Starting patients on PRADAXA

Assess renal function prior to initiating treatment with PRADAXA1

Indication-specific dosage stengths available: 75 mg, 110 mg, and 150 mg

Dosing Information

  • Should be taken with a full glass of water
    Should be taken with a full glass of water1
  • Taken with or without food
    Taken with or without food1
  • No INR monitoring required
    No INR monitoring required1
  • Taken with or without food
    Rapid onset—maximum plasma concentrations achieved 1-3 hours after administration1
  • P450
    Not metabolized by the cytochrome P450 system1
Periodically assess renal function as clinically indicated and adjust therapy accordingly1
  • Assess more frequently in clinical situations that may be associated with a decline in renal function
  • Discontinue PRADAXA in patients who develop acute renal failure and consider alternative anticoagulant therapy
  • Generally, the extent of anticoagulation does not need to be assessed. When necessary, use aPTT and not INR to assess for anticoagulant activity in patients on PRADAXA
When converting patients to PRADAXA from:
  • Warfarin: Discontinue warfarin and start PRADAXA when INR is <2.01
  • Parenteral anticoagulants: Start PRADAXA 0 to 2 hours before the time that the next dose of the parenteral drug was to have been administered or at the time of discontinuation of a continuously administered parenteral drug (eg, intravenous unfractionated heparin)1

PRADAXA: Dosing for multiple uses1

Reduce Stroke
Risk in NVAF
150 mg
Twice Daily
Patients with
CrCI >30 mL/min
75 mg
Twice Daily
Patients with
CrCI 15-30 mL/min
Treat DVT & PE or
Reduce Risk
of Recurrence
150 mg
Twice Daily
For treatment only: Initial
treatment with parenteral
anticoagulant for 5-10 days
Patients with
CrCI >30 mL/min
Reduce DVT & PE
Risk After Hip
Replacement Surgery
110 mg
1-4 hours post-surgery and after
achieving hemostasis, then
220 mg Once Daily
for 28-35 days
Patients with
CrCI >30 mL/min
Dosing recommendation cannot be provided for patients with
  • NVAF: CrCl <15 mL/min or on dialysis
  • DVT/PE & HIP: CrCl ≤30 mL/min or on dialysis
Reduce Stroke
Risk in NVAF
150 mg
Twice Daily
Patients with
CrCI >50 mL/min
75 mg
Twice Daily
Patients with
CrCI 30-50 mL/min
with dronedarone or
systemic ketoconazole
Treat DVT & PE or
Reduce Risk
of Recurrence
150 mg
Twice Daily
For treatment only: Initial
treatment with parenteral
anticoagulant for 5-10 days
Patients with
CrCI ≥50 mL/min
Reduce DVT & PE
Risk After Hip
Replacement Surgery
110 mg
1-4 hours post-surgery and after
achieving hemostasis, then
220 mg Once Daily
for 28-35 days
Patients with
CrCI ≥50 mL/min
Avoid co-administration in patients with
  • NVAF: CrCl <30 mL/min
  • DVT/PE & HIP: CrCl <50 mL/min
Download the full PRADAXA dosing guide here

IMPORTANT SAFETY INFORMATION

WARNING: (A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA

(A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS
Premature discontinuation of any oral anticoagulant, including PRADAXA, increases the risk of thrombotic events. If anticoagulation with PRADAXA is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant

INDICATIONS AND USAGE

Pradaxa® (dabigatran etexilate mesylate) capsules is indicated:
  • to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation;
  • for the treatment of deep venous thrombosis and pulmonary embolism in patients who have been treated with a parenteral anticoagulant for 5-10 days;
  • to reduce the risk of recurrence of deep venous thrombosis and pulmonary embolism in patients who have been previously treated

IMPORTANT SAFETY INFORMATION

WARNING: (A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA

(A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS
Premature discontinuation of any oral anticoagulant, including PRADAXA, increases the risk of thrombotic events. If anticoagulation with PRADAXA is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant

(B) SPINAL/EPIDURAL HEMATOMA

Epidural or spinal hematomas may occur in patients treated with PRADAXA who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:

  • use of indwelling epidural catheters
  • concomitant use of other drugs that affect hemostasis, such as non-steroidal anti‑inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants
  • a history of traumatic or repeated epidural or spinal punctures
  • a history of spinal deformity or spinal surgery
  • optimal timing between the administration of PRADAXA and neuraxial procedures is not known

Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider the benefits and risks before neuraxial intervention in patients who are or will be anticoagulated.

