n (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.
FULL PRESCRIBING INFORMATION
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES
•Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO. Interrupt or discontinue BLINCYTO as recommended. [See Dosage and Administration (2.3), Warnings and Precautions (5.1)].
•Neurological toxicities, which may be severe, life-threatening, or fatal, occurred in patients receiving BLINCYTO. Interrupt or discontinue BLINCYTO as recommended. [See D |
