gaging in hazardous occupations or activities such as operating heavy or potentially dangerous machinery while BLINCYTO is being administered. (5.6)
Preparation and Administration Errors: Strictly follow instructions for preparation (including admixing) and administration. (5.9)
ADVERSE REACTIONS
The most common adverse reactions (≥ 20%) were pyrexia, headache, peripheral edema, febrile neutropenia, nausea, hypokalemia, tremor, rash, and constipation. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
There is limited experience in pediatric patients. (8.4)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 12/2014
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES
1. INDICATIONS AND USAGE
2. DOSAGE AND ADMINISTRATION
2.1 Dosage 2.2 Administration 2.3 Dosage Adjustments 2.4 Reconstitution and Preparation of Solution for Infusion 2.5 Storage Requirements 3. DOSAGE FORMS AND STRENGTHS
4. CONTRAINDICATIONS
5. WARNINGS AND PRECAUTIONS
5.1 Cytokine Release Syndrome 5.2 Neurological Toxicities 5.3 Infections 5.4 Tumor Lysis Syndrome 5.5 Neutropenia and Febrile Neutropenia 5.6 Effects on Ability to Drive and Use Machines 5.7 Elevated Liver Enzymes 5.8 Leukoencephalopathy 5.9 Preparation and Administration Errors 6. ADVERSE REACTIONS
6.1 Clinical Trials Experience 6.2 Immunogenicity 7. DRUG INTERACTIONS
8. USE IN SPECIFIC POPULATIONS
8.1 Pregnancy 8.3 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Hepatic Impairment 8.7 Renal Impairment 10. OVERDOSAGE
11. DESCRIPTION
12. CLINICAL PHARMACOLOGY
12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13. NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14. CLINICAL STUDIES
14.1 Acute Lymphoblastic Leukemia 16. HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied 16.2 Storage and Handling 17. PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed. Close
1. INDICATIONS AND USAGE
BLINCYTO is indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification of clinical benefit in subsequent trials [see Clinical Studies (14.1)].
2. DOSAGE AND ADMINISTRATIO |