INDICATIONS AND USAGE

Pradaxa® (dabigatran etexilate mesylate) capsules is indicated:
  • to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation;

CONTRAINDICATIONS

PRADAXA is contraindicated in patients with:

  • active pathological bleeding;
  • known serious hypersensitivity reaction to PRADAXA (e.g., anaphylactic reaction or anaphylactic shock);
  • mechanical prosthetic heart valve

WARNINGS & PRECAUTIONS

Increased Risk of Thrombotic Events after Premature Discontinuation

Premature discontinuation of any oral anticoagulant, including PRADAXA, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. If PRADAXA is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant and restart PRADAXA as soon as medically appropriate.

Risk of Bleeding

  • PRADAXA increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding. Promptly evaluate any signs or symptoms of blood loss (e.g., a drop in hemoglobin and/or hematocrit or hypotension). Discontinue PRADAXA in patients with active pathological bleeding.
  • Risk factors for bleeding include concomitant use of medications that increase the risk of bleeding (e.g., anti-platelet agents, heparin, fibrinolytic therapy, and chronic use of NSAIDs). PRADAXA’s anticoagulant activity and half-life are increased in patients with renal impairment.
  • Reversal of Anticoagulant Effect: A specific reversal agent (idarucizumab) for dabigatran is available when reversal of the anticoagulant effect of dabigatran is needed:
    • For emergency surgery/urgent procedures
    • In life-threatening or uncontrolled bleeding
  • Hemodialysis can remove dabigatran; however clinical experience for hemodialysis as a treatment for bleeding is limited. Prothrombin complex concentrates or recombinant Factor VIIa may be considered but their use has not been evaluated. Protamine sulfate and vitamin K are not expected to affect dabigatran anticoagulant activity. Consider administration of platelet concentrates where thrombocytopenia is present or long-acting antiplatelet drugs have been used.

Thromboembolic and Bleeding Events in Patients with Prosthetic Heart Valves

The use of PRADAXA is contraindicated in patients with mechanical prosthetic valves due to a higher risk for thromboembolic events, especially in the post-operative period, and an excess of major bleeding for PRADAXA vs. warfarin. Use of PRADAXA for the prophylaxis of thromboembolic events in patients with AFib in the setting of other forms of valvular heart disease, including bioprosthetic heart valve, has not been studied and is not recommended.

Effect of P-gp Inducers & Inhibitors on Dabigatran Exposure

Concomitant use of PRADAXA with P‑gp inducers (e.g., rifampin) reduces exposure to dabigatran and should generally be avoided. P‑gp inhibition and impaired renal function are major independent factors in increased exposure to dabigatran. Concomitant use of P‑gp inhibitors in patients with renal impairment is expected to increase exposure of dabigatran compared to either factor alone.
Reduction of Risk of Stroke/Systemic Embolism in NVAF

  • For patients with moderate renal impairment (CrCl 30‑50 mL/min), reduce the dose of PRADAXA to 75 mg twice daily when dronedarone or systemic ketoconazole is coadministered with PRADAXA.
  • For patients with severe renal impairment (CrCl 15‑30 mL/min), avoid concomitant use of PRADAXA and P‑gp inhibitors.
Treatment and Reduction in the Risk of Recurrence of DVT/PE & Prophylaxis of DVT/PE Following Hip Replacement Surgery
  • For patients with CrCl <50 mL/min, avoid use of PRADAXA and concomitant P‑gp inhibitors

ADVERSE REACTIONS

The most common adverse reactions reported with PRADAXA were related to gastritis-like symptoms and bleeding.

Other Measures Evaluated

In NVAF patients, a higher rate of clinical MI was reported in patients who received PRADAXA (0.7/100 patient-years for 150 mg dose) than in those who received warfarin (0.6).

USE IN SPECIFIC POPULATIONS

  • Pregnancy: The limited available data on PRADAXA use in pregnant women are insufficient to determine drug-associated risks for adverse developmental outcomes.
  • Lactation: Breastfeeding is not recommended.
  • Geriatric: Risk of bleeding increases with age.
CL-PX-100018 August 2018