SYNRIBO- omacetaxine mepesuccinate injection, powder, lyophilized, for solution 
Cephalon, Inc.

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MEDICATION GUIDE

SYNRIBO® (sin-RYE-bo)
(omacetaxine mepesuccinate)
for injection, for subcutaneous use

Read this Medication Guide before you start using SYNRIBO and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

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:

 
  • fever
 
  • feeling very tired
 
  • chills
 
  • shortness of breath
 
  • body aches
 
  • 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 or severe stomach bleeding, that can lead to death. 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
 
  • confusion
 
  • easy bruising
 
  • slurred speech
 
  • blood in urine or stool
 
  • 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 (leukemia) called chronic myeloid leukemia (CML):

It is not known if SYNRIBO is safe and effective in children.

What should I tell my healthcare provider before using SYNRIBO?

Before using SYNRIBO, tell your healthcare provider if you:

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?

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:

The most common side effects of SYNRIBO are:

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the side effects of SYNRIBO. For more information, ask your healthcare provider or pharmacist.

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?

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.

If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about SYNRIBO that is written for health professionals.

For more information, go to www.synribo.com or call Teva at 1-800-896-5855.

What are the ingredients in SYNRIBO?

Active ingredient: omacetaxine mepesuccinate

Inactive ingredients: mannitol

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Distributed by:

Teva logo

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454

SYNMG-001

Issued: April 2014

Revised: 1/2019
Cephalon, Inc.