Nubeqa

Last updated on RxList: 1/25/2021
Nubeqa Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Nubeqa?

Nubeqa (darolutamide) is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.

What Are Side Effects of Nubeqa?

Common side effects of Nubeqa include:

  • fatigue,
  • pain in extremities, and
  • rash

Dosage for Nubeqa

The dose of Nubeqa is 600 mg, (two 300 mg tablets) administered orally twice daily with food. Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.

What Drugs, Substances, or Supplements Interact with Nubeqa?

Nubeqa may interact with rifampicin, itraconazole, midazolam, and rosuvastatin. Tell your doctor all medications and supplements you use.

Nubeqa During Pregnancy and Breastfeeding

It is unknown if Nubeqa is safe for use in women or children. Nubeqa is not recommended for use during pregnancy; it may harm a fetus or cause loss of pregnancy. Males with female partners of reproductive potential are advised to use effective contraception during treatment with Nubeqa and for at least 1 week after the last dose. It is unknown if Nubeqa passes into breast milk or how it would affect a nursing infant Consult your doctor before breastfeeding.

Additional Information

Our Nubeqa (darolutamide) Tablets, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Nubeqa Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe ongoing nausea or diarrhea;
  • painful or difficult urination;
  • blood in your urine;
  • severe headache, blurred vision, pounding in your neck or ears;
  • slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);
  • signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
  • signs of a lung infection--fever, chills, cough with mucus, chest pain, shortness of breath.

Your cancer treatments may be delayed if you have certain side effects.

Common side effects may include:

  • feeling tired;
  • pain in your arms, hands, legs, or feet;
  • rash;
  • low white blood cells; or
  • abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Nubeqa (Darolutamide Tablets)

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Nubeqa Professional Information

SIDE EFFECTS

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

ARAMIS, a randomized (2:1), double-blind, placebo-controlled, multi-center clinical study, enrolled patients who had non-metastatic castration-resistant prostate cancer (nmCRPC). In this study, patients received either NUBEQA at a dose of 600 mg, or a placebo, twice a day. All patients in the ARAMIS study received a concomitant gonadotropin-releasing hormone (GnRH) analog or had a bilateral orchiectomy. The median duration of exposure was 14.8 months (range: 0 to 44.3 months) in patients who received NUBEQA.

Overall, serious adverse reactions occurred in 25% of patients receiving NUBEQA and in 20% of patients receiving placebo. Serious adverse reactions in ≥ 1 % of patients who received NUBEQA included urinary retention, pneumonia and hematuria. Overall 3.9% of patients receiving NUBEQA and 3.2% of patients receiving placebo died from adverse reactions, which included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%) for NUBEQA.

Permanent discontinuation due to adverse reactions occurred in 9% of patients receiving NUBEQA or placebo. The most frequent adverse reactions requiring permanent discontinuation in patients who received NUBEQA included cardiac failure (0.4%), and death (0.4%).

Dosage interruptions due to adverse reactions occurred in 13% of patients treated with NUBEQA. The most frequent adverse reactions requiring dosage interruption in patients who received NUBEQA included hypertension (0.6%), diarrhea (0.5%), and pneumonia (0.5%).

Dosage reductions due to adverse reactions occurred in 6% of patients treated with NUBEQA. The most frequent adverse reactions requiring dosage reduction in patients treated with NUBEQA included fatigue (0.7%), hypertension (0.3%), and nausea (0.3%).

Table 1 shows adverse reactions in ARAMIS reported in the NUBEQA arm with a ≥2% absolute increase in frequency compared to placebo. Table 2 shows laboratory test abnormalities related to NUBEQA treatment and reported more frequently in NUBEQA-treated patients compared to placebo-treated patients in the ARAMIS study.

Table 1: Adverse Reactions in ARAMIS

Adverse Reaction2NUBEQA
(n=954)
Placebo
(n=554)
All Grades
%
Grades ≥ 3
%
All Grades
%
Grades ≥ 3
%
Fatigue1160.6111.1
Pain in extremity6030.2
Rash30.110
1 Includes fatigue and asthenia
2 Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Additionally, clinically significant adverse reactions occurring in 2% or more of patients treated with NUBEQA included ischemic heart disease (4.0% versus 3.4% on placebo) and heart failure (2.1% versus 0.9% on placebo).

Table 2: Laboratory Test Abnormalities in ARAMIS

Laboratory AbnormalityNUBEQA
(N=954)
Placebo
(N=554)
All Grades2
%
Grade 3-42
%
All Grades2
%
Grade 3-42
%
Neutrophil count decreased20490.6
AST increased230.5140.2
Bilirubin increased160.170
1 The denominator used to calculate the rate varied based on the number of patients with a baseline value and at least one post-treatment value.
2 Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Read the entire FDA prescribing information for Nubeqa (Darolutamide Tablets)

© Nubeqa Patient Information is supplied by Cerner Multum, Inc. and Nubeqa Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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