edwatch.
USE IN SPECIFIC POPULATIONS
•Pregnancy: Based on animal data, may cause fetal harm. Use only if clearly needed. (8.1)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 02/2012
Back to Highlights and Tabs
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: FATAL INFUSION REACTIONS, GRAFT VERSUS HOST DISEASE,
ENGRAFTMENT SYNDROME AND GRAFT FAILURE
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dosing
2.2 Preparation for Infusion
2.3 Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Allergic Reactions and Anaphylaxis
5.2 Infusion Reactions
5.3 Graft-versus-Host Disease (GVHD)
5.4 Engraftment Syndrome
5.5 Graft Failure
5.6 Malignancies of Donor Origin
5.7 Transmission of Serious Infections
5.8 Transmission of Rare Genetic Diseases
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Disease
10 OVERDOSAGE
10.1 Human Overdosage Experience
10.2 Management of Overdose
11 DESCRIPTION
12. CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
INSTRUCTIONS FOR PREPARATION FOR INFUSION
*
Sections or subsections omitted from the full prescribing information are not listed.
FULL PRESCRIBING INFORMATION
WARNING: FATAL INFUSION REACTIONS, GRAFT VERSUS HOST DISEASE,
ENGRAFTMENT SYNDROME AND GRAFT FAILURE
Fatal infusion reactions: HEMACORD administration can result in serious, including fatal, infusion reactions. Monitor patients and discontinue HEMACORD infusion for severe reactions. Use is contraindicated in patients with known allergy to dimethyl sulfoxide (DMSO), Dextran 40 or human serum albumin. [See Contraindications (4) and Warnings and Precautions (5.1, 5.2)]
Graft-vs-host disease (GVHD): GVHD is expected after administration of HEMACORD, and may be fatal. Administration of immunosuppressive therapy may decrease the risk of GVHD. [See Warnings and Precautions (5.3)]
Engraftment syndrome: Engraftment syndrome may progress to multiorgan failure and death. Treat engraftment syndrome promptly with corticosteroids.[See Warnings and Precautions (5.4)]
Graft failure: Graft failure may be fatal. Monitor patients for laboratory evidence of hematopoietic recovery. Prior to choosing a specific unit of HEMACORD, consider testing for HLA antibodies to identify patients who are alloimmunized. [See Warnings and Precautions (5.5)]
1 INDICATIONS AND USAGE
HEMACORD is an allogeneic cord blood hematopoietic progenitor cell therapy indicated for use in unrelated donor hematopoietic progenitor stem cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.
The risk benefit assessment for an individual patient depends on the patient characteristics, including disease, stage, risk factors, and specific manifestations of the disease, on characteristics of the graft, and on other available treatments or types of hematopoietic progenitor cells.
2 DOSAGE AND ADMINISTRATION
For intravenous use only.
Do not irradi |
