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Praxbind® - Idarucizumab

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Presentation on theme: "Praxbind® - Idarucizumab"— Presentation transcript:

1 Praxbind® - Idarucizumab
Manufacturer: Boehringer Ingelheim Pharmaceuticals, Inc. FDA Approval Date: 10/16/2015

2 Praxbind® - Idarucizumab Objectives
At the end of this presentation participants will be able to: Appropriately recommend Praxbind® - (idarucizumab) Effectively educate patients on the purpose, proper use and potential adverse effects of Praxbind® - (idarucizumab)

3 Praxbind® - Idarucizumab Clinical Application
Indications: Patient’s treated with Pradaxa (dabigatran) that require anticoagulation reversal in cases of: Emergency Surgery or Urgent Procedure Life Threatening Bleeding Place in therapy: First in market reversal agent for new oral anticoagulation dabigatran Praxbind ® [package insert].

4 Praxbind® - Idarucizumab Clinical Application
Contraindications: None Warnings and Precautions: Thromboembolic risk Re-elevation of coagulation parameters Hypersensitivity Fructose intolerance Praxbind ® [package insert].

5 Praxbind® - Idarucizumab Clinical Application
Pregnancy: No Data Lactation: Praxbind ® [package insert].

6 Praxbind® - Idarucizumab Drug Facts
Pharmacology: Humanized monoclonal antibody fragment (Fab) that binds to dabigatran and its acylglucuronide metabolites with an affinity higher than that of thrombin This specific binding neutralizes the anticoagulation effect of dabigatran Antibody is lock/key with dabigatran Praxbind ® [package insert].

7 Praxbind® - Idarucizumab Drug Facts
Pharmacokinetics: A – t ½ 47 minutes, terminal t ½ 10.3h D – Multiphasic with limited extravascular distribution. VoD 8.9 L M – Biodegradation of the antibody to small peptides E – ~30% eliminated in the urine, the rest is eliminated via degradation Praxbind ® [package insert].

8 Praxbind® - Idarucizumab Drug Interactions
No remarkable drug interactions determined via a theoretical mechanism, in vitro assessment, or in animal models Praxbind ® [package insert].

9 Praxbind® - Idarucizumab Adverse Effects
Healthy volunteers Headache 5% REVERSE-AD trial Hypokalemia: 7% Delirium: 7% Constipation 7% Pyrexia: 6% Pneumonia: 6% Serious Adverse Effects: 5 of 123 patients in the REVERSE-AD trial had a thrombotic event Praxbind ® [package insert].

10 Praxbind® - Idarucizumab Monitoring Parameters
Efficacy Monitoring: Baseline aPTT, re-evaluation of aPTT at 12 and 24 hours Monitor for signs and symptoms of bleed Toxicity Monitoring: Monitor for hypersensitivity or immunogenic reactions Praxbind ® [package insert].

11 Praxbind® - Idarucizumab Prescription Information
Dosing: 5 g infusion: provided as two 2.5g/50 mL vials. There is limited data to support a second 5 g infusion Cost: – NEJM Journal Watch. November 5, 2015 2.5g/50 mL vial ~$3500 Cost per treatment: $7000 Praxbind ® [package insert].

12 Praxbind® - Idarucizumab RE-VERSE AD Trial
Pollack CV, et al. N Engl J Med Aug 6;373(6):

13 Praxbind® - Idarucizumab RE-VERSE AD Trial
Purpose: Examine efficacy and safety of idarucizumab for dabigatran reversal Study Design: Multicenter, prospective cohort study Interim analysis, data on 90 of 300 pts Each patient received two 2.5 g infusions 15 minutes apart Pollack CV, et al. N Engl J Med Aug 6;373(6):

14 Praxbind® - Idarucizumab REVERSE-AD Trial
Inclusion: 18 y/o, and on dabigatran Group A: Life-threatening bleed Group B: Urgent surgery or procedure required Pollack CV, et al. N Engl J Med Aug 6;373(6):

15 Praxbind® - Idarucizumab Endpoints
Primary: Maximum percentage reversal Secondary: Proportion with normalization of dilute thrombin time Proportion with normalization of ecarin clotting time Reduction in concentration of unbound dabigatran Safety: All adverse events captured Pollack CV, et al. N Engl J Med Aug 6;373(6):

16 Praxbind® - Idarucizumab Patient Characteristics
Baseline Characteristics Age 77 Race 87% CrCL 62 mL/min Atrial Fibrillation 96% Last dose of dabigatran 15 hr Elevated Dilute thrombin time at baseline 76% Elevated ecarin clotting time at baseline 90% Pollack CV, et al. N Engl J Med Aug 6;373(6):

17 Praxbind® - Idarucizumab Results
22 patients had dilute thrombin times that were within normal limits and 9 of those patients had normal clotting times excluding these 22 pts from analysis (Group A - 40 patients and Group B patients). 81 of 90 were assessed with ecarin-clotting time test (Group A - 47 patients and Group B patients). All patients received idarucizumab regardless of their inclusion in the efficacy analysis Pollack CV, et al. N Engl J Med Aug 6;373(6):

18 Praxbind® - Idarucizumab Results
Primary: Maximum percentage reversal in Groups A and B was 100% Reversal was evident on first sample taken after infusion Secondary: Normalization of clotting time Dilute Thrombin Time Ecarin Clotting Time Group A 98% 89% Group B 93% 88% -Of the 22 patients with normal dilute thrombin time and ecarin clotting time, renal function was better than those included in analysis (67 mL/min versus 48 mL/min) -Baseline unbound dabigatran concentration was 84 ng/mL in Group A and 76 ng/mL in Group B. Unbound dabigatran was less than 20 ng/mL in all patients but one after reversal Pollack CV, et al. N Engl J Med Aug 6;373(6):

19 Praxbind® - Idarucizumab Safety
Safety Outcomes Death 18/90 (20%) Serious Adverse Event 21/90 (23.3%) MI 1/90 (1%) Stroke DVT/PE 3/90 (3.3%) Pollack CV, et al. N Engl J Med Aug 6;373(6):

20 Praxbind® - Idarucizumab Conclusions
Praxbind® is effective in reversing anticoagulation of dabigatran Minimal adverse event profile Small population using dabigatran will limit the impact of this medication Pollack CV, et al. N Engl J Med Aug 6;373(6):

21 Praxbind® - Idarucizumab Summary
Praxbind®, idarucizumab, is a humanized monoclonal antibody that reverses the anticoagulation effect of dabigatran Idarucizumab is indicated for patients treated with dabigatran that have a life-threatening or uncontrolled bleed, or require an emergency or urgent procedure Idarucizumab is 5g administered as two 2.5g infusions There is a risk of rebound anticoagulation hours after administration Hypersensitivity reactions are possible despite humanization of the antibody

22 Praxbind® - Idarucizumab References
Accessed 11/20/2015. Praxbind package insert. Boehringer Ingelheim Pharmaceuticals, Inc. Oct 2015. Boehringer Ingelheim Pharmaceuticals Inc. Praxbind ® approval announcement. provedDrugs/ucm htm. Accessed 11/20/15. Pollack CV Jr, Reilly PA, Eikelboom J, et al. Idarucizumab for Dabigatran Reversal. N Engl J Med Aug 6;373(6):


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