Generic name: DAROLUTAMIDE 300mg
Dosage form: tablet, film coated
Medically reviewed by Drugs.com. Last updated on Jul 31, 2019.
The recommended dose of NUBEQA is 600 mg (two 300 mg film-coated tablets) taken orally, twice daily, equivalent to a total daily dose of 1200 mg. Swallow tablets whole with food [see Clinical Pharmacology (12.3)].
Patients receiving NUBEQA should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had a bilateral orchiectomy.
Advise patients to take any missed dose as soon as they remember prior to the next scheduled dose, and not to take two doses together to make up for a missed dose.
If a patient experiences a greater than or equal to Grade 3 toxicity or an intolerable adverse reaction, withhold dosing or reduce to 300 mg twice daily until symptoms improve. Then the treatment may be resumed at a dose of 600 mg twice daily.
Dose reduction below 300 mg twice daily is not recommended.
Recommended Dosage in Patients with Severe Renal Impairment
For patients with severe renal impairment (eGFR 15–29 mL/min/1.73 m2) not receiving hemodialysis, the recommended dose of NUBEQA is 300 mg twice daily [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
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