Praxbind (Page 4 of 4)

16  HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

  • PRAXBIND is a sterile, preservative-free, colorless to slightly yellow, clear to slightly opalescent solution supplied as 2 single-dose vials each containing 2.5 g/50 mL of idarucizumab.
  • NDC number 0597-0197-05: Carton containing two 2.5 g/50 mL vials.

16.2 Storage and Handling

  • Store PRAXBIND vials in the refrigerator at 2ºC to 8ºC (36ºF to 46ºF) in the original carton to protect from light. Do not freeze. Do not shake.
  • PRAXBIND vials may be stored at room temperature, 25°C (77°F), for up to 48 hours in the original carton to protect from light.
  • PRAXBIND vials may be stored at room temperature, 25°C (77°F), out of the carton and exposed to light but must be used within 6 hours [see Dosage and Administration (2.2)].

17  PATIENT COUNSELING INFORMATION

Thromboembolic Risk
Inform patients that reversing dabigatran therapy exposes them to the thromboembolic risk of their underlying disease. To reduce this risk, resumption of anticoagulant therapy should be considered as soon as the patient is sufficiently stable [see Warnings and Precautions (5.1)].

Recurrence of Bleeding
Inform patients to get immediate medical attention for any signs or symptoms of bleeding [see Warnings and Precautions (5.2)].

Hypersensitivity Reactions
Inform patients of signs and symptoms of allergic hypersensitivity reactions such as anaphylactoid reactions that may be experienced during or after injection of PRAXBIND [see Warnings and Precautions (5.3)].

Risk of Serious Adverse Reactions in Patients with Hereditary Fructose Intolerance due to Sorbitol Excipient
Inform patients with hereditary fructose intolerance (HFI) that PRAXBIND contains sorbitol. Parenteral administration of sorbitol in patients who have HFI has been associated with reports of hypoglycemia, hypophosphatemia, metabolic acidosis, increase in uric acid, acute liver failure with breakdown of excretory and synthetic function, and death and may occur during or after injection of PRAXBIND [see Warnings and Precautions (5.4)].

Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield, CT 06877 USA
US License No. 2006

Product of Germany

Licensed from:
Boehringer Ingelheim International GmbH

Copyright © 2021 Boehringer Ingelheim International GmbH
ALL RIGHTS RESERVED

COL10514AJ182021

Praxbind® 2.5 g/50 mL LabelNDC: 0597­0197­05

praxbind-label
(click image for full-size original)
PRAXBIND idarucizumab injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0597-0197
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IDARUCIZUMAB (IDARUCIZUMAB) IDARUCIZUMAB 50 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0597-0197-05 2 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
1 50 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0597-0197-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761025 10/21/2015
Labeler — Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)
Registrant — Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)
Establishment
Name Address ID/FEI Operations
Boehringer Ingelheim Pharma GmbH and Co. KG 340700520 API MANUFACTURE (0597-0197), MANUFACTURE (0597-0197), PACK (0597-0197), LABEL (0597-0197), ANALYSIS (0597-0197)

Revised: 10/2021 Boehringer Ingelheim Pharmaceuticals, Inc.

Page 4 of 4 1 2 3 4

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.