Country: Canada
Language: English
Source: Health Canada
DEGARELIX (DEGARELIX ACETATE)
FERRING INC
L02BX02
DEGARELIX
80MG
POWDER FOR SOLUTION
DEGARELIX (DEGARELIX ACETATE) 80MG
SUBCUTANEOUS
80MG
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0152667001; AHFS:
APPROVED
2009-11-16
_Pr_ _FIRMAGON_ _®_ _ _ _Page 1 of 46 _ PRODUCT MONOGRAPH Pr FIRMAGON ® Degarelix for Injection 120 mg degarelix (as degarelix acetate) per vial 80 mg degarelix (as degarelix acetate) per vial Gonadotropin-Releasing Hormone Receptor Antagonist Ferring Pharmaceuticals 200 Yorkland Blvd., Suite 500 North York, Ontario M2J 5C1 DATE OF REVISION: March 18, 2016 SUBMISSION CONTROL NO: 180927 _Pr_ _FIRMAGON_ _®_ _ _ _Page 2 of 46 _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS ..................................................................................4 ADVERSE REACTIONS ....................................................................................................8 DRUG INTERACTIONS ..................................................................................................11 DOSAGE AND ADMINISTRATION ..............................................................................12 OVERDOSAGE ................................................................................................................26 ACTION AND CLINICAL PHARMACOLOGY ............................................................26 STORAGE AND STABILITY ..........................................................................................30 SPECIAL HANDLING INSTRUCTIONS .......................................................................30 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................30 PART II: SCIENTIFIC INFORMATION ...............................................................................31 PHARMACEUTICAL INFORMATION ............................................ Read the complete document