1 INDICATIONS AND USAGE
 
2 DOSAGE AND ADMINISTRATION
 
2.1 Induction Schedule
 
2.2 Maintenance Dosing
 
2.3 Dose Adjustments and Modifications
 
2.4 Preparation and Administration Precautions
 
3 DOSAGE FORMS AND STRENGTHS
 
4 CONTRAINDICATIONS
 
5 WARNINGS AND PRECAUTIONS
 
5.1 Myelosuppression
 
5.2 Bleeding
 
5.3 Hyperglycemia
 
5.4 Embryo-Fetal Toxicity
 
6 ADVERSE REACTIONS
 
6.1 Clinical Trials Experience
 
6.2 Additional Data From Safety Population
 
7 DRUG INTERACTIONS
 
8 USE IN SPECIFIC POPULATIONS
 
8.1 Pregnancy
 
8.3 Nursing Mothers
 
8.4 Pediatric Use
 
8.5 Geriatric Use
 
8.6 Renal Impairment
 
8.7 Hepatic Impairment
 
8.8 Effect of Gender
 
10 OVERDOSAGE
 
11 DESCRIPTION
 
12 CLINICAL PHARMACOLOGY
 
12.1 Mechanism of Action
 
12.3 Pharmacokinetics
 
12.6 Assessment for Risk of QT Prolongation
 
13 NONCLINICAL TOXICOLOGY
 
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
 
14 CLINICAL STUDIES
 
14.1 Chronic Phase CML (CP CML)
 
14.2 Accelerated Phase CML (AP CML)
 
15 REFERENCES
 
16 HOW SUPPLIED/STORAGE AND HANDLING
 
16.1 How Supplied
 
16.2 Storage and Handling
 
17 PATIENT COUNSELING INFORMATION
 
LABEL FOR OMACETAXINE MEPESUCCINATE NDC 63459-177-14
 
CARTON FOR OMACETAXINE MEPESUCCINATE NDC 63459-177-14
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FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE
 
SYNRIBO is indicated for the treatment of adult patients with chronic or accelerated phase chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKI). This indication is based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with SYNRIBO.

2 DOSAGE AND ADMINISTRATION

2.1 Induction Schedule
 
The recommended starting schedule for induction is 1.25 mg/m2 administered subcutaneously twice daily for 14 consecutive days every 28 days, over a 28-day cycle. Cycles should be repeated every 28 days until patients achieve a hematologic response.

2.2 Maintenance Dosing
 
The recommended maintenance schedule is 1.25 mg/m2 administered subcutaneously twice daily for 7 consecutive days every 28 days, over a 28-day cycle. Treatment should continue as long as patients are clinically benefiting from therapy.

2.3 Dose Adjustments and Modifications
 
Hematologic Toxicity:

SYNRIBO treatment cycles may be delayed and/or the number of days of dosing during the cycle reduced for hematologic toxicities (e.g. neutropenia, thrombocytopenia). [see Warnings and Precautions (5.1)]

Complete blood counts (CBCs) should be performed weekly during induction and initial maintenance cycles. After initial maintenance cycles, monitor CBCs every two weeks or as clinically indicated. If a patient experiences Grade 4 neutropenia (absolute neutrophil count (