Names and pronunciation
(da-bye-gat′ran) Pradaxa
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Drug reference
(da-bye-gat′ran) Pradaxa
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Func. class.: Anticoagulant
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Chem. class.: Direct thrombin inhibitor
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ACTION: Direct thrombin inhibitor that inhibits both free and clot-bound thrombin; prevents thrombin-induced platelet aggre- gation and thrombus formation by prevent- ing conversion of fibrinogen to fibrin
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USES: Stroke/systemic embolism prophy- laxis with nonvalvular atrial fibrillation, DVT, pulmonary embolism in hip replacement
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CONTRAINDICATIONS: Hyper- sensitivity, active bleeding, prosthetic heart valves, use with P-gp inducers Precautions: Pregnancy, labor, obstetric delivery, breastfeeding, children, geriatric patients, abrupt discontinuation, antico- agulant therapy, renal disease, surgery
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Black Box Warning: Abrupt discontinu- ation, epidural/spinal anesthesia, lumbar puncture Black Box Warning: Premature dis- continuation: risk of thrombosis/MI/ emboli: swelling, pain, redness, difficulty breathing, chest pain, tachypnea, cough, coughing up blood, cyanosis • Postthrombotic syndrome: pain, heaviness, itching/tingling, swelling, varicose veins, brownish/reddish skin discoloration, ulcers; use of ambulation, compression stockings, adequate anticoagulation can prevent this syndrome • Surgery: discontinue 24-48 hr prior to surgery in those with CCr ≥50 mL/min, 72-96 hr in those with CCr <50 mL/min; longer times may be needed in major surgery; restart after surgery, spinal epi- dural catheter Black Box Warning: Epidural/spinal anesthesia, lumbar puncture: risk of hematoma that may cause permanent paralysis; indwelling epidural catheters and products that cause coagulation changes (NSAIDs, anticoagulants) may increase the risk of paralysis Black Box Warning: Do not discontinue abruptly D • Pregnancy/breastfeeding: no well- controlled studies; bleeding may occur if used during pregnancy; discontinue breastfeeding or product, unknown if ex- creted in breast milk Black Box Warning: Neurologic chang- es: to notify prescriber immediately of bowel or bladder changes, numbness in lower extremities, midline back pain • Not to use any other OTC products, herbs without prescriber approval • That lab tests may be required during treatment
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SIDE EFFECTS GI: Abdominal pain, dyspepsia, esophagi- tis, gastritis, diarrhea HEMA: Bleeding (any site) SYST: Anaphylaxis (rare), angioedema
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INTERACTIONS Increase: bleeding risk—amiodarone, other anticoagulants, clopidogrel, ketocon- azole, quiNIDine, thrombolytics, verapamil P-gp inhibitors: dose should be reduced to 150 mg/day (75 mg bid) in those with CCr 30-50 mL/min Decrease: dabigatran effect—rifAMPin; avoid concurrent use Decrease: dabigatran effect—P-glyco- protein inducers (carBAMazepine, rifAMPin, tipranavir) Drug/Herb Decrease: dabigatran—St. John’s wort Drug/Lab Test Increase: thrombin time, aPTT
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DOSAGE AND ROUTES Stroke prophylaxis, atrial fibrillation, and DVT/PE prophylaxis • Adult: PO 150 mg bid For conversion from an alternative anticoagulant to dabigatran • When converting from warfarin to dabigatran, discontinue warfarin and ini- tiate dabigatran when the INR is <2.0; when converting from a parenteral anti- coagulant to dabigatran, initiate dabiga- tran 0-2 hr prior to the time of the next scheduled anticoagulant dose or at the time of discontinuation of a continuously administered anticoagulant (IV unfrac- tionated heparin) For conversion from dabigatran to warfarin • Adult: CCr >50 mL/min, start warfarin 3 days prior to discontinuing dabigatran; CCr 31-50 mL/min, start warfarin 2 days prior to discontinuing dabigatran; CCr 15- 30 mL/min, start warfarin 1 day prior to discontinuing