Dabigatran Use Guidelines

Inclusion:

1. Reduction of stroke and systemic embolism in non-valvular atrial fibrillation
2. Utilization peri-procedurally for direct current cardioversion (DCC) and/or radiofrequency ablation (RFA) as recommended by electrophysiology
3. Treatment for venous thromboembolism after receiving at least 5 days of initial parenteral anticoagulant treatment

Exclusion:

1. Creatinine clearance based upon indication (see section IV. Dosing below)
2. Prosthetic mechanical heart valve
3. Active bleeding
4. Pregnancy
5. Hemodynamically unstable pulmonary embolism
6. Venous thromboembolism prophylaxis
7. Concurrent epidural use
8. Pediatrics (< 18 years of age) due to the lack of data to guide safe use

1. Dosing differs based upon indication for use and renal function, expressed as mL/min as calculated via the Cockroft-Gault equation.
2. All doses are administered orally.
3. If a dose is missed and the next dose is due within 6 hours, skip the missed dose and resume previous dosing schedule.

1. Routine administration times will default to 06:00 and 18:00 to minimize medication interactions.
2. Dabigatran should not be open, chewed, or crushed prior to administration and should not be administered via any feeding tubes. The oral bioavailability increases by 75% when the pellets are taken without the capsule shell when compared to the intact capsule formulation.

1. Baseline monitoring
   • aPTT, INR/PT, platelet count, and hemoglobin/hematocrit and serum creatinine
2. On-going monitoring
   • Patients in an intensive care unit will have serum creatinine monitored at least every 3 days. All other patients will have serum creatinine monitored at least once per week. Hemoglobin/hematocrit will be monitored at least weekly while hospitalized.
   • On-going monitoring of anticoagulant assays is not routinely recommended. If the clinician feels monitoring is necessary (e.g. concern for overdose) consider use of anti-IIa inhibitor assay calibrated for dabigatran (DABIG).
     • A correlation of anti-IIa activity and therapeutic benefit has not been demonstrated. If this test result is greater than 0.04 ug/mL, then the patient has some anticoagulant effect from dabigatran. Normal individuals have no dabigatran activity

1. Black Box Warning: Discontinuing dabigatran in patients being treated for atrial fibrillation places patients at an increased risk of thrombotic events. An increased rate of stroke was observed following discontinuation of dabigatran in clinical trials in patients with nonvalvular atrial fibrillation. If anticoagulation with dabigatran must be discontinued for a reason other than pathological bleeding, coverage with another anticoagulant should be strongly considered.
2. Converting from warfarin to dabigatran
   • Discontinue warfarin and begin dabigatran when the INR is below 2.0
3. Converting from dabigatran to warfarin
   • When converting from dabigatran to warfarin the INR is unlikely to be useful until at least two days after discontinuation of dabigatran.

1. Converting from another anticoagulant other than warfarin to dabigatran

1. Converting from dabigatran to another anticoagulant other than warfarin

Pre-operative/Pre-procedural management

• Low thrombotic risk★ patients

• Intermediate -high thrombotic risk# patients

★#Patient criteria as outlined in UMHS Perioperative and Periprocedural Warfarin Guidelines for Adult and Pediatric Patients

† Types of surgery associated with a high risk of bleeding (or in major surgery where complete hemostasis may be required)

may include but are not limited to cardiac surgery, neurosurgery, or others determined by the proceduralist or surgeon. Other procedures such as spinal anesthesia may also require complete hemostatic function. Other important determinants of bleeding risk may include advancing age, co-morbidities (e.g. renal or liver disease) and concomitant use of antiplatelet therapy.

iii. Bridging with a parenteral anticoagulant prior to a procedure/operation is not necessary. However, physicians may choose to use a parenteral anticoagulant instead of dabigatran prior to surgery.

Post-operative/Post-procedural management

• Resuming treatment dose dabigatran: Subject to surgeon approval. Minimum 24 hours after procedure.

Dabigatran and Central Neuraxial Blockade

1. Use of dabigatran during the use of central neuraxial blockade is contraindicated.
2. Dabigatran should be discontinued 48 hours before epidural catheter placement.
   • For patients with CrCl less than 50 mL/min discontinuing dabigatran 3-5 days before epidural catheter placement may be warranted.
3. Dabigatran may be restarted 2 hours after epidural catheter removal.

Peri-procedural during DCC or RFA

1. Refer to electrophysiology guidelines
   • (See Antithrombotic/Antiplatelet Agents & Central Neuraxial Blockade Guidelines for Adult and Pediatric Patients)

There is no antidote to dabigatran

*UMHS Factor VIIa (Novoseven) Guidelines: Adult Patients

‡ Consult inpatient nephrology service