ytopenia) • diarrhea • decreased strength and tiredness • lower respiratory tract infection • nausea
These are not all of the possible side effects of ALIQOPA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of ALIQOPA
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your healthcare provider or pharmacist for information about ALIQOPA that is written for health professionals.
What are the ingredients in ALIQOPA?
Active ingredient: copanlisib
Inactive ingredients: citric acid anhydrous, mannitol, sodium hydroxide
Manufactured in Germany
Manufactured for: Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981 USA
© 2017 Bayer HealthCare Pharmaceuticals Inc.
For more information, go to www.aliqopa.com or call 1-888-842-2937.
This Patient Information has been approved by the U.S. Food and Drug Administration Issued: September 2017
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC 50419-385-01
Rx only
Aliqopa (copanlisib)
60 mg*
*Equivalent to 69.1 mg copanlisib dihydrochloride
For intravenous infusion only.
Must be reconstituted and diluted.
Single dose vial - discard unused portion
Aliqopa Carton
INGREDIENTS AND APPEARANCE
ALIQOPA
copanlisib injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50419-385
Route of Administration INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
COPANLISIB (UNII: WI6V529FZ9) (COPANLISIB - UNII:WI6V529FZ9) COPANLISIB 15 mg in 1 mL
Inactive Ingredients
Ingredient Name
Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
MANNITOL (UNII: 3OWL53L36A)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
#
Item Code
Package Description
Marketing Start Date
Marketing End Date
1NDC:50419-385-01 1 in 1 CARTON 09/14/2017
1 4 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
NDA NDA209936 09/14/2017
Labeler - Bayer HealthCare Pharmaceuticals Inc. (005436809)
