da-bi-GAT-ran

• Reduction in the risk of stroke/systemic embolization associated with nonvalvular atrial fibrillation (AF).
• Treatment of venous thromboembolic events (including deep vein thrombosis [DVT] or pulmonary embolism [PE]) in patients who have been treated with a parenteral anticoagulant for 5 days.
• Reduction in the risk of recurrence of VTE in patients who have been previously treated.
• Prevention of DVT and PE following hip replacement surgery.

• Acts as a direct inhibitor of thrombin.

• Reduced risk of thrombotic sequelae (stroke and systemic embolism) in nonvalvular AF.
• Reduced risk of recurrent PE and DVT.
• Resolution of DVT and PE.

Absorption: 3–7% absorbed following oral administration. Bioavailability of oral pellets higher than that of capsules in adults.

Distribution: Unknown.

Metabolism/Excretion: Of the amount absorbed, mostly excreted by kidneys (80%); 86% of ingested dose is eliminated in feces due to poor bioavailability.

Half-life: 12–17 hr.

Contraindicated in:

• Hypersensitivity
• Active pathological bleeding
• Concurrent use of P-glycoprotein (P-gp) inducers
• Prosthetic heart valves (mechanical or bioprosthetic)
• Triple-positive antiphospholipid syndrome (↑ risk of thrombosis)
• OB: Pregnancy
• Lactation: Lactation.

Use Cautiously in:

• Neuroaxial spinal anesthesia or spinal puncture, especially if concurrent with an indwelling epidural catheter, drugs affecting hemostasis, history of traumatic/repeated spinal puncture or spinal deformity (↑ risk of spinal hematoma)
• Concurrent medications/pre-existing conditions that ↑ bleeding risk (other anticoagulants, antiplatelet agents, fibrinolytics, heparins, chronic NSAID use, labor and delivery)
• Renal impairment
• Surgical procedures (discontinue 1–2 days prior if CCr 50 mL/min or 3–4 days prior if CCr <50 mL/min
• Rep: Women of reproductive potential
• Pedi: Safety and effectiveness in children <3 mo (treatment and reduction in risk of VTE) and <18 yr (all other indications) not established
• Geri: ↑risk of bleeding in older adults.

GI: abdominal pain, diarrhea, dyspepsia, gastritis, esophageal ulceration, nausea.

Hemat: bleeding, thrombocytopenia.

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA).

Drug-Drug:

• Concurrent use of other anticoagulants, antiplatelet agents, fibrinolytics, heparins, prasugrel, clopidogrel, or chronic use of NSAIDs↑ risk of bleeding.
• Concurrent use of P-gp inducers including rifampin↓ levels and effectiveness; avoid concurrent use.
• P-gp inhibitors, including dronedarone, ketoconazole (systemic), verapamil, quinidine, and ticagrelor may ↑ levels and the risk of bleeding; concomitant use should be avoided in patients with CCr 15–30 mL/min.

Reduction in Risk of Stroke/Systemic Embolism in Nonvalvular Atrial Fibrillation

• PO (Adults): Capsules — 150 mg twice daily.

Treatment of and Reduction in Risk of Recurrence of Deep Vein Thrombosis or Pulmonary Embolism

