Firmagon
Degarelix · Kit
Uses
1 INDICATIONS AND USAGE FIRMAGON ® is indicated for treatment of patients with advanced prostate cancer. FIRMAGON is a GnRH receptor antagonist indicated for treatment of patients with advanced prostate cancer. ( 1 )
Dosage and administration
2 DOSAGE AND ADMINISTRATION FIRMAGON is for subcutaneous use only Starting Dosage: 240 mg given as two injections of 120 mg each ( 2.1 ) Maintenance Dosage: 80 mg administered as a single injection every 28 days ( 2.1 ) 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 Each vial is to be reconstituted with a prefilled syringe containing 3 mL of Sterile Water for Injection. 3 mL is withdrawn to deliver 120 mg degarelix at a concentration of 40 mg/mL.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 Each vial is to be reconstituted with a prefilled syringe containing 4.2 mL of Sterile Water for Injection. 4 mL is withdrawn to deliver 80 mg degarelix at a concentration of 20 mg/mL.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.
Dosage forms and strengths
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. For injection: FIRMAGON (240 mg): Two single-dose vials each delivering 120 mg of degarelix in a lyophilized powder for reconstitution supplied with diluent in two prefilled syringes ( 3 ) FIRMAGON (80 mg): One single-dose vial delivering 80 mg of degarelix in a lyophilized powder for reconstitution supplied with diluent in one prefilled syringe ( 3 )
Contraindications
4 CONTRAINDICATIONS 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) ] . Patients with history of severe hypersensitivity reactions to degarelix or to any of the product components ( 4 )
Warnings and precautions
Hypersensitivity: Anaphylaxis, urticaria and angioedema have been reported. Discontinue FIRMAGON if a severe hypersensitivity reaction occurs and manage as clinically indicated ( 5.1 ) QT Interval Prolongation: Androgen deprivation therapy treatment with FIRMAGON may prolong the QT interval. ( 5.2 ) Embryo-Fetal Toxicity: FIRMAGON can cause fetal harm. ( 5.4 , 8.1 ) 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. 5.2 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. 5.3 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. 5.4 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) ].
Side effects
Most common adverse reactions (≥10%) are injection site reactions (e.g., pain, erythema, swelling or induration), hot flashes, and increases in serum levels of transaminases and gamma-glutamyltransferase (GGT) ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ferring at 1-888-FERRING (1-888-337-7464) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 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. FIRMAGON was studied in a randomized, open-label trial in which patients with prostate cancer were randomized to receive FIRMAGON (subcutaneous) or leuprolide (intramuscular) monthly for 12 months [see Clinical Studies (14) ] . The most common adverse reactions (≥10%) during FIRMAGON therapy are injection site reactions (e.g., pain, erythema, swelling or induration), hot flashes, 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. Adverse reactions reported in ≥ 5% of patients treated with FIRMAGON (subcutaneous) 240 mg starting dose and then 80 mg maintenance dose once every 28 days or who were treated with 7.5 mg of leuprolide (intramuscular) every 28 days are shown in Table 2. Table 2: Adverse Reactions Reported in ≥ 5% of Patients FIRMAGON 240/80 mg (subcutaneous) N = 207 Leuprolide 7.5 mg (intramuscular) N = 201 Any adverse reaction 79% 78% Body as a whole Injection site reactions Includes pain, erythema, swelling, induration, or nodule. 35% <1% Weight increase 9% 12% Chills 5% 0% Cardiovascular system Hot flash 26% 21% Hypertension 6% 4% Digestive system Increases in Transaminases and GGT 10% 5% Constipation 5% 5% Musculoskeletal system Back pain 6% 8% Arthralgia 5% 9% Urogenital system Urinary tract infection 5% 9% The following adverse reactions occurred in 1 to < 5% of patients treated with FIRMAGON: Body as a whole: Asthenia, fatigue, fever, night sweats Digestive system: Nausea Nervous system: Dizziness, headache, insomnia The following adverse reactions, not already listed, occurred in ≥ 1% of patients treated in any study with FIRMAGON: Reproductive System: Erectile dysfunction, testicular atrophy Endocrine Disorders: Gynecomastia General : Hyperhidrosis Gastrointestinal : Diarrhea Injection Site Reactions 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 FIRMAGON. Hepatic Laboratory Abnormalities 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. FIRMAGON Extension Study The safety of FIRMAGON administered once every 28 days was evaluated further in an extension study (NCT00451958) in 385 patients who completed the above active-controlled trial. Of the 385 patients, 251 patients continued treatment with FIRMAGON and 135 patients crossed over treatment from leuprolide to FIRMAGON. The median treatment duration on the extension study was approximately 43 months (range 1 to 58 months). The most common adverse reactions reported in ≥10% of the patients were injection site reactions (e.g., pain, erythema, swelling, induration or inflammation), pyrexia, hot flush, weight loss or gain, fatigue, increases in serum levels of hepatic transaminases and GGT. One percent of patients had injection site infections including abscess. Hepatic laboratory abnormalities in the extension study included the following: Grade 1/2 elevations in hepatic transaminases occurred in 47% of patients and Grade 3 elevations occurred in 1% of patients. 6.2 Immunogenicity As with all peptides, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. Anti-Degarelix Antibodies 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. 6.3 Postmarketing Experience The following adverse reactions have been identified during post-approval use of FIRMAGON. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 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.
