Rx Item-Synribo 3.5Mg Vial 8Ml By Teva Pharma

SYNRIBO- omacetaxine mepesuccinate injection, powder, lyophilized, for solution
Cephalon, Inc.

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).

2 DOSAGE AND ADMINISTRATION

2.1 Induction Schedule


The recommended starting schedule for induction is 1.25 mg/m2 administered subcutaneously twice daily at approximately 12 hour intervals 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 at approximately 12 hour intervals for 7 consecutive days every 28 days, over a 28-day cycle. Treatment should continue as long as patients are clinically benefiting
DOSAGE FORMS AND STRENGTHS

SYNRIBO for Injection contains 3.5 mg omacetaxine mepesuccinate; as a sterile, preservative-free, white to off-white lyophilized powder in a single-use vial.
DESCRIPTION

SYNRIBO contains the active ingredient omacetaxine mepesuccinate, a cephalotaxine ester. It is a protein synthesis inhibitor. Omacetaxine mepesuccinate is prepared by a semi-synthetic process from cephalotaxine, an extract from the leaves of Cephalotaxus sp. The chemical name of omacetaxine mepesuccinate is cephalotaxine, 4-methyl (2R)-hydroxyl-2-(4-hydroxyl-4-methylpentyl) butanedioate (ester).
The molecular formula is C29 H39 NO9 with a molecular weight of 545.6 g/mol. SYNRIBO for Injection is a sterile, preservative-free, white to off-white, lyophilized powder in a single-use vial. Each vial contains 3.5 mg omacetaxine mepesuccinate and mannitol.

SYNRIBO is intended for subcutaneous administration after reconstitution with 1.0 mL of 0.9% Sodium Chloride Injection, USP. The pH of the reconstituted solution is between 5.5 and 7.0.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action
The mechanism of action of omacetaxine mepesuccinate has not been fully elucidated but includes inhibition of protein synthesis and is independent of direct Bcr-Abl binding. Omacetaxine mepesuccinate binds to the A-site cleft in the peptidyl-transferase center of the large ribosomal subunit from a strain of archaeabacteria. In vitro, omacetaxine mepesuccinate reduced protein levels of the Bcr-Abl oncoprotein and Mcl-1, an anti-apoptotic Bcl-2 family member. Omacetaxine mepesuccinate showed activity in mouse models of wild-type and T315I mutated Bcr-Abl CML.
HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied
SYNRIBO (omacetaxine mepesuccinate) for Injection is supplied in 8 mL clear glass single-use vial in individual cartons. Each vial contains 3.5 mg of SYNRIBO (omacetaxine mepesuccinate) for Injection (NDC 63459-177-14).

16.2 Storage and Handling


Store unopened vials at 20o C to 25�C (68o F to 77�F); excursions permitted from 15�C to 30�C (59�F to 86�F) [see USP Controlled Room Temperature]. Prior to re-constitution, keep product in carton to protect from light.

Omacetaxine mepesuccinate is a cytotoxic drug. Follow special handling and disposal procedures1

RX ITEM-Synribo 3.5Mg Vial 8Ml By Teva P
NDC 63459-0177-14 UPC/GTIN No.3-63459-17714-4 Mfg.Part No.17714

Synribo 3.5Mg Vial 8Ml By Teva Pharma
BRAND: SYNRIBO NDC: 63459-0177-14,63459017714 UPC: 3-63459-17714-4,363459177144 Teva Pharmaceuticals USA/Brand

OMACETAXINE MEPESUCCINATE
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