Degarelix: Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag=
|authorTag={{AV}}
 
|genericName=Degarelix
 
|aOrAn=an
<!--Overview-->
|drugClass=[[anti -neoplastic agent]]
 
|indicationType=treatment
|genericName=
|indication=patients with advanced prostate cancer.
 
|adverseReactions=<!--Black Box Warning-->
 
|blackBoxWarningTitle=Title
 
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
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a
 
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Yes
 
|adverseReactions=
 
 
 
<!--Black Box Warning-->
 
|blackBoxWarningTitle=
Title
 
|blackBoxWarningBody=
<i><span style="color:#FF0000;">ConditionName: </span></i>


* Content
* Content
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<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult======Condition1=====
=====Dosing Information=====
*FIRMAGON is for subcutaneous administration only and is not to be administered intravenously.
TABLE02
*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 reconstitution procedure needs to be carefully followed. Administration of other concentrations is not recommended.  See Instructions for Proper Use.
=====Instructions for Proper Use=====
*NOTE:
:*Gloves should be worn during preparation and administration
:*Reconstituted drug must be administered within one hour after addition of Sterile Water for Injection, USP (WFI)
:*Keep the vials vertical at all times
:*Do not shake the vials
:*Follow aseptic technique
=====FIRMAGON 120 mg=====
*The Treatment Initiation pack contains 2 vials of FIRMAGON 120 mg that must be prepared for 2 subcutaneous injections. Hence, the instructions here below need to be repeated a second time.
*Prepare FIRMAGON 120 mg for reconstitution by gathering the following:
:*6 mL of Sterile Water for Injection, USP (WFI); Do not use Bacteriostatic Water for Injection
:*2 reconstitution needles – 21G / 2 inch
:*2 administration needles for subcutaneous injection – 27G / 1-1/4 inch
:*2 injection syringes (5 mL)
*Draw up 3 mL WFI with a reconstitution needle (21G / 2 in).
*Inject the WFI slowly into the FIRMAGON 120 mg vial. To keep the product and syringe sterile, do not remove the syringe and the needle.
*Keeping the vial in an upright position, swirl it very gently until the liquid looks clear and without undissolved powder or particles. If the powder adheres to the vial over the liquid surface, the vial can be tilted slightly to dissolve powder. 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 up to 15 minutes.
*Tilt the vial slightly and keep the needle in the lowest part of the vial. Withdraw 3 mL of FIRMAGON 120 mg without turning the vial upside down.
*Exchange the reconstitution needle with the administration needle for deep subcutaneous injection (27G / 1-1/4 in). Remove any air bubbles.
*Inject 3 mL of FIRMAGON 120 mg subcutaneously immediately after reconstitution.
:*Grasp the skin of the abdomen, elevate the subcutaneous tissue. Insert the needle deeply at an angle of not less than 45 degrees.
:*Gently pull back the plunger to check if blood is aspirated. If blood appears in the syringe, the reconstituted product can no longer be used. Discontinue the procedure and discard the syringe and the needle (reconstitute a new dose for the patient).
*Repeat reconstitution procedure for the second dose. Choose a different injection site and inject 3 mL.
=====FIRMAGON 80 mg=====
*The Treatment Maintenance pack contains 1 vial of FIRMAGON 80 mg that must be prepared for subcutaneous injection.
*Prepare FIRMAGON 80 mg for reconstitution by gathering the following:
:*4.2 mL of Sterile Water for Injection, USP (WFI); Do not use Bacteriostatic Water for Injection
:*1 reconstitution needle – 21G / 2 inch
:*1 administration needle for subcutaneous injection – 27G / 1-1/4 inch
:*1 injection syringe (5 mL)
*Draw up 4.2 mL WFI with the reconstitution needle (21G / 2 in).
*Inject the WFI slowly into the FIRMAGON 80 mg vial. To keep the product and syringe sterile, do not remove the syringe and the needle.
*Keeping the vial in an upright position, swirl it very gently until the liquid looks clear and without undissolved powder or particles. If the powder adheres to the vial over the liquid surface, the vial can be tilted slightly to dissolve powder. 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 up to 15 minutes.
*Tilt the vial slightly and keep the needle in the lowest part of the vial. Withdraw 4 mL of FIRMAGON 80 mg without turning the vial upside down.
*Exchange the reconstitution needle with the administration needle for deep subcutaneous injection (27G / 1-1/4 in). Remove any air bubbles.
*Inject 4 mL of FIRMAGON 80 mg subcutaneously immediately after reconstitution:
:*Grasp the skin of the abdomen, elevate the subcutaneous tissue. Insert the needle deeply at an angle of not less than 45 degrees.
:*Gently pull back the plunger to check if blood is aspirated. If blood appears in the syringe, the reconstituted product can no longer be used. Discontinue the procedure and discard the syringe and the needle (reconstitute a new dose for the patient).


