BIVALIRUDIN
| BIVALIRUDIN (bi-val'i-ru-den) Angiomax Classifications: anticoagulant; thrombin inhibitor; Therapeutic: thrombin inhibitor Prototype: Lepirudin Pregnancy Category: B |
Availability
250 mg vial
Action
Direct inhibitor of thrombin similar to lepirudin. Capable of inhibiting the action of both free and clot-bound thrombin.
Therapeutic Effect
Reversibly binds to the thrombin active site, thereby blocking the thrombogenic activity of thrombin.
Uses
Used with aspirin as an anticoagulant in patients undergoing PTCA or PCR, patients at risk for HIT undergoing PCI.
Unlabeled Uses
DVT prevention.
Contraindications
Hypersensitivity to bivalirudin; cerebral aneurysm, intracranial hemorrhage; patients with increased risk of bleeding (e.g., recent surgery, trauma, CVA, hepatic disease); coagulopathy; lactation. Safety and efficacy in children are not established.
Cautious Use
Asthma or allergies; blood dyscrasia or thrombocytopenia; GI ulceration, serious hepatic disease; hypertension, renal impairment, pregnancy (category B).
Route & Dosage
| Anticoagulation Adult: IV 0.75 mg/kg bolus (5 min after the bolus, ACT should be performed and 0.3 mg/kg given if needed) followed by 1.75 mg/kg/h for the duration of the procedure, may continue at 0.2 mg/kg/h up to 20 h if needed; intended for use with aspirin 300–325 mg Renal Impairment If Clcr <30 mL/min, give maintenance dose of 1 mg/kg/h. Hemodialysis: Give 0.25 mg/kg/h maintenance dose |
Administration
| Intravenous PREPARE: Direct/Continuous: Direct IV bolus dose and initial 4-h continuous infusion: Reconstitute each 250 mg vial with 5 mL of sterile water for injection; gently swirl until dissolved. Must further dilute each reconstituted vial in 50 mL of D5W or NS to yield 5 mg/mL. Continuous: Subsequent low-dose, continuous infusions. Reconstitute each 250 mg vial as above. Further dilute each reconstituted vial in 500 mL of D5W or NS to yield 0.50 mg/mL. ADMINISTER: Direct: Give bolus dose over 3–5 sec. Continuous: Give 1.75 mg/kg/h for the duration of the PTCA procedure. Subsequent doses, give 0.2 mg/kg/h for up to 20 h as ordered. INCOMPATIBILITIES Y-site: Alteplase, amiodarone, amphotericin B, chlorpromazine, diazepam, prochlorperazine, reteplase, streptokinase, vancomycin. |
- Store reconstituted vials refrigerated at 2°–8° C (35.6°–46.4° F) for up to 24 h. Store diluted concentrations between 0.5 mg/mL and 5 mg/mL at room temperature, 15°–30° C (59°–86° F), for up to 24 h.
Adverse Effects (≥1%)
Body as a Whole: Back pain, pain, fever. CV: Hypotension, hypertension, bradycardia. GI: Nausea, vomiting, dyspepsia, abdominal pain. Hematologic: Bleeding. CNS: Headache, anxiety, nervousness. Urogenital: Urinary retention, pelvic pain. Other: Injection site pain.Interactions
No clinically significant interactions established.Pharmacokinetics
Duration: 1 h. Distribution: No protein binding. Metabolism: Proteolytic cleavage and renal metabolism. Elimination: Renal. Half-Life: 25 min.Nursing Implications
Assessment & Drug Effects
- Monitor cardiovascular status carefully during therapy.
- Monitor for and report S&S of bleeding: Ecchymosis, epistaxis, GI bleeding, hematuria, hemoptysis.
- Patients with history of GI ulceration, hypertension, recent trauma or surgery are at increased risk for bleeding.
- Monitor neurologic status and report immediately: focal or generalized deficits.
- Lab tests: Baseline and periodic ACT (activated clotting time), APTT, PT, INR, thrombin time (TT), plasma fibrinopeptide A (especially in unstable angina), platelet count, Hgb and Hct; periodic serum creatinine, stool for occult blood, urinalysis.
Patient & Family Education
- Report any of the following immediately: Unexplained back or stomach pain; black, tarry stools; blood in urine, coughing up blood; difficulty breathing; dizziness or fainting spells; heavy menstrual bleeding; nosebleeds; unusual bruising or bleeding at any site.
Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; 
Canadian drug name; 
Prototype drug