for injection, for subcutaneous use
What is the most important information I should know about SYNRIBO?
SYNRIBO can cause serious side effects including:
Low blood counts. Low blood counts are common when using SYNRIBO, including low red blood cells, white blood cells, and platelets, and can be severe. If your white blood cell count becomes very low, you are at increased risk for infection which can lead to death. Your healthcare provider will check your blood counts regularly during treatment with SYNRIBO. Tell your healthcare provider right away if you get any of the following symptoms:
- body aches
- feeling very tired
- shortness of breath
- bleeding (see below)
Bleeding. SYNRIBO causes severe low platelet counts that may increase your risk of severe bleeding. Severe low platelet counts can cause you to have bleeding in your brain that can lead to death, or severe stomach bleeding. Your healthcare provider will check your platelet counts regularly during treatment with SYNRIBO. Tell your healthcare provider right away if you get any of the following symptoms:
- unusual bleeding
- easy bruising
- blood in urine or stool
- slurred speech
- vision changes
See “What are the possible side effects of SYNRIBO?” for more information about side effects.
What is SYNRIBO?
SYNRIBO is a prescription medicine used to treat adults with a type of blood cancer called chronic myeloid leukemia (CML):
- that is in the chronic phase or accelerated phase, and
- who have not responded to (resistant) or cannot tolerate 2 or more medicines called tyrosine kinase inhibitors.
It is not known if SYNRIBO is safe and effective in children.
Before using SYNRIBO, tell your healthcare provider about all of your medical conditions, including if you:
- have diabetes or a family history of diabetes
- have bleeding problems
- plan to have any dental or surgical procedures
- are pregnant or plan to become pregnant. SYNRIBO can harm your unborn baby. You should not become pregnant during treatment with SYNRIBO. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with SYNRIBO.
Females who are able to become pregnant:
- Your healthcare provider may give you a pregnancy test before you start treatment with SYNRIBO.
- You should use effective birth control (contraception) during treatment with SYNRIBO and for 6 months after the final dose.
Males with female partners who are able to become pregnant should use effective birth control during treatment with SYNRIBO and for 3 months after the final dose.
- are breastfeeding or plan to breastfeed. It is not known if SYNRIBO passes into your breast milk. Do not breastfeed during treatment with SYNRIBO and for 2 weeks after the final dose.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I use SYNRIBO?
Follow the detailed Instructions for Use at the end of this Medication Guide for information about the right way to:
properly handle and inject SYNRIBO
dispose of used supplies for injecting SYNRIBO
clean up any spilled SYNRIBO
- Your healthcare provider will tell you how much SYNRIBO to inject and the timing of when to inject it. Inject SYNRIBO exactly as prescribed.
- Do not change your dose or the timing of when you inject SYNRIBO, unless your healthcare provider tells you to.
- SYNRIBO is given as an injection under the skin (subcutaneous injection) of your thigh or stomach-area (abdomen). The injection can be given in the back of the arm if a caregiver is giving the injection.
- If your healthcare provider decides that you or a caregiver can inject SYNRIBO, your healthcare provider will show you or your caregiver how to prepare for an injection and how to inject SYNRIBO before you use it for the first time.
- Inject SYNRIBO 2 times each day, about every 12 hours.
- Your healthcare provider may tell you to stop using SYNRIBO for a period of time, or tell you to use SYNRIBO less often if you get certain side effects.
- Your healthcare provider will arrange for you to receive syringes filled with SYNRIBO that are ready to inject, along with the other supplies that you will need to inject SYNRIBO. Each syringe contains 1 dose of SYNRIBO as prescribed by your healthcare provider.
- Follow your healthcare provider’s instructions for how to carry (transport) SYNRIBO using ice packs or a cooler.
- Do not eat or drink while handling SYNRIBO.
- Inject SYNRIBO in a place away from children and pregnant women.
- You or your caregiver should wear gloves and protective eyewear, for example protective eyeglasses (not regular eyeglasses) or face shield when handling SYNRIBO and while giving your injection.
- If you or your caregiver get SYNRIBO on your skin, wash the area with soap and water and call your healthcare provider right away.
- If you or your caregiver get SYNRIBO in your eyes, flush your eyes with water and call your healthcare provider right away.
- 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 2 doses of SYNRIBO at the same time to make up for a missed dose.
- If you inject too much SYNRIBO, call your healthcare provider or go to the nearest emergency room right away. Follow your healthcare provider’s instructions for when you should inject your next dose of SYNRIBO.
- If someone other than the patient is injected with SYNRIBO, or if anyone accidentally swallows SYNRIBO, call your healthcare provider or get emergency help right away.
What should I avoid while using SYNRIBO?
SYNRIBO may cause tiredness. Avoid driving or operating dangerous tools or machinery if you develop tiredness when using SYNRIBO.
What are the possible side effects of SYNRIBO?
SYNRIBO may cause serious side effects, including:
- See “What is the most important information I should know about SYNRIBO?”
High blood sugar levels (hyperglycemia). If you have diabetes or are at risk for diabetes, your healthcare provider will check your blood sugar levels often during treatment with SYNRIBO. If you have diabetes or if your blood sugar is not well controlled, your healthcare provider may decide not to start treatment with SYNRIBO until your diabetes is under control first.
The most common side effects of SYNRIBO include:
- infections. See the information about low blood cell counts in the section “What is the most important information I should know about SYNRIBO?”
- redness, swelling, or pain at injection site
Tell your healthcare provider or get medical help right away if you get nausea, diarrhea, stomach (abdominal) pain, severe or worsening skin rash, or itching that does not go away.
You may have hair loss during treatment with SYNRIBO.
SYNRIBO may cause fertility problems in males, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.
These are not all of the side effects of SYNRIBO.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store SYNRIBO?
- Carry (transport) SYNRIBO as instructed by your healthcare provider. It is important to use ice packs or a cooler.
- When stored in a refrigerator 36°F to 46°F (2°C to 8°C), use SYNRIBO within 6 days from when it was mixed.
- When stored at room temperature, 68°F to 77°F (20°C to 25°C), use SYNRIBO within 12 hours from when it was mixed.
- When stored in a refrigerator, keep SYNRIBO from coming into contact with food or drink.
Keep SYNRIBO and all medicines out of the reach of children.
General information about the safe and effective use of SYNRIBO.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SYNRIBO for a condition for which it was not prescribed. Do not give SYNRIBO to other people even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about SYNRIBO that is written for health professionals.
What are the ingredients in SYNRIBO?
Active ingredient: omacetaxine mepesuccinate
Inactive ingredients: hydrochloric acid, mannitol, sodium bicarbonate
Distributed by: Teva Pharmaceuticals USA, Inc.
Parsippany, NJ 07054
For more information, go to www.synribo.com or call Teva Pharmaceuticals at 1-888-483-8279.