Prescription Drug Information: Pradaxa

PRADAXA- dabigatran etexilate mesylate pellet
Boehringer Ingelheim Pharmaceuticals, Inc.

WARNING: (A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS, and (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 [see Dosage and Administration (2.5, 2.6, 2.7) and Warnings and Precautions (5.1)].

(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 [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 Treatment of Venous Thromboembolic Events in Pediatric Patients

PRADAXA Oral Pellets are indicated for the treatment of venous thromboembolic events (VTE) in pediatric patients aged 3 months to less than 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days.

1.2 Reduction in the Risk of Recurrence of Venous Thromboembolic Events in Pediatric Patients

PRADAXA Oral Pellets are indicated to reduce the risk of recurrence of VTE in pediatric patients aged 3 months to less than 12 years of age who have been previously treated.

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 (for example, capsules) for oral pellets 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 PRADAXA Oral Pellets Dose for Pediatric Patients

PRADAXA Oral Pellets can be used in pediatric patients aged 3 months to less than 12 years as soon as they are able to swallow soft food. For the treatment of VTE in pediatric patients, treatment should be initiated following treatment with a parenteral anticoagulant for at least 5 days. For reduction in risk of recurrence of VTE, treatment should be initiated following previous treatment.

The recommended dose of PRADAXA Oral Pellets is based on the patient’s age and actual weight as shown in the tables below. PRADAXA Oral Pellets is administered twice daily. Adjust the dose according to age and actual weight as treatment progresses.

Table 1 Age- and Weight-Based Dosing for PRADAXA Oral Pellets for Pediatric Patients less than 2 Years Old
Actual Weight (kg) Age (in months) Dose (mg) twice daily Number of Packets Needed
3 kg to less than 4 kg 3 to less than 6 months 30 mg one 30 mg packet twice daily
4 kg to less than 5 kg 3 to less than 10 months 40 mg one 40 mg packet twice daily
5 kg to less than 7 kg 3 to less than 5 months 40 mg one 40 mg packet twice daily
5 to less than 24 months 50 mg one 50 mg packet twice daily
7 kg to less than 9 kg 3 to less than 4 months 50 mg one 50 mg packet twice daily
4 to less than 9 months 60 mg two 30 mg packets twice daily
9 to less than 24 months 70 mg one 30 mg packet plus one 40 mg packet twice daily
9 kg to less than 11 kg 5 to less than 6 months 60 mg two 30 mg packets twice daily
6 to less than 11 months 80 mg two 40 mg packets twice daily
11 to less than 24 months 90 mg one 40 mg packet plus one 50 mg packet twice daily
11 kg to less than 13 kg 8 to less than 18 months 100 mg two 50 mg packets twice daily
18 to less than 24 months 110 mg one 110 mg packet twice daily
13 kg to less than 16 kg 10 to less than 11 months 100 mg two 50 mg packets twice daily
11 to less than 24 months 140 mg one 30 mg packet plus one 110 mg packet twice daily
16 kg to less than 21 kg 12 to less than 24 months 140 mg one 30 mg packet plus one 110 mg packet twice daily
21 kg to less than 26 kg 18 to less than 24 months 180 mg one 30 mg packet plus one 150 mg packet twice daily
Table 2 Weight-Based Dosing for PRADAXA Oral Pellets for Pediatric Patients between 2 Years to less than 12 Years Old
Actual Weight (kg) Dose (mg) twice daily Number of Packets Needed
7 kg to less than 9 kg 70 mg one 30 mg packet plus one 40 mg packet twice daily
9 kg to less than 11 kg 90 mg one 40 mg packet plus one 50 mg packet twice daily
11 kg to less than 13 kg 110 mg one 110 mg packet twice daily
13 kg to less than 16 kg 140 mg one 30 mg packet plus one 110 mg packet twice daily
16 kg to less than 21 kg 170 mg one 20 mg packet plus one 150 mg packet twice daily
21 kg to less than 41 kg 220 mg two 110 mg packets twice daily
41 kg or greater 260 mg one 110 mg packet plus one 150 mg packet twice daily

Evaluation of the extent of anticoagulation in pediatric patients on PRADAXA Oral Pellets may be accomplished using dTT or ECT, and not INR [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.2)].

2.3 Dosage Adjustments

Pediatric Patients with Renal Impairment

Assess renal function prior to initiation of treatment with PRADAXA Oral Pellets. 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 Oral Pellets in patients who develop acute renal failure while on PRADAXA Oral Pellets and consider alternative anticoagulant therapy.

Prior to the initiation of treatment with PRADAXA Oral Pellets, estimate the glomerular filtration rate (eGFR) using the Schwartz formula, eGFR (Schwartz) = (0.413 × height in cm) / serum creatinine in mg/dL.

Due to lack of data in pediatric patients with an eGFR < 50 mL/min/1.73m2 and the risk of increased exposure, avoid use of PRADAXA Oral Pellets in these patients. Treat patients with an eGFR > 50 mL/min/1.73m2 with the dose according to Tables 1 and 2 [see Dosage and Administration (2.2)].

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