Pharmacologic class: Thrombin inhibitor
Therapeutic class: Anticoagulant
Pregnancy risk category B
Selectively inhibits thrombin by binding to its receptor sites, causing inactivation of coagulation factors V, VIII, and XII and thus preventing conversion of fibrinogen to fibrin
Powder for injection: 250 mg/vial
Indications and dosages
➣ Patients with unstable angina who are undergoing percutaneous transluminal coronary angioplasty (PTCA); patients with or at risk for heparin-induced thrombocytopenia or heparin-induced thrombocytopenia and thrombosis syndrome undergoing percutaneous coronary intervention
Adults: 0.75 mg by I.V. bolus followed by 1.75 mg/kg/hour by I.V. infusion for duration of procedure. Five minutes after bolus is administered, an activated clotting time should be obtained and an additional bolus of 0.3 mg/kg should be given if needed. Continuation of infusion for up to 4 hours post-procedure is optional, and at discretion of treating physician. After 4 hours, an additional I.V. infusion may be initiated at rate of 0.2 mg/kg/hour for up to 20 hours if needed.
• Renal impairment
• Dialysis patients
• PCTA (regardless of history of unstable angina)
• Anticoagulation during orthopedic surgery
• Hypersensitivity to drug
• Active major bleeding
Use cautiously in:
• renal impairment, severe hepatic dysfunction, bacterial endocarditis, cerebrovascular accident, severe hypertension, heparin-induced thrombocytopenia, thrombosis syndrome
• diseases associated with increased risk of bleeding
• concurrent use of other platelet aggregation inhibitors
• pregnant or breastfeeding patients
• For I.V. injection and infusion, add 5 ml of sterile water to each 250-mg vial; gently mix until dissolved. Further dilute in 50 ml of dextrose 5% in water or normal saline solution for injection to a final concentration of 5 mg/ml.
• Don't mix with other drugs.
• Don't give by I.M. route.
• Know that drug is intended for use with aspirin.
CNS: headache, anxiety, nervousness, insomnia
CV: hypotension, hypertension, bradycardia, ventricular fibrillation
GI: nausea, vomiting, abdominal pain, dyspepsia, severe spontaneous GI bleeding
GU: urinary retention, severe spontaneous GU bleeding
Hematologic: severe spontaneous bleeding
Musculoskeletal: pelvic or back pain
Other: fever, pain at injection site
Drug-drug. Abciximab, anticoagulants (including heparin, low-molecular-weight heparins, and heparinoids),
thrombolytics, ticlopidine, warfarin: increased risk of bleeding
Drug-diagnostic tests. Activated partial thromboplastin time, prothrombin time: increased
Drug-herbs. Ginkgo biloba: increased risk of bleeding
☞ Monitor blood pressure, hemoglobin, and hematocrit. Be aware that decrease in blood pressure or hematocrit may signal hemorrhagic event.
• Monitor venipuncture site closely for bleeding.
☞ Instruct patient to immediately report bleeding, bruising, or tarry stools.
• Tell patient to avoid activities that can cause injury. Advise him to use soft toothbrush and electric razor to avoid gum and skin injury.
Pharmacologic: thrombin inhibitors
Time/action profile (anticoagulant effect)
Adverse Reactions/Side Effects
Central nervous system
- headache (most frequent)
- hypotension (most frequent)
- nausea (most frequent)
- abdominal pain
- bleeding (life-threatening)
- injection site pain
- back pain (most frequent)
- pain (most frequent)
- pelvic pain
Drug-Drug interactionRisk of bleeding may be ↑ by concurrent use of abciximab, heparin, low molecular weight heparins, clopidogrel, thrombolytics, or any other drugs that inhibit coagulation.↑ risk of bleeding with arnica, chamomile, clove, dong quai, feverfew, garlic, ginger, gingko, Panax ginseng, and others.
Renal ImpairmentIntravenous (Adults) No ↓ in the bolus dose is needed in any patient with renal impairment. GFR 10–29 mL/min—↓ infusion rate to 1 mg/kg/hr; Dialysis-dependent patients (off dialysis)—↓ infusion rate to 0.25 mg/kg/hr. ACT should be monitored in all patients with renal impairment.
