"The U.S. Food and Drug Administration today approved Gazyva (obinutuzumab) for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia (CLL).
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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).
DOSAGE AND ADMINISTRATION
The recommended starting schedule for induction is 1.25 mg/m²administered 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/m²administered 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
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 (36°F to 46°F). Protect reconstituted solution from light. After administration, any unused solution should be discarded properly1.
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.
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).
Storage And Handling
Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F). Until use, keep product in carton to protect from light. Omacetaxine mepesuccinate is an antineoplastic product. Follow special handling and disposal procedures1.
1. OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html.
Distributed by: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454. Revised: February 2014.
Last reviewed on RxList: 2/20/2014
This monograph has been modified to include the generic and brand name in many instances.
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