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.

-
-

ANOTHER TREATMENT DIRECTION

Learn how SYNRIBO works against CML   

-

SYNCare IS HERE FOR YOU

Learn how SYNCare supports you through treatment   

General SYNCare Information

What is SYNCare?

SYNCare is a program that supports you during SYNRIBO treatment, once your doctor has decided that you or your caregiver can administer SYNRIBO at home. SYNCare arranges for SYNRIBO to be delivered directly to your door and provides educational and injection training materials to help you through the home administration process. SYNCare is also available to answer your questions through the 24/7 toll-free hotline (1-844-SYNCare [1-844-796-2273]). Reimbursement services provided by the specialty pharmacy partner are independent and separate from the SYNCare program.

What types of support and services does SYNCare provide?

SYNCare aims to support you during SYNRIBO home administration therapy from the moment the prescription is written through the completion of your treatment. This includes a range of services:

  • SYNRIBO is prepared by healthcare professionals at the specialty pharmacy and delivered to your door
  • Your shipment of SYNRIBO is tailored to your unique dose as directed by your doctor
  • Supplies necessary for proper injection, cleanup, and disposal of materials are delivered directly to your home
  • Educational materials about treatment and injection are provided to your doctor’s office to be shared with you and/or your caregiver

Reimbursement services provided by the specialty pharmacy partner are independent from the SYNCare program.

All services listed above are provided at no cost to you. More details on support and services can be found at SYNRIBO.com.

Why did Teva Oncology develop SYNCare?

SYNCare was developed to support the entire SYNRIBO home administration process, including preparation, distribution, and administration of SYNRIBO, with educational and training materials and a 24/7 toll-free support hotline. Reimbursement services provided by the specialty pharmacy partner are independent and separate from the SYNCare program. All services are provided at no cost to you.

How can I contact SYNCare?

SYNCare can easily be reached by calling the 24/7 toll-free hotline (1-844-SYNCare [1-844-796-2273]). Trained personnel are available to answer questions about the support program and home administration of SYNRIBO.

How do I enroll in SYNCare?

Your doctor will enroll you in the SYNCare program as part of the prescription process once he or she decides that you are an appropriate candidate for home administration. You will not need to do anything to enroll in SYNCare.

Do I have to be enrolled in SYNCare?

Once it is determined that you are an appropriate candidate for home administration, your doctor will enroll you in the SYNCare program to receive the related injection, cleanup, and disposal supplies. You will not be enrolled in SYNCare if your doctor decides you are not an appropriate candidate for home administration.

Now that home administration is available for SYNRIBO, who is responsible for preparing my medication?

SYNRIBO is prepared by a healthcare professional at the specialty pharmacy. Each dose is carefully mixed, drawn into a syringe, and delivered to your door.

Can the first dose of SYNRIBO be sent to my doctor so he/she can train me to inject?

At your and your doctor’s request, the SYNCare specialty pharmacy can arrange for the first dose to be delivered to your doctor’s office to enable your doctor or another healthcare professional at the office to teach you how to inject. The remainder of the first shipment will be delivered directly to your home. Do not inject until you have been trained by a healthcare professional.

Will I still be under my doctor’s care after enrolling in SYNCare?

Absolutely. SYNCare is not intended to replace your doctor’s expertise, but rather to assist you and your doctor during treatment. In working with the specialty pharmacy, SYNCare helps facilitate the care plan your doctor has created for you. SYNCare also provides a 24/7 support hotline to answer questions related to SYNRIBO home administration. However, as always, specific care questions are best answered by your doctor.

How will the SYNCare team interact with me?

SYNCare works with you in a number of ways:

  • Ensuring you are receiving the prescription and refills of SYNRIBO—as well as necessary injection, cleanup, and disposal supplies (a biohazard container)—on a timely basis
  • Facilitating disposal of injection waste when your biohazard container is full
  • Answering your questions and addressing your concerns. Trained personnel are available 24/7 through the toll-free hotline (1-844-SYNCare [1-844-796-2273])

Program Materials and Supplies

Will SYNCare provide materials to train me to inject?

SYNCare and Teva Oncology Account Specialists will provide your doctor with educational resources that can be used during injection training.

What materials will I receive from the SYNCare program?

Shipments from SYNCare will include:

  • SYNRIBO prepared syringes—you will receive shipments appropriate for your personal treatment schedule. These prepared syringes should be refrigerated until you are ready to use them
  • Supplies necessary for a safe injection such as alcohol swabs, gauze pads, protective eyewear and gloves, absorbent pads, and a biohazard container for proper disposal of used injection materials
  • Spill kit with all the materials necessary to safely clean up product spills or leaks
  • Medication Guide and Instructions for Use, a resource that answers questions you may have about SYNRIBO home administration and the injection process

In addition to these injection and cleanup materials, you will also have access to educational brochures, injection guides, and the SYNCare toll-free hotline (1-844-SYNCare [1-844-796-2273]). All of these materials and services are provided at no cost to you.

What if I run out of some of my supplies?

