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Nubeqa(darolutamide)
NUBEQA 300 MG Oral Tablet
NO BOXED WARNING

Dosage & Administration

Dosage & Administration

Recommended Dosage: NUBEQA 600 mg, (two 300 mg tablets) administered orally twice daily. Swallow tablets whole. Take NUBEQA with food.

For patients with mHSPC treated with NUBEQA in combination with docetaxel, administer the first cycle of docetaxel within 6 weeks after the start of NUBEQA treatment.

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

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Nubeqa Prescribing Information

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prior authorization

Nubeqa Prior Authorization Resources

Most recent state uniform prior authorization forms

Verified: Jul 26, 2024Arizona - Uniform Prior Authorization Form
Verified: Jul 26, 2024Colorado - Uniform Prior Authorization Form
Verified: Jul 26, 2024Hawaii - Uniform Prior Authorization Form
Verified: Jul 26, 2024Illinois - Uniform Prior Authorization Form
Verified: Jul 26, 2024Indiana - Uniform Prior Authorization Form
Verified: Jul 26, 2024Louisiana - Uniform Prior Authorization Form
Verified: Jul 26, 2024Minnesota - Uniform Prior Authorization Form
Verified: Jul 26, 2024New Hampshire - Uniform Prior Authorization Form
Verified: Jul 26, 2024New Mexico - Uniform Prior Authorization Form
Verified: Jul 26, 2024Oregon - Uniform Prior Authorization Form
Verified: Jul 26, 2024Texas - Uniform Prior Authorization Form
Verified: Jul 07, 2024Washington - Uniform Prior Authorization Form
Verified: Jul 07, 2024Wisconsin - Uniform Prior Authorization Form
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Nubeqa Patient Education

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people also ask

Nubeqa FAQs

8.1 PregnancyThe safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy based on its mechanism of action. However, animal embryo-fetal developmental toxicology studies were not conducted with darolutamide. There are no human data on the use of NUBEQA in pregnant females.
8.2 LactationThe safety and efficacy of NUBEQA have not been established in females. There is no available data on the presence of darolutamide or its metabolites in human milk, the effect on the breastfed child, or the effect on milk production.
8.3 Females and Males of Reproductive Potential - Contraception (Males)Male patients with female partners of reproductive potential should use effective contraception during treatment and for 1 week after the last dose of NUBEQA based on the mechanism of action.
8.3 Females and Males of Reproductive Potential - Infertility (Males)Based on animal studies, NUBEQA may impair fertility in males of reproductive potential.
8.4 Pediatric UseSafety and effectiveness of NUBEQA in pediatric patients have not been established.
8.5 Geriatric UseIn clinical studies, a significant proportion of patients were 65 years and older, and no overall differences in safety or efficacy were observed between these patients and younger patients.
8.6 Renal ImpairmentPatients with severe renal impairment (eGFR 15–29 mL/min/1.73 m²) not receiving hemodialysis have a higher exposure to NUBEQA, and dose reduction is recommended. No dose reduction is needed for patients with mild or moderate renal impairment (eGFR 30-89 mL/min/1.73 m²). The effect of end-stage renal disease (eGFR ≤15 mL/min/1.73 m²) on darolutamide pharmacokinetics is unknown.
8.7 Hepatic ImpairmentPatients with moderate hepatic impairment (Child-Pugh Class B) have a higher exposure to NUBEQA, and dose reduction is recommended. No dose reduction is needed for patients with mild hepatic impairment. The effect of severe hepatic impairment (Child-Pugh C) on darolutamide pharmacokinetics is unknown.
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