|fdaLIADAdult=
=====Condition1=====


* Dosing Information
:* Dosage
=====Condition2=====
* Dosing Information
:* Dosage
=====Condition3=====
* Dosing Information
:* Dosage
=====Condition4=====
* Dosing Information
:* Dosage


<!--Off-Label Use and Dosage (Adult)-->
<!--Off-Label Use and Dosage (Adult)-->


<!--Guideline-Supported Use (Adult)-->
<!--Guideline-Supported Use (Adult)-->
 
|offLabelAdultGuideSupport======Condition1=====
|offLabelAdultGuideSupport=
 
=====Condition1=====


* Developed by:  
* Developed by:  
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<!--Non–Guideline-Supported Use (Adult)-->
<!--Non–Guideline-Supported Use (Adult)-->
 
|offLabelAdultNoGuideSupport======Condition1=====
|offLabelAdultNoGuideSupport=
 
=====Condition1=====


* Dosing Information
* Dosing Information
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<!--FDA-Labeled Indications and Dosage (Pediatric)-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
 
|fdaLIADPed======Condition1=====
|fdaLIADPed=
 
=====Condition1=====


* Dosing Information
* Dosing Information
Line 124: Line 108:


<!--Guideline-Supported Use (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
 
|offLabelPedGuideSupport======Condition1=====
|offLabelPedGuideSupport=
 
=====Condition1=====


* Developed by:  
* Developed by:  
Line 144: Line 125:


<!--Non–Guideline-Supported Use (Pediatric)-->
<!--Non–Guideline-Supported Use (Pediatric)-->
 
|offLabelPedNoGuideSupport======Condition1=====
|offLabelPedNoGuideSupport=
 
=====Condition1=====


* Dosing Information
* Dosing Information
Line 158: Line 136:


<!--Contraindications-->
<!--Contraindications-->
 
|contraindications=*FIRMAGON is contraindicated in patients with known hypersensitivity to degarelix or to any of the product components.
|contraindications=
*Degarelix is contraindicated in women who are or may become pregnant. Degarelix can cause fetal harm when administered to a pregnant woman.  Degarelix given to rabbits during organogenesis at doses that were 0.02% of the clinical loading dose (240 mg) on a mg/m2 basis caused embryo/fetal lethality and abortion.  When degarelix was given to female rats during organogenesis, at doses that were just 0.036% of the clinical loading dose on a mg/m2 basis, there was an increase post implantation loss and a decrease in the number of live fetuses.  If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
 
* Condition1


<!--Warnings-->
<!--Warnings-->
 
|warnings======Effect on QT/QTc Interval=====
|warnings=
*Long-term androgen deprivation therapy prolongs the QT interval. Physicians should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, electrolyte abnormalities, or congestive heart failure and in patients taking Class IA (e.g. quinidine, procainamide) or Class III (e.g. amiodarone, sotalol) antiarrhythmic medications.
 
