PRADAXA ORAL PELLETS Dosage & Rx Info

Pradaxa Oral Pellets Generic Name & Formulations

Legal Class

General Description

Dabigatran etexilate mesylate 20mg, 30mg, 40mg, 50mg, 110mg, 150mg; per packet.

Pharmacological Class

Direct thrombin inhibitor.

How Supplied

Caps, pellets (packets)—60

Manufacturer

Boehringer Ingelheim Pharmaceuticals

Generic Availability

Mechanism of Action

Dabigatran and its acyl glucuronides are competitive, direct thrombin inhibitors. Since thrombin (serine protease) enables the conversion of fibrinogen into fibrin during the coagulation cascade, its inhibition prevents the development of a thrombus.

Pradaxa Oral Pellets Indications

Indications

Treatment of venous thromboembolic events (VTE) in patients aged 3 months–<12yrs who have been treated with a parenteral anticoagulant for at least 5 days. To reduce the risk of recurrent VTE in patients aged 3 months–<12yrs who have been previously treated.

Pradaxa Oral Pellets Dosage and Administration

Adult

Not applicable.

Children

<3 months: not established. Prior to initiation, estimate the glomerular filtration rate (eGFR). Give twice daily (approx. 12hrs apart) at the same time every day with apple juice or only specific soft foods (eg, mashed carrots, applesauce, mashed banana). Do not administer via syringes, feeding tubes, or milk products. 3 months–<2yrs: Give based on age- and weight-dosing. 3–<4kg (3–<6mos): 30mg twice daily. 4–<5kg (3–<10mos): 40mg twice daily. 5–<7kg (3–<5mos): 40mg twice daily; (5–<24mos): 50mg twice daily. 7–<9kg (3–<4mos): 50mg twice daily; (4–<9mos): 60mg (two 30mg packets) twice daily; (9–<24mos): 70mg (30mg + 40mg packets) twice daily. 9–<11kg (5–<6mos): 60mg (two 30mg packets) twice daily; (6–<11mos): 80mg (two 40mg packets) twice daily); (11–<24mos): 90mg (40mg + 50mg packets) twice daily. 11–<13kg (8–<18mos): 100mg (two 50mg packets) twice daily; (18–<24mos): 110mg twice daily. 13–<16kg (10–<11mos): 100mg (two 50mg packets) twice daily; (11–<24mos): 140mg (30mg + 110mg packets) twice daily. 16–<21kg (12–<24mos): 140mg (30mg + 110mg packets) twice daily. 21–<26kg (18–<24mos): 180mg (30mg + 150mg packets) twice daily. 2–<12yrs: Give based on weight-dosing. 2–<12yrs (7–<9kg): 70mg (30mg + 40mg packets) twice daily; (9–<11kg): 90mg (40mg + 50mg packets) twice daily; (11–<13kg): 110mg twice daily; (13–<16kg): 140mg (30mg + 110mg packets) twice daily; (16–<21kg): 170mg (20mg + 150mg packets) twice daily; (21–<41kg): 220mg (two 110mg packets) twice daily; (≥41kg): 260mg (110mg + 150mg packets) twice daily. Renal impairment (eGFR <50mL/min/1.73m²): avoid. Converting from/to warfarin or parenteral anticoagulants, discontinuation for surgery and other interventions: see full labeling.

Administration

Take missed dose as soon as possible on same day; skip dose if it cannot be taken at least 6hrs before the next scheduled dose; do not double doses.

Pradaxa Oral Pellets Contraindications

Contraindications

Active pathological bleeding. Mechanical prosthetic heart valve.

Pradaxa Oral Pellets Boxed Warnings

Boxed Warning

Premature discontinuation of Pradaxa increases the risk of thrombotic events. Spinal/epidural hematoma.

Pradaxa Oral Pellets Warnings/Precautions

Warnings/Precautions

Capsules and oral pellets are not substitutable on a mg-to-mg basis; do not combine dosage forms. Premature discontinuation increases risk of thrombotic events; if discontinued for reason other than bleeding or therapy completion, consider coverage with another anticoagulant and restart dabigatran as soon as appropriate. Increased risk of spinal/epidural hematoma in anticoagulated patients receiving neuraxial anesthesia or undergoing spinal puncture; monitor for signs/symptoms of neurological impairment. Increased risk of serious bleeding. Promptly evaluate signs/symptoms of blood loss (eg, a drop in hemoglobin and/or hematocrit or hypotension). Use specific reversal agent (idarucizumab) to reverse anticoagulant effect of dabigatran as needed (eg, emergency surgery/urgent procedures, life-threatening/uncontrolled bleeding); efficacy and safety of idarucizumab in pediatric patients have not been established. Suspend treatment before invasive therapy or surgery, including dental procedures (see full labeling); restart promptly. Bioprosthetic heart valve or triple-positive antiphospholipid syndrome: not recommended. Monitor renal function prior to initiation, then periodically as clinically indicated; discontinue if acute renal failure develops and consider alternate therapy. Avoid lapses in therapy. Renal impairment (see Adult dosage & Children dosage). Bleeding risk can be assessed by ecarin clotting time (ECT), or if not available, aPTT. Elderly (>75yrs). Labor & delivery. Neonates. Pregnancy. Females of reproductive potential. Abnormal uterine bleeding. Nursing mothers: not recommended.

Pradaxa Oral Pellets Pharmacokinetics

Absorption

Absolute bioavailability: ~3–7% for capsules; oral bioavailability increases by 75% when the oral pellets are taken without the capsule shell.

Distribution

Volume of distribution: 50–70 L. Plasma protein bound: ~35%.

Metabolism

Hepatic.

Elimination

Fecal (86%), renal (7%). Half-life: approximately 9–11 hours.

Pradaxa Oral Pellets Interactions

Interactions

Antagonized by P-gp inducers (eg, rifampin); avoid. Increased dabigatran levels in renal impairment with concomitant P-gp inhibitors (eg, [dronedarone, systemic ketoconazole; reduce dabigatran dose], verapamil, amiodarone, quinidine, clarithromycin, ticagrelor). May be potentiated by P-gp inhibitors in pediatric patients: not studied. Concomitant NSAIDs, platelet inhibitors, heparin, fibrinolytic therapy: increased risk of bleeding. Switching to or from warfarin: monitor closely.

Pradaxa Oral Pellets Adverse Reactions

Adverse Reactions

Gastritis-like symptoms (eg, GERD, esophagitis, erosive gastritis, gastric hemorrhage, ulcer), bleeding (may be fatal); also for oral pellets: dyspepsia, upper abdominal pain, vomiting, nausea, diarrhea.

Pradaxa Oral Pellets Clinical Trials

See Literature

Pradaxa Oral Pellets Note

Not Applicable

Pradaxa Oral Pellets Patient Counseling