Names and pronunciation
(bye-val-i-rue′din) Angiomax
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Drug reference
(bye-val-i-rue′din) Angiomax
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Func. class.: Anticoagulant
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Chem. class.: Direct thrombin inhibitor
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ACTION: Direct inhibitor of thrombin that is highly specific; able to inhibit free and clot-bound thrombin
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USES: Unstable angina in patients undergoing percutaneous transluminal coronary angioplasty (PTCA), used with aspirin; heparin-induced thrombocyto- penia, with/without thrombosis syn- drome, PCI with IIb/IIIa Unlabeled: ST-elevation MI (primary PCI), non-ST elevation, ACS (moderate- high risk) early invasive strategy
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CONTRAINDICATIONS: Hyper- sensitivity, active bleeding, cerebral aneurysm, intracranial hemorrhage, recent surgery, CVA Precautions: Pregnancy, breastfeeding, children, geriatric patients, renal function impairment, hepatic disease, asthma, blood dyscrasias, thrombocytopenia, GI ulcers, hypertension, inflammatory bowel disease, vitamin K deficiency, asthma
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SIDE EFFECTS CNS: Headache, insomnia, anxiety, nervousness CV: Hypo/hypertension, bradycardia, ventricular fibrillation GI: Nausea, vomiting, abdominal pain, dyspepsia HEMA: Hemorrhage, thrombocytopenia MISC: Pain at injection site, pelvic pain, uri- nary retention, fever, anaphylaxis, infection MS: Back pain GU: Urinary retention, renal failure, oliguria
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INTERACTIONS Increase: bleeding risk—abciximab, anti- coagulants, aspirin, thrombolytics, cepha- losporins, use together cautiously Drug/Herb Increase: bleeding risk—angelica, chamo- mile, devil’s claw, dong quai, garlic, ginger, ginkgo, ginseng, horse chestnut, licorice, saw palmetto; avoid concurrent use
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DOSAGE AND ROUTES Anticoagulation in unstable angina in those undergoing PTCA or PCI with provisional use of platelet glycoprotein inhibitor • Adult: IV BOLUS 0.75 mg/kg, then IV INFUSION 1.75 mg/kg/hr for 4 hr; an- other IV INFUSION may be used at 0.2 mg/kg/hr for ≤20 hr; this product is intended to be used with aspirin (325 mg/day) adjusted to body weight Patients undergoing PCI at risk for HIT/HITTS or ST elevation in patients undergoing primary PCI (unlabeled) Adult: IV BOLUS 0.75 mg/kg, then con- tinuous infusion 1.75 mg/kg/hr for dura- tion of procedure, may give another infu- sion after 4 hr of 0.2 mcg/kg/hr up to 20 hr, give with aspirin 325 mg ST-elevation MI (undergoing primary PCI) (unlabeled) Adults: 0.75 mg/kg/IV bolus, then 1.75 mg/kg IV infusion for duration. May give additional 0.3 mg/kg bolus dose if needed. May continue bolus dose if needed. May continue infusion at 1.75 mg/kg for up to 4 hr after procedure. If infusion is continued, may continue in- fusion at 0.2 mg/kg for up to 20 hr Non-ST-elevation ACS (moderate to high risk) (early invasive strategy) (unlabeled) Adults: If initiating during PCI, give 0.75 mg/kg IV bolus, followed by 1.75 mg/kg/ hr IV infusion for duration of procedure. May give additional 0.3 mg/kg bolus dose if needed. May continue infusion at 1.75 mg/kg for up to 4 hr after procedure. If infusion is continued and an additional infusion is necessary, may continue infu- sion at a reduced dose of 0.2 mg/kg for up to 20 hr. If unfractionated heparin was given before procedure, wait 30 min before using bivalirudin. If initiating before PCI or diagnostic angiography, give 0.1 mg/kg IV bolus, then by 0.25 mg/ kg IV infusion, continue until angiogram or PCI Renal dose • Adult: IV CCr ≥30 mL/min no adjust- ment; CCr 10-29 mL/min consider reduc- ing to 1 mL/kg/hr; hemodialysis 0.25 mg/ kg/hr, same bolus dose
