Nubeqa (Darolutamide)

Brand Name

Nubeqa

Generic Name

Darolutamide

View Brand Information

FDA approval date: July 31, 2019

Form: Tablet

What is Nubeqa (Darolutamide)?

NUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with: non-metastatic castration-resistant prostate cancer . , metastatic hormone-sensitive prostate cancer in combination with docetaxel. NUBEQA is indicated for the treatment of adult patients with:, non-metastatic castration resistant prostate cancer , metastatic hormone-sensitive prostate cancer in combination with docetaxel.

Approved To Treat

Prostate Cancer

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Brand Information

NUBEQA (darolutamide)

1DOSAGE FORMS AND STRENGTHS

Tablets (300 mg): white to off-white oval film-coated tablets marked with "300" on one side and "Bayer" on the other.

2CONTRAINDICATIONS

None.

3OVERDOSAGE

There is no known specific antidote for darolutamide overdose. The highest dose of NUBEQA studied clinically was 900 mg twice daily, equivalent to a total daily dose of 1800 mg. No dose limiting toxicities were observed with this dose.

Considering the saturable absorption and the absence of evidence for acute toxicity, an intake of a higher than recommended dose of darolutamide is not expected to lead to systemic toxicity in patients with intact hepatic and renal function

In the event of intake of a higher than recommended dose in patients with severe renal impairment or moderate hepatic impairment, if there is suspicion of toxicity, interrupt NUBEQA treatment and undertake general supportive measures until clinical toxicity has been diminished or resolved. If there is no suspicion of toxicity, NUBEQA treatment can be continued with the next dose as scheduled.

4DESCRIPTION

NUBEQA is an androgen receptor inhibitor. The chemical name is N-{(2S)-1-[3-(3-chloro-4-cyanophenyl)-1H-pyrazol-1-yl]propan-2-yl}-5-(1-hydroxyethyl)-1H-pyrazole-3-carboxamide.

The molecular weight is 398.85 and the molecular formula is C

Darolutamide is an optically active with a specific rotation value [α]

NUBEQA (darolutamide) is supplied as film-coated tablets containing 300 mg of darolutamide for oral use. The inactive ingredients of the tablet are: calcium hydrogen phosphate, croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone K 30, hypromellose 15 cP, macrogol 3350, and titanium dioxide.

5PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information)

6PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

50419-395-01

Rx Only

NUBEQA

(darolutamide) tablets

300 mg

120 film-coated tablets