Nubeqa
(darolutamide)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
NUBEQA is indicated for the treatment of adult patients with:
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- non-metastatic castration resistant prostate cancer (nmCRPC)
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- metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel.
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 ].
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 ].
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 ].
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 and Clinical Pharmacology ].
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 and Clinical Pharmacology ].
Tablets (300 mg): white to off-white oval film-coated tablets marked with “300” on one side and “Bayer” on the other.
Pregnancy
Risk Summary
The safety and efficacy of NUBEQA have not been established in females. Based on its mechanism of action, NUBEQA can cause fetal harm and loss of pregnancy [see Clinical Pharmacology ]. Animal embryo-fetal developmental toxicology studies were not conducted with darolutamide. There are no human data on the use of NUBEQA in pregnant females.
Lactation
Risk Summary
The safety and efficacy of NUBEQA have not been established in females. There are no data on the presence of darolutamide or its metabolites in human milk, the effect on the breastfed child, or the effect on milk production.
Females and Males of Reproductive Potential
Contraception
Males
Based on the mechanism of action, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 1 week after the last dose of NUBEQA [see Use in Specific Populations ].
Infertility
Males
Based on animal studies, NUBEQA may impair fertility in males of reproductive potential [see Nonclinical Toxicology ].
Pediatric Use
Safety and effectiveness of NUBEQA in pediatric patients have not been established.
Geriatric Use
Of the 954 patients who received NUBEQA in ARAMIS, 88% of patients were 65 years and over, and 49% were 75 years and over. Of the 652 patients who received NUBEQA in ARASENS, 63% of patients were 65 years and over, and 16% were 75 years and over. No overall differences in safety or efficacy were observed between these patients and younger patients in both studies.
Renal Impairment
Patients 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 and Clinical Pharmacology ]. 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.
Hepatic Impairment
Patients 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 and Clinical Pharmacology ]. 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.
Ischemic Heart Disease
Ischemic heart disease, including fatal cases, occurred in patients receiving NUBEQA.
In a randomized study of patients with nmCRPC (ARAMIS), ischemic heart disease occurred in 3.2% of patients receiving NUBEQA and 2.5% receiving placebo, including Grade 3-4 events in 1.7% and 0.4%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA and 0.2% receiving placebo.
In a randomized study of patients with mHSPC (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
Seizure occurred in patients receiving NUBEQA.
In ARAMIS, Grade 1-2 seizure occurred in 0.2% of patients receiving NUBEQA and 0.2% receiving placebo. Seizure occurred 261 and 456 days after initiation of NUBEQA.
In ARASENS, seizure occurred in 0.6% of patients receiving NUBEQA with docetaxel, including one Grade 3 event, and 0.2% receiving placebo with docetaxel. Seizure occurred 38 to 340 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.
Embryo-Fetal Toxicity
The safety and efficacy of NUBEQA have not been established in females. Based on its mechanism of action, NUBEQA can cause fetal harm and loss of pregnancy when administered to a pregnant female [see Clinical Pharmacology ].
Advise males with female partners of reproductive potential to use effective contraception during treatment and for 1 week after the last dose of NUBEQA [see Use in Specific Populations ].