Drug interactions
No drug-drug interaction studies were conducted. Degarelix is not a substrate for the human CYP450 system. Degarelix is not an inducer or inhibitor of the CYP450 system in vitro . Therefore, clinically significant CYP450 pharmacokinetic drug-drug interactions are unlikely.
Use in specific populations
Females and males of reproductive potential: FIRMAGON may impair fertility ( 8.3 ) Patients with severe liver or kidney dysfunction have not been studied and caution is therefore warranted ( 8 ) 8.1 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. 8.2 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. 8.3 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) ]. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 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. 8.6 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. 8.7 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.
Pregnancy
8.1 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.
Pediatric use
8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established.
Geriatric use
8.5 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.
Overdosage
There have been no reports of overdose with FIRMAGON. In the case of overdose, however, discontinue FIRMAGON, treat the patient symptomatically, and institute supportive measures.
Description
11 DESCRIPTION FIRMAGON is a sterile lyophilized powder for injection containing degarelix (as the acetate) and mannitol. Degarelix is a synthetic linear decapeptide amide containing seven unnatural amino acids, five of which are D-amino acids. The acetate salt of degarelix is a white to off-white amorphous powder of low density as obtained after lyophilization. The chemical name of degarelix is D-Alaninamide, N -acetyl-3-(2-naphthalenyl)-D-alanyl-4-chloro-D-phenylalanyl-3-(3-pyridinyl)-D-alanyl-L-seryl-4-[[[(4S)-hexahydro-2,6-dioxo-4-pyrimidinyl]carbonyl]amino]-L phenylalanyl-4-[(aminocarbonyl)amino]-D-phenylalanyl-L-leucyl- N 6–(1-methylethyl)-L-lysyl-L-prolyl. It has an empirical formula of C 82 H 103 N 18 O 16 Cl and a molecular weight of 1632.3 Da. Degarelix acetate has the following structural formula: FIRMAGON is available in two packaging configurations: Starting Dose: Two vial carton with each vial delivering 120 mg of degarelix (equivalent to the median value of 126 mg degarelix acetate). Each 120 mg dose contains 150 mg mannitol. Maintenance Dose: One-vial carton delivering 80 mg of degarelix (equivalent to the median value of 84 mg degarelix acetate). Each 80 mg dose contains 200 mg mannitol. Chemical Structure
Mechanism of action
12.1 Mechanism of Action Degarelix is a GnRH receptor antagonist. It binds reversibly to the pituitary GnRH receptors, thereby reducing the release of gonadotropins and consequently testosterone.
How supplied
16 HOW SUPPLIED/STORAGE AND HANDLING FIRMAGON is available as: NDC 55566-8403-1, Starting dose – One carton contains: Two single-dose vials each delivering 120 mg of degarelix in a white to off-white lyophilized powder for injection Two prefilled syringes each containing 3 mL of Sterile Water for Injection, USP Two vial adapters Two administration needles NDC 55566-8303-1, Maintenance dose – One carton contains: One single-dose vial delivering 80 mg of degarelix in a white to off-white lyophilized powder for injection One prefilled syringe containing 4.2 mL of Sterile Water for Injection, USP One vial adapter One administration needle Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [see USP Controlled Room Temperature].
Storage
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [see USP Controlled Room Temperature].
Patient information
Advise the patient to read the FDA-approved patient labeling (Patient Information). Hypersensitivity Inform patients that if they have experienced severe hypersensitivity with degarelix or to any of the product components, FIRMAGON is contraindicated [see Contraindications (4) ]. Instruct patients to immediately report signs of a severe hypersensitivity reaction [see Warnings and Precautions (5.1) ]. QT Interval Prolongation Advise patients that androgen deprivation therapy treatment with FIRMAGON may prolong the QT interval. Inform patients of the signs and symptoms of QT prolongation. Advise patients to contact their healthcare provider immediately for signs or symptoms of QT prolongation [see Warnings and Precautions (5.2) ]. Androgen Deprivation Inform patients about adverese reactions related to androgen deprivation therapy with FIRMAGON, including hot flashes, flushing of the skin, increased weight, decreased sex drive, and difficulties with erectile function [see Adverse Reactions (6.1) ] . Injection Site Reactions Inform patients that FIRMAGON may cause redness, swelling, and itching at the injection site. Advise patients that these adverse reactions are usually mild, self limiting, and decrease within three days [see Adverse Reactions (6.1) ] . Infertility Inform patients that FIRMAGON may cause infertility [see Use in Specific Populations (8.3) ].
Label text from the FDA structured product label by Ferring Pharmaceuticals Inc. (revised Jan 30, 2024). Long sections are shortened; the complete label is on DailyMed.
Firmagon NDC products (2)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 55566-8303 | Kit | Ferring Pharmaceuticals Inc. | NDA |
| 55566-8403 | Kit | Ferring Pharmaceuticals Inc. | NDA |
Frequently asked questions
What is Firmagon used for?
1 INDICATIONS AND USAGE FIRMAGON ® is indicated for treatment of patients with advanced prostate cancer. FIRMAGON is a GnRH receptor antagonist indicated for treatment of patients with advanced prostate cancer. ( 1 )
What are the side effects of Firmagon?
Most common adverse reactions (≥10%) are injection site reactions (e.g., pain, erythema, swelling or induration), hot flashes, and increases in serum levels of transaminases and gamma-glutamyltransferase (GGT) ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ferring at 1-888-FERRING (1-888-337-7464) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because… See the full label for the complete list.
Who makes Firmagon?
Firmagon is listed by 1 labeler in the FDA NDC directory, including Ferring Pharmaceuticals Inc..