argatroban

ROUTE	ONSET	PEAK	DURATION
IV	immediate	1–3 hr	2–4 hr

IV (Adults ): 2 mcg/kg/min as a continuous infusion; adjust infusion rate on the basis of activated partial thromboplastin time (aPTT). Patients undergoing PCI: 350 mcg/kg bolus followed by infusion at 25 mcg/kg/min, activated clotting time (ACT) should be assessed 5–10 min later. If ACT is 300–450 sec, procedure may be started. If ACT <300 sec, give additional bolus of 150 mcg/kg and ↑ infusion rate to 30 mcg/kg/min. If ACT is >450 sec, infusion rate should be ↓ to 15 mcg/kg/min and ACT rechecked after 5–10 min. If thrombotic complications occur or ACT drops to <300 sec, an additional bolus of 150 mcg/kg may be given and the infusion rate ↑ to 40 mcg/kg/min followed by ACT monitoring. If anticoagulation is required after surgery, lower infusion rates should be used.

Hepatic Impairment

IV (Adults ): 0.5 mcg/kg/min as a continuous infusion; adjust infusion rate on the basis of aPTT.

Availability ⬆ ⬇

(Generic available)

Premixed infusion: 50 mg/50 mL
Solution for injection: 100 mg/mL

Assessment ⬆ ⬇

Monitor vital signs periodically during therapy. Unexplained ↓ in BP may indicate hemorrhage. Assess patient for bleeding. Minimize arterial and venous punctures, IM injections, and use of urinary catheters, nasotracheal intubation, and nasogastric tubes. Avoid noncompressible sites for IV access. Monitor for blood in urine, lower back pain, or pain or burning on urination. If bleeding cannot be controlled with pressure, ↓ dose or discontinue argatroban immediately.
Monitor for signs and symptoms of anaphylaxis (rash, coughing, dyspnea) during therapy. Implement medical management (epinephrine) if necessary.

Lab Test Considerations:

Monitor aPTT before initiation of continuous infusion, 2 hr after initiation of therapy, and periodically during therapy to confirm aPTT is within desired therapeutic range.
- For patients undergoing PCI, monitor ACT as described in Route and Dose section.
- Assess hemoglobin, hematocrit, and platelet count before and periodically during argatroban therapy. May ↓ hemoglobin and hematocrit. Unexplained ↓ hematocrit may indicate hemorrhage.
- Use of argatroban concurrently with multiple doses of warfarin will result in more prolonged prothrombin time and INR (although there is not an ↑ in vitamin K–dependent factor Xa activity). Monitor INR daily during concomitant therapy. Repeat INR 4–6 hr after argatroban is discontinued. If repeat value is below desired therapeutic value for warfarin alone, restart argatroban therapy and continue until desired therapeutic range for warfarin alone is reached. To obtain the INR for warfarin alone when dose of argatroban is >2 mcg/kg/min, temporarily ↓ argatroban dose to 2 mcg/kg/min; INR for combined therapy may then be obtained 4–6 hr after argatroban dose was ↓.

Toxicity and Overdose:

There is no specific antidote for argatroban. If overdose occurs, discontinue argatroban. Anticoagulation parameters usually return to baseline with 2–4 hr after discontinuation.

Implementation ⬆ ⬇

Do not confuse argatroban with Aggrastat.
Discontinue all parenteral anticoagulants before argatroban therapy is started. Oral anticoagulation may be initiated with maintenance dose of warfarin; do not administer loading dose. Discontinue argatroban therapy when INR for combined therapy is >4.

IV Administration:

