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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ANOTHER TREATMENT DIRECTION

Learn how SYNRIBO works against CML   

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SYNCare IS HERE FOR YOU

Learn how SYNCare supports you through treatment   

What are some things I should tell my doctor before I take SYNRIBO?

Tell your doctor:

  • If you have diabetes. Your doctor may have to make adjustments to treatment based on this information
  • If you are planning to become pregnant or are nursing a child
  • About all the prescription and over-the-counter medications you use

How often should I receive treatment?

  • Initially, you should receive 1.25 mg/m2 of SYNRIBO twice daily (at about 12 hours apart) for 14 days of each 28-day cycle until you achieve a hematologic response
  • After reaching hematologic response (high counts of undeveloped cells, platelets, and white blood cells decrease to normal levels), you should receive SYNRIBO twice daily for 7 days of each 28-day cycle
  • You should continue your 28-day cycles of SYNRIBO as long as you continue to benefit from this therapy
  • The dose of SYNRIBO may be adjusted by your doctor to help address side effects

I don’t know how to perform an injection on myself. Can I still receive SYNRIBO?

Don’t worry, your doctor or nurse will give you a training session before you even begin treatment with SYNRIBO. You will also receive educational materials, like a guide that walks you step-by-step through the injection process, so you can refer to it then go at your own pace until you’re feeling more comfortable with the process. If you have any questions or concerns about your injection, call SYNCare at 1-844-SYNCare.

Each prescription of SYNRIBO comes with a Medication Guide and Instructions for Use that will walk you through the injection steps, as well as other important information about taking SYNRIBO.

What else do I need to inject SYNRIBO?

All the supplies necessary for injection are shipped with your SYNRIBO at no cost to you, including protective eyewear and gloves, gauze pads, absorbent pads, alcohol wipes, an injection waste container specifically for chemotherapy like SYNRIBO, and a spill kit. The spill kit is only in case your SYNRIBO leaks or spills from its syringe. It has all the tools to safely clean up and dispose of a SYNRIBO spill. Supplies are included with each shipment.

How do I store SYNRIBO?

Once your shipment arrives, open the box and separate SYNRIBO cartons from the other injection supplies. SYNRIBO cartons should be stored in a refrigerator until ready to use. When kept refrigerated (2°C to 8°C [36°F to 46°F]), SYNRIBO will remain usable for 6 days. When SYNRIBO is left at room temperature (20°C to 25°C [68°F to 77°F]), it will remain usable for 12 hours.

What if my SYNRIBO is damaged or unusable?

If a SYNRIBO syringe shows any damage, you should put it inside the biohazard container and contact SYNCare at 1-844-SYNCare (1-844-796-2273) for further direction.

How will I know if treatment is working?

Your doctor will regularly check your response to SYNRIBO treatment.

Why don’t I receive treatment every day?

The recommended dosing schedules, which include days off treatment, are the same schedules used in clinical studies.

What if I miss an injection?

If you miss a dose of SYNRIBO, just skip the missed dose. Give your next injection of SYNRIBO at your next scheduled time. Do not give two doses of SYNRIBO at the same time to make up for a missed dose.

What are the most common side effects?

  • Decreased blood counts. Symptoms include: unexplained bleeding or bruising, blood in urine or stool, unexplained weakness, fever, and infection
  • High blood sugar levels (hyperglycemia). If you are diabetic or at risk for diabetes, your doctor will check these levels throughout treatment
  • Diarrhea
  • Nausea
  • Tiredness
  • Weakness
  • Redness, swelling, or pain at injection site
  • Fever
  • Infections

See the answers to SYNCare FAQs >

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.