*In the randomized, active-controlled trial comparing FIRMAGON to leuprolide, periodic electrocardiograms were performed. Seven patients, three (<1%) in the pooled degarelix group and four (2%) patients in the leuprolide 7.5 mg group, had a QTcF > 500 msec.  From baseline to end of study the median change for FIRMAGON was 12.3 msec and for leuprolide was 16.7 msec.
* Description
===== Laboratory Testing=====
 
*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.
====Precautions====
 
* Description


<!--Adverse Reactions-->
<!--Adverse Reactions-->


<!--Clinical Trials Experience-->
<!--Clinical Trials Experience-->
 
|clinicalTrials=*Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
|clinicalTrials=
*A total of 1325 patients with prostate cancer received FIRMAGON either as a monthly treatment (60-160 mg) or as a single dose (up to 320 mg).  A total of 1032 patients (78%) were treated for at least 6 months and 853 patients (64%) were treated for one year or more.  The most commonly observed adverse reactions during FIRMAGON therapy included injection site reactions (e.g., pain, erythema, swelling, or induration), hot flashes, increased weight, fatigue, and increases in serum levels of transaminases and gamma-glutamyltransferase (GGT). The majority of the adverse reactions were Grade 1 or 2, with Grade 3/4 adverse reaction incidences of 1% or less.
 
*FIRMAGON was studied in an active-controlled trial (N = 610) in which patients with prostate cancer were randomized to receive FIRMAGON (subcutaneous) or leuprolide (intramuscular) monthly for 12 months. Adverse reactions reported in 5% of patients or more are shown in Table 1.
There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
TABLE03
 
*The most frequently reported adverse reactions at the injection sites were pain (28%), erythema (17%), swelling (6%), induration (4%) and nodule (3%). These adverse reactions were mostly transient, of mild to moderate intensity, occurred primarily with the starting dose and led to few discontinuations (<1%).  Grade 3 injection site reactions occurred in 2% or less of patients receiving degarelix.
=====Body as a Whole=====
*Hepatic laboratory abnormalities were primarily Grade 1 or 2 and were generally reversible. Grade 3 hepatic laboratory abnormalities occurred in less than 1% of patients.
 
*In 1-5% of patients the following adverse reactions, not already listed, were considered related to FIRMAGON by the investigator:
 
*Body as a whole: Asthenia, fever, night sweats; Digestive system: Nausea; Nervous system: Dizziness, headache, insomnia.
 
*The following adverse reactions, not already listed, were reported to be drug-related by the investigator in ≥1% of patients: erectile dysfunction, gynecomastia, hyperhidrosis, testicular atrophy, and diarrhea.
 
*Changes in bone density:
=====Cardiovascular=====
:*Decreased bone density has been reported in the medical literature in men who have had orchiectomy or who have been treated with a GnRH agonist. It can be anticipated that long periods of medical castration in men will result in decreased bone density.
 
*Anti-degarelix antibody development has been observed in 10% of patients after treatment with FIRMAGON for 1 year. There is no indication that the efficacy or safety of FIRMAGON treatment is affected by antibody formation.
 
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
 
 
=====Digestive=====
 
 
 
 
=====Endocrine=====
 
 
 
 
=====Hematologic and Lymphatic=====
 
 
 
 
=====Metabolic and Nutritional=====
 
 
 
 
=====Musculoskeletal=====
 
 
 
 
=====Neurologic=====
 
 
 
 
=====Respiratory=====
 
 
 
 
=====Skin and Hypersensitivy Reactions=====
 
 
 
 
=====Special Senses=====
 
 
 
 
=====Urogenital=====
 
 
 
 
=====Miscellaneous=====
 
 
 
<!--Postmarketing Experience-->
 
|postmarketing=
 
There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.


