To ensure the best results with darolutamide:

• Take Exactly as Prescribed: Follow your doctor’s instructions carefully. Take the prescribed dose at the same times each day, and do not skip doses.
• With Food: Darolutamide should be taken with food to help the body absorb the medication more effectively.
• Do Not Chew or Break Tablets: Swallow the tablets whole with a glass of water.

Darolutamide works by inhibiting the androgen receptor, which is a protein found on the surface of prostate cancer cells. Androgens, like testosterone, usually bind to these receptors and stimulate the growth of cancer cells. By blocking the androgen receptor, darolutamide prevents testosterone and other hormones from affecting the cancer cells, helping to stop or slow the growth of the tumor.

This medication is effective in treating non-metastatic prostate cancer, meaning it helps control the disease before it spreads to other parts of the body.

Like all medications, darolutamide can cause side effects. Some common side effects include:

• Fatigue: Some patients may feel unusually tired or weak while on darolutamide.
• Skin Rash: A rash or other skin reactions may occur in some individuals.
• Back Pain: Back pain or muscle pain may develop.
• Joint Pain: Some patients may experience joint discomfort or stiffness.
• Headache: Mild headaches are also a common side effect.

Serious side effects, although rare, may include:

• Liver Problems: Symptoms such as yellowing of the skin or eyes (jaundice), dark urine, or upper stomach pain could indicate liver issues.
• Heart Problems: Uncommon, but some people may experience changes in heart rate or rhythm.

If you experience any unusual symptoms or signs of severe reactions, contact your healthcare provider immediately.

Before starting darolutamide, be sure to discuss any existing health conditions with your doctor, especially:

• Liver Problems: If you have liver issues, your doctor may need to monitor your liver function during treatment.
• Pregnancy and Breastfeeding: Darolutamide is not intended for use by women, especially during pregnancy or breastfeeding, as it can harm an unborn baby.
• Heart Issues: If you have a history of heart problems, including heart rhythm disorders, inform your doctor, as darolutamide may affect your heart rate.
• Allergies: Let your doctor know if you are allergic to darolutamide or any of its ingredients.

Darolutamide can interact with certain medications, so it’s important to inform your doctor about all other drugs you are taking, including over-the-counter medications and supplements. Some notable interactions include:

• CYP3A4 Inhibitors: Medications that affect the CYP3A4 enzyme, such as ketoconazole, itraconazole, and some HIV medications, can increase the levels of darolutamide in your body, which may increase the risk of side effects.
• CYP3A4 Inducers: Medications that increase the activity of the CYP3A4 enzyme, like rifampin or St. John’s Wort, may lower the effectiveness of darolutamide by reducing its levels in the bloodstream.
• Other Medications for Prostate Cancer: If you are taking other drugs for prostate cancer, such as LHRH agonists or anti-androgens, make sure your doctor is aware, as these may affect how darolutamide works.

• Starting Dose: 600 mg per day (two 300 mg tablets), divided into two doses (one in the morning and one in the evening).
• Adjustments: Your doctor may adjust your dosage if needed based on how you respond to the treatment.

Darolutamide is available only by prescription. Your doctor will evaluate your condition to determine if darolutamide is the right treatment option for you, and will guide you through the treatment process.

1. What is Darolutamide used for?
   Treatment of non-metastatic castration-resistant prostate cancer (nmCRPC).

2. How does Darolutamide work?
   It is an androgen receptor inhibitor that blocks the effects of male hormones fueling prostate cancer.

3. Is Darolutamide a hormone therapy?
   Yes, it targets androgen receptors specifically.

4. How is Darolutamide administered?
   Orally, usually as tablets taken twice daily.

5. What is the usual dose of Darolutamide?
   600 mg twice daily (four 150 mg tablets per dose).

6. Can Darolutamide be taken with food?
   Yes, it can be taken with or without food.

7. What are common side effects of Darolutamide?
   Fatigue, pain, rash, headache, and hypertension.

8. Does Darolutamide affect the brain or cause seizures?
   It has a low penetration of the blood-brain barrier; seizures are rare.

9. Is Darolutamide safe for women?
   It is intended for men; safety in women is not established.

10. Can Darolutamide be used with other prostate cancer treatments?
    Yes, often used with androgen deprivation therapy (ADT).

11. Does Darolutamide cause hair loss?
    Hair loss is uncommon but possible.

12. Are there any drug interactions with Darolutamide?
    Yes, especially with CYP3A4, CYP2C9, and CYP2C19 substrates and inhibitors.

13. Is Darolutamide approved by the FDA?
    Yes, approved for nmCRPC treatment.

14. How long is treatment with Darolutamide?
    Typically continued until disease progression or unacceptable toxicity.

15. Is Darolutamide a chemotherapy drug?
    No, it is a targeted hormonal therapy.

16. Does Darolutamide increase risk of fractures?
    Bone health should be monitored; fractures are a known risk in advanced prostate cancer.

17. Can Darolutamide cause liver damage?
    Rare liver toxicity can occur; liver function tests are recommended periodically.

18. Is dose adjustment needed for kidney or liver problems?
    Caution advised; dose adjustment may be necessary depending on severity.

19. Is Darolutamide a controlled substance?
    No.

20. Is Darolutamide available as a generic?
    No generic available yet.