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Firmagon

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Firmagon

INDICATIONS

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

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 of 120 mg at a concentration of 40 mg/mL 80 mg given as one subcutaneous 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).

Figure A

Snap the adapter into place - Illustration

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).

Figure B

Attach the syringe to the vial - Illustration

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.

Figure C

Swirl the gently - Illustration

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.

Figure D

Withdraw the precise volume - Illustration

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.

Figure E

Insert the needle at a 45 degree angle - Illustration

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.

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).

Figure A

Snap adapter in place - Illustration

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).

Figure B

Attach the syringe to the vial -  Illustration

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.

Figure C

FIRMAGON® (degarelix for injection) Figure CGently swirl the vial - Illustration

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.

Figure D

Withdraw the precise volume - Illustration

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).

Figure E

Insert the needle at a 45 degree angle - Illustration

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.

HOW SUPPLIED

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.

Powder for injection 80 mg:

One vial of FIRMAGON 80 mg contains 80 mg degarelix. 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.

Storage And Handling

FIRMAGON is available as:

NDC 55566-8401-2, Starting dose – One carton contains:
Two vials each with 120 mg powder for injection
Two prefilled syringes containing 3 mL of sterile water for injection, USP
Two vial adapters
Two administration needles

NDC 55566-8301-2, Maintenance dose – One carton contains:
One vial with 80 mg powder for injection
One prefilled syringe containing 4.2 mL of sterile water for injection, USP
One vial adapter One administration needle

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).

Caution should be exercised in handling and preparing the solution of FIRMAGON. Several guidelines on proper handling and disposal of anticancer drugs have been published.1-4 To minimize the risk of dermal exposure, always wear impervious gloves when handling FIRMAGON. If FIRMAGON 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 [see CONTRAINDICATIONS and Nonclinical Toxicology

REFERENCES

1. NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165.

2. OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html

3. American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2006; 63:1172-1193.

4. Polovich, M., White, J. M., & Kelleher, L.O. (eds.) 2005. Chemotherapy and biotherapy guidelines and recommendations for practice (2nd. ed.) Pittsburgh, PA: Oncology Nursing Society.

Manufactured for: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054 By: Rentschler Biotechnologie GmbH, Germany 6415-08 08/2013

Last reviewed on RxList: 9/4/2013
This monograph has been modified to include the generic and brand name in many instances.

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