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Available forms: Injection, lyophilized 250 mg/vial
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Administer: • Before PTCA; give with aspirin (325 mg) • Store reconstituted vials in refrigerator for up to 24 hr; store diluted concentra- tions at room temperature for 24 hr IV, direct route • Dilute by adding 5 mL of sterile water for injection/250 mg bivalirudin, swirl until dissolved, further dilute in 50 mL of D5W or 0.9% NaCl (5 mg/mL), give by bolus injection 0.75 mg/kg, then inter- mittent infusion Continuous IV INFUSION route • To each 250-mg vial add 5 mL of sterile water for injection, swirl until dissolved, B further dilute in 500 mL D5W or 0.9% NaCl (0.5 mg/mL); give infusion after bo- lus dose at a rate of 1.75 mg/kg/hr; may give an additional infusion at 0.2 mg/kg/hr Y-site compatibilities: Abciximab, acyclo- vir, alfentanil, allopurinol, amifostine, ami- kacin, aminocaproic acid, aminophylline, amphotericin B liposome, ampicillin, ampicillin-sulbactam, anidulafungin, arg- atroban, arsenic trioxide, atenolol, atracu- rium, atropine, azithromycin, aztreonam, bleomycin, bumetanide, buprenorphine, busulfan, butorphanol, calcium chloride/ gluconate, capreomycin, CARBOplatin, carmustine, ceFAZolin, cefepime, cefotax- ime, cefoTEtan, cefOXitin, cefTAZidime, ceftizoxime, cefTRIAXone, cefuroxime, chloramphenicol, cimetidine, ciprofloxa- cin, cisatracurium, CISplatin, clindamycin, cyclophosphamide, cycloSPORINE, cytara- bine, dacarbazine, DACTINomycin, DAP- TOmycin, DAUNOrubicin, DAUNOrubicin liposome, dexamethasone, dexmedetomi- dine, dexrazoxane, digoxin, diltiazem, diphenhydrAMINE, DOCEtaxel, dolasetron, DOPamine, DOXOrubicin, DOXOrubicin liposomal, doxycycline, droperidol, enala- prilat, ePHEDrine, EPINEPHrine, epirubi- cin, epoprostenol, eptifibatide, ertapenem, erythromycin, esmolol, etoposide, etopo- side phosphate, famotidine, fenoldopam, fentaNYL, fluconazole, fludarabine, fluoro- uracil, foscarnet, fosphenytoin, furose- mide, gallium, ganciclovir, gatifloxacin, gemcitabine, gentamicin, glycopyrrolate, granisetron, haloperidol, heparin, hydrAL- AZINE, hydrocortisone, HYDROmorphone, hydrOXYzine, IDArubicin, ifosfamide, imi- penem-cilastatin, inamrinone, insulin (regular), irinotecan, isoproterenol, ketorolac, labetalol, leucovorin, levofloxa- cin, lidocaine, linezolid, LORazepam, magnesium, mannitol, mechlorethamine, melphalan, meperidine, meropenem, mesna, methohexital, methotrexate, meth- yldopate, methylPREDNISolone, metoclo- pramide, metoprolol, metroNIDAZOLE, midazolam, milrinone, mitoMYcin, mito- XANtrone, mivacurium, morphine, moxifloxacin, mycophenolate mofetil, naf- cillin, nalbuphine, naloxone, nesiritide, niCARdipine, nitroglycerin, nitroprusside, norepinephrine, octreotide, ofloxacin, ondansetron, oxaliplatin, oxytocin, PACLi- taxel, palonosetron, pamidronate, pan- curonium, PEMEtrexed, PENTobarbital, PHENobarbital, phenylephrine, piperacil- lin, piperacillin-tazobactam, polymyxin B, potassium acetate/chloride/phosphates, procainamide, promethazine, proprano- lol, ranitidine, remifentanil, rocuronium, sodium acetate/bicarbonate/phosphates, streptozocin, succinylcholine, SUFentanil, sulfamethoxazole-trimethoprim, tacroli- mus, teniposide, theophylline, thiopental, thiotepa, ticarcillin, ticarcillin-clavulanate, tigecycline, tirofiban, tobramycin, topote- can, vasopressin, vecuronium, verapamil, vinBLAStine, vinCRIStine, vinorelbine, vori- conazole, warfarin, zidovudine, zoledronic acid