• PO (Adults): 150 mg twice daily.
• PO (Children 8–<18 yr and 81 kg actual body weight): 260 mg (one 150-mg capsule + one 110-mg capsule or one 110–mg capsule + two 75–mg capsules) twice daily.
• PO (Children 8–<18 yr and 61–<81 kg actual body weight): 220 mg (two 110-mg capsules) twice daily.
• PO (Children 8–<18 yr and 41–<61 kg actual body weight): 185 mg (one 110-mg capsule + one 75-mg capsule) twice daily.
• PO (Children 8–<18 yr and 26–<41 kg actual body weight): 150 mg (one 150-mg capsule or two 75-mg capsules) twice daily.
• PO (Children 8–<18 yr and 16–<26 kg actual body weight): 110 mg (one 110-mg capsule) twice daily.
• PO (Children 8–<18 yr and 11–<16 kg actual body weight): 75 mg (one 75-mg capsule) twice daily.
Oral Pellets
• PO (Children 2–<12 yr and 41 kg actual body weight): 260 mg (one 110-mg pkt + one 150-mg pkt) twice daily.
• PO (Children 2–<12 yr and 21–<41 kg actual body weight): 220 mg (two 110-mg pkts) twice daily.
• PO (Children 2–<12 yr and 16–<21 kg actual body weight): 170 mg (one 20-mg pkt + one 150-mg pkt) twice daily.
• PO (Children 2–<12 yr and 13–<16 kg actual body weight): 140 mg (one 30-mg pkt + one 110-mg pkt) twice daily.
• PO (Children 2–<12 yr and 11–<13 kg actual body weight): 110 mg (one 110-mg pkt) twice daily.
• PO (Children 2–<12 yr and 9–<11 kg actual body weight): 90 mg (one 40-mg pkt + one 50-mg pkt) twice daily.
• PO (Children 2–<12 yr and 7–<9 kg actual body weight): 70 mg (one 30-mg pkt + one 40-mg pkt) twice daily.
• PO (Children 18 mo-<2 yr and 21–<26 kg actual body weight): 180 mg (one 30-mg pkt + one 150-mg pkt) twice daily.
• PO (Children 12 mo-<2 yr and 16–<21 kg actual body weight): 140 mg (one 30-mg pkt + one 110-mg pkt) twice daily.
• PO (Children 11 mo-<2 yr and 13–<16 kg actual body weight): 140 mg (one 30-mg pkt + one 110-mg pkt) twice daily.
• PO (Children 10 mo-<11 mo and 13–<16 kg actual body weight): 100 mg (two 50-mg pkts) twice daily.
• PO (Children 18 mo-<2 yr and 11–<13 kg actual body weight): 110 mg (one 110-mg pkt) twice daily.
• PO (Children 8 mo-<18 mo and 11–<13 kg actual body weight): 100 mg (two 50-mg pkts) twice daily.
• PO (Children 11 mo-<2 yr and 9–<11 kg actual body weight): 90 mg (one 40-mg pkt + one 50-mg pkt) twice daily.
• PO (Children 6–<11 mo and 9–<11 kg actual body weight): 80 mg (two 40-mg pkts) twice daily.
• PO (Children 5–<6 mo and 9–<11 kg actual body weight): 60 mg (two 30-mg pkts) twice daily.
• PO (Children 9 mo-<2 yr and 7–<9 kg actual body weight): 70 mg (one 30-mg pkt + one 40-mg pkt) twice daily.
• PO (Children 4–<9 mo and 7–<9 kg actual body weight): 60 mg (two 30-mg pkts) twice daily.
• PO (Children 3–<4 mo and 7–<9 kg actual body weight): 50 mg (one 50-mg pkt) twice daily.
• PO (Children 5 mo–<2 yr and 5–<7 kg actual body weight): 50 mg (one 50-mg pkt) twice daily.
• PO (Children 3–<5 mo and 5–<7 kg actual body weight): 40 mg (one 40-mg pkt) twice daily.
• PO (Children 3–<10 mo and 4–<5 kg actual body weight): 40 mg (one 40-mg pkt) twice daily.
• PO (Children 3–<6 mo and 3–<4 kg actual body weight): 30 mg (one 30-mg pkt) twice daily.

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

• PO (Adults): Capsules — 110 mg taken 1–4 hr after surgery and once hemostasis achieved, then 220 mg once daily for 28–35 days; if unable to start on day of surgery, once hemostasis achieved, start with 220 mg once daily.

