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Nubeqa

Nubeqa

darolutamide

Manufacturer:

Bayer

Distributor:

Zuellig
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Concise Prescribing Info
Contents
Darolutamide
Indications/Uses
Non-metastatic castration resistant prostate cancer (nmCRPC) in adult men who are at high risk of developing metastatic disease.
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Dosage/Direction for Use
600 mg (two 300-mg tab) bd. Patient w/ severe renal impairment (eGFR 15-29 mL/min/1.73 m2) not receiving haemodialysis Initially 300 mg bd. Patient w/ moderate & severe hepatic impairment (Child-Pugh B & C) Initially 300 mg bd.
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Overdosage
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Administration
Should be taken with food.
Contraindications
Hypersensitivity. Women who are or may become pregnant.
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Special Precautions
Patients w/ clinically significant CV disease in the past 6 mth including stroke, MI, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, & symptomatic CHF; patients w/ history of risk factors for QT prolongation & patients concomitantly taking medicinal products that might prolong the QT interval. Not recommended w/ concomitant use of strong CYP3A4 & P-gp inducers. Patients should be monitored for adverse reactions of BCRP, OATP1B1 & OATP1B3 substrates, if concomitantly taking such products. Avoid co-administration w/ rosuvastatin. Patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Patients w/ severe renal impairment or moderate to severe hepatic impairment. May cause foetal harm. Men engaging in sexual activity w/ a woman of childbearing potential should use a highly effective contraceptive method during & for 1 wk after completion of treatment. May impair fertility in males of reproductive potential.
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Adverse Reactions
Fatigue/asthenic conditions; neutrophil count decreased, bilirubin increased, AST increased. Ischaemic heart disease, heart failure; rash; pain in extremity, musculoskeletal pain, fractures.
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Drug Interactions
Decreased exposure & Cmax w/ strong & moderate CYP3A4 & P-gp inducers (eg, carbamazepine, phenobarb, St. John's Wort, phenytoin, rifampicin). Increased exposure w/ combined P-gp & strong CYP3A4 inhibitor. Increased exposure & Cmax of rosuvastatin. May increase plasma conc of other concomitant BCRP, OATP1B1 & OATP1B3 substrates (eg, methotrexate, sulfasalazine, fluvastatin, atorvastatin, pitavastatin). Decreased exposure & Cmax of midazolam (sensitive CYP3A4 substrate). Additive effect on QT interval w/ medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes eg, class IA or III antiarrhythmics, methadone, moxifloxacin, antipsychotics (eg, haloperidol).
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Caution For Usage
For caution against possible variation of physical aspect of medicine... Click to view Nubeqa detailed prescribing information
Storage
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Description
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Action
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MIMS Class
Cancer Hormone Therapy
ATC Classification
L02BB06 - darolutamide ; Belongs to the class of anti-androgens. Used in treatment of neoplastic diseases.
Presentation/Packing
Form
Nubeqa FC tab 300 mg
Packing/Price
112's
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