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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SYNCare IS HERE FOR YOU

Learn about SYNCare services available to support your treatment experience   

SYNRIBO is given as a subcutaneous (under the skin) injection twice daily, about every 12 hours, with no limits on food. There are 2 options for receiving treatment: home administration or administration by your doctor. You and your doctor will decide which option is best for you.

Home administration

If your doctor decides that you or a caregiver can inject SYNRIBO, they will explain how to prepare for and perform an injection before you use it for the first time. This will include instruction on how to properly handle, store, and inject SYNRIBO, dispose of used supplies, and clean up any spilled SYNRIBO. Do not attempt to self-inject SYNRIBO before being trained by your doctor or nurse.

Your doctor will help you enroll in the SYNCare support program, which will arrange delivery of SYNRIBO syringes that are prepared by a healthcare professional and ready to inject. You will also receive other supplies that you will need to inject SYNRIBO, including protective eyewear, gloves, a biohazard container, absorbent pads, alcohol swabs, and gauze pads.

The SYNCare support program is available to assist with questions about SYNRIBO home administration.

Be sure to read the Medication Guide and Instructions for Use that come with your SYNRIBO prescription. They contain important information about the risks of SYNRIBO, and detailed instructions on how to administer injections.

Administration by your doctor

If home administration is not an option for you, you will need to have your doctor administer your treatment. During the dosing period of each treatment cycle, you will need to visit your doctor’s office twice daily (approximately every 12 hours) to receive your injections.

Treatment schedule

The initial schedule is followed every 28 days until you achieve a hematologic response (a decrease in high counts of undeveloped cells, platelets, and white blood cells). You then move to the maintenance schedule.

The maintenance schedule is followed every 28 days as long as you continue to benefit from
treatment. Your doctor will check your response to treatment regularly. Your blood counts will be checked weekly, then every 2 weeks at your doctor’s discretion. The dose of SYNRIBO may be changed by your doctor to help address side effects.

Hematologic response means a decrease in high blood counts of undeveloped cells, platelets, and white blood cells.

Check out the SYNCare Support Program >

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.