You can call the toll-free hotline (1-844-SYNCare [1-844-796-2273]) at any time if you need additional supplies shipped ahead of the planned schedule. Additional copies of the SYNRIBO Instructions for Use—or any educational brochures—can be requested at any time at no cost to you from the SYNCare toll-free hotline or downloaded from SYNRIBO.com.

Injection Questions

Can SYNCare-trained personnel talk me through the injection process again?

While it is the responsibility of your doctor to provide live training the first time, SYNCare will provide training support resources to you at no cost. Supporting materials are also available online at SYNRIBO.com. If you still have concerns or questions, the SYNCare toll-free hotline (1-844-SYNCare [1-844-796-2273]) is available 24/7 to help.

How should I store SYNRIBO?

SYNRIBO should be stored in a refrigerator at 36°F to 46°F (2°C to 8°C) in the syringes in which it was shipped and used within 6 days. If a SYNRIBO syringe is stored at room temperature, 68°F to 77°F (20°C to 25°C), use SYNRIBO within 12 hours.

When traveling, carry SYNRIBO as instructed by your healthcare provider. It is important to use ice packs or a cooler when traveling with SYNRIBO.

Keep SYNRIBO from coming into contact with food or drink, and keep SYNRIBO and all medicines out of the reach of children.

Can SYNCare email me or send me a hard copy of instructions on injection?

The detailed SYNRIBO Instructions for Use—which walks you step-by-step through the injection process—is available as a PDF download from SYNRIBO.com. An additional copy of the Medication Guide and Instructions for Use will be provided with each shipment.

Product Shipment Questions

What if a SYNRIBO delivery sits on my doorstep for several hours before it is opened? Is the product okay?

SYNRIBO will be shipped in a temperature-controlled storage container designed to keep it refrigerated for an extended period. That said, we recommend that delivered packages be signed for and opened, and that the prepared syringes be refrigerated immediately.

Acceptable storage conditions and use times for reconstituted SYNRIBO:

  • When stored in a refrigerator (2°C to 8°C [36°F to 46°F]), use within 6 days (144 hours)
  • When stored at room temperature (not to exceed 25°C [77°F]), use within 12 hours

What if I don’t receive a SYNRIBO shipment on schedule?

SYNRIBO shipments are scheduled to arrive before you use up all of the doses from the previous shipment. If a shipment were to be delayed, you should have enough doses still available to keep you on your treatment schedule.

SYNCare works with you to help make sure that each shipment arrives in a timely manner. If a shipment is delayed, you should call the SYNCare toll-free hotline (1-844-SYNCare [1-844-796-2273]) immediately. Trained personnel are available and can work to determine where the shipment is, why it is delayed, and when you should expect delivery if timing has changed. In the event that you are at risk of missing a dose due to an interruption in shipping, SYNCare will work with your doctor to find an expedient solution.

Will I know when my next shipment is coming?

SYNCare will work with you to schedule your shipments.

How many doses will I receive with my SYNRIBO shipment?

There is not a fixed number of doses in each shipment. SYNCare will ensure that each shipment contains the number of doses appropriate for you at that time based on a few key factors such as product stability and the scheduled prescribed treatment. You may receive multiple doses in each shipment, and the next shipment will be scheduled to arrive before the doses from the previous shipment have all been used.

What if a SYNRIBO prepared syringe appears damaged? Is the product okay?
Can I still use it?

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) immediately.

What if I just received a shipment of SYNRIBO and it appears to be a mistake?
What should I do?

If you receive a shipment of SYNRIBO that you believe is wrong, you should not use it. You should place the doses in the refrigerator and contact SYNCare at 1-844-SYNCare (1-844-796-2273) for further direction.

What if my SYNRIBO treatment is stopped? Should I return the doses I have to the specialty pharmacy?

If you stop SYNRIBO treatment, you should NOT send your unused SYNRIBO back to the specialty pharmacy. Once SYNRIBO is shipped, for safety reasons it cannot be returned for use by another patient. Remaining doses must be discarded in the biohazard container for proper disposal.

Payment Questions

What is the co-pay or coinsurance amount for a SYNRIBO prescription? How often do I need to pay this amount?

Co-pay and coinsurance costs for SYNRIBO will vary from patient to patient, payer to payer, and plan to plan. There are also many factors that influence how often (or long) one has to pay these costs, such as deductibles and cumulative annual out-of-pocket limits. While there is no simple answer that applies to all patients, the SYNCare support program will help you understand your coverage for SYNRIBO and how your individual policy affects your ongoing treatment.

Can I pay my co-pay or coinsurance with a credit card? Money order?
Personal check?

The specialty pharmacy that delivers SYNRIBO has a traditional billing system that allows you to pay for treatment the way you would with other providers or pharmacies, with the exception of cash. Payments are made online, over the phone, or through the mail. For this reason, cash is not accepted.

If I do not use some of the SYNRIBO, can I get a refund on all (or a portion) of the co-pay or coinsurance?

The co-pay and coinsurance policies are determined by patients’ individualized plans, but generally patients are not reimbursed for unused medications. Once SYNRIBO is reconstituted and dispensed, SYNCare and Teva Oncology cannot provide a refund or credit.

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.