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).
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*
*Affected 5% or more of accelerated phase patients; affected less than 5% of chronic
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)
- Redness, swelling, or pain at injection site
You are encouraged to report side effects of prescription drugs to the FDA. Visit
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.