SYNRIBO is a prescription medicine used to treat adults with chronic or accelerated phase chronic myeloid leukemia (CML) who are no longer responding to, and/or who could not tolerate, two or more tyrosine kinase inhibitors (TKI). Learn about Important Safety Information including Warnings and Precautions regarding Low Blood Counts, Bleeding, High Blood Sugar Levels, and Harm to an Unborn Baby.

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Accelerated phase CML: The accelerated phase is the second phase of CML. The disease is more aggressive, with the marrow or peripheral blood made up of a high number (10­–20%) of immature cells and white blood cells. Symptoms are also more apparent in this phase.

BCR-ABL1: Short for breakpoint cluster region-Abelson. BCR-ABL1 is created when chromosomes 9 and 22 break off and switch places. The changed chromosome 22, which carries the BCR-ABL1 oncogene, is called the Philadelphia (Ph) chromosome.

Chronic phase CML: The chronic phase is the first phase of CML. The symptoms are usually mild or minimal compared to later phases. Examples include feeling unusually tired and a feeling of fullness near the belly. Patients in chronic phase generally respond better to treatment than those in later phases.

Hematologic response: A return of blood cells to normal levels and a decrease of blast cells and other immature cells in peripheral blood.

Intolerance: Intolerance is when the side effects of a medication are so challenging that they become hard to tolerate. Sometimes treatment is stopped as a result of intolerance.

MaHR: A major hematologic response means that blood cells returned to normal levels (a decrease in high counts of undeveloped cells, platelets, and white blood cells). In SYNRIBO clinical studies, major hematologic responses were either a complete hematologic response or no evidence of leukemia.

MCyR: A major cytogenetic response is a decrease in the number of cells with the CML chromosome to less than 36%.

Myelosuppression: A decrease in bone marrow activity, resulting in lower blood counts, and sometimes resulting from cancer treatment.

Ph: Ph is short for the Philadelphia chromosome. It is also known as the CML chromosome. This hallmark of CML is represented by an abnormality of chromosome 22 in which part of chromosome 9 is transferred to it.

Resistance: Resistance is when treatment does not produce an initial response or when a response is reached, but then is lost as treatment continues. This can happen in the first year of treatment or after several years. It may be caused by many factors, such as:

  • Changes to the CML gene (BCR-ABL1) known as mutations
  • Not taking medicine as prescribed
  • Genetic changes
  • CML cells that don't respond to treatment

While SYNRIBO was studied in patients with resistance, the effectiveness of SYNRIBO was not evaluated at the level of underlying causes of resistance.

Important Safety Information

Warnings and Precautions

Low Blood Counts: SYNRIBO is associated with low blood counts (myelosuppression) that can lead to tiredness, bleeding, or increased risk of infection. Your doctor will regularly check (weekly or every 2 weeks) your blood counts throughout treatment. Low blood counts were usually managed in clinical studies by delaying the next cycle and/or reducing days of treatment. Complications from low blood counts can be severe and/or fatal. Call your doctor immediately if you experience fever, aches, chills, nausea, vomiting, significant tiredness, shortness of breath, or bleeding.

Bleeding: Serious bleeding can occur. Low platelet counts (thrombocytopenia) can lead to bleeding in the brain or severe stomach bleeding, which can sometimes be fatal. Your doctor will regularly check (weekly or every 2 weeks) your blood counts, including platelets, throughout treatment. Call your doctor immediately if you see signs of internal bleeding (unusual bleeding, easy bruising, or blood in urine or stool; confusion, slurred speech, or altered vision).

High Blood Sugar Levels: SYNRIBO can cause high blood sugar levels (hyperglycemia). If you have diabetes or are at risk for diabetes, your doctor will check your blood sugar levels often during treatment.

Harm to an Unborn Baby: Fetal harm can occur in pregnant women. If you are pregnant or plan to become pregnant, please speak with your doctor before starting treatment.

Related Side Effects

Serious side effects (occurring in 5% or more of studied patients) in chronic and accelerated phase CML:

  • Inability to produce certain types of blood cells (bone marrow failure)
  • Low platelet count (thrombocytopenia)
  • Low white blood cell count with a fever (febrile neutropenia)
  • Low red blood cell count (anemia) which can leave you easily tired*
  • Diarrhea*
  • Infections

*Affected 5% or more of accelerated phase patients; affected less than 5% of chronic phase patients.

The most common side effects (occurring in 20% or more of studied patients) in chronic and accelerated phase CML:

  • Decreased blood counts (thrombocytopenia, anemia, neutropenia, or lymphopenia)
  • Diarrhea
  • Nausea
  • Tiredness
  • Weakness
  • Redness, swelling, or pain at injection site
  • Fever
  • Infections

Indication

SYNRIBO® (omacetaxine mepesuccinate) for injection, for subcutaneous use, is a prescription medicine used to treat adults with chronic or accelerated phase chronic myeloid leukemia (CML) who are no longer responding to, and/or who could not tolerate, two or more tyrosine kinase inhibitors (TKI).

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, call 1-800-FDA-1088, or fax to 1-800-FDA-0178.
For more information about SYNRIBO, ask your doctor or call 1-800-896-5855.
This information does not take the place of talking with your doctor for medical advice about your condition or treatment.