- Assess for bleeding. Most common is oozing from the arterial access site for cardiac catheterization. Arterial and venous punctures, IM injections, and use of urinary catheters, nasotracheal intubation, and nasogastric tubes should be minimized. Noncompressible sites for IV access should be avoided. 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.
- 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.
- Monitor ACT periodically in patients with renal dysfunction.
Potential Nursing DiagnosesIneffective tissue perfusion (Indications)
- Administer IV just prior to PTCA, in conjunction with aspirin 300 mg to 325 mg/day. Do not administer IM.
- pH: 5.0–6.0.
- (for bolus dose)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: 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.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).
- Y-Site Compatibility: acyclovir, allopurinol, amifostine, amikacin, aminocaproic acid, aminophylline, amphotericin B liposome, ampicillin, ampicillin-sulbactam, anidulafungin, argatroban, arsenic trioxide, atracurium, atropine, azithromycin, aztreonam, bleomycin, bumetanide, buprenorphine, busulfan, butorphanol, calcium chloride, calcium gluconate, carboplatin, carmustine, cefazolin, cefepime, cefoperazone, cefotaxime, cefoxitin, ceftazidime, ceftozoxime, ceftriaxone, cefuroxime, chloramphenicol, cimetidine, ciprofloxacin, cisatracurium, cisplatin, clindamycin, cyclophosphamide, cyclosporine, cytarabine, dacarbazine, dactinomycin, daptomycin, daunorubicin, dexamethasone, dexmedetomidine, dexrazoxane, digoxin, diltiazem, diphenhydramine, docetaxel, dolasetron, dopamine, doxorubicin, doxorubicin liposome, doxycycline, droperidol, enaprilat, ephedrine, epinephrine, epirubicin, epoprostenol, eptifibatide, ertapenem, erythromycin, esmolol, etoposide, etoposide phosphate, famotidine, fenoldopam, fentanyl, fluconazole, fludarabine, fluorouracil, foscarnet, fosphenytoin, furosemide, ganciclovir, gemcitabine, gentamicin, glycopyrrolate, granisetron, haloperidol, heparin, hydralazine, hydrocortisone, hydromorphone, idarubicin, ifosfamide, imipenem/cilastatin, insulin, irinotecan, isoproterenol, ketorolac, labetalol, leucovorin, levofloxacin, lidocaine, linezolid, lorazepam, magnesium sulfate, mannitol, mechlorethamine, melaphalan, meperidine, meropenem, mesna, methohexital, methotrexate, methyldopate, methylprednisolone, metoclopramide, metoprolol, metronidazole, midazolam, milrinone, mitomycin, mitoxantrone, morphine, mycophenolate, nafcillin, nalbuphine, naloxone, nesiritide, nicardipine, nitroglycerin, nitroprusside, norepinephrine, octreotide, ondansetron, oxaliplatin, oxytocin, paclitaxel, palonosetron, pamidronate, pancuronium, pemetrexed, pentobarbital, phenobarbital, phenylephrine, piperacillin-tazobactam, potassium acetate, potassium chloride, potassium phosphate, procainamide, promethazine, ranitidine, remifentanil, rocuronium, sodium acetate, sodium bicarbonate, sodium phosphates, streptozocin, succinylcholine, sufentanil, tacrolimus, teniposide, theophylline, thiopental, thiotepa, ticarcillin-clavulanate, tigecycline, tirofiban, tobramycin, topotecan, trimethoprim/sulfamethoxazole, vasopressin, vecuronium, verapamil, vinblastine, vincristine, vinorelbine, voriconazole, warfarin, zidovudine, zoledronic acid
- Y-Site Incompatibility: alteplase, amiodarone, amphotericin B, amphotericin B lipid complex, caspofungin, chlorpromazine, dantrolene, diazepam, pentamidine, pentazocine, phenytoin, prochlorperazine, quinupristin/dalfopristin, reteplase, streptokinase, vancomycin
- Inform patient of the purpose of bivalirudin.
- Instruct patient to notify health care professional immediately if any bleeding is noted.
- Decreased acute ischemic complications in patients with unstable angina (death, MI or the urgent need for revascularization procedures).
Angiomax™A specific and reversible direct thrombin inhibitor.
Anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA) and percutaneous coronary intervention (PCI), especially in patients with, or at risk of, HIT/HITTS.
Back or other regional pain, nausea, headache, hypotension.