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Indications & Uses
Degarelix Acetate is a gonadotrophin releasing hormone (GnRH) antagonist. Doctors use it to treat adult men who have advanced hormone-dependent prostate cancer.
Pharmacology
Degarelix is a selective gonadotrophin releasing-hormone (GnRH) antagonist. It binds to the GnRH receptors in the pituitary gland, competitively and reversibly, and this quickly lowers the release of the gonadotrophins luteinizing hormone (LH) and follicle stimulating hormone (FSH). With less LH and FSH, the testes secrete less testosterone (T). Prostatic carcinoma is known to be androgen sensitive, so it responds to treatment that removes the source of androgen.
GnRH agonists can cause an LH surge after treatment starts, followed by a testosterone surge, tumour stimulation and a possible symptomatic flare. GnRH antagonists like degarelix don't do this.
A single dose of 240 mg degarelix, followed by a monthly maintenance dose of 80 mg, quickly lowers the concentrations of LH, FSH and then testosterone. The serum concentration of dihydrotestosterone (DHT) falls in a similar way to testosterone. Degarelix achieves and maintains testosterone suppression well below the medical castration level of 0.5 ng/ml. With monthly maintenance dosing of 80 mg, testosterone stayed suppressed for at least one year in 97% of patients. No testosterone microsurges were seen after re-injection during degarelix treatment. After one year of treatment the median testosterone level was 0.087 ng/ml (interquartile range 0.06 to 0.15), N=167.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
The starting dose of degarelix is 240 mg, given as two consecutive subcutaneous injections of 120 mg each. After that comes the maintenance dose, 80 mg as one subcutaneous injection, given monthly. The first maintenance dose should be given one month after the starting dose.
The therapeutic effect of degarelix should be monitored by clinical parameters and prostate specific antigen (PSA) serum levels. Clinical studies have shown that testosterone (T) suppression occurs immediately after the starting dose. After three days, 96% of the patients had serum testosterone levels corresponding to medical castration (T≤0.5 ng/ml), and after one month it was 100%. With long term treatment on the maintenance dose for up to 1 year, 97% of the patients kept their testosterone levels suppressed (T≤0.5 ng/ml).
If a patient's clinical response appears to be sub-optimal, confirm that serum testosterone levels are remaining sufficiently suppressed. Since degarelix does not induce a testosterone surge, it is not necessary to add an anti androgen as surge protection at initiation of therapy.
Side Effects
In the confirmatory phase III study (N=409), the side effects seen most often with degarelix were the expected result of lowering testosterone, along with reactions at the injection site. Hot flushes and weight increase were reported in 25% and 7% of patients, respectively, among those treated for one year. Chills, fever or influenza like illness came on a few hours after a dose, in 3%, 2% and 1% of patients, respectively, and these were transient. The injection site reactions were mainly pain and erythema, reported in 28% and 17% of patients, respectively. Swelling (6%), induration (4%) and nodule (3%) were reported less often. These events happened mostly with the starting dose. During maintenance therapy with the 80 mg dose, the incidence per 100 injections was 3 for pain and <1 for erythema, swelling, nodule and induration. The reported events were mostly transient and of mild to moderate intensity, and they led to very few discontinuations (<1%). Serious injection site reactions were very rarely reported. These included injection site infection, injection site abscess or injection site necrosis, and they could require surgical treatment or drainage.
Cautions & Contraindications
Contraindications
Degarelix Acetate must not be given to anyone who is hypersensitive to the active substance or to any of the excipients in the preparation.
Pregnancy & Breastfeeding
Degarelix Acetate has no relevant use in women. In men, it may reduce fertility for as long as the testosterone level stays suppressed.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Elderly, hepatically or renal impaired patients: Degarelix Acetate needs no dose adjustment for elderly patients, or for patients with mild or moderate liver or kidney impairment. Patients with severe liver or kidney impairment haven't been studied, so caution is needed.
Paediatric population: Degarelix Acetate has no relevant use in children and adolescents for treating adult male patients with advanced hormone-dependent prostate cancer.
Overdose
Nobody has clinical experience of what happens after an acute overdose of degarelix. If an overdose does occur, the patient should be monitored, and appropriate supportive treatment should be given if it's considered necessary.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Degarelix Acetate doesn't need any special storage conditions. Once it has been reconstituted, its chemical and physical stability has been shown for 2 hours at 25°C. From a microbiological point of view, the product should be used immediately, unless the way it was reconstituted rules out the risk of microbial contamination. If it isn't used straight away, the storage times and conditions after preparation are the responsibility of the user.
Drug Interactions
Common questions about Degaris 120 mg
What is Degaris 120 mg SC Injection?
Degaris 120 mg SC Injection is a medicine that contains Degarelix Acetate. It is made by Eskayef Pharmaceuticals Ltd. It belongs to the Drugs affecting (inhibiting) gonadotrophin group of medicines.
What is Degaris used for?
Degarelix Acetate is a gonadotrophin releasing hormone (GnRH) antagonist. Doctors use it to treat adult men who have advanced hormone-dependent prostate cancer.
What are the side effects of Degaris?
In the confirmatory phase III study (N=409), the side effects seen most often with degarelix were the expected result of lowering testosterone, along with reactions at the injection site. Hot flushes and weight increase were reported in 25% and 7% of patients, respectively, among those treated for one year.
Can I take Degaris during pregnancy or while breastfeeding?
Degarelix Acetate has no relevant use in women. In men, it may reduce fertility for as long as the testosterone level stays suppressed. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Degaris?
Nobody has clinical experience of what happens after an acute overdose of degarelix. If an overdose does occur, the patient should be monitored, and appropriate supportive treatment should be given if it's considered necessary. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Degaris?
Degarelix Acetate doesn't need any special storage conditions. Once it has been reconstituted, its chemical and physical stability has been shown for 2 hours at 25°C.
Can I take other medicines with Degaris?
Some medicines can interact with Degarelix Acetate, for example: Amiodarone Hydrochloride, Disopyramide, Moxifloxacin, Sotalol Hydrochloride, Dofetilide. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Degaris?
Degaris is a prescription (Rx) medicine. Take it as your doctor advises.