Angiomax


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bivalirudin

Angiomax, Angiox (UK)

Pharmacologic class: Thrombin inhibitor

Therapeutic class: Anticoagulant

Pregnancy risk category B

Action

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

Availability

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.

Dosage adjustment

• Renal impairment
• Dialysis patients

Off-label uses

• PCTA (regardless of history of unstable angina)
• Anticoagulation during orthopedic surgery

Contraindications

• Hypersensitivity to drug
• Active major bleeding

Precautions

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
• children.

Administration

• 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.

Adverse reactions

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

Interactions

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

Patient monitoring

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.

Patient teaching

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.

bivalirudin

(bi-val-i-roo-din) ,

Angiomax

(trade name)

Classification

Therapeutic: anticoagulants
Pharmacologic: thrombin inhibitors
Pregnancy Category: B

Indications

Used in conjunction with aspirin to reduce the risk of acute ischemic complications in patients with unstable angina who are undergoing percutaneous transluminal angioplasty (PCTA) or percutaneous coronary intervention (PCI).Patients with or at risk of heparin-induced thrombocytopenia (HIT) and thrombosis syndrome (HITTS) who are undergoing PCI.

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).

Pharmacokinetics

Absorption: IV administration results in complete bioavailability.
Distribution: Unknown.
Metabolism and 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)

ROUTEONSETPEAKDURATION
IVimmediateunknown1–2 hr

Contraindications/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 PTCA;Patients with other acute coronary syndromes;Concurrent use with other platelet aggregation inhibitors (safety not established);Renal impairment (↓ infusion rate if GFR <30 mL/min); Lactation / Pediatric: Safety not established; Obstetric: Use only if clearly needed.

Adverse Reactions/Side Effects

Central nervous system

  • headache (most frequent)
  • anxiety
  • insomnia
  • nervousness

Cardiovascular

  • hypotension (most frequent)
  • bradycardia
  • hypertension

Gastrointestinal

  • nausea (most frequent)
  • abdominal pain
  • dyspepsia
  • vomiting

Hematologic

  • bleeding (life-threatening)

Local

  • injection site pain

Musculoskeletal

  • back pain (most frequent)

Miscellaneous

  • pain (most frequent)
  • fever
  • pelvic pain

Interactions

Drug-Drug interaction

Risk 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.

Route/Dosage

Intravenous (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. If needed, the infusion may be continued beyond this initial 4 hr at a rate of 0.2 mg/kg/hr for up to 20 hr. Therapy should be initiated prior to the procedure and given in conjunction with aspirin.

Renal Impairment

Intravenous (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.

Availability

Powder for injection: 250 mg/vial

Nursing implications

Nursing assessment

  • 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 Diagnoses

Ineffective tissue perfusion (Indications)

Implementation

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

Patient/Family Teaching

  • Inform patient of the purpose of bivalirudin.
  • Instruct patient to notify health care professional immediately if any bleeding is noted.

Evaluation/Desired Outcomes

  • 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.
 
Indications
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.

Adverse effects
Back or other regional pain, nausea, headache, hypotension.
References in periodicals archive ?
14, 2014 /PRNewswire/ -- Angiomax (Acute Coronary Syndrome) - Forecast and Market Analysis to 2023
The FDA didn't clear the use of Angiomax in hospital emergency rooms for acute coronary syndrome, a range of disorders including chest pain that can signal reduced blood flow to the heart.
The significantly lower rate of bleeding with Angiomax demonstrated in the ACUITY trial is particularly important as physicians and hospitals seek to improve patient outcomes and implement quality care initiatives," said ACUITY principal investigator Gregg W.
The data were collected in the Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)-2 trial, which compared two different anticoagulant regimens in 6,010 patients undergoing PCI.
Professor Harvey White, principal investigator in the trial, reported to the European Society of Cardiology meeting in Stockholm, that in the trial ANGIOMAX reduced the combined incidence of death or investigator-reported second myocardial infarction compared to heparin at 30 days by 1.
In the United States, Angiomax with provisional use of glycoprotein IIb/IIIa inhibitor (GPI) is indicated for use in patients undergoing angioplasty, also called percutaneous coronary intervention (PCI), and in patients with, or at risk of, heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI.
A Comparative Study of Heparin Against Angiomax II-41
In the United States, a similar Angiomax ACS filing is being reviewed by the U.
The Medicines Company (NASDAQ: MDCO) announced that a prospective analysis of the ACUITY (Acute Catheterization and Urgent Intervention Triage StrategY) trial showed that total hospital stay costs were lowest with Angiomax monotherapy (mean difference range: $184 to $1,081, p <0.
The HORIZONS-AMI trial compared Angiomax to heparin plus a platelet GPI in 3,602 patients presenting with the most severe form of heart attack, known as ST-elevation myocardial infarction (STEMI) undergoing a primary PCI strategy.
The one-year results from the ACUITY trial in conjunction with recent 30- day findings from the HORIZONS trial in heart attack patients further substantiate Angiomax as a replacement for heparin therapy across a broad range of patients undergoing angioplasty," said John Kelley, President and Chief Operating Officer of The Medicines Company , which markets Angiomax.