FIRMAGON® (degarelix for injection) -------------WARNINGS AND PRECAUTIONS-----------------­ HIGHLIGHTS OF PRESCRIBING INFORMATION • Hypersensitivity: Anaphylaxis, urticaria and angioedema These highlights do not include all the information needed to have been reported. Discontinue Firmagon if a serious use FIRMAGON® (degarelix for injection) safely and hypersensitivity reaction occurs, and manage as clinically effectively. See full prescribing information for indicated. (5.2) FIRMAGON. • Effect on QT/QTc Interval: Androgen deprivation therapy FIRMAGON® (degarelix for injection) for subcutaneous may prolong the QT interval. Consider risks and benefits. administration (5.3) Initial U.S. Approval: 2008 ----------------------ADVERSE REACTIONS----------------------­ ---------------------RECENT MAJOR CHANGES-----------------­ The most commonly observed adverse reactions (≥10%) during Warnings and Precautions, (5.3) 02/2015 FIRMAGON therapy included injection site reactions (e.g., pain, erythema, swelling or induration), hot flashes, increased weight, -----------------------INDICATIONS AND USAGE----------------­ and increases in serum levels of transaminases and gamma­ FIRMAGON is a GnRH receptor antagonist indicated for glutamyltransferase (GGT). (6) treatment of patients with advanced prostate cancer. (1) To report SUSPECTED ADVERSE REACTIONS, contact ------------DOSAGE AND ADMINISTRATION----------------­ Ferring at 1-888-FERRING (1-888-337-7464) or FDA at 1­ • FIRMAGON is for subcutaneous administration only. 800-FDA-1088 or www.fda.gov/medwatch. • Treatment is started with a dose of 240 mg given as two -----------------------DRUG INTERACTIONS---------------------­ injections of 120 mg each. Clinically significant CYP450 pharmacokinetic drug-drug • The starting dose is followed by maintenance doses of interactions are unlikely. (7) 80 mg administered as a single injection every 28 days. (2) -----------------------USE IN SPECIFIC POPULATIONS-------------­ --------------DOSAGE FORMS AND STRENGTHS-------------­ There is no need to adjust the dose for the elderly or in patients • FIRMAGON (degarelix for injection) 120 mg per vial with mild or moderate liver or kidney function impairment. • FIRMAGON (degarelix for injection) 80 mg per vial Patients with severe liver or kidney dysfunction have not been studied and caution is therefore warranted. (8) ------------------------CONTRAINDICATIONS--------------------­ FIRMAGON is contraindicated in: See 17 for PATIENT COUNSELING INFORMATION (and • Patients with previous hypersensitivity reactions to FDA approved Patient Labeling) degarelix. (4) Revised: 02/2015 • Pregnancy Category X. Fetal harm can occur when administered to pregnant women. (4) FULL PRESCRIBING INFORMATION: CONTENTS* 10 OVERDOSAGE 11 DESCRIPTION 1 INDICATIONS AND USAGE 12 CLINICAL PHARMACOLOGY 2 DOSAGE AND ADMINISTRATION 12.1 Mechanism of Action 3 DOSAGE FORMS AND STRENGTHS 12.2 Pharmacodynamics 4 CONTRAINDICATIONS 12.3 Pharmacokinetics 5 WARNINGS AND PRECAUTIONS 13 NONCLINICAL TOXICOLOGY 5.1 Use in Pregnancy 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5.2 Hypersensitivity Reactions 14 CLINICAL STUDIES 5.3 Effect on QT/QTc Interval 15 REFERENCES 5.4 Laboratory Testing 16 HOW SUPPLIED/STORAGE AND HANDLING 6 ADVERSE REACTIONS 17 PATIENT COUNSELING INFORMATION 7 DRUG INTERACTIONS 17.1 Information 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use *Sections or subsections omitted from the full prescribing information are 8.6 Renal impairment not listed. 8.7 Hepatic impairment Reference ID: 3704666 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE FIRMAGON is a GnRH receptor antagonist indicated for treatment of patients with advanced prostate cancer. 2 DOSAGE AND ADMINISTRATION FIRMAGON is for subcutaneous administration only. Dosing information: Starting dose Maintenance dose – Administration every 28 days 240 mg given as two subcutaneous injections 80 mg given as one subcutaneous of 120 mg at a concentration of 40 mg/mL injection at a concentration of 20 mg/mL The first maintenance dose should be given 28 days after the starting dose. FIRMAGON is administered as a subcutaneous injection in the abdominal region. As with other drugs administered by subcutaneous injection, the injection site should vary periodically. Injections should be given in areas of the abdomen that will not be exposed to pressure, e.g., not close to waistband or belt nor close to the ribs. FIRMAGON is supplied as a powder to be reconstituted with Sterile Water for Injection, USP (WFI). The instruction for reconstitution needs to be carefully followed. Administration of other concentrations is not recommended. See Instructions for Proper Use. Instructions for Reconstitution The following information is intended for healthcare professionals only: NOTE: • Reconstituted drug must be administered within one hour after addition of Sterile Water for Injection, USP • Do not shake the vials • Follow aseptic technique FIRMAGON 240 mg – Starting Dose The pack contains 2 sets of FIRMAGON 120 mg vial, Sterile Water for Injection, USP syringe, vial adapter, and administration needle. For each subcutaneous injection, the drug product must be prepared using the following instructions. 