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Chỉ định và Liều dùng
Oral
Locally advanced basal cell carcinoma Adult: In cases that have recurred following surgery or radiation therapy, or in those who are not eligible for surgery or radiation therapy: 200 mg once daily. Continue until disease progression or unacceptable toxicity occurs. Dose reduction, dosing interruption, or discontinuation may be required according to individual safety or tolerability (refer to detailed product guidelines).
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Cách dùng
Should be taken on an empty stomach.
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Chống chỉ định
Women of childbearing potential who cannot comply with pregnancy prevention programme (i.e. using 2 methods of recommended contraception). Pregnancy and lactation. Concomitant use with strong CYP3A inhibitors, and strong and moderate CYP3A inducers.
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Thận trọng
Patient with neuromuscular disorders (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).
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Tác dụng không mong muốn
Significant: Musculoskeletal toxicity (including muscle spasms, musculoskeletal pain, and myalgia), increased serum creatine kinase levels.
Blood and lymphatic system disorders: Anaemia, lymphocytopenia. Gastrointestinal disorders: Diarrhoea, abdominal pain, nausea, vomiting, dysgeusia, dyspepsia, constipation, GERD. General disorders and administration site conditions: Fatigue, pain. Investigations: Decreased weight; increased serum creatinine, lipase, ALT/AST and amylase. Metabolism and nutrition disorders: Decreased appetite, dehydration, hyperglycaemia. Musculoskeletal and connective tissue disorders: Myopathy. Nervous system disorders: Headache. Reproductive system and breast disorders: Amenorrhoea. Skin and subcutaneous tissue disorders: Alopecia, abnormal hair growth, pruritus, rash. |
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Chỉ số theo dõi
Obtain serum creatine kinase and serum creatinine at baseline and periodically during treatment. Verify pregnancy status of women of childbearing potential prior to initiation of treatment. Monitor liver function; signs or symptoms of musculoskeletal adverse reactions (e.g. unexplained muscle pain, tenderness, weakness).
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Tương tác
Increased plasma concentrations with moderate CYP3A inhibitors (e.g. erythromycin).
Potentially Fatal: Concomitant use with strong CYP3A inhibitors (e.g. ketoconazole, ritonavir, telithromycin, nefazodone) increases the plasma concentration and efficacy of sonidegib. Strong and moderate CYP3A inducers (e.g. rifampicin, carbamazepine, phenytoin, efavirenz) decreases the plasma concentration and efficacy of sonidegib. |
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Tương tác với thức ăn
Increased bioavailability with food. Increased systemic exposure with a high-fat meal. Concomitant use with St. John's wort decreases the plasma concentration and efficacy of sonidegib.
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Tác dụng
Description:
Mechanism of Action: Sonidegib selectively inhibits Hedgehog (Hh) pathway by binding to the Smoothened (SMO) transmembrane protein, thereby inhibiting Hh signalling and consequently blocking signal transduction. Synonyms: erismodegib; LDE-225. Pharmacokinetics: Absorption: Poorly absorbed from the gastrointestinal tract. Increased systemic exposure with a high-fat meal. Bioavailability: <10%; increased with food. Time to peak plasma concentration: 2-4 hours. Distribution: Plasma protein binding: >97%. Metabolism: Metabolised mainly in the liver by CYP3A4 isoenzyme. Excretion: Mainly via faeces (approx 70%); urine (30%). Elimination half-life: Approx 28 days. |
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Đặc tính
 Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 24775005, Sonidegib. https://pubchem.ncbi.nlm.nih.gov/compound/Sonidegib. Accessed Feb. 23, 2022. |
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Bảo quản
Store below 30°C. Protect from moisture. Follow applicable procedures for receiving, handling, administration, and disposal.
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Phân loại MIMS
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Phân loại ATC
L01XJ02 - sonidegib ; Belongs to the class of hedgehog pathway inhibitors. Used in the treatment of cancer.
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Tài liệu tham khảo
Anon. Sonidegib. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 31/12/2021. Anon. Sonidegib. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 31/12/2021. Buckingham R (ed). Sonidegib. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 31/12/2021. Odomzo 200 mg Hard Capsules (Sun Pharmaceutical Industries Europe B.V). European Medicines Agency [online]. Accessed 31/12/2021. Odomzo Capsule (Sun Pharmaceutical Industries, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 31/12/2021.
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