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Chỉ định và Liều dùng
Subcutaneous
Advanced prostate cancer Adult: Loading dose: As 40 mg/mL solution: 240 mg (given as 2 separate injections of 120 mg). Maintenance: As 20 mg/mL solution: 80 mg once every 28 days, starting 28 days after the initial dose. Doses are administered in the abdominal area.
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Hướng dẫn pha thuốc
Add 4.2 or 3 mL of sterile water for injection to a vial containing 80 or 120 mg, respectively, to provide a 20 or 40 mg/mL solution, respectively. Swirl gently, do not shake.
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Chống chỉ định
Hypersensitivity. Pregnancy and lactation.
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Thận trọng
Patient with congenital long QT syndrome, history of or risk factors for QT prolongation (e.g. cardiac failure, electrolyte imbalance) and CV disease; diabetes, risk factors for low BMD. Moderate to severe renal (CrCl <50 mL/min) and severe hepatic impairment.
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Tác dụng không mong muốn
Significant: Anaemia, hypersensitivity reactions, QT prolongation, decreased BMD, decreased glucose tolerance, CV disease, antibody formation.
Gastrointestinal disorders: Nausea, constipation, diarrhoea. General disorders and administration site conditions: Chills, fatigue, pyrexia, influenza-like illness, injection site reactions (e.g. erythema, pain), asthenia, night sweats. Investigations: Increased hepatic transaminases. Metabolism and nutrition disorders: Increased weight. Musculoskeletal and connective tissue disorders: Back pain, arthralgia. Nervous system disorder: Dizziness, headache. Psychiatric disorders: Insomnia. Reproductive system and breast disorders: Gynaecomastia, erectile dysfunction, testicular atrophy. Skin and subcutaneous tissue disorders: Rash, hyperhidrosis. Vascular disorders: Hot flush, hypertension. Potentially Fatal: Rarely, anaphylaxis. |
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Thông tin tư vấn bệnh nhân
This drug may cause dizziness and fatigue, if affected, do not drive or operate machinery.
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Chỉ số theo dõi
Monitor prostate-specific antigen (PSA), serum testosterone levels, LFTs, serum electrolytes (e.g. Na, K, Ca, Mg), BMD, ECG.
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Tương tác
Increased risk of QT prolongation with class IA (e.g. disopyramide) or class III (e.g. amiodarone) antiarrhythmics, antipsychotics, methadone and moxifloxacin.
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Ảnh hưởng đến kết quả xét nghiệm
May interfere with diagnostic test results for gonadotropic and gonadal functions.
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Tác dụng
Description:
Mechanism of Action: Degarelix, a synthetic decapeptide, reversibly and competitively binds to gonadotropin-releasing hormone (GnRH) receptors in the anterior pituitary gland, thereby decreasing secretion of luteinising hormone (LH) and follicle stimulating hormone (FSH), and subsequently reducing testicular androgen synthesis. Pharmacokinetics: Absorption: Time to peak plasma concentration: Within 2 days (loading dose). Distribution: Volume of distribution: Approx 1 L/kg. Plasma protein binding: Approx 90%. Metabolism: Undergoes peptide hydrolysis in the hepato-biliary system. Excretion: Mainly via faeces (approx 70-80%, mainly as peptide fragments); via urine (approx 20-30%). Terminal elimination half-life: Approx 43-53 days (loading dose); approx 28 days (maintenance dose). |
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Đặc tính
 Source: National Center for Biotechnology Information. PubChem Database. Degarelix, CID=16136245, https://pubchem.ncbi.nlm.nih.gov/compound/Degarelix (accessed on Jan. 20, 2020) |
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Bảo quản
Store at or below 25°C.
Follow applicable procedures for receiving, handling, administration and disposal. Wear gloves during receiving, unpacking, and placing in storage. |
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Phân loại MIMS
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Phân loại ATC
L02BX02 - degarelix ; Belongs to the class of other hormone antagonists and related agents. Used in the treatment of advanced prostate cancer.
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Tài liệu tham khảo
Anon. Degarelix. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 03/04/2018. Anon. Degarelix. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 03/04/2018. Buckingham R (ed). Degarelix. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com . Accessed 03/04/2018. Firmagon (Ferring Pharmaceuticals Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 03/04/2018. Joint Formulary Committee. Degarelix. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/04/2018.
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