1. Uncap vial and wipe the vial rubber stopper with an alcohol pad. Remove the cover from the vial adapter package. Attach the vial adapter to the vial by pressing the adapter down until the spike pushes through the rubber stopper and the adapter snaps in place (see Figure A). 2. Assembly of the syringe is required. Prepare the prefilled syringe by attaching the plunger. 2 Reference ID: 3704666 3. Remove the cap of the prefilled syringe. Attach the syringe to the vial by screwing it on to the adapter. Transfer all Sterile Water for Injection, USP to the vial (see Figure B). 4. With the syringe still attached to the adapter, swirl gently until the liquid looks clear and free of powder or particles (see Figure C). If the powder adheres to the side of the vial above the liquid surface, the vial can be tilted slightly. Avoid shaking to prevent foam formation. A ring of small air bubbles on the surface of the liquid is acceptable. The reconstitution procedure may take, in some cases, up to 15 minutes, but usually takes a few minutes. 5. Turn the vial upside down and draw up to the 3 mL mark on the syringe for injection (see Figure D). Always make sure to withdraw the precise volume and expel any air bubbles. 6. Detach the syringe from the vial adapter and attach the administration needle to the syringe. 7. Immediately after reconstitution, inject 3 mL of FIRMAGON 120 mg slowly. Perform a deep subcutaneous injection. To do so: pinch the skin of the abdomen, elevate the subcutaneous tissue and insert the needle at a 45 degree angle (see Figure E). Do not inject into a vein or muscle. Gently pull back the plunger to check if blood is aspirated. If blood appears in the syringe, the product can no longer be used. Discontinue the injection and discard the syringe and the needle (reconstitute a new dose for the patient). No injections should be given in areas where the patient will be exposed to pressure, e.g., around the belt or waistband or close to the ribs. 8. Repeat the reconstitution procedure for the second 120 mg vial to complete the 240 mg starting dose and choose a different injection site for the second dose. 3 Reference ID: 3704666 FIRMAGON 80 mg – Maintenance Dose The pack contains 1 set of FIRMAGON 80 mg vial, Sterile Water for Injection, USP syringe, vial adapter, and administration needle. For the subcutaneous injection, the drug product must be prepared using the following instructions. 1. Uncap vial and wipe the vial rubber stopper with an alcohol pad. Remove the cover from the vial adapter package. Attach the adapter to the powder vial by pressing the adapter down until the spike pushes through the rubber stopper and the adapter snaps in place (see Figure A). 2. Assembly of the syringe is required. Prepare the prefilled syringe by attaching the plunger. 3. Remove the cap of the prefilled syringe. Attach the syringe to the vial by screwing it on to the adapter. Transfer all Sterile Water for Injection, USP to the vial (see Figure B). 4. With the syringe still attached to the adapter, swirl gently until the liquid looks clear and free of powder or particles (see Figure C). If the powder adheres to the side of the vial above the liquid surface, the vial can be tilted slightly. Avoid shaking to prevent foam formation. A ring of small air bubbles on the surface of the liquid is acceptable. The reconstitution procedure may take, in some cases, up to 15 minutes, but usually takes a few minutes. 5. Turn the vial upside down and draw up to the 4 mL mark on the syringe for injection (see Figure D). Always make sure to withdraw the precise volume and expel any air bubbles. 6. Detach the syringe from the vial adapter and attach administration needle to the syringe. 7. Immediately after reconstitution, inject 4 mL of FIRMAGON 80 mg slowly. Perform a deep subcutaneous injection. To do so: pinch the skin of the abdomen, elevate the subcutaneous tissue and insert the needle at a 45 degree angle (see Figure E). Do not inject into a vein or muscle. Gently pull back the plunger to check if blood is aspirated. If blood appears in the syringe, the product can no longer be used. Discontinue the injection and 4 Reference ID: 3704666 discard the syringe and the needle (reconstitute a new dose for the patient). No injections should be given in areas where the patient will be exposed to pressure, e.g., around the belt or waistband or close to the ribs. 3 DOSAGE FORMS AND STRENGTHS Starting dose One starting dose comprises 240 mg given as two 3 mL injections of 120 mg each. Powder for injection 120 mg: One vial of FIRMAGON 120 mg contains 120 mg degarelix. Each vial is to be reconstituted with a prefilled syringe containing 3 mL of Sterile Water for Injection. 3 mL is withdrawn to deliver 120 mg degarelix at a concentration of 40 mg/mL. Maintenance dose One maintenance dose comprises 80 mg given as one 4 mL injection.