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Firmagon® Dosage & Administration

  • Prefilled Kit
  • /
  • Preparing FIRMAGON

FIRMAGON® IS ADMINISTERED AS A DEEP SUBCUTANEOUS INJECTION IN THE ABDOMINAL REGION EVERY 28 DAYS1

Dosing Guide to Nadir
  • To determine the lowest PSA achieved, multiple measurements of PSA will be required
Firmagon® hormone testosterone therapy starting dose

Starting Dose

240 mg: 2 x 120 mg

(2 x 3 mL injection)

Firmagon® hormone testosterone therapy maintenance dose

Maintenance Dose

80 mg: 1 x 80 mg

(1 x 4 mL injection)

Use product-specific HCPCS code J9155 for both doses of FIRMAGON

The injection site should vary periodically

THE FIRMAGON® PREFILLED KIT

DESIGNED FOR EFFICIENT RECONSTITUTION

The Firmagon® Prefilled Kit
  • FIRMAGON powder for injection
  • Vial adaptor(s)
  • Prefilled syringes containing Sterile Water for Injection, USP
  • OSHA-approved safety administration needles
The Firmagon® Prefilled Kit

Requires reconstitution but not refrigeration.

PREPARING THE FIRMAGON® DOSE1

FOLLOW ASEPTIC TECHNIQUE

Use only the materials provided in kit for reconstitution and injection.

Caution should be exercised in handling and preparing the solution of FIRMAGON. To minimize the risk of dermal exposure, always wear impervious gloves when handling. If solution contacts the skin, immediately wash the skin thoroughly with soap and water. If FIRMAGON contacts mucous membranes, the membranes should be flushed immediately and thoroughly with water.

Watch the Firmagon® injection video

Attach the vial adaptor

Preparing Firmagon® dose step 1: prepare the vial
1

Uncap the vial and wipe the vial rubber stopper with an alcohol pad. IMPORTANT: Do not touch the top of the vial after wiping.

2

Peel off the seal from the vial adaptor cover. IMPORTANT: Do not touch the sterile spike inside of the vial adaptor.

3

Firmly press the vial adaptor onto the vial until the adaptor snaps into place.

4

Pull the vial adaptor cover off of the vial.

5

The reconstituted medication must be administered within 1 hour after the addition of the Sterile Water.

Preparing Firmagon® dose step 1: prepare the vial

Assemble the syringe

Preparing Firmagon® dose step 2: transfer water from the prefilled syringe
1

Insert the plunger rod into the prefilled syringe containing Sterile Water, USP, and screw the plunger rod clockwise to tighten. IMPORTANT: Do not pull the back stopper (flange) off of the syringe.

NOTE: You will only feel light resistance when screwing the plunger rod into position.

2

Unscrew the gray syringe plug from the Luer lock adaptor on the syringe.
IMPORTANT: Do not pull off the Luer lock adaptor.

3

Carefully twist the prefilled syringe containing Sterile Water, USP, onto the vial adaptor of the vial until it is tight. IMPORTANT: Be careful not to over-twist the syringe.

4

Press the plunger slowly to transfer all of the Sterile Water, USP, from the syringe to the vial.

Preparing Firmagon® dose step 2: transfer water from the prefilled syringe

Reconstitute

Preparing Firmagon® dose step 3: reconstitute
1

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 minutes but usually takes a few minutes
Preparing Firmagon® dose step 3: reconstitute

Transfer liquid to syringe and prepare for injection

Preparing Firmagon® dose step 4: fill the syringe
1

Turn the vial completely upside down and pull down the plunger to withdraw all of the reconstituted liquid from the vial and into the syringe.

2

Tap the syringe gently with your fingers to raise air bubbles in the syringe tip.

3

Press the plunger to the line marked on the syringe to expel all air bubbles.

4

Detach the syringe by unscrewing it from the vial adaptor.
NOTE: Reconstitute just prior to administration.

5

Screw the injection needle onto the syringe clockwise.

Preparing Firmagon® dose step 4: fill the syringe

ADMINISTERING THE FIRMAGON® DOSE1

Prepare the patient

Administering Firmagon® dose step 1: choose site for injection
1

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 the areas around the belt or waistband or close to the ribs
  • Vary the injection site periodically during treatment to minimize patient discomfort
2

Clean the injection site with an alcohol pad.

Administering Firmagon® dose step 1: choose site for injection

Perform the injection

Administering Firmagon® dose step 2: elevate the subcutaneous tissue
1

Move the needle guard away from the needle and carefully remove the needle cover.

Pinch and elevate the skin of the abdomen.

Administering Firmagon® dose step 3: insert the needle
2

Insert the needle into the skin at a 45-degree angle all the way to the hub.

3

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).

Administering Firmagon® dose step 4: aspirate, then depress
4

Perform a slow, deep subcutaneous injection over 30 sec.

 

IMPORTANT: Trauma can occur in the dermal layer if the medication is injected
too fast.

5

Inject all of the medication in the syringe before removing the needle from the abdomen.

