Nubeqa
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Omid Afkhami Ardakani
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Overview
Nubeqa is a Nonsteroidal Antiandrogen (NSAA) that is FDA approved for the treatment of Non-metastatic Castration-Resistant Prostate Cancer (nmCRPC) in adult men. It can also be used for treatment of Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) in combination with docetaxel in adult men.. Common adverse reactions include Fatigue, Pain in extremities, Rash, Decreased neutrophil count, and Increased liver enzymes.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Non-metastatic Castration-Resistant Prostate Cancer (nmCRPC): The recommended dosage is 600 mg (two 300 mg tablets) taken orally twice daily, equivalent to a total daily dose of 1200 mg.
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC): The recommended dosage is 600 mg (two 300 mg tablets) taken orally twice daily, in combination with docetaxel.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Nubeqa FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
Ischemic Heart Disease: Ischemic heart disease occurred in 4.3% of patients receiving darolutamide. Monitor for signs and symptoms of ischemic heart disease.
Heart Failure: Heart failure occurred in 2.1% of patients receiving darolutamide. Monitor for signs and symptoms of heart failure.
Warnings
There is limited information regarding Nubeqa Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
Fatigue Pain in extremities Rash Decreased neutrophil count Increased liver enzymes
Postmarketing Experience
Hypersensitivity reactions Seizures Clostridium difficile-associated diarrhea
Drug Interactions
P-gp and BCRP Substrates: Darolutamide is a P-gp and BCRP inhibitor. Concomitant use may increase plasma concentrations of P-gp or BCRP substrates. Monitor for adverse reactions and consider dose reduction of these substrates.
OATP1B1 and OATP1B3 Substrates: Darolutamide inhibits OATP1B1 and OATP1B3 transporters. Concomitant use may increase plasma concentrations of OATP1B1 or OATP1B3 substrates. Monitor for adverse reactions and consider dose reduction of these substrates.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Nubeqa in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Nubeqa in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Nubeqa during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Nubeqa in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Nubeqa in pediatric settings.
Geriatic Use
No overall differences in safety or effectiveness were observed between elderly and younger patients.
Gender
There is no FDA guidance on the use of Nubeqa with respect to specific gender populations.
Race
There is no FDA guidance on the use of Nubeqa with respect to specific racial populations.
Renal Impairment
No dosage adjustment is necessary for patients with mild to moderate renal impairment. For patients with severe renal impairment, the recommended dosage is 300 mg taken orally twice daily.
Hepatic Impairment
No dosage adjustment is necessary for patients with mild hepatic impairment. For patients with moderate hepatic impairment, the recommended dosage is 300 mg taken orally twice daily.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Nubeqa in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Nubeqa in patients who are immunocompromised.
Administration and Monitoring
Administration
Darolutamide is administered orally. Swallow tablets whole with food.
Monitoring
Monitor for signs and symptoms of ischemic heart disease and heart failure.
IV Compatibility
There is limited information regarding the compatibility of Nubeqa and IV administrations.
Overdosage
In the event of an overdose, symptomatic and supportive measures should be taken. There is no specific antidote for darolutamide. The drug's extensive protein binding and metabolism limit its removal by dialysis.
Pharmacology
There is limited information regarding Nubeqa Pharmacology in the drug label.
Mechanism of Action
Darolutamide is a nonsteroidal androgen receptor inhibitor that binds to the androgen receptor with high affinity, preventing androgen-receptor mediated signaling. This inhibits the growth of androgen-dependent prostate cancer cells.
Structure
There is limited information regarding Nubeqa Structure in the drug label.
Pharmacodynamics
Darolutamide reduces prostate-specific antigen (PSA) levels in men with prostate cancer. It exhibits anti-androgenic activity, contributing to the inhibition of tumor growth.
Pharmacokinetics
After oral administration, darolutamide reaches its peak plasma concentration (C_max) within 4 hours. It is metabolized primarily via CYP3A4 and excreted mainly through urine and feces. The terminal half-life of darolutamide is approximately 20 hours.
Nonclinical Toxicology
There is limited information regarding Nubeqa Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Nubeqa Clinical Studies in the drug label.
How Supplied
Darolutamide is supplied as 300 mg film-coated tablets. It is available in bottles of 120 tablets.
Storage
Store darolutamide at room temperature, between 20°C to 25°C (68°F to 77°F). Protect from moisture and light. Keep the container tightly closed.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
Patients should be informed to:
Take darolutamide twice daily with food as prescribed.
Notify their healthcare provider if they experience symptoms of ischemic heart disease (e.g., chest pain) or heart failure (e.g., shortness of breath or edema).
Continue therapy even if symptoms improve and follow up regularly with their healthcare provider
Precautions with Alcohol
There are no specific interactions between darolutamide and alcohol. However, alcohol may exacerbate certain adverse effects such as fatigue or dizziness, so caution is advised.
Brand Names
Nubeqa is the primary brand name for darolutamide.
Look-Alike Drug Names
There is limited information regarding Nubeqa Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.