Dabigatran Etexilate
DABIGATRAN ETEXILATE — dabigatran etexilate mesylate capsule
Camber Pharmaceuticals, Inc.
WARNING: (A) PREMATURE DISCONTINUATION OF DABIGATRAN ETEXILATE CAPSULES INCREASES THE RISK OF THROMBOTIC EVENTS, and (B) SPINAL/EPIDURAL HEMATOMA
(A) PREMATURE DISCONTINUATION OF DABIGATRAN ETEXILATE CAPSULES INCREASES THE RISK OF THROMBOTIC EVENTS
Premature discontinuation of any oral anticoagulant, including dabigatran etexilate capsules, increases the risk of thrombotic events. If anticoagulation with dabigatran etexilate capsules are discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant
[see Dosage and Administration (
2.6,
2.7,
2.8) and Warnings and Precautions (
5.1)].
(B) SPINAL/EPIDURAL HEMATOMA
Epidural or spinal hematomas may occur in patients treated with dabigatran etexilate capsules 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 dabigatran etexilate capsules and neuraxial procedures is not known
[see Warnings and Precautions (
5.3)].
Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary
[see Warnings and Precautions (
5.3)].
Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated
[see Warnings and Precautions (
5.3)].
1 INDICATIONS AND USAGE
1.1 Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation in Adult Patients
Dabigatran etexilate capsules are indicated to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation.
1.2 Treatment of Deep Venous Thrombosis and Pulmonary Embolism in Adult Patients
Dabigatran etexilate capsules are indicated for the treatment of deep venous thrombosis and pulmonary embolism in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days.
1.3 Reduction in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary Embolism in Adult Patients
Dabigatran etexilate capsules are indicated to reduce the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patients who have been previously treated.
Pediatric use information is approved for Boehringer Ingelheim Pharmaceuticals, Inc.’s Pradaxa (dabigatran etexilate) capsules. However, due to Boehringer Ingelheim Pharmaceuticals, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosage Information
Dabigatran etexilate is available in different dosage forms and not all dosage forms are approved for the same indications and age groups. In addition, there are differences between the dosage forms with respect to dosing due to differences in bioavailability. Do not substitute different dosage forms on a milligram-to-milligram basis and do not combine more than one dosage form to achieve the total dose [see Clinical Pharmacology ( 12.3)].
2.2 Recommended Dabigatran etexilate capsules Dose for Adults
| Indication | Dosage | |
| Reduction in Risk of Stroke and Systemic Embolism in Non-valvular AF | CrCl >30 mL/min: CrCl 15 to 30 mL/min: CrCl <15 mL/min or on dialysis: | 150 mg twice daily 75 mg twice daily 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 coadministration | |
| Treatment of DVT and PE Reduction in the Risk of Recurrence of DVT and PE | CrCl >30 mL/min: CrCl ≤30 mL/min or on dialysis: | 150 mg twice daily Dosing recommendations cannot be provided |
| CrCl <50 mL/min with concomitant use of P-gp inhibitors: | Avoid coadministration | |
Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation in Adult Patients
For patients with creatinine clearance (CrCl) >30 mL/min, the recommended dose of dabigatran etexilate capsules is 150 mg taken orally, twice daily. For patients with severe renal impairment (CrCl 15 to 30 mL/min), the recommended dose of dabigatran etexilate capsules is 75 mg twice daily
[see Use in Specific Populations (
8.6) and Clinical Pharmacology (
12.3)].
Dosing recommendations for patients with a CrCl <15 mL/min or on dialysis cannot be provided.
Treatment of Deep Venous Thrombosis and Pulmonary Embolism in Adult Patients
For patients with CrCl >30 mL/min, the recommended dose of dabigatran etexilate capsules is 150 mg taken orally, twice daily, after 5 to 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 (
8.6) and Clinical Pharmacology (
12.3)].
Reduction in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary Embolism in Adult Patients
For patients with CrCl >30 mL/min, the recommended dose of dabigatran etexilate capsules 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 (
8.6) and Clinical Pharmacology (
12.3)].
Pediatric use information is approved for Boehringer Ingelheim Pharmaceuticals, Inc.’s Pradaxa (dabigatran etexilate) capsules. However, due to Boehringer Ingelheim Pharmaceuticals, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.
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