• Do not confuse dabigatran with vigabatrin. Do not confuse Pradaxa (dabigatran) with Plavix (clopidogrel).
• Do not exchange capsule for oral pellets. Doses are not equal.
• When converting from warfarin, discontinue warfarin and start dabigatran when INR is <2.0.
• When converting from dabigatran to warfarin, adjust starting time based on CCr. For CCr >50 mL/min, start warfarin 3 days before discontinuing dabigatran. For CCr 31–50 mL/min, start warfarin 2 days before discontinuing dabigatran. For CCr 15–30 mL/min, start warfarin 1 day before discontinuing dabigatran. For CCr <15 mL/min, no recommendations can be made. INR will better reflect warfarin's effect after dabigatran has been stopped for at least 2 days.
• When converting from parenteral anticoagulants, start dabigatran up to 2 hr before next dose of parenteral drug is due or at time of discontinuation of parenteral therapy.
• When converting from dabigatran to parenteral anticoagulants, wait 12 hrs (CCr 30 mL/min) or 24 hr (CCr <30 mL/min) after last dose of dabigatran before initiating parenteral anticoagulant therapy.
• For surgery, discontinue dabigatran 1–2 days (CCr 50 mL/min) or 3–5 days (CCr <50 mL/min) before invasive or surgical procedures; consider longer times for major surgery, spinal puncture, or placement of a spinal or epidural catheter. If surgery cannot be delayed, bleeding risk is ↑. Assess bleeding risk with ECT or aPTT if ECT is not available.
• PO: Administer twice daily, at the same time each day, about 12 hr apart with a full glass of water without regard to food. DNC: Swallow capsule whole; do not open, crush, or chew; may result in increased exposure.
  • Administer pellets immediately after mixing or within 30 min after mixing. If not administered within 30 min of mixing, discard dose, and prepare a new dose. Mix pellets with 2 teaspoons of soft food (baby rice cereal prepared with water, mashed carrots, apple sauce, mashed banana) at room temperature or spoon pellets directly into mouth and swallowed apple juice or added to 1–2 oz of apple juice for drinking. Do not administer pellets via syringes or feeding tubes, or with milk, milk products, or soft foods containing milk products.
  • If dabigatran is discontinued, consider starting another anticoagulant; discontinuation of dabigatran increases risk of thromboembolic events.

Pradaxa

Therapeutic Classification: anticoagulants

Pharmacologic Classification: thrombin inhibitors

(Generic available)

• Capsules: 75 mg; 110 mg; 150 mg;
• Oral pellets: 20 mg/pkt; 30 mg/pkt; 40 mg/pkt; 50 mg/pkt; 110 mg/pkt; 150 mg/pkt;

(effects on coagulation)

†Following discontinuation, 3–5 days in renal impairment.

• Assess for symptoms of stroke or peripheral vascular disease periodically during therapy.
• Assess for symptoms of bleeding and blood loss; may be fatal. If reversal of anticoagulant effect is required, may use idarucizumab.

• Use aPTT or ecarin clotting time (ECT), not INR, to assess anticoagulant activity, if needed.
  • Monitor renal function prior to and periodically during therapy. Patients with renal impairment may require dose reduction or discontinuation.

• Instruct patient to take dabigatran as directed. Take missed doses as soon as remembered within 6 hr. If <6 hr until next dose, skip dose and take next dose when scheduled; do not double doses. Do not discontinue without consulting health care professional. If temporarily discontinued, restart as soon as possible. Store dabigatran at room temperature. After opening bottle, use within 4 mo; discard unused dabigatran after 4 mo. Advise patient to read Medication Guide before starting therapy and with each Rx refill in case of changes.
• Inform patient that they may bleed more easily or longer than usual. Advise patient to notify health care professional immediately if signs of bleeding (unusual bruising; pink or brown urine; red or black, tarry stools; coughing up blood; vomiting blood; pain or swelling in a joint; headache; dizziness; weakness; recurring nose bleeds; unusual bleeding from gums; heavier than normal menstrual bleeding; dyspepsia; abdominal pain; epigastric pain) occur.
• Advise patient to notify health care professional of medication regimen prior to treatment or surgery.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
• Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected and to avoid breast feeding during therapy. May increase risk of bleeding in the fetus and neonate. Monitor neonates for bleeding. May increase risk of uterine bleeding; advise patient to notify health care professional if significant uterine bleeding occurs.

• Reduction in the risk of stroke and systemic embolism.
• Reduced risk of recurrent PE and DVT.
• Resolution of DVT and PE.

