arterial and venous punctures, IM injections, and use of urinary catheters, nasotracheal intubation, and nasogastric tubes. Avoid noncompressible sites for IV access. If bleeding cannot be controlled with pressure, discontinue bivalirudin immediately.
Monitor vital signs. May cause bradycardia, hypertension, or hypotension. An unexplained decrease in BP may indicate hemorrhage.
Monitor patients with STEMI undergoing primary PCI with bivalirudin for acute stent thrombosis for at least 24 hrs in a facility capable of managing ischemic complications.

Lab Test Considerations:

Assess hemoglobin, hematocrit, and platelet count prior to bivalirudin therapy and periodically during therapy. May cause ↓ hemoglobin and hematocrit. An unexplained ↓ in hematocrit may indicate hemorrhage.
- Bivalirudin interferes with INR measurements; INR may not be useful in determining appropriate dose of warfarin.
- Monitor ACT periodically in patients with renal dysfunction.

Implementation ⬆ ⬇

Administer IV just prior to PCI, in conjunction with aspirin 300 mg to 325 mg/day. Do not administer IM.

IV Administration:

(for bolus dose)
Reconstitution: Reconstitute each 250-mg vial with 5 mL of sterile water for injection. Reconstituted vials are stable for 24 hr if refrigerated.Diluent: Further dilute in 50 mL of D5W or 0.9% NaCl. Withdraw bolus dose out of bag. Infusion is stable for 24 hr at room temperature.Concentration: Final concentration of infusion is 5 mg/mL.
Rate: Administer as a bolus injection.
Intermittent Infusion: Reconstitution: Reconstitute each 250-mg vial as per the above directions.Diluent: Further dilute in 50 mL of D5W or 0.9% NaCl. If infusion is to be continued after 4 hr (at a rate of 0.2 mg/kg/hr), reconstituted vial should be diluted in 500 mL of D5W or 0.9% NaCl. Infusion is stable for 24 hr at room temperature. Premixed infusion is stable for 24 hr at room temperature or 14 days if refrigerated.Concentration: 5 mg/mL (for infusion rate of 1.75 mg/kg/hr); 0.5 mg/mL (for infusion rate of 0.2 mg/kg/hr).
Rate: Based on patient's weight (see Route/Dosage section).

Patient/Family Teaching ⬆ ⬇

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 if breastfeeding.

Evaluation/Desired Outcomes ⬆ ⬇

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

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

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)

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)

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
  - 63323-562-10- 10 VIAL, SINGLE-USE in 1 CARTON (63323-562-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE

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)

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)

section name header

Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