Is Darolutamide approved by the FDA?

Yes, Darolutamide is FDA approved. The U.S. Food and Drug Administration (FDA) approved Darolutamide, marketed under the brand name Nubeqa, on July 30, 2019.

What is Darolutamide?

Darolutamide is an antiandrogen medication used primarily to treat nonmetastatic castration-resistant prostate cancer (nmCRPC). It is classified under the drug classes of antiandrogens and hormones/antineoplastics. The medication comes in the form of an oral tablet, typically dosed at 300 mg.

Uses of Darolutamide

Darolutamide is used to treat prostate cancer that has not spread to other parts of the body (nonmetastatic). It is usually prescribed when other treatments, such as surgery or other medications, have not been successful or have stopped working. The primary use of Darolutamide is for men with nonmetastatic castration-resistant prostate cancer (nmCRPC), which means the cancer continues to grow despite low levels of testosterone.

Dosage

The usual dosage of Darolutamide for adults is 600 mg (two 300 mg tablets) taken orally twice a day. The medication should be taken with food. Patients are often also prescribed a gonadotropin-releasing hormone (GnRH) analog or must have had a bilateral orchiectomy (surgical removal of the testicles) to lower testosterone levels in the body.

Side Effects

Common Side Effects:

• Feeling tired
• Pain in the arms, hands, legs, or feet
• Rash
• Low white blood cell count
• Abnormal liver function tests

Serious Side Effects:

• Severe ongoing nausea or diarrhea
• Painful or difficult urination
• Blood in urine
• Severe headache, blurred vision
• Slow heart rate, weak pulse
• Signs of a blood clot in the lung (chest pain, sudden cough, wheezing, rapid breathing, coughing up blood)
• Signs of a lung infection (fever, chills, cough with mucus, chest pain, shortness of breath)

Warnings and Precautions

• Allergic Reactions: If you experience hives, difficulty breathing, or swelling of the face, lips, tongue, or throat, seek emergency medical help.
• Pregnancy: Darolutamide is not for use by women, especially those who are pregnant or can become pregnant, as it can harm an unborn baby.
• Liver or Kidney Disease: Inform your doctor if you have a history of liver or kidney disease.
• Fertility: It may be harder for men to father a child while using Darolutamide, and effective birth control should be used to prevent pregnancy during treatment and for at least one week after the last dose.

How to Take Darolutamide

• With Food: Darolutamide should be taken with food to enhance absorption.
• Do Not Crush or Chew: Swallow the tablet whole without crushing, chewing, or breaking it.
• Consistency: Take the medication exactly as prescribed by your doctor, typically twice a day.

Drug Interactions

Darolutamide can interact with other medications, which may increase side effects or reduce effectiveness. It is important to inform your healthcare provider about all medications you are taking, including prescription and over-the-counter medicines, vitamins, and herbal products.

Conclusion

Darolutamide (Nubeqa) is an FDA-approved medication used to treat nonmetastatic castration-resistant prostate cancer. Approved on July 30, 2019, it provides a valuable option for men whose prostate cancer has not responded to other treatments. Always consult with a healthcare professional for personalized advice and treatment plans.

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