Dabigatran (Pradaxa®) Considerations for Use*

US/FDA Approved Indications: Stroke Prevention in Non-valvular Atrial Fibrillation

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Mechanism of Action

Direct thrombin inhibitor

Dosing

Adult: 150 mg PO twice daily

Elderly: No dosage adjustment necessary

Hepatic Impairment: No dosage adjustment necessary

Renal Impairment:
CrCl 15 to 30 mL/min: 75 mg PO twice daily
CrCl < 15 mL/min or on dialysis: not recommended

Contraindications

Active pathological bleeding, mechanical prosthetic heart valve

Major Side Effects

Hemorrhagic event

Dosage forms and Strengths

PO: 75, 150mg capsules

Reversal

There is no rapid reversal agent for dabigatran.

  • Discontinue dabigatran
  • Limited data shows that h emodialysis can remove 49-57% of dabigatran over 4 hours
  • Measurement of aPTT or ECT may help guide therapy
  • Surgery and interventions:

  • If possible, discontinue for 1 to 2 days with CrCl ≥ 50 mL/min or 3 to 5 days with CrCl < 50mL/min prior to procedure.
  • Longer times may be required for patients undergoing major surgery, spinal puncture, or placement of epidural or spinal catheter/port, in who complete homeostasis may be required
  • Conversion to/from other drugs

    From dabigatran to warfarin:

  • If CrCl ≥ 50 mL/min, start warfarin 3 days before discontinuing dabigatran
  • If CrCl 30 to 50 mL/min, start warfarin 2 days before discontinuing dabigatran
  • If CrCl 15 to 30 mL/min, start warfarin 1 day before discontinuing dabigatran
  • If CrCl < 15 mL/min, no recommendations can be made
  • From dabigatran to parenteral anticoagulant:

  • Wait 12 hrs (CrCl ≥ 30mL/min) or 24 hrs (CrCl < 30mL/min) after last dabigatran dose before initiating parenteral anticoagulant
  • From warfarin to dabigatran:

  • Discontinue warfarin and start dabigatran when INR < 2
  • From parenteral anticoagulant to dabigatran:

  • Start dabigatran 0 to 2 hrs before the time that the next dose of parenteral anticoagulant was to have been given or initiate when discontinuing IV continuous heparin
  • Special Notes

    Has many potential drug interactions.

  • Do not use with P-gp inducers (ex. rifampin).
  • Do not use with P-gp inhibitors and CrCl < 30 mL/min.
  • With concomitant dronedarone or systemic ketoconazole in patients with CrCl 30 to 50 mL/min, consider using a lower dose of dabigatran (75 mg PO twice daily).
  • Can increase INR. INR will better reflect only warfarin’s effect when the patient has been off the dabigatran for at least 2 days.

    Counseling

    DO NOT break, chew or open the capsules.

    Keep this medication in its original bottle or blister package to protect it from moisture. Do not put this medication into a pillbox or pill organizer.

    Tightly close the bottle right away after you take the dose.

    Only remove the medication from the blister package when it is time to take the dose.

    When you open a new bottle, write down the date that you opened the bottle. Discard the bottle 4 months after it was first opened, even if you have not taken all the medication in the bottle.

    Do not discontinue this medication without talking to the healthcare provider who prescribed it. Consult healthcare professional prior to using new drug (prescription, OTC, herbal).

    Report signs and symptoms of bleeding (e.g., unexpected bleeding or bleeding that lasts a long time; red or black, tarry stool; pink or brown urine; unusual bruising; coughing up blood; vomiting blood or vomit that looks like coffee grounds; unexplained pain, swelling, or joint pain; unusual headaches, dizziness, or weakness; recurring nose bleeds).

    Tell your healthcare professional if you have had or will have surgery to place a prosthetic heart valve.

    Tell your healthcare professional if you are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed during treatment.

    *Refer to prescribing information for more complete information.
    †Dosages given in the table may differ from those recommended by the manufacturers.


    Source:

    1. American College of Cardiology (ACC), American Heart Association (AHA), and Heart Rhythm Society (HRS). 2011 ACCF/AHA/HRS Focused Update on the Management of Patients With Atrial Fibrillation (Update on Dabigatran). Washington, DC: American College of Cardiology Foundation. 2011.
    2. Pradaxa® Prescribing information, 12/19/12.
    3. Chest Supplement, Antithrombotic Therapy and Prevention of Thrombosis, 9th edition, American College of Chest Physicians.