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Omacetaxine Mepesuccinate

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Overview

What is SYNRIBO?

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 . The chemical name of omacetaxine mepesuccinate is cephalotaxine, 4-methyl (2)-hydroxyl-2-(4-hydroxyl-4-methylpentyl) butanedioate (ester).

Omacetaxine mepesuccinate has the following chemical structure:

The molecular formula is CHNO 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-dose 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.



What does SYNRIBO look like?



What are the available doses of SYNRIBO?

Single-dose vial containing 3.5 mg of omacetaxine mepesuccinate as a lyophilized powder ().

What should I talk to my health care provider before I take SYNRIBO?

How should I use SYNRIBO?

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).

The recommended starting schedule for induction is 1.25 mg/m 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.


What interacts with SYNRIBO?

Sorry No Records found


What are the warnings of SYNRIBO?

Sorry No Records found


What are the precautions of SYNRIBO?

Sorry No Records found


What are the side effects of SYNRIBO?

Sorry No records found


What should I look out for while using SYNRIBO?

None.


What might happen if I take too much SYNRIBO?

A patient in the clinical expanded access program received an overdose of 2.5 mg/m twice daily for 5 days in the 16 cycle. The patient presented with gastrointestinal disorders, gingival hemorrhage, alopecia, and Grade 4 thrombocytopenia and neutropenia. When SYNRIBO treatment was temporarily interrupted the gastrointestinal disorders and hemorrhagic syndrome resolved, and neutrophil values returned to within normal range. The alopecia and thrombocytopenia (Grade 1) improved, and SYNRIBO was restarted.

No specific antidote for SYNRIBO overdose is known. Management of overdosage should include general supportive measures, including monitoring of hematologic parameters.


How should I store and handle SYNRIBO?

Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F) until time of use. Keep the vial in the outer carton in order to protect from light. the vial. Product: 63629-1345NDC: 63629-1345-3 14 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-2 20 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-1 30 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-4 60 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-5 90 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-6 6 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-7 120 TABLET, FILM COATED in a BOTTLEProduct: 63629-1345NDC: 63629-1345-3 14 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-2 20 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-1 30 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-4 60 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-5 90 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-6 6 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-7 120 TABLET, FILM COATED in a BOTTLEProduct: 63629-1345NDC: 63629-1345-3 14 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-2 20 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-1 30 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-4 60 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-5 90 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-6 6 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-7 120 TABLET, FILM COATED in a BOTTLEProduct: 63629-1345NDC: 63629-1345-3 14 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-2 20 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-1 30 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-4 60 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-5 90 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-6 6 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-7 120 TABLET, FILM COATED in a BOTTLEProduct: 63629-1345NDC: 63629-1345-3 14 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-2 20 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-1 30 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-4 60 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-5 90 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-6 6 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-7 120 TABLET, FILM COATED in a BOTTLEProduct: 63629-1345NDC: 63629-1345-3 14 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-2 20 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-1 30 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-4 60 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-5 90 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-6 6 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-7 120 TABLET, FILM COATED in a BOTTLEProduct: 63629-1345NDC: 63629-1345-3 14 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-2 20 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-1 30 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-4 60 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-5 90 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-6 6 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-7 120 TABLET, FILM COATED in a BOTTLEProduct: 63629-1345NDC: 63629-1345-3 14 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-2 20 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-1 30 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-4 60 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-5 90 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-6 6 TABLET, FILM COATED in a BOTTLENDC: 63629-1345-7 120 TABLET, FILM COATED in a BOTTLE


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

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.

Non-Clinical Toxicology
None.

See Table 1 for clinically significant drug interactions with naproxen.

Drug/Laboratory Test Interactions

In uncontrolled trials with SYNRIBO, patients with chronic phase and accelerated phase CML experienced NCI CTC (version 3.0) Grade 3 or 4 thrombocytopenia (85%, 88%), neutropenia (81%, 71%), and anemia (62%, 80%), respectively. Fatalities related to myelosuppression occurred in 3% of patients in the safety population (N=163). Patients with neutropenia are at increased risk for infections, and should be monitored frequently and advised to contact a physician if they have symptoms of infection or fever.

Monitor complete blood counts weekly during induction and initial maintenance cycles and every two weeks during later maintenance cycles, as clinically indicated. In clinical trials myelosuppression was generally reversible and usually managed by delaying next cycle and/or reducing days of treatment with SYNRIBO

The following serious adverse reactions have been associated with SYNRIBO in clinical trials and are discussed in greater detail in other sections of the label.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Interactions

Interactions

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