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Assess: • Bleeding: check arterial and venous sites, IM injection sites, catheters; all punctures should be minimized; fall in B/P or Hct may indicate hemorrhage; hematoma, hemorrhage at puncture site are more common in the elderly; moni- tor coagulation studies, Hct before use; baseline and periodic ACT, aPTT, PT, INR, TT, platelets, HB, Hct • CV status: B/P; watch for hypo/hyper- tension, bradycardia • Neurologic status: any focal or gener- alized deficits should be reported imme- diately • PCI use: possible thrombosis, stenosis, unplanned stent, prolonged ischemia, de- creased reflow • Renal function: dosage reductions may be required Pregnancy/breastfeeding: use only if clearly needed, use cautiously in breastfeeding
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Evaluate: • Therapeutic response: anticoagulation with PTCA, PCI; resolution of heparin- induced thrombocytopenia, thrombosis syndrome
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • About the reason for the product and expected results • To report black, tarry stools; blood in urine; difficulty breathing • Not to use any OTC, herbal products unless approved by prescriber • Not to use hard-bristle toothbrush or regular razor to avoid any injury; hemor- rhage may result • Pregnancy/breastfeeding: Report if pregnancy is planned or suspected or if breastfeeding HIGH ALERT
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PHARMACOKINETICS Excreted in urine, half-life 25 min, onset rapid, peak immediate duration 1 hr, no protein binding
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• Adult: IV BOLUS 0.75 mg/kg, then IV INFUSION 1.75 mg/kg/hr for 4 hr; an- other IV INFUSION may be used at 0.2 mg/kg/hr for ≤20 hr; this product is intended to be used with aspirin (325 mg/day) adjusted to body weight Patients undergoing PCI at risk for HIT/HITTS or ST elevation in patients undergoing primary PCI (unlabeled) Adult: IV BOLUS 0.75 mg/kg, then con- tinuous infusion 1.75 mg/kg/hr for dura- tion of procedure, may give another infu- sion after 4 hr of 0.2 mcg/kg/hr up to 20 hr, give with aspirin 325 mg ST-elevation MI (undergoing primary PCI) (unlabeled) Adults: 0.75 mg/kg/IV bolus, then 1.75 mg/kg IV infusion for duration. May give additional 0.3 mg/kg bolus dose if needed. May continue bolus dose if needed. May continue infusion at 1.75 mg/kg for up to 4 hr after procedure. If infusion is continued, may continue in- fusion at 0.2 mg/kg for up to 20 hr Non-ST-elevation ACS (moderate to high risk) (early invasive strategy) (unlabeled) Adults: If initiating during PCI, give 0.75 mg/kg IV bolus, followed by 1.75 mg/kg/ hr IV infusion for duration of procedure. May give additional 0.3 mg/kg bolus dose if needed. May continue infusion at 1.75 mg/kg for up to 4 hr after procedure. If infusion is continued and an additional infusion is necessary, may continue infu- sion at a reduced dose of 0.2 mg/kg for up to 20 hr. If unfractionated heparin was given before procedure, wait 30 min before using bivalirudin. If initiating before PCI or diagnostic angiography, give 0.1 mg/kg IV bolus, then by 0.25 mg/ kg IV infusion, continue until angiogram or PCI Renal dose
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• Adult: IV CCr ≥30 mL/min no adjust- ment; CCr 10-29 mL/min consider reduc- ing to 1 mL/kg/hr; hemodialysis 0.25 mg/ kg/hr, same bolus dose
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