=====Body as a Whole=====
=====Body as a Whole=====
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<!--Drug Interactions-->
<!--Drug Interactions-->
 
|drugInteractions=* Drug
|drugInteractions=
 
* Drug
:* Description
:* Description


<!--Use in Specific Populations-->
<!--Use in Specific Populations-->
 
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyFDA=
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
* '''Pregnancy Category'''
 
|useInPregnancyAUS=
* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''


There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
 
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInLaborDelivery=
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
 
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInNursing=
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
 
|useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
|useInPed=
|useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
 
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
|useInGeri=
There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
 
|useInGender=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
 
|useInRace=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
 
|useInRenalImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
 
|useInHepaticImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
 
|useInReproPotential=
There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
 
|useInImmunocomp=
There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.


<!--Administration and Monitoring-->
<!--Administration and Monitoring-->
 
|administration=* Oral
|administration=
 
* Oral


* Intravenous
* Intravenous
 
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
|monitoring=
 
There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.


* Description
* Description


<!--IV Compatibility-->
<!--IV Compatibility-->
 
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
|IVCompat=
 
There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.


<!--Overdosage-->
<!--Overdosage-->
 
|overdose====Acute Overdose===
|overdose=
 
===Acute Overdose===


====Signs and Symptoms====
====Signs and Symptoms====
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<!--Drug box 2-->
<!--Drug box 2-->
 
|drugBox=<!--Mechanism of Action-->
|drugBox=
|mechAction=*  
 
 
 
<!--Mechanism of Action-->
 
|mechAction=
 
*  


<!--Structure-->
<!--Structure-->
 
|structure=*  
|structure=
 
*  


: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]


<!--Pharmacodynamics-->
<!--Pharmacodynamics-->
 
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
|PD=
 
There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.


<!--Pharmacokinetics-->
<!--Pharmacokinetics-->
 
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
|PK=
 
There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.


<!--Nonclinical Toxicology-->
<!--Nonclinical Toxicology-->
 
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
|nonClinToxic=
 
There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.


<!--Clinical Studies-->
<!--Clinical Studies-->
 
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
|clinicalStudies=
 
There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.


<!--How Supplied-->
<!--How Supplied-->
 
|howSupplied=*  
|howSupplied=
 
*  


<!--Patient Counseling Information-->
<!--Patient Counseling Information-->
 
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
|fdaPatientInfo=
 
There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.


<!--Precautions with Alcohol-->
<!--Precautions with Alcohol-->
 
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|alcohol=
 
* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.


<!--Brand Names-->
<!--Brand Names-->
 
|brandNames=* ®<ref>{{Cite web | title =  | url =  }}</ref>
|brandNames=
 
* ®<ref>{{Cite web | title =  | url =  }}</ref>


<!--Look-Alike Drug Names-->
<!--Look-Alike Drug Names-->
 
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<!--Pill Image-->


{{PillImage
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<!--Label Display Image-->


{{LabelImage
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{{LabelImage
 
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
 
}}


<!--Category-->
<!--Category-->


[[Category:Drug]]
[[Category:Drug]]

Revision as of 14:13, 4 February 2015

Degarelix
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Aparna Vuppala, M.B.B.S. [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Overview

Degarelix is an anti -neoplastic agent that is FDA approved for the treatment of patients with advanced prostate cancer.. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1
Dosing Information
  • FIRMAGON is for subcutaneous administration only and is not to be administered intravenously.

