Advise patients of the possibility of serious bleeding due to low platelet counts. Instruct patients to report immediately any signs or symptoms suggestive of hemorrhage (unusual bleeding, easy bruising or blood in urine or stool; confusion, slurred speech, or altered vision).
• Myelosuppression

Advise patients of the likelihood that SYNRIBO will cause a decrease in white blood cells, platelets, and red blood cells and that monitoring of these parameters will be needed. Instruct patients to contact a health care professional if they develop a fever, or other signs/symptoms of infection; shortness of breath, significant fatigue, or bleeding.
• Hyperglycemia

Advise patients with diabetes of the possibility of hyperglycemia and the need for careful monitoring of blood glucose levels. Patients with poorly controlled diabetes mellitus should not be treated with omacetaxine mepesuccinate until good glycemic control has been established.
• Pregnancy and Nursing

Advise patients that omacetaxine mepesuccinate can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential hazard to the fetus and to avoid becoming pregnant. Advise females to avoid nursing while receiving SYNRIBO.
• Gastrointestinal Complaints

Advise patients that they may experience nausea, diarrhea, abdominal pain, constipation, and vomiting. If these symptoms persist, they should seek medical attention.
• Fatigue

Advise patients that SYNRIBO may cause tiredness and to avoid driving any vehicle or operating any dangerous tools or machinery if they experience this side effect.
• Rash

Advise patients that they may experience skin rash. Advise patients to immediately report severe or worsening rash or itching.
• Alopecia

Advise patients that they may experience hair loss.
 
SYN-001
 
Distributed by:

Teva Pharmaceuticals USA, Inc.
 
North Wales, PA 19454
 
LABEL FOR OMACETAXINE MEPESUCCINATE NDC 63459-177-14

CARTON FOR OMACETAXINE MEPESUCCINATE NDC 63459-177-14

SYNRIBO
omacetaxine mepesuccinate injection, powder, lyophilized, for solution

Product Information

Product Type

HUMAN PRESCRIPTION DRUG

Item Code (Source)

NDC:63459-177

Route of Administration

SUBCUTANEOUS

DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Strength

OMACETAXINE MEPESUCCINATE (OMACETAXINE)

OMACETAXINE MEPESUCCINATE

3.5 mg  in 1 mL

Inactive Ingredients
 
Ingredient Name

Strength
 

MANNITOL

Product Characteristics

Color
  

Score

Shape

Size

Flavor

Imprint Code

Contains

Packaging

Item Code

Package Description

Multilevel Packaging

1

NDC:63459-177-14

1 VIAL, SINGLE-USE in 1 CARTON

contains a VIAL, SINGLE-USE

1

1 mL in 1 VIAL, SINGLE-USE

This package is contained within the CARTON (63459-177-14)
 
Marketing Information

Marketing Category

Application Number or Monograph Citation

Marketing Start Date

Marketing End Date

NDA

NDA203585

10/26/2012

Labeler - Cephalon, Inc. (183236314)

Establishment