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 Description

SYNRIBO contains the active ingredient omexetine mesylate succinate, a type of ceftazidoxime. It is a protein synthesis inhibitor. Omascitabine syringate is prepared through a semi-synthetic process of ceftazidine, which is an extract of the leaves of the genus Ceftazid. The chemical name of omestatin mesylate succinate is ceftacine, 4-methyl butyrate (2R)-hydroxy-2-(4-hydroxy-4-methylpentyl).

Oxcarbetine mesylate succinate has the following chemical structure:

SYNRIBO® (Omexitine mesylate succinate) structure diagram

The molecular formula is C29H39NO9 and the molecular weight is 545.6 g/mol. SYNRIBO for injection is a single-use sterile, preservative-free, white to off-white freeze-dried powder. Each vial contains 3.5 mg omecetine mesylate succinate and mannitol. SYNRIBO is intended to be reconstituted with 1.0 mL of 0.9% Sodium Chloride Injection (USP) for subcutaneous administration. The pH of the reconstituted solution is between 5.5 and 7.0.

Indications and dosage

Indications

SYNRIBO is suitable for the treatment of adult patients with chronic or accelerated chronic myeloid leukemia (CML) who are resistant and/or intolerant to two or more tyrosine kinase inhibitors (TKI).

Dosage and administration

Entry timetable

The recommended induction timetable is 28 days a day, 28 consecutive days every 14 days for about 14 consecutive days, about 12 hours a day, two subcutaneous injections at a dose of 1.25 mg/m². The cycle should be repeated every 28 days until the patient reaches a hematological response.

Maintenance dose

The recommended maintenance schedule is 28 days a day, every 28 days for 7 consecutive days with approximately 12 hour intervals for subcutaneous injections of 1.25 mg/m² twice a day. As long as the patient can benefit from the treatment clinically, treatment should be continued.

Dose adjustment and modification

Blood toxicity

Due to hematological toxicity (eg, neutropenia, thrombocytopenia), the SYNRIBO treatment cycle may be delayed and/or reduce the number of days of administration in the cycle [see Warnings and Precautions].

Perform a complete blood count (CBC) once a week during the induction and initial maintenance cycle. After the initial maintenance cycle, monitor CBC every two weeks or according to clinical instructions. If the patient experiences grade 4 neutropenia (absolute neutrophil count (ANC) less than 0.5 x 109/L) or grade 3 thrombocytopenia (platelet count less than 50 x 109/L) in one cycle, please Delay the start of the next cycle until the ANC becomes greater than or equal to 1.0 x 109 / L and the platelet count is greater than or equal to 50 x 109 / L. Likewise, for the next cycle, reduce the number of dosing days by 2 days (for example, to 12 or 5 days).

Non-hematological toxicity

Symptomatic treatment of other clinically significant non-hematological toxicities. Interrupt and/or delay SYNRIBO until the toxicity disappears.

Reorganization instructions and handling precautions

SYNRIBO should be prepared in a medical institution and must be reorganized by medical professionals.

Before subcutaneous injection, SYNRIBO was reconstituted with 1 mL of 0.9% Sodium Chloride Injection USP. After adding the diluent, swirl gently until a clear solution is obtained. The lyophilized powder should be completely dissolved in less than one minute. The resulting solution is clear and colorless and contains 3.5 mg/mL SYNRIBO. When the solution and container permit, the parenteral drug should be visually inspected for particulate matter and discoloration before administration.

SYNRIBO does not contain antibacterial preservatives. Therefore, care must be taken to ensure that the injection solution is not contaminated during the preparation process.

SYNRIBO is a cytotoxic drug. Please follow special handling and disposal procedures1. When operating and managing the product, please wear protective glasses and gloves. Proper aseptic technique should be used. Avoid contact with skin and eyes. If SYNRIBO contacts the skin, immediately wash the affected area thoroughly with soap and water. If eye contact occurs, flush eyes thoroughly with water.

Storage conditions and storage time after syringe preparation

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