TABLE02

  • 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 reconstitution procedure needs to be carefully followed. Administration of other concentrations is not recommended. See Instructions for Proper Use.
Instructions for Proper Use
  • NOTE:
  • Gloves should be worn during preparation and administration
  • Reconstituted drug must be administered within one hour after addition of Sterile Water for Injection, USP (WFI)
  • Keep the vials vertical at all times
  • Do not shake the vials
  • Follow aseptic technique
FIRMAGON 120 mg
  • The Treatment Initiation pack contains 2 vials of FIRMAGON 120 mg that must be prepared for 2 subcutaneous injections. Hence, the instructions here below need to be repeated a second time.
  • Prepare FIRMAGON 120 mg for reconstitution by gathering the following:
  • 6 mL of Sterile Water for Injection, USP (WFI); Do not use Bacteriostatic Water for Injection
  • 2 reconstitution needles – 21G / 2 inch
  • 2 administration needles for subcutaneous injection – 27G / 1-1/4 inch
  • 2 injection syringes (5 mL)
  • Draw up 3 mL WFI with a reconstitution needle (21G / 2 in).
  • Inject the WFI slowly into the FIRMAGON 120 mg vial. To keep the product and syringe sterile, do not remove the syringe and the needle.
  • Keeping the vial in an upright position, swirl it very gently until the liquid looks clear and without undissolved powder or particles. If the powder adheres to the vial over the liquid surface, the vial can be tilted slightly to dissolve powder. 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 up to 15 minutes.
  • Tilt the vial slightly and keep the needle in the lowest part of the vial. Withdraw 3 mL of FIRMAGON 120 mg without turning the vial upside down.
  • Exchange the reconstitution needle with the administration needle for deep subcutaneous injection (27G / 1-1/4 in). Remove any air bubbles.
  • Inject 3 mL of FIRMAGON 120 mg subcutaneously immediately after reconstitution.
  • Grasp the skin of the abdomen, elevate the subcutaneous tissue. Insert the needle deeply at an angle of not less than 45 degrees.
  • Gently pull back the plunger to check if blood is aspirated. If blood appears in the syringe, the reconstituted product can no longer be used. Discontinue the procedure and discard the syringe and the needle (reconstitute a new dose for the patient).
  • Repeat reconstitution procedure for the second dose. Choose a different injection site and inject 3 mL.
FIRMAGON 80 mg
  • The Treatment Maintenance pack contains 1 vial of FIRMAGON 80 mg that must be prepared for subcutaneous injection.
  • Prepare FIRMAGON 80 mg for reconstitution by gathering the following:
  • 4.2 mL of Sterile Water for Injection, USP (WFI); Do not use Bacteriostatic Water for Injection
  • 1 reconstitution needle – 21G / 2 inch
  • 1 administration needle for subcutaneous injection – 27G / 1-1/4 inch
  • 1 injection syringe (5 mL)
  • Draw up 4.2 mL WFI with the reconstitution needle (21G / 2 in).
  • Inject the WFI slowly into the FIRMAGON 80 mg vial. To keep the product and syringe sterile, do not remove the syringe and the needle.
  • Keeping the vial in an upright position, swirl it very gently until the liquid looks clear and without undissolved powder or particles. If the powder adheres to the vial over the liquid surface, the vial can be tilted slightly to dissolve powder. 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 up to 15 minutes.
  • Tilt the vial slightly and keep the needle in the lowest part of the vial. Withdraw 4 mL of FIRMAGON 80 mg without turning the vial upside down.
  • Exchange the reconstitution needle with the administration needle for deep subcutaneous injection (27G / 1-1/4 in). Remove any air bubbles.
  • Inject 4 mL of FIRMAGON 80 mg subcutaneously immediately after reconstitution:
  • Grasp the skin of the abdomen, elevate the subcutaneous tissue. Insert the needle deeply at an angle of not less than 45 degrees.
  • Gently pull back the plunger to check if blood is aspirated. If blood appears in the syringe, the reconstituted product can no longer be used. Discontinue the procedure and discard the syringe and the needle (reconstitute a new dose for the patient).

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Degarelix in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Degarelix in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Degarelix in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Degarelix in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Degarelix in pediatric patients.

