See How SYNRIBO Works
SYNRIBO Effectiveness
Questions About SYNRIBO

Discover how SYNRIBO, a protein
synthesis inhibitor, works against CML

Learn more about SYNRIBO clinical study results

See the safety profile of SYNRIBO to learn about
side effects associated with treatment

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, or who could not tolerate, two or more tyrosine kinase inhibitors (TKI).

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
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.