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
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 (TKIs). SYNRIBO
was approved by the FDA based on the percent of patients responding to treatment
(response rate) in clinical studies. There are no studies confirming an improvement
in disease-related symptoms or increased survival with SYNRIBO.
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.
Serious side effects (occurring in 5% or more of studied patients) in chronic and
accelerated phase CML:
*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:
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