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Darolutamide is available as a 300 mg oral tablet.

Darolutamide is an anti-androgen and is used for the following:
Castration-resistant prostate cancer that hasn’t yet spread to other areas of the body Metastatic, hormone-sensitive prostate cancer, given together with a chemotherapy called docetaxel (Taxotere)

Darolutamide is an androgen receptor inhibitor (antiandrogen). It’s a type of hormone therapy that works by blocking testosterone from binding to prostate cancer cells. Without testosterone, cancer cells won’t have the fuel they need to grow or spread as well.

Darolutamide is dosed as follows:

• Adults: The typical dose is 600 mg taken by mouth twice a day

Your dose might be different if you have kidney or liver problems.

Darolutamide is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.

Common side effects of Darolutamide:

• Extreme tiredness
• Lower red blood cell count
• Higher blood sugar levels
• Lower white blood cell count
• Changes in liver labs
• Lower blood calcium level
• Constipation
• Not eating as much or not feeling hungry
• Rash
• Bleeding that’s difficult to stop
• Weight gain
• Headaches, dizziness, and other symptoms of high blood pressure

Serious side effects are rare with Darolutamide. Contact your healthcare provider immediately if you experience any of the following.

• Seizures
• Heart problems: chest pain, racing heartbeat, shortness of breath, arm or shoulder pain, swelling of your legs or feet, sudden weight gain, sweating, fatigue, dizziness, nausea or vomiting
• Serious bleeds: bleeding or bruising that doesn’t stop or go away, large amount of bleeding, blood in the urine, throwing up blood, bloody or black and tarry stool
• Severe skin reactions: painful blisters, skin wounds, peeling skin

The following medications may interact with Darolutamide:

• Combined P-gp and Strong or Moderate CYP3A Inducers: Avoid concomitant use
• Combined P-gp and Strong CYP3A Inhibitors: Monitor patients more frequently for Darolutamide adverse reactions
• BCRP Substrates: Avoid concomitant use with drugs that are BCRP substrates where possible. If used together, monitor patients more frequently for adverse reactions and consider dose reduction of the BCRP substrate drug
• OATP1B1 and OATP1B3 Substrates: Concomitant use of Darolutamide may increase the plasma concentrations of OATP1B1 or OATP1B3 substrates. If used together, monitor patients more frequently for adverse reactions and consider dose reduction of these drugs

Various FDA-approved generic manufacturers

Darolutamide can cause harm to your unborn baby and loss of pregnancy (miscarriage). Males who have female partners who may become pregnant should use effective birth control (contraception) during treatment and for 1 week after the last dose of Darolutamide. Talk with your healthcare provider about birth control methods.

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