IV: Do not administer solutions that are cloudy or contain particulate matter. Discard unused portion.
IV Push: Diluent: Bolus dose of 350 mcg/kg should be given prior to continuous infusion in patients undergoing PCI. For diluent information, see Continuous Infusion section below.
Rate: Administer bolus over 3–5 min.
Continuous Infusion: Diluent: Dilute 250 mg in 250 mL of 0.9% NaCl, D5W, or LR. 1 mg/mL. Mix by repeated inversion for 1 min. Diluted solution is slightly viscous, clear, and colorless to pale yellow; may show a slight haziness that disappears upon mixing; solution must be clear before use. Solution is stable at controlled room temperature and ambient light for 24 hr, or for 96 hr at controlled room temperature or refrigerated and protected from light; do not expose to direct sunlight. Premixed solutions are clear, colorless, and ready to be infused (no further dilution needed). Store at room temperature; do not refrigerate or freeze.
Rate: Based on patient's weight (see Route/Dosage section). Dose adjustment may be made 2 hr after starting infusion or changing dose until steady-state aPTT is 1.5–3 times the initial baseline value (not to exceed 100 sec).
Y-Site Compatibility:
- acyclovir
- alemtuzumab
- allopurinol
- amikacin
- aminocaproic acid
- aminophylline
- amphotericin B liposomal
- ampicillin
- ampicillin/sulbactam
- anidulafungin
- arsenic trioxide
- atracurium
- atropine
- azithromycin
- aztreonam
- bivalirudin
- bleomycin
- bumetanide
- buprenorphine
- busulfan
- butorphanol
- calcium acetate
- calcium chloride
- calcium gluconate
- carboplatin
- carmustine
- caspofungin
- cefazolin
- cefotaxime
- cefotetan
- cefoxitin
- ceftazidime
- ceftriaxone
- cefuroxime
- chloramphenicol
- chlorpromazine
- ciprofloxacin
- cisatracurium
- cisplatin
- clindamycin
- cyclophosphamide
- cyclosporine
- cytarabine
- dacarbazine
- dactinomycin
- daptomycin
- daptomycin
- daunorubicin
- dexamethasone
- dexmedetomidine
- dexrazoxane
- digoxin
- diltiazem
- diphenhydramine
- dobutamine
- docetaxel
- dopamine
- doxorubicin hydrochloride
- doxorubicin liposomal
- doxycycline
- droperidol
- enalaprilat
- ephedrine
- epinephrine
- epirubicin
- eptifibatide
- ertapenem
- erythromycin
- esmolol
- etoposide
- etoposide phosphate
- famotidine
- fentanyl
- fluconazole
- fludarabine
- fluorouracil
- foscarnet
- fosphenytoin
- furosemide
- ganciclovir
- gemcitabine
- gemtuzumab ozogamicin
- gentamicin
- glycopyrrolate
- granisetron
- haloperidol
- heparin
- hydralazine
- hydrocortisone
- hydromorphone
- ibutilide
- idarubicin
- ifosfamide
- imipenem/cilastatin
- insulin, regular
- irinotecan
- isoproterenol
- ketorolac
- labetalol
- leucovorin
- levofloxacin
- lidocaine
- linezolid
- lorazepam
- magnesium sulfate
- mannitol
- melphalan
- meperidine
- meropenem
- mesna
- methadone
- methotrexate
- methylprednisolone
- metoclopramide
- metoprolol
- midazolam
- milrinone
- mitomycin
- mitoxantrone
- morphine
- moxifloxacin
- mycophenolate
- nafcillin
- nalbuphine
- naloxone
- nicardipine
- nitroglycerin
- nitroprusside
- norepinephrine
- octreotide
- ondansetron
- oxaliplatin
- oxytocin
- paclitaxel
- palonosetron
- pamidronate
- pantoprazole
- pentamidine
- pentobarbital
- phenobarbital
- phentolamine
- phenylephrine
- phenytoin
- piperacillin/tazobactam
- potassium acetate
- potassium chloride
- potassium phosphate
- procainamide
- prochlorperazine
- promethazine
- propranolol
- remifentanil
- rocuronium
- sodium acetate
- sodium bicarbonate
- sodium phosphate
- succinylcholine
- sufentanil
- tacrolimus
- theophylline
- thiotepa
- tigecycline
- tirofiban
- tobramycin
- topotecan
- trimethoprim/sulfamethoxazole
- vancomycin
- vasopressin
- vecuronium
- verapamil
- vinblastine
- vincristine
- vinorelbine
- voriconazole
- zidovudine
- zoledronic acid
Y-Site Incompatibility:
- cefepime
- dantrolene
- diazepam
- phenytoin

Patient/Family Teaching ⬆ ⬇

Explain the purpose and side effects of the medication to patient.
Advise patient to avoid other products known to affect bleeding.
Instruct patient to notify health care professional immediately if any bleeding or signs and symptoms of allergic reaction is noted.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes ⬆ ⬇

Decreased thrombus formation and extension with decreased sequelae of thrombosis (emboli, postphlebitic syndromes).

