Pradaxa - Dabigatran

Question 1

MOA

Answer 1

• Direct Thrombin Inhibitor - Inhibits factor II
• a Prodrug => inhibitors or inducers will alter levell
• Amiodarone, keto, verapamil: Increase level
• Rifampin: taken 12H prior: reduce level

Question 2

Indications

Answer 2

• Reduce risk of stroke and systemic embolism in pts w/ non-valvular A.fib (NVAF)

Question 3

MOA of clearance

Answer 3

Renally cleared

Question 4

Pregnancy Cat

Answer 4

C

Question 5

Dose

Dosage Forms:

Answer 5

• CrCl > 30 mL/min: 150 mg PO BID
• CrCl 15-30 mL/min: 75mg PO BID
• Dosage forms: Cap 75mg & 150 mg.
• Do not chew, break, or open capsules

Question 6

Convert from warfarin to Pradaxa

Answer 6

• D/c warfarin

- Start Pradaxa when INR < 2

Question 7

Convert from Pradaxa (P) to Warfarin (W)

Answer 7

Adjust the starting time of warfarin based on CrCl:

• CrCl > 50: start W 3 days b/4 d/c P
• CrCl 31-50: start W 2 days b/4 d/c P
• CrCl 15-30: Start W 1 day b/c d/c P
• CrCl < 15: no rec can be made

B/c P can contribute to incr INR, the INR will better reflect W’s effect after P has been d/c at least 2 days

Question 8

Converting Pradaxa (P) from or to parental anticoagualatns

• Currently receiving parental anticoag
• Currently taking pradaxa

Answer 8

Currently receiving parental anticoag:

• Start P 0-2H b4 the next dose of the parental drug was to be given or
• (if parental anticoag like Heparin is givne w/ cont infusion, give P at the same tiem of d/c of infusion

Currently taking pradaxa
- Wait 12H (CrCl > 30) or 24H (CrCl < 30) after the last dose of P b4 initiating tx w/ a parenteral anticoag

Question 9

Pradaxa and surgery

Answer 9

B/4 surgery, d/c Pradaxa

• 1 -2 days for CrCl >/= 50
• 3-5 days for CrCl < 50 before
• Consider longer times for major surgery, spinal puncture, or replacement of a spinal or epidural catheter
• If surgery can’t be delayed, risk of bleeding should be weighted against the benefit of urgent surgery

Question 10

Monitoring

Answer 10

• Ecarin clotting time (ECT): assess Pradaxa risk of bleeding
• If ECT not available, then aPTT test

Question 11

ADEs

Answer 11

• GI: heartburn, GERD, ulcers of digestive tract (P is better abs at a low pH, so the tablets contain a tartaric acid core which may cause GI irritation)
• Bleeding
• Allergic rxn
• Report any ADEs to FDA MedWatch

Question 12

Antidote

Answer 12

• No antidote
• If bleeding occurs, stop dabigatran
• For severe bleeding, pts may need FFP or whole blood

Question 13

Storage

Answer 13

• Store in the original bottle or blister package to protect from moisture
• For bottle: only open 1 bottle at a time, once opens, use w/in 4 mo
• For blister: open blister at time of use. Do not open or puncture the blister any earlier than the time of use