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FOR U.S. HEALTHCARE PROFESSIONALS ONLY
FOR U.S. HEALTHCARE PROFESSIONALS ONLY

Proven Efficacy in the Treatment of Deep Vein Thrombosis and Pulmonary Embolism (DVT and PE)

As effective as warfarin for the treatment of DVT and PE1

Composite of fatal PE, symptomatic non-fatal PE, and/or DVT
(Primary efficacy endpoint: 34 vs. 32 events, HR: 1.05, 95% CI [0.65, 1.70])2

The protocol specified non-inferiority margin (2.75) for the HR was derived based on the upper limit of the 95% CI of the historical warfarin effect.
PRADAXA retains at least 66.9% of the historical warfarin effect, based on the primary composite endpoint.

Composite of fatal PE, symptomatic non-fatal PE, and/or DVT
(Primary efficacy endpoint: 34 vs. 30 events, HR: 1.13, 95% CI [0.69, 1.85])3

The protocol specified non-inferiority margin (2.75) for the HR was derived based on the upper limit of the 95% CI of the historical warfarin effect.
PRADAXA retains at least 63.9% of the historical warfarin effect, based on the primary composite endpoint.

Proven Efficacy in the Reduction in Risk of Recurrence of DVT and PE

As effective as warfarin in the reduction in risk of recurrence of DVT and PE1

RE-MEDY™ Trial4

Composite of fatal PE, symptomatic non-fatal PE, and/or DVT
(Primary efficacy endpoint: 26 vs. 18 events, HR: 1.44, 95% CI [0.78, 2.64])1,4

The protocol specified non-inferiority margin (2.85) for the HR was derived based on the point estimate of the historical warfarin effect. PRADAXA retains at least 63.0% of the historical warfarin effect. If the non-inferiority margin was derived based on the 50% retention of the upper limit of the 95% CI, PRADAXA was demonstrated to retain at least 33.4% of the historical warfarin effect based on the composite primary endpoint.1

Superior 92% reduction in risk of recurrence of DVT and PE vs. placebo1

RE-SONATE® Trial1,4

Composite of fatal PE, unexplained death,
or symptomatic non-fatal PE and/or DVT
References: 1. Pradaxa [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc. 2. Schulman S, Kearon C, Kakkar AK; for the RE‑COVER Study Group. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med. 2009;361(24):23‍42-23‍52. 3. Schulman S, Kakkar AK, Goldhaber SZ; for the RE‑COVER II Trial Investigators. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation. 2014;129(7):764-772. 4. Schulman S, Kearon C, Kakkar AK; for the RE‑MEDY and the RE‑SONATE Trial Investigators. Extended use of dabigatran, warfarin, or placebo in venous thromboembolism. N Engl J Med. 2013;368(8):709-718.

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
Please see full Prescribing Information, including
boxed WARNING and Medication Guide.