us.
Infection can also happen with normal white blood cells counts.
Tell your doctor right away if you have any of these symptoms: fever, cough, flu-like symptoms, burning on urination, muscle aches, or worsening of skin problems.
Changes in the electrical activity of your heart seen on ECG (electrocardiogram). Your doctor may check your ECG as needed for this problem. Tell your doctor if your feel an abnormal heart beat, chest pain or shortness of breath.
Common side effects of ISTODAX include:
nausea, vomiting, diarrhea, and loss of appetite.
tiredness
Tell your doctor if you have any side effect that bothers you or does not go away.
These are not all the possible side effects of ISTODAX. For more information, ask your doctor or pharmacist.
Ask your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Generalinformation about ISTODAX
Medicines are sometimes prescribed for purposes other than those listed in patient information leaflets.
This patient information leaflet summarizes the most important information about ISTODAX. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about ISTODAX that is written for health professionals. For more information, go to www.ISTODAX.com or call 1-888-423-5436.
What are the ingredients in ISTODAX?
Active ingredient: romidepsin
Inactive ingredients: povidone. The diluent contains 80% propylene glycol and 20% dehydrated alcohol.
Manufactured for:
Celgene Corporation
Summit, NJ 07901
ISTODAX® is a registered trademark of Astellas Pharma, Inc.
U.S. Patents: 4,977,138; 7,608,280; 7,611,724
ISTBVPPI.001 03/10
PRINCIPAL DISPLAY PANEL - Kit Carton
NDC 59572-983-01
ISTODAX® Kit
(romidepsin)
for
injection
10 mg
per single-use vial
Rx Only
Reconstitution and dilution required.
After reconstitution with 2 mL of supplied Diluent,
the concentration of ISTODAX® is 5 mg/mL.
Discard unused portion.
Each kit contains:
–
One single-use vial with 10 mg of ISTODAX®
–
One single-use vial with 2 mL of Diluent
For Intravenous Use Only
PRINCIPAL DISPLAY PANEL - Istodax - 10 mg Vial Label
PRINCIPAL DISPLAY PANEL - Sterile Diluent - 2 mL Vial Label
ISTODAX
romidepsin kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 59572-983
Packaging
NDC Package Description Multilevel Packaging
1 59572-983-01 1 KIT In 1 CARTON None
QUANTITY OF PARTS
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, GLASS 2 mL
Part 2 1 VIAL, GLASS 2 mL
Part 1 of 2
ISTODAX
romidepsin injection, powder, lyophilized, for solution
Product Information
NDC Product Code (Source) 59572-961
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
romidepsin (romidepsin) romidepsin 10 mg in 2 mL
Inactive Ingredients
Ingredient Name Strength
povidone
Product Characteristics
Color Score
Shape Size
Flavor Imprint C