dabigatran For conversion from dabigatran to parenteral anticoagulants • Adult: PO discontinue dabigatran; start parenteral anticoagulant 12 hr (CCr ≥30 mL/min) or 24 hr (CCr <30 mL/ min) after the last dabigatran dose Deep venous thrombus (DVT)/ pulmonary embolism (PE) prophylaxis • Adult: PO 220 mg or 150 mg/day × 28-35 days, starting with ½ dose 1-4 hr after surgery (knee replacement); 110 mg on first day 1-4 hr after surgery, he- mostasis achieved, then 220 mg daily × 28-35 days; those previously treated 150 mg bid (hip replacement) DVT/PE/treated with a parenteral anticoagulant × 5-10 days • Adult: PO 150 mg bid Renal dose • Adult: PO CCr 15-30 mL/min, 75 mg bid (for reduction in stroke risk and systemic embolism in nonvalvular atrial fibrillation)
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Available forms: Capsules 75, 110, 150 mg
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Administer: • Prior to surgery, discontinue product; restart after surgery is completed • Do not crush, break, chew, or empty contents of capsule • Without regard to food • Store in original package at room temperature until time of use; discard after 30 days; protect from moisture
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Assess: • Stroke: facial palsy, weakness, headache, blurred vision, speaking dif- ficulty • DVT/PE: Pain in calf, swelling, or be- hind knee, trouble breathing, chest pain, lightheadedness • Bleeding: blood in urine or emesis, dark tarry stools, lower back pain; caution with arterial/venous punctures, catheters, NG tubes; monitor vital signs frequently; elderly patients more prone to serious bleeding, monitor aPTT, ecarin clotting time baseline and during treatment
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Evaluate: • Therapeutic response: decreased thrombus formation/extension, absence of emboli, postthrombotic effects
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • About the purpose and expected re- sults; to take at same time of day; not to skip or double doses; if dose is missed, to take as soon as remembered if on the same day; do not administer if <6 hr be- fore next dose; to store in original con- tainer, protect from moisture • To take without regard to food; to swallow capsule whole, not to open; to take with a full glass of water • To notify all providers that this prod- uct is being used; to check with pre- scriber about when to discontinue • Bleeding: to report any bleeding or bruising, including blood in stool, emesis, urine; nosebleeds
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PHARMACOKINETICS Protein binding 35%, half-life 12-17 hr (extended in renal disease), onset unknown, peak 1-2 hr, duration unknown, high-fat meal delays peak
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• Adult: PO 150 mg bid For conversion from an alternative anticoagulant to dabigatran
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• Adult: CCr >50 mL/min, start warfarin 3 days prior to discontinuing dabigatran; CCr 31-50 mL/min, start warfarin 2 days prior to discontinuing dabigatran; CCr 15- 30 mL/min, start warfarin 1 day prior to discontinuing dabigatran For conversion from dabigatran to parenteral anticoagulants
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• Adult: PO discontinue dabigatran; start parenteral anticoagulant 12 hr (CCr ≥30 mL/min) or 24 hr (CCr <30 mL/ min) after the last dabigatran dose Deep venous thrombus (DVT)/ pulmonary embolism (PE) prophylaxis
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• Adult: PO 220 mg or 150 mg/day × 28-35 days, starting with ½ dose 1-4 hr after surgery (knee replacement); 110 mg on first day 1-4 hr after surgery, he- mostasis achieved, then 220 mg daily × 28-35 days; those previously treated 150 mg bid (hip replacement) DVT/PE/treated with a parenteral anticoagulant × 5-10 days
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• Adult: PO 150 mg bid Renal dose
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• Adult: PO CCr 15-30 mL/min, 75 mg bid (for reduction in stroke risk and systemic embolism in nonvalvular atrial fibrillation)
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