Code ⬆

NDC Code

0143- Hikma Pharmaceuticals USA Inc.
- 0143-9288- Argatroban
  - 0143-9288-01- 1 VIAL in 1 CARTON (0143-9288-01) / 2.5 mL in 1 VIAL

0143- Hikma Pharmaceuticals USA Inc.
- 0143-9377- Argatroban
  - 0143-9377-01- 1 VIAL in 1 CARTON (0143-9377-01) / 50 mL in 1 VIAL

0143- Hikma Pharmaceuticals USA Inc.
- 0143-9559- Argatroban
  - 0143-9559-01- 1 VIAL in 1 CARTON (0143-9559-01) / 50 mL in 1 VIAL

0143- Hikma Pharmaceuticals USA Inc.
- 0143-9674- Argatroban
  - 0143-9674-01- 2.5 mL in 1 VIAL (0143-9674-01)

0409- Hospira, Inc.
- 0409-1140- Argatroban
  - 0409-1140-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-1140-01) / 2.5 mL in 1 VIAL, SINGLE-DOSE

16729- Accord Healthcare Inc.
- 16729-430- ARGATROBAN
  - 16729-430-11- 1 VIAL, SINGLE-USE in 1 CARTON (16729-430-11) / 50 mL in 1 VIAL, SINGLE-USE

16729- Accord Healthcare Inc.
- 16729-430- ARGATROBAN
  - 16729-430-43- 10 VIAL, SINGLE-USE in 1 CARTON (16729-430-43) / 50 mL in 1 VIAL, SINGLE-USE

25021- Sagent Pharmaceuticals
- 25021-414- Argatroban
  - 25021-414-50- 1 VIAL in 1 CARTON (25021-414-50) / 50 mL in 1 VIAL

42023- Endo USA, Inc.
- 42023-182- Argatroban
  - 42023-182-01- 1 VIAL in 1 CARTON (42023-182-01) / 2.5 mL in 1 VIAL

42023- Endo USA, Inc.
- 42023-182- Argatroban
  - 42023-182-89- 1 VIAL in 1 CARTON (42023-182-89) / 2.5 mL in 1 VIAL

45562- Lundbeck Pharmaceuticals Italy S.p.A.
- 45562-1124-
  - 45562-1124-0- 5 kg in 1 DRUM (45562-1124-0)

55150- Eugia US LLC
- 55150-241- Argatroban
  - 55150-241-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-241-01) / 50 mL in 1 VIAL, SINGLE-DOSE

55150- Eugia US LLC
- 55150-241- Argatroban
  - 55150-241-10- 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-241-10) / 50 mL in 1 VIAL, SINGLE-DOSE

55486- Curia Italy S.r.l.
- 55486-1582-
  - 55486-1582-0- 50 kg in 1 DRUM (55486-1582-0)

62227- BrightGene Bio-Medical Technology Co., Ltd.
- 62227-015-
  - 62227-015-01- 2 kg in 1 DRUM (62227-015-01)

63323- Fresenius Kabi USA, LLC
- 63323-526- Argatroban
  63323-526-03- 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-526-03) / 2.5 mL in 1 VIAL, SINGLE-DOSE

65145- Caplin Steriles Limited
- 65145-126- ARGATROBAN
  - 65145-126-01- 1 VIAL in 1 CARTON (65145-126-01) / 50 mL in 1 VIAL

65219- Fresenius Kabi USA, LLC
- 65219-429- Argatroban
  - 65219-429-50- 1 VIAL in 1 CARTON (65219-429-50) / 50 mL in 1 VIAL

67457- Mylan Institutional LLC
- 67457-212- Argatroban
  - 67457-212-02- 1 VIAL, GLASS in 1 CARTON (67457-212-02) / 2.5 mL in 1 VIAL, GLASS

68083- Gland Pharma Limited
- 68083-141- Argatroban
  - 68083-141-02- 2 VIAL in 1 CARTON (68083-141-02) / 125 mL in 1 VIAL (68083-141-01)

68083- Gland Pharma Limited
- 68083-568- Argatroban
  - 68083-568-01- 1 VIAL in 1 CARTON (68083-568-01) / 50 mL in 1 VIAL

70121- Amneal Pharmaceuticals LLC
- 70121-1037- Argatroban
  - 70121-1037-1- 1 VIAL, GLASS in 1 CARTON (70121-1037-1) / 2.5 mL in 1 VIAL, GLASS

76339- Apothecon Pharmaceuticals Pvt Ltd
- 76339-118-
  - 76339-118-00- 1 BAG in 1 DRUM (76339-118-00) / 1 BAG in 1 BAG / .999 kg in 1 BAG

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