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.
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 )
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 <span class="opacity-50 text-xs">[see Contraindications (4) ]</span>. 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 <span class="opacity-50 text-xs">[see Use in Specific Populations (8.1) ]</span>.