bivalirudin

High Alert

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

Contraind./Precautions ⬆ ⬇

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.

Availability ⬆ ⬇

(Generic available)

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

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.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

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.

Therapeutic effects:

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

Classifications ⬆ ⬇

Therapeutic Classification: anticoagulants

Pharmacologic Classification: thrombin inhibitors

Pharmacokinetics ⬆ ⬇

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).

Time/Action Profile ⬆ ⬇

(anticoagulant effect)

ROUTE	ONSET	PEAK	DURATION
IV	immediate	unknown	1–2 hr

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.

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Indications ⬇