2 DOSAGE AND ADMINISTRATION

2.1 Dosing information

FIRMAGON is administered as a subcutaneous injection in the abdominal region only at the dosages in Table 1 below.

Table 1: FIRMAGON Recommended Dosages
Starting Dosage	Maintenance Dosage – Administered once every 28 days
240 mg given as two subcutaneous injections of 120 mg at a concentration of 40 mg/mL	The first maintenance dose should be given 28 days after the starting dose. 80 mg given as one subcutaneous injection at a concentration of 20 mg/mL

2.2 Reconstitution and Administration Instructions

FIRMAGON is to be administered by a healthcare professional only.

Before administering FIRMAGON read the Instructions for reconstitution and administration carefully.

As with other drugs administered by subcutaneous injection, the injection site should vary periodically. Injections should be given only 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.

Starting dose (240 mg): Two single-dose vials each delivering 120 mg of degarelix in a white to off-white lyophilized powder for reconstitution supplied with diluent in two prefilled syringes. Each vial is to be reconstituted with a prefilled syringe containing 3 mL of Sterile Water for Injection. 3 mL is withdrawn to deliver 120 mg degarelix at a concentration of 40 mg/mL.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 (80 mg): One single-dose vial delivering 80 mg of degarelix in a white to off-white lyophilized powder for reconstitution supplied with diluent in one prefilled syringe. Each vial is to be reconstituted with a prefilled syringe containing 4.2 mL of Sterile Water for Injection. 4 mL is withdrawn to deliver 80 mg degarelix at a concentration of 20 mg/mL.

Follow the instructions for reconstitution closely and read the complete instructions before performing the subcutaneous injection.

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 Kit contains: 2 vials containing the 120 mg FIRMAGON powder (a) 2 syringes containing Sterile Water for Injection, USP (b) 2 vial adapters (c) 2 25 gauge × 1 inch injection needles (d) 2 plunger rods (e)

	FIRMAGON 80 mg Maintenance Dose Kit contains: 1 vial containing the 80 mg FIRMAGON powder (f) 1 syringe containing Sterile Water for Injection, USP (g) 1 vial adapter (h) 1 25 gauge × 1 inch injection needle (i) 1 plunger rod (j)

	In addition the healthcare professional will need: gloves (k) alcohol pads (l) a clean, flat surface (m) to work on, like a table a sharps disposal container (n) for throwing away your used needles and syringes. See "Disposing used needles and syringes" at the end of these instructions.

The drug product must be prepared using the following instructions:

NOTE: The mixing process must be repeated for the two injections of the Starting Dose prior to injecting the product into the patient's abdomen.

	Step 1: Attaching the vial adaptor to the vial Thoroughly wash your hands using soap and water and put on a pair of clean gloves. Place all the supplies required on a clean surface. Check that there is powder in the FIRMAGON vial and that the Sterile Water for Injection, USP is clear and free from particles. IMPORTANT: DO NOT USE if there is no powder in the vial or the Sterile Water for Injection, USP is discolored.
	Uncap the vial containing the FIRMAGON powder (o). Wipe the vial rubber stopper with an alcohol pad. IMPORTANT: Do not touch the top of the vial after wiping.
	Peel off the seal from the vial adaptor cover. IMPORTANT: Do not touch the vial adapter. Firmly press the vial adaptor (p) onto the vial containing the FIRMAGON powder until the adaptor snaps into place.
	Pull the vial adaptor cover off the vial.

	Step 2: Assembling the syringe Insert the plunger rod (q) into the prefilled syringe containing Sterile Water for Injection, USP (r) and screw the plunger rod clockwise to tighten. IMPORTANT: Do not pull the back stopper (flange) (s) off the syringe. NOTE: You will only feel light resistance screwing the plunger rod in position.

	Step 3: Transferring Sterile Water for Injection, USP from the syringe to the vial Unscrew the gray syringe plug (t) attached to the Luer lock adaptor on the syringe. IMPORTANT: Do not pull off the Luer lock adaptor (u).
	Carefully twist the prefilled syringe containing Sterile Water for Injection, USP onto the vial adapter on the FIRMAGON powder vial, until it is tight. IMPORTANT: Be careful not to over twist the syringe.
	Press the plunger slowly to transfer all the Sterile Water for Injection, USP from the syringe to the FIRMAGON powder vial.

	Step 4: Preparing the reconstituted injection With the syringe still attached to the vial adaptor, swirl gently until the liquid is clear with no powder or visible particles. IMPORTANT: Do not shake the vial as this will cause bubbles. Reconstitute just prior to administration. NOTE: If the powder adheres to the side of the vial, tilt the vial slightly. A ring of small air bubbles on the surface of the liquid is acceptable. Reconstitution time can take up to 15 min but usually takes a few minutes.

	Step 5: Transferring the liquid to the syringe Turn the vial completely upside down and pull down the plunger to withdraw all of the reconstituted liquid from the vial to the syringe. Tap the syringe gently with your fingers to raise air bubbles in the syringe tip. Press the plunger to the line marked on the syringe to expel all air bubbles.

	Step 6: Preparing the syringe for injection Holding the vial adaptor detach the syringe from the vial by unscrewing the syringe from the vial adaptor. NOTE: Reconstitute just prior to administration.
	While holding the syringe with the tip pointing up, screw the injection needle (v) clockwise (right) onto the syringe.

	Step 7: Preparing the patient Select one of the four available injection sites on the abdomen. IMPORTANT:
		Do not inject in areas where the patient will be exposed to pressure, such as area around the belt of the waistband or close to the ribs. Vary the injection site periodically during treatment to minimize discomfort to the patient.
	Clean the injection site with an alcohol pad.

	Step 8: Performing the injection Move the needle shield (w) away from the needle and carefully remove the needle cover (x).
	Pinch and elevate the skin of the abdomen. Insert the needle into the skin at a 45 degree angle all the way to the hub. Do not inject into a vein or muscle. Gently pull back the plunger to check if blood is aspirated. IMPORTANT: If blood appears in the syringe, the product should not be injected. Discontinue the injection and discard the syringe and the needle (reconstitute a new dose for the patient). Perform a slow, deep subcutaneous injection over 30 seconds.
	Remove the needle and then release the skin. IMPORTANT: Do not rub the injection site after retracting the needle.

	Step 9: Locking the needle into the shield Position the needle shield approximately 45 degrees to a flat surface. Press down with a firm, quick motion until a distinct, audible "click" is heard.
	Visually confirm that the needle is fully engaged under the lock (y). IMPORTANT: Syringe is for single use only. Do not reuse the syringe and needle.

	Step 10: Advising the patient Instruct the patient not to rub or scratch the injection site. Inform that some patients may feel a lump at the injection site and experience redness, soreness and discomfort for a few days after the injection.

Disposing used needles and syringes

Put used alcohol swabs, needles and syringes in an FDA-cleared sharps disposal container right away after use. Do not throw away loose needles and syringes in the trash.
For more information about safe sharps disposal, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.