Contraindications

  • FIRMAGON is contraindicated in patients with known hypersensitivity to degarelix or to any of the product components.
  • Degarelix is contraindicated in women who are or may become pregnant. Degarelix can cause fetal harm when administered to a pregnant woman. Degarelix given to rabbits during organogenesis at doses that were 0.02% of the clinical loading dose (240 mg) on a mg/m2 basis caused embryo/fetal lethality and abortion. When degarelix was given to female rats during organogenesis, at doses that were just 0.036% of the clinical loading dose on a mg/m2 basis, there was an increase post implantation loss and a decrease in the number of live fetuses. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Warnings

Effect on QT/QTc Interval
  • Long-term androgen deprivation therapy prolongs the QT interval. Physicians should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, electrolyte abnormalities, or congestive heart failure and in patients taking Class IA (e.g. quinidine, procainamide) or Class III (e.g. amiodarone, sotalol) antiarrhythmic medications.
  • In the randomized, active-controlled trial comparing FIRMAGON to leuprolide, periodic electrocardiograms were performed. Seven patients, three (<1%) in the pooled degarelix group and four (2%) patients in the leuprolide 7.5 mg group, had a QTcF > 500 msec. From baseline to end of study the median change for FIRMAGON was 12.3 msec and for leuprolide was 16.7 msec.
Laboratory Testing
  • 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.

Adverse Reactions

Clinical Trials Experience

  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
  • A total of 1325 patients with prostate cancer received FIRMAGON either as a monthly treatment (60-160 mg) or as a single dose (up to 320 mg). A total of 1032 patients (78%) were treated for at least 6 months and 853 patients (64%) were treated for one year or more. The most commonly observed adverse reactions during FIRMAGON therapy included injection site reactions (e.g., pain, erythema, swelling, or induration), hot flashes, increased weight, fatigue, and increases in serum levels of transaminases and gamma-glutamyltransferase (GGT). The majority of the adverse reactions were Grade 1 or 2, with Grade 3/4 adverse reaction incidences of 1% or less.
  • FIRMAGON was studied in an active-controlled trial (N = 610) in which patients with prostate cancer were randomized to receive FIRMAGON (subcutaneous) or leuprolide (intramuscular) monthly for 12 months. Adverse reactions reported in 5% of patients or more are shown in Table 1.

TABLE03

  • The most frequently reported adverse reactions at the injection sites were pain (28%), erythema (17%), swelling (6%), induration (4%) and nodule (3%). These adverse reactions were mostly transient, of mild to moderate intensity, occurred primarily with the starting dose and led to few discontinuations (<1%). Grade 3 injection site reactions occurred in 2% or less of patients receiving degarelix.
  • Hepatic laboratory abnormalities were primarily Grade 1 or 2 and were generally reversible. Grade 3 hepatic laboratory abnormalities occurred in less than 1% of patients.
  • In 1-5% of patients the following adverse reactions, not already listed, were considered related to FIRMAGON by the investigator:
  • Body as a whole: Asthenia, fever, night sweats; Digestive system: Nausea; Nervous system: Dizziness, headache, insomnia.
  • The following adverse reactions, not already listed, were reported to be drug-related by the investigator in ≥1% of patients: erectile dysfunction, gynecomastia, hyperhidrosis, testicular atrophy, and diarrhea.
  • Changes in bone density:
  • Decreased bone density has been reported in the medical literature in men who have had orchiectomy or who have been treated with a GnRH agonist. It can be anticipated that long periods of medical castration in men will result in decreased bone density.
  • Anti-degarelix antibody development has been observed in 10% of patients after treatment with FIRMAGON for 1 year. There is no indication that the efficacy or safety of FIRMAGON treatment is affected by antibody formation.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Degarelix in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Degarelix in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Degarelix during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Degarelix with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Degarelix with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Degarelix with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Degarelix with respect to specific gender populations.

Race

There is no FDA guidance on the use of Degarelix with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Degarelix in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Degarelix in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Degarelix in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Degarelix in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Degarelix in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Degarelix in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Degarelix in the drug label.

Pharmacology

There is limited information regarding Degarelix Pharmacology in the drug label.

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Degarelix in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Degarelix in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Degarelix in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Degarelix in the drug label.

How Supplied

Storage

There is limited information regarding Degarelix Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Degarelix in the drug label.

Precautions with Alcohol

  • Alcohol-Degarelix interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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