Synribo (omacetaxine mepesuccinate)

Synribo can cause serious side effects including:

• Low blood counts.Low blood counts are common when using Synribo, including lowred blood cells、白细胞和血小板,可以be severe. If your white blood cell count becomes very low, you are at increased risk for infection which can lead to death. Your healthcare provider will check your blood counts regularly during treatment with Synribo. Tell your healthcare provider right away if you get any of the following symptoms:
  • fever
  • chills
  • body aches
  • feeling very tired
  • shortness of breath
  • bleeding (see below)
• Bleeding.Synribo causes severe low platelet counts that may increase your risk of severe bleeding. Severe low platelet counts can cause you to have bleeding in your brain that can lead to death, or severe stomach bleeding. Your healthcare provider will check your platelet counts regularly during treatment with Synribo. Tell your healthcare provider right away if you get any of the following symptoms:
  • unusual bleeding
  • easy bruising
  • blood in urineorstool
  • confusion
  • slurred speech
  • vision changes

The most common side effects of Synribo include:

• infections,
• diarrhea,
• nausea,
• tiredness,
• weakness,
• redness, swelling, orpainat injection site; and
• fever.

Tell your healthcare provider or get medical help right away if you getnausea,diarrhea, stomach (abdominal)pain, severe or worsening skinrash, oritchingthat does not go away.

You may havehair lossduring treatment with Synribo. Synribo may causefertilityproblems in males, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.

这些不是所有Synribo的副作用。

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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.

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 from therapy.

Dose Adjustments And Modifications

Hematologic Toxicity

• Synribo treatment cycles may be delayed and/or the number of days of dosing during the cycle reduced for hematologic toxicities (e.g.neutropenia,血小板减少症).
• Perform complete blood counts (CBCs) 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 4neutropenia(absolute neutrophil count(ANC) less than 0.5 x 10⁹/L) or Grade 3血小板减少症(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 andplatelet countis 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).

Non-Hematologic Toxicity

• Manage other clinically significant non-hematologic toxicity symptomatically. Interrupt and/or delay Synribo until toxicity is resolved.

• Based on its mechanism of action and findings from animal studies, Synribo can cause fetal harm when administered topregnantwomen.
• 没有可用数据Synribo use inpregnantwomen to evaluate for a drug-associated risk of majorbirth defects,miscarriageor adverse maternal or fetal outcomes.
• There are no data on the presence of omacetaxine mepesuccinate in either human or animal milk, the effects on thebreastfedchild, or the effects on milk production.
• Because of the potential for serious adverse reactions in the breastfed child, advise patients thatbreastfeedingis not recommended during treatment with Synribo, and for 2 weeks after the final dose.