 

IMPORTANT: Once the needle is removed, continue to hold the skin for ≈15 seconds to allow the injection tract to close. Then, release the skin.

Administering Firmagon® dose step 2: elevate the subcutaneous tissue Administering Firmagon® dose step 3: insert the needle Administering Firmagon® dose step 4: aspirate, then depress

WHEN THE INJECTION IS COMPLETE, PLACE THE NEEDLE GUARD OVER THE NEEDLE UNTIL IT CLICKS, AND DISPOSE INTO A SHARPS CONTAINER.

Post-injection care instructions for patients

Here is a quick rundown of what to tell patients right after their injection:

  • Do not rub or scratch the injection site
    • Keep the site clean and wear loose clothing to avoid irritating it
  • There can be a lump at the injection site and redness, soreness, and discomfort for a few days
  • The lump is a depot—or medication deposit—that supplies the body with a continuous release of FIRMAGON over time
    • The lump will eventually subside
  • Schedule the next dose of FIRMAGON before your patient leaves the office

Abbreviations: HCPCS = Health Care Procedure Coding System; OSHA = Occupational Safety and Health Administration; USP = United States Pharmacopeia.

REFERENCE: 1. FIRMAGON® [package insert]. Parsippany, NJ: Ferring Pharmaceuticals Inc.

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Important Safety Information

FIRMAGON is contraindicated in patients with a known hypersensitivity to degarelix or to any of the product components and in women who are or may become pregnant. FIRMAGON can cause fetal harm when administered to a pregnant woman.

Hypersensitivity reactions, including anaphylaxis, urticaria, and angioedema, have been reported post-marketing with FIRMAGON. In case of a serious hypersensitivity reaction, discontinue FIRMAGON immediately if the injection has not been completed, and manage as clinically indicated. Patients with a known history of serious hypersensitivity reactions to FIRMAGON should not be re-challenged with FIRMAGON.

Long-term androgen deprivation therapy (ADT) prolongs the QT interval. Physicians should consider whether the benefits of ADT outweigh the potential risks in patients with congenital long QT syndrome, electrolyte abnormalities, or congestive heart failure and in patients taking Class IA or Class III antiarrhythmic medications.

Therapy with FIRMAGON results in suppression of the pituitary gonadal system. Results of diagnostic tests of the pituitary gonadotropic and gonadal functions conducted during and after FIRMAGON may be affected. The therapeutic effect of FIRMAGON should be monitored by measuring serum concentrations of prostate-specific antigen (PSA) periodically. If PSA increases, serum concentrations of testosterone should be measured.

The most common adverse reactions (≥10%) during FIRMAGON therapy included injection site reactions (eg, pain, erythema, swelling, or induration), hot flashes, increased weight, fatigue, and increases in serum levels of transaminases and gamma-glutamyltransferase. The majority of adverse reactions were Grade 1 or 2; 1% or less were Grade 3/4. Injection site reactions were mostly transient, of mild to moderate intensity, occurred primarily with the starting dose, and led to few discontinuations (<1%).

Indication

FIRMAGON® is a GnRH receptor antagonist indicated for treatment of patients with advanced prostate cancer.

Important Safety Information

FIRMAGON is contraindicated in patients with a known hypersensitivity to degarelix or to any of the product components and in women who are or may become pregnant. FIRMAGON can cause fetal harm when administered to a pregnant woman.

Hypersensitivity reactions, including anaphylaxis, urticaria, and angioedema, have been reported post-marketing with FIRMAGON. In case of a serious hypersensitivity reaction, discontinue FIRMAGON immediately if the injection has not been completed, and manage as clinically indicated. Patients with a known history of serious hypersensitivity reactions to FIRMAGON should not be re-challenged with FIRMAGON.

Long-term androgen deprivation therapy (ADT) prolongs the QT interval. Physicians should consider whether the benefits of ADT outweigh the potential risks in patients with congenital long QT syndrome, electrolyte abnormalities, or congestive heart failure and in patients taking Class IA or Class III antiarrhythmic medications.

Therapy with FIRMAGON results in suppression of the pituitary gonadal system. Results of diagnostic tests of the pituitary gonadotropic and gonadal functions conducted during and after FIRMAGON may be affected. The therapeutic effect of FIRMAGON should be monitored by measuring serum concentrations of prostate-specific antigen (PSA) periodically. If PSA increases, serum concentrations of testosterone should be measured.

The most common adverse reactions (≥10%) during FIRMAGON therapy included injection site reactions (eg, pain, erythema, swelling, or induration), hot flashes, increased weight, fatigue, and increases in serum levels of transaminases and gamma-glutamyltransferase. The majority of adverse reactions were Grade 1 or 2; 1% or less were Grade 3/4. Injection site reactions were mostly transient, of mild to moderate intensity, occurred primarily with the starting dose, and led to few discontinuations (<1%).

Indication

FIRMAGON® is a GnRH receptor antagonist indicated for treatment of patients with advanced prostate cancer.