NDC Code^*

• 0597- Boehringer Ingelheim Pharmaceuticals Inc.
  • 0597-0108- Pradaxa
    • 0597-0108-54- 1 BOTTLE in 1 CARTON (0597-0108-54) > 60 CAPSULE in 1 BOTTLE

• 0597- Boehringer Ingelheim Pharmaceuticals Inc.
  • 0597-0108- Pradaxa
    • 0597-0108-60- 10 BLISTER PACK in 1 CARTON (0597-0108-60) > 6 CAPSULE in 1 BLISTER PACK

• 0597- Boehringer Ingelheim Pharmaceuticals Inc.
  • 0597-0135- Pradaxa
    • 0597-0135-12- 2 BLISTER PACK in 1 CARTON (0597-0135-12) > 6 CAPSULE in 1 BLISTER PACK

• 0597- Boehringer Ingelheim Pharmaceuticals Inc.
  • 0597-0135- Pradaxa
    • 0597-0135-54- 1 BOTTLE in 1 CARTON (0597-0135-54) > 60 CAPSULE in 1 BOTTLE

• 0597- Boehringer Ingelheim Pharmaceuticals Inc.
  • 0597-0135- Pradaxa
    • 0597-0135-60- 10 BLISTER PACK in 1 CARTON (0597-0135-60) > 6 CAPSULE in 1 BLISTER PACK

• 0597- Boehringer Ingelheim Pharmaceuticals Inc.
  • 0597-0149- Pradaxa
    • 0597-0149-12- 2 BLISTER PACK in 1 CARTON (0597-0149-12) > 6 CAPSULE in 1 BLISTER PACK

• 0597- Boehringer Ingelheim Pharmaceuticals Inc.
  • 0597-0149- Pradaxa
    • 0597-0149-54- 1 BOTTLE in 1 CARTON (0597-0149-54) > 60 CAPSULE in 1 BOTTLE

• 0597- Boehringer Ingelheim Pharmaceuticals Inc.
  • 0597-0149- Pradaxa
    • 0597-0149-60- 10 BLISTER PACK in 1 CARTON (0597-0149-60) > 6 CAPSULE in 1 BLISTER PACK

• 0597- Boehringer Ingelheim Pharmaceuticals Inc.
  • 0597-0355- Pradaxa
    • 0597-0355-09- 1 BOTTLE in 1 CARTON (0597-0355-09) > 60 CAPSULE in 1 BOTTLE

• 0597- Boehringer Ingelheim Pharmaceuticals Inc.
  • 0597-0355- Pradaxa
    • 0597-0355-53- 12 BLISTER PACK in 1 CARTON (0597-0355-53) > 1 CAPSULE in 1 BLISTER PACK

• 0597- Boehringer Ingelheim Pharmaceuticals Inc.
  • 0597-0355- Pradaxa
    • 0597-0355-56- 60 BLISTER PACK in 1 CARTON (0597-0355-56) > 1 CAPSULE in 1 BLISTER PACK

• 0597- Boehringer Ingelheim Pharmaceuticals Inc.
  • 0597-0360- Pradaxa
    • 0597-0360-42- 12 BLISTER PACK in 1 CARTON (0597-0360-42) > 1 CAPSULE in 1 BLISTER PACK

• 0597- Boehringer Ingelheim Pharmaceuticals Inc.
  • 0597-0360- Pradaxa
    • 0597-0360-55- 1 BOTTLE in 1 CARTON (0597-0360-55) > 60 CAPSULE in 1 BOTTLE

• 0597- Boehringer Ingelheim Pharmaceuticals Inc.
  • 0597-0360- Pradaxa
    • 0597-0360-82- 60 BLISTER PACK in 1 CARTON (0597-0360-82) > 1 CAPSULE in 1 BLISTER PACK

• 50090- A-S Medication Solutions
  • 50090-3617- Pradaxa
    • 50090-3617-0- 1 BOTTLE in 1 CARTON (50090-3617-0) > 60 CAPSULE in 1 BOTTLE

• 50090- A-S Medication Solutions
  • 50090-4480- Pradaxa
    • 50090-4480-0- 1 BOTTLE in 1 CARTON (50090-4480-0) > 60 CAPSULE in 1 BOTTLE

• 63629- Bryant Ranch Prepack
  • 63629-8242- Pradaxa
    • 63629-8242-1- 30 CAPSULE in 1 BOTTLE (63629-8242-1)