Antiandrogens
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Nubeqa Dosage

Drug Detail:Nubeqa (Darolutamide [ dar-oh-loo-ta-mide ])

Generic Name: DAROLUTAMIDE 300mg

Dosage Form: tablet, film coated

Drug Class: Antiandrogens Hormones / antineoplastics

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

Recommended Dosage

​nmCRPC and mHSPC

​The recommended dose of NUBEQA is 600 mg (two 300 mg tablets) taken orally, twice daily, with food [see Clinical Pharmacology (12.3)].

​Continue treatment until disease progression or unacceptable toxicity occurs.

​Patients receiving NUBEQA should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or have had a bilateral orchiectomy.

​Advise patients to swallow tablets whole with food, 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.

​mHSPC

​For patients with mHSPC treated with NUBEQA in combination with docetaxel, administer the first of 6 cycles of docetaxel within 6 weeks after the start of NUBEQA treatment. Refer to docetaxel prescribing information for additional dosing information, including dosage modifications.

​Treatment with NUBEQA may be continued until disease progression or unacceptable toxicity, even if a cycle of docetaxel is delayed, interrupted, or discontinued [see Dosage and Administration (2.2)].

Dosage Modification

If a patient experiences a greater than or equal to Grade 3 or an intolerable adverse reaction, withhold NUBEQA or reduce dosage to 300 mg twice daily until symptoms improve. NUBEQA may be resumed at a dose of 600 mg twice daily, when adverse reaction returns to baseline [see Adverse Reactions (6.1]. Dosage reduction below 300 mg twice daily is not recommended.

​For ischemic heart disease, seizure and hepatotoxicity [see Warnings and Precautions (5.1, 5.2, and 5.3)].

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)].

Recommended Dosage in Patients with Moderate Hepatic Impairment

For patients with moderate hepatic impairment (Child-Pugh Class B), the recommended dose of NUBEQA is 300 mg twice daily [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

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