Darolutamide
Prostatic Neoplasms
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Drug Status
Government Approvals
US(FDA), UK(BNF)
WHO Essential Medicine
NO
Known Teratogen
NO
Pharmaceutical Class
NA
Controlled Drug Substance
NO
Darolutamide
Summary
Darolutamide is used to treat certain types of prostate cancer, including nonmetastatic castration-resistant prostate cancer and metastatic hormone-sensitive prostate cancer.
Darolutamide works by blocking the effects of androgens, which are male hormones that can promote the growth of cancer cells. This helps to stop the growth and spread of cancer cells.
The usual daily dose for adults is 600 mg taken orally twice a day with food, totaling 1200 mg per day. It's not recommended for use in children.
Common side effects include fatigue, pain in the extremities, and rash. Serious adverse effects can include ischemic heart disease and seizures.
Darolutamide is not for use in women, especially those who are pregnant or may become pregnant. It can interact with certain drugs, affecting its effectiveness. It may also decrease fertility in men. Patients should be monitored for cardiovascular risks.
Indications and Purpose
How does Darolutamide work?
Darolutamide is an androgen receptor inhibitor that blocks the effects of androgens, which are male hormones that can promote the growth of prostate cancer cells. By inhibiting these hormones, Darolutamide helps to stop the growth and spread of cancer cells.
Is Darolutamide effective?
Darolutamide has been shown to improve metastasis-free survival and overall survival in patients with non-metastatic castration-resistant prostate cancer and metastatic hormone-sensitive prostate cancer. Clinical trials demonstrated significant benefits in delaying disease progression and improving survival rates.
What is Darolutamide?
Darolutamide is used to treat certain types of prostate cancer, including non-metastatic castration-resistant prostate cancer and metastatic hormone-sensitive prostate cancer. It works by blocking the effects of androgens, male hormones that can promote the growth of cancer cells.
Directions for Use
For how long do I take Darolutamide?
Darolutamide is typically used until disease progression or unacceptable toxicity occurs. The exact duration varies based on individual response and medical condition.
How do I take Darolutamide?
Darolutamide should be taken with food, twice a day. Patients should avoid grapefruit and grapefruit juice while taking this medication.
How should I store Darolutamide?
Store Darolutamide at room temperature between 68°F to 77°F (20°C to 25°C). Keep the bottle tightly closed after first opening and out of reach of children.
What is the usual dose of Darolutamide?
The usual daily dose for adults is 600 mg taken orally twice a day with food, totaling 1200 mg per day. Darolutamide is not indicated for use in children, so there is no recommended dose for this age group.
Warnings and Precautions
Can Darolutamide be taken safely while breastfeeding?
Darolutamide is not indicated for use in women, and there is no data on its presence in human milk. Women should not take this medication while breastfeeding.
Can Darolutamide be taken safely while pregnant?
Darolutamide is not for use in women, especially those who are pregnant or may become pregnant, as it can harm the fetus. Male patients with female partners of reproductive potential should use effective contraception during treatment and for 1 week after the last dose.
Can I take Darolutamide with other prescription drugs?
Darolutamide interacts with drugs that are strong CYP3A4 inducers or inhibitors, which can affect its effectiveness. Patients should avoid using St. John's Wort and consult their doctor about all medications they are taking to avoid interactions.
Is Darolutamide safe for the elderly?
Darolutamide is used in elderly patients, with 88% of study participants being 65 years or older. No overall differences in safety or efficacy were observed between older and younger patients, but elderly patients should be monitored closely for side effects.
Who should avoid taking Darolutamide?
Important warnings include the risk of ischemic heart disease, seizures, and embryo-fetal toxicity. Darolutamide is contraindicated in women who are or may become pregnant. Patients should be monitored for cardiovascular risks and advised on effective contraception.