Nubeqa (Darolutamide)
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Dosage & administration
Recommended Dosage
: NUBEQA 600 mg (two 300 mg tablets) administered orally twice daily. Swallow tablets whole. Take NUBEQA with food. (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) agonist or antagonist concurrently or have had a bilateral orchiectomy.
When used in combination with docetaxel for mCSPC, 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)]
.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.
For patients with mCSPC treated with NUBEQA in combination with docetaxel, administer the first cycle of docetaxel within 6 weeks after the start of NUBEQA treatment. (
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) agonist or antagonist concurrently or have had a bilateral orchiectomy.
When used in combination with docetaxel for mCSPC, 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)]
.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.
Patients should also receive a gonadotropin-releasing hormone (GnRH) agonist or antagonist concurrently or have had bilateral orchiectomy. (
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) agonist or antagonist concurrently or have had a bilateral orchiectomy.
When used in combination with docetaxel for mCSPC, 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)]
.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.
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Nubeqa prescribing information
Indications and Usage (NUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with:
NUBEQA is indicated for the treatment of adult patients with:
| 6/2025 |
Dosage and Administration (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) agonist or antagonist concurrently or have had a bilateral orchiectomy. When used in combination with docetaxel for mCSPC, 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)] .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. | 6/2025 |
Warnings and Precautions (Ischemic heart disease, including fatal cases, occurred in patients receiving NUBEQA. In a pooled analysis of ARAMIS and ARANOTE, ischemic heart disease occurred in 3.4% of patients receiving NUBEQA and 2.2% receiving placebo, including Grade 3-4 events in 1.4% and 0.3%, respectively. Ischemic events led to death in 0.4% of patients receiving NUBEQA and 0.4% receiving placebo. In ARASENS, ischemic heart disease occurred in 3.2% of patients receiving NUBEQA with docetaxel and 2% receiving placebo with docetaxel, including Grade 3-4 events in 1.3% and 1.1%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA with docetaxel and 0% receiving placebo with docetaxel. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue NUBEQA for Grade 3-4 ischemic heart disease. , Seizure occurred in patients receiving NUBEQA. In a pooled analysis of ARAMIS and ARANOTE, Grade 1-3 seizure occurred in 0.2% of patients receiving NUBEQA. Seizure occurred from 261 to 665 days after initiation of NUBEQA. In ARASENS, seizure occurred in 0.8% of patients receiving NUBEQA with docetaxel, including two Grade 3 events. Seizure occurred from 38 to 1754 days after initiation of NUBEQA. It is unknown whether anti-epileptic medications will prevent seizures with NUBEQA. Advise patients of the risk of developing a seizure while receiving NUBEQA and of engaging in any activity where sudden loss of consciousness could cause harm to themselves or others. Consider discontinuation of NUBEQA in patients who develop a seizure during treatment. | 6/2025 |
NUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with:
- non-metastatic castration-resistant prostate cancer (nmCRPC). ()
1 INDICATIONS AND USAGENUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with:
- non-metastatic castration-resistant prostate cancer (nmCRPC).
- metastatic castration-sensitive prostate cancer (mCSPC).
- metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel.
NUBEQA is indicated for the treatment of adult patients with:
- non-metastatic castration resistant prostate cancer (nmCRPC)
- metastatic castration-sensitive prostate cancer (mCSPC)
- metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel.
- metastatic castration-sensitive prostate cancer (mCSPC). ()
1 INDICATIONS AND USAGENUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with:
- non-metastatic castration-resistant prostate cancer (nmCRPC).
- metastatic castration-sensitive prostate cancer (mCSPC).
- metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel.
NUBEQA is indicated for the treatment of adult patients with:
- non-metastatic castration resistant prostate cancer (nmCRPC)
- metastatic castration-sensitive prostate cancer (mCSPC)
- metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel.
- metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel. ()
1 INDICATIONS AND USAGENUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with:
- non-metastatic castration-resistant prostate cancer (nmCRPC).
- metastatic castration-sensitive prostate cancer (mCSPC).
- metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel.
NUBEQA is indicated for the treatment of adult patients with:
- non-metastatic castration resistant prostate cancer (nmCRPC)
- metastatic castration-sensitive prostate cancer (mCSPC)
- metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel.
Recommended Dosage
: NUBEQA 600 mg (two 300 mg tablets) administered orally twice daily. Swallow tablets whole. Take NUBEQA with food. (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) agonist or antagonist concurrently or have had a bilateral orchiectomy.
When used in combination with docetaxel for mCSPC, 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)]
.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.
For patients with mCSPC treated with NUBEQA in combination with docetaxel, administer the first cycle of docetaxel within 6 weeks after the start of NUBEQA treatment. (
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) agonist or antagonist concurrently or have had a bilateral orchiectomy.
When used in combination with docetaxel for mCSPC, 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)]
.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.
Patients should also receive a gonadotropin-releasing hormone (GnRH) agonist or antagonist concurrently or have had bilateral orchiectomy. (
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) agonist or antagonist concurrently or have had a bilateral orchiectomy.
When used in combination with docetaxel for mCSPC, 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)]
.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.
Tablets (300 mg): white to off-white oval film-coated tablets marked with "300" on one side and "Bayer" on the other.
- Severe Renal Impairment (not on hemodialysis):Recommended dose is 300 mg twice daily. ()
8.6 Renal ImpairmentPatients with severe renal impairment (eGFR 15–29 mL/min/1.73 m2) who are not receiving hemodialysis have a higher exposure to NUBEQA and reduction of the dose is recommended
[see Dosage and Administration (2.3)and Clinical Pharmacology (12.3)].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. - Moderate Hepatic Impairment:Recommended dose is 300 mg twice daily. ()
8.7 Hepatic ImpairmentPatients with moderate hepatic impairment (Child-Pugh Class B) have a higher exposure to NUBEQA and reduction of the dose is recommended
[see Dosage and Administration (2.4)and Clinical Pharmacology (12.3)].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.
None.
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