Generic name: omacetaxine mepesuccinate
Dosage form: injection, powder, lyophilized, for solution
This dosage information does not include all the information needed to use Synribo safely and effectively. See full prescribing information for Synribo.
The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.
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.
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.
Dose Adjustments and Modifications
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 (ANC) less than 0.5 x 109/L) or Grade 3 thrombocytopenia (platelet counts less than 50 x 109/L) during a cycle, delay starting the next cycle until ANC is greater than or equal to 1.0 x 109/L and platelet count is greater than or equal to 50 x 109/L. Also, for the next cycle, reduce the number of dosing days by 2 days (e.g. to 12 or 5 days).
Manage other clinically significant non-hematologic toxicity symptomatically. Interrupt and/or delay SYNRIBO until toxicity is resolved.
Preparation and Administration Precautions
SYNRIBO should be prepared in a healthcare facility and administered by a healthcare professional. Omacetaxine mepesuccinate is an antineoplastic product. Follow special handling and disposal procedures.
Reconstitute SYNRIBO with one mL of 0.9% Sodium Chloride Injection, USP, prior to subcutaneous injection. After addition of the diluent, gently swirl until a clear solution is obtained. The lyophilized powder should be completely dissolved in less than one minute. The resulting solution will contain 3.5 mg/mL SYNRIBO.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Avoid contact with the skin. If SYNRIBO comes into contact with skin, immediately and thoroughly wash affected area with soap and water.
Use SYNRIBO within 12 hours of reconstitution when stored at room temperature and within 24 hours of reconstitution if stored at 2°C to 8 °C (36oF to 46oF). Protect reconstituted solution from light. After administration, any unused solution should be discarded properly1.