Firmagon
(degarelix)Dosage & Administration
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Firmagon Prescribing Information
FIRMAGON® is indicated for treatment of patients with advanced prostate cancer.
Dosing information
FIRMAGON is administered as a subcutaneous injection in the abdominal region only at the dosages in Table 1 below.
| Starting Dosage | Maintenance Dosage – Administered once every 28 days |
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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 Each vial is to be reconstituted with a prefilled syringe containing 3 mL of Sterile Water for Injection. 3 mL is withdrawn to deliver 120 mg degarelix at a concentration of 40 mg/mL.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 Each vial is to be reconstituted with a prefilled syringe containing 4.2 mL of Sterile Water for Injection. 4 mL is withdrawn to deliver 80 mg degarelix at a concentration of 20 mg/mL.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:
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| FIRMAGON 80 mg Maintenance Dose Kit contains:
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| In addition the healthcare professional will need:
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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
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| Step 2: Assembling 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
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| Step 4: Preparing the reconstituted injection
Reconstitution time can take up to 15 min but usually takes a few minutes. | |
| Step 5: Transferring the liquid to the syringe
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| Step 6: Preparing the syringe for injection
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| Step 7: Preparing the patient
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| Step 8: Performing the injection
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| Step 9: Locking the needle into the shield
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| Step 10: Advising the patient
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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.
For injection:
- FIRMAGON (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.
- FIRMAGON (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.
Pregnancy
Risk Summary
The safety and efficacy of FIRMAGON have not been established in women.
Based on findings in animal studies and mechanism of action, FIRMAGON can cause fetal harm and loss of pregnancy when administered to a pregnant woman [see Clinical Pharmacology (12.1)]. There are no human data on the use of FIRMAGON in pregnant women to inform the drug-associated risk. In animal developmental and reproductive toxicity studies in rats and rabbits, oral administration of degarelix during organogenesis caused embryo-fetal lethality and abortion as well as increased post-implantation loss and decreased the number of live fetuses in animals at doses less than the clinical loading dose based on body surface area (see Data). Advise pregnant patients and females of reproductive potential of the potential risk to the fetus.
Data
Animal Data
When degarelix was given to rabbits during early organogenesis at doses of 0.002 mg/kg/day (about 0.02% of the clinical loading dose based on body surface area), there was an increase in early post-implantation loss. Degarelix given to rabbits during mid and late organogenesis at doses of 0.006 mg/kg/day (about 0.05% of the clinical loading dose based on body surface area) caused embryo/fetal lethality and abortion. When degarelix was given to female rats during early organogenesis, at doses of 0.0045 mg/kg/day (about 0.036% of the clinical loading dose based on body surface area), there was an increase in early post-implantation loss. When degarelix was given to female rats during mid and late organogenesis, at doses of 0.045 mg/kg/day (about 0.36% of the clinical loading dose based on body surface area), there was an increase in the number of minor skeletal abnormalities and variants.
Lactation
The safety and efficacy of FIRMAGON have not been established in females. There are no data on the presence of degarelix in human milk, the effects on the breastfed child, or the effects on milk production. Because many drugs are present in human milk and because of the potential for serious adverse reactions in a breastfed child from degarelix, a decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother.
Females and Males of Reproductive Potential
Infertility
Based on findings in animals and mechanism of action, degarelix may impair fertility in males and females of reproductive potential [see Nonclinical Toxicology (13.1)].
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
Of the total number of subjects in clinical studies of FIRMAGON, 82% were age 65 and over, while 42% were age 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.
Renal Impairment
No pharmacokinetic studies in renally impaired patients have been conducted. At least 20-30% of a given dose of degarelix is excreted unchanged in the urine. A population pharmacokinetic analysis of data from the randomized study demonstrated that there is no significant effect of mild renal impairment [creatinine clearance (CrCL) 50-80 mL/min] on either the degarelix concentration or testosterone concentration. Data on patients with moderate or severe renal impairment is limited and therefore degarelix should be used with caution in patients with CrCL < 50 mL/min.
Hepatic Impairment
Patients with hepatic impairment were excluded from the randomized trial.
A single dose of 1 mg degarelix administered as an intravenous infusion over 1 hour was studied in 16 non-prostate cancer patients with either mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment. Compared to non-prostate cancer patients with normal liver function, the exposure of degarelix decreased by 10% and 18% in patients with mild and moderate hepatic impairment, respectively. Therefore, dose adjustment is not necessary in patients with mild or moderate hepatic impairment. However, since hepatic impairment can lower degarelix exposure, it is recommended that in patients with hepatic impairment testosterone concentrations should be monitored on a monthly basis until medical castration is achieved. Once medical castration is achieved, an every-other-month testosterone monitoring approach could be considered.
Patients with severe hepatic dysfunction have not been studied and caution is therefore warranted in this group.
FIRMAGON is contraindicated in patients with history of severe hypersensitivity to degarelix or to any of the product components [see Warnings and Precautions (5.1)].
Hypersensitivity Reactions
FIRMAGON is contraindicated in patients with history of severe hypersensitivity to degarelix or to any of the product components [see Contraindications (4)].
Hypersensitivity reactions, including anaphylaxis, urticaria and angioedema, have been reported post-marketing with FIRMAGON.
In case of a severe hypersensitivity reaction, discontinue FIRMAGON immediately if the injection has not been completed, and manage as clinically indicated. Patients with a known history of severe hypersensitivity reactions to FIRMAGON should not be re-challenged with FIRMAGON.
QT Interval Prolongation
Androgen deprivation therapy may prolong the QT interval. Providers should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities, and in patients taking drugs known to prolong the QT interval. Electrolyte abnormalities should be corrected. Consider periodic monitoring of electrocardiograms and electrolytes.
In the randomized, active-controlled trial comparing FIRMAGON to leuprolide, periodic electro-cardiograms 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
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.
Embryo-Fetal Toxicity
Based on findings in animal studies, FIRMAGON can cause fetal harm and loss of pregnancy when administered to a pregnant woman. In animal developmental and reproductive toxicity studies in rats and rabbits, oral administration of degarelix during organogenesis caused embryo-fetal lethality and abortion as well as increased post-implantation loss and decreased the number of live fetuses in animals at doses less than the clinical loading dose based on body surface area. Advise pregnant patients and females of reproductive potential of the potential risk to the fetus [see Use in Specific Populations (8.1)].