July 1, 2016
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Pradaxa

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Pradaxa




Indications
Dosage
How Supplied

INDICATIONS

Reduction Of Risk Of Stroke And Systemic Embolism In Non-valvular Atrial Fibrillation

PRADAXA is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

Treatment Of Deep Venous Thrombosis and Pulmonary Embolism

PRADAXA is indicated for the treatment of deep venous thrombosis and pulmonary embolism in patients who have been treated with a parenteral anticoagulant for 5-10 days.

Reduction In The Risk Of Recurrence Of Deep Venous Thrombosis And Pulmonary Embolism

PRADAXA is indicated to reduce the risk of recurrence of deep venous thrombosis and pulmonary embolism in patients who have been previously treated.

Prophylaxis Of Deep Vein Thrombosis And Pulmonary Embolism Following Hip Replacement Surgery

PRADAXA is indicated for the prophylaxis of deep vein thrombosis and pulmonary embolism, in patients who have undergone hip replacement surgery.

DOSAGE AND ADMINISTRATION

Recommended Dose

Indication Dosage
Reduction in Risk of Stroke andSystemic Embolism in Non-valvular AF CrCl > 30 mL/min: 150 mg twice daily
CrCl 15 to 30 mL/min: 75 mg twice daily
CrCl < 15 mL/min or on dialysis: Dosing recommendations cannot be provided
CrCl 30 to 50 mL/min with concomitant use of P-gp inhibitors: Reduce dose to 75 mg twice daily if given with P-gp inhibitors dronedarone or systemic ketoconazole.
CrCl < 30 mL/min with concomitant use of P-gp inhibitors: Avoid co-administration
Treatment of DVT and PE CrCl > 30 mL/min: 150 mg twice daily
Reduction in the Risk of Recurrence of DVT and PE CrCl ≤ 30 mL/min or on dialysis: Dosing recommendations cannot be provided
CrCl < 50 mL/min with concomitant use of P-gp inhibitors: Avoid co-administration
Prophylaxis of DVT and PE Following Hip Replacement Surgery CrCl > 30 mL/min: 110 mg for first day, then 220 mg once daily
CrCl ≤ 30 mL/min or on dialysis: Dosing recommendations cannot be provided
CrCl < 50 mL/min with concomitant use of P-gp inhibitors: Avoid co-administration

Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation

For patients with creatinine clearance (CrCl) > 30 mL/min, the recommended dose of PRADAXA is 150 mg taken orally, twice daily. For patients with severe renal impairment (CrCl 15-30 mL/min), the recommended dose of PRADAXA is 75 mg twice daily [see Use In Specific Populations and CLINICAL PHARMACOLOGY]. Dosing recommendations for patients with a CrCl < 15 mL/min or on dialysis cannot be provided.

Treatment of Deep Venous Thrombosis and Pulmonary Embolism

For patients with CrCl > 30 mL/min, the recommended dose of PRADAXA is 150 mg taken orally, twice daily, after 5-10 days of parenteral anticoagulation. Dosing recommendations for patients with a CrCl ≤ 30 mL/min or on dialysis cannot be provided [see Use in Specific Populations and CLINICAL PHARMACOLOGY].

Reduction in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary Embolism

For patients with CrCl > 30 mL/min, the recommended dose of PRADAXA is 150 mg taken orally, twice daily after previous treatment. Dosing recommendations for patients with a CrCl ≤ 30 mL/min or on dialysis cannot be provided [see Use in Specific Populations and CLINICAL PHARMACOLOGY].

Prophylaxis of Deep Vein Thrombosis and Pulmonary Embolism Following Hip Replacement Surgery

For patients with CrCl > 30 mL/min, the recommended dose of PRADAXA is 110 mg taken orally 1-4 hours after surgery and after hemostasis has been achieved, then 220 mg taken once daily for 28-35 days. If PRADAXA is not started on the day of surgery, after hemostasis has been achieved initiate treatment with 220 mg once daily. Dosing recommendations for patients with a CrCl ≤ 30 mL/min or on dialysis cannot be provided [see Use in Specific Populations and CLINICAL PHARMACOLOGY].

Dosing Adjustments

Assess renal function prior to initiation of treatment with PRADAXA. Periodically assess renal function as clinically indicated (i.e., more frequently in clinical situations that may be associated with a decline in renal function) and adjust therapy accordingly. Discontinue PRADAXA in patients who develop acute renal failure while on PRADAXA and consider alternative anticoagulant therapy.

Generally, the extent of anticoagulation does not need to be assessed. When necessary, use aPTT or ECT, and not INR, to assess for anticoagulant activity in patients on PRADAXA [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation

In patients with moderate renal impairment (CrCl 30-50 mL/min), concomitant use of the P-gp inhibitor dronedarone or systemic ketoconazole can be expected to produce dabigatran exposure similar to that observed in severe renal impairment. Reduce the dose of PRADAXA to 75 mg twice daily [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

Treatment and Reduction in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary Embolism

Dosing recommendations for patients with CrCl ≤ 30 mL/min cannot be provided. Avoid use of concomitant P-gp inhibitors in patients with CrCl < 50 mL/min [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

Prophylaxis of Deep Vein Thrombosis and Pulmonary Embolism Following Hip Replacement Surgery

Dosing recommendations for patients with CrCl ≤ 30 mL/min or on dialysis cannot be provided. Avoid use of concomitant P-gp inhibitors in patients with CrCl < 50 mL/min [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

Instructions To Patients

Instruct patients to swallow the capsules whole. PRADAXA should be taken with a full glass of water. Breaking, chewing, or emptying the contents of the capsule can result in increased exposure [see CLINICAL PHARMACOLOGY].

If a dose of PRADAXA is not taken at the scheduled time, the dose should be taken as soon as possible on the same day; the missed dose should be skipped if it cannot be taken at least 6 hours before the next scheduled dose. The dose of PRADAXA should not be doubled to make up for a missed dose.

Converting From Or To Warfarin

When converting patients from warfarin therapy to PRADAXA, discontinue warfarin and start PRADAXA when the INR is below 2.0.

When converting from PRADAXA to warfarin, adjust the starting time of warfarin based on creatinine clearance as follows:

  • For CrCl ≥ 50 mL/min, start warfarin 3 days before discontinuing PRADAXA.
  • For CrCl 30-50 mL/min, start warfarin 2 days before discontinuing PRADAXA.
  • For CrCl 15-30 mL/min, start warfarin 1 day before discontinuing PRADAXA.
  • For CrCl < 15 mL/min, no recommendations can be made.

Because PRADAXA can increase INR, the INR will better reflect warfarin's effect only after PRADAXA has been stopped for at least 2 days [see CLINICAL PHARMACOLOGY].

Converting From Or To Parenteral Anticoagulants

For patients currently receiving a parenteral anticoagulant, 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 (e.g., intravenous unfractionated heparin).

For patients currently taking PRADAXA, wait 12 hours (CrCl ≥ 30 mL/min) or 24 hours (CrCl < 30 mL/min) after the last dose of PRADAXA before initiating treatment with a parenteral anticoagulant [see CLINICAL PHARMACOLOGY].

Discontinuation For Surgery And Other Interventions

If possible, discontinue PRADAXA 1 to 2 days (CrCl ≥ 50 mL/min) or 3 to 5 days (CrCl < 50 mL/min) before invasive or surgical procedures because of the increased risk of bleeding. Consider longer times for patients undergoing major surgery, spinal puncture, or placement of a spinal or epidural catheter or port, in whom complete hemostasis may be required [see Use in Specific Populations and CLINICAL PHARMACOLOGY].

If surgery cannot be delayed, there is an increased risk of bleeding [see WARNINGS AND PRECAUTIONS]. This risk of bleeding should be weighed against the urgency of intervention [see WARNINGS AND PRECAUTIONS]. Use a specific reversal agent (idarucizumab) in case of emergency surgery or urgent procedures when reversal of the anticoagulant effect of dabigatran is needed. Refer to the idarucizumab prescribing information for additional information. Restart PRADAXA as soon as medically appropriate.

HOW SUPPLIED

Dosage Forms And Strengths

150 mg capsules with a light blue opaque cap imprinted in black with the Boehringer Ingelheim company symbol and a cream-colored opaque body imprinted in black with “R150”.

110 mg capsules with a light blue opaque cap imprinted in black with the Boehringer Ingelheim company symbol and a light blue opaque body imprinted in black with “R110”.

75 mg capsules with a cream-colored opaque cap imprinted in black with the Boehringer Ingelheim company symbol and a cream-colored opaque body imprinted in black with “R75”.

Storage And Handling

PRADAXA 75 mg capsules have a cream-colored opaque cap imprinted with the Boehringer Ingelheim company symbol and a cream-colored opaque body imprinted with “R75”. The color of the imprinting is black. The capsules are supplied in the packages listed:

NDC 0597-0149-54 Unit of use bottle of 60 capsules
NDC
0597-0149-60 Blister package containing 60 capsules (10 x 6 capsule blister cards)

PRADAXA 110 mg capsules have a light blue opaque cap imprinted with the Boehringer Ingelheim company symbol and a light blue opaque body imprinted with “R110”. The color of the imprinting is black. The capsules are supplied in the packages listed:

NDC 0597-0108-54 Unit of use bottle of 60 capsules
NDC
0597-0108-60 Blister package containing 60 capsules (10 x 6 capsule blister cards)

PRADAXA 150 mg capsules have a light blue opaque cap imprinted with the Boehringer Ingelheim company symbol and a cream-colored opaque body imprinted with “R150”. The color of the imprinting is black. The capsules are supplied in the packages listed:

NDC 0597-0135-54 Unit of use bottle of 60 capsules
NDC 0597-0135-60 Blister package containing 60 capsules (10 x 6 capsule blister cards)

Bottles

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Once opened, the product must be used within 4 months. Keep the bottle tightly closed. Store in the original package to protect from moisture.

Blisters

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Store in the original package to protect from moisture.

Keep out of the reach of children.

Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc.; Ridgefield, CT 06877 USA. Revised: November 2015

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 12/7/2015

Indications
Dosage
How Supplied

Pradaxa - User Reviews

Pradaxa User Reviews

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