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DBID
Registration ID: 176322642
Trade License: TRAD/DNCC/040904/2023
Copyright © All Samadhan - Operated by M/S. Genius Experts | All Rights Reserved
DBID
Registration ID: 176322642
Trade License: TRAD/DNCC/040904/2023
Beacon Pharmaceuticals PLC · Tablet
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The information provided on All Samadhan is intended for general informational purposes only and is prepared based on our best practices. It is not a substitute for professional medical advice, diagnosis, or treatment. While we strive to keep the information accurate and up to date, we do not guarantee its completeness or accuracy. The absence of specific information or warnings about any medicine or service should not be considered as an assurance or endorsement by All Samadhan. All Samadhan shall not be held responsible for any consequences arising from the use of this information. We strongly recommend consulting a qualified healthcare professional or physician for any medical concerns, questions, or clarifications.
Darolutamide is indicated for the treatment of patients with non-metastatic castration resistant prostate cancer.
Darolutamide is an androgen receptor (AR) inhibitor. Darolutamide competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription. A major metabolite, keto-darolutamide, exhibited similar in vitro activity to Darolutamide. In addition, Darolutamide functioned as a progesterone receptor (PR) antagonist in vitro (approximately 1% activity compared to AR). Darolutamide decreased prostate cancer cell proliferation in vitro and tumor volume in mouse xenograft models of prostate cancer.
The recommended dose of Darolutamide is 600 mg (two 300 mg tablets) administered orally twice daily, equivalent to a total dose of 1200 mg. Swallow tablets whole with food. Advice patients to take any missed dose as soon as they remember prior to the next scheduled dose, and not to take two doses together to make up for a missed dose. Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.
Combined P-gp and Strong or Moderate CYP3A Inducers: Avoid concomitant use of Darolutamide with combined P-gp and strong or moderate CYP3A4 Inducers.Combined P-gp and Strong CYP3A4 Inhibitors: Concomitant use of Darolutamide with a combined P-gp and strong CYP3A4 inhibitor increases Darolutamide exposure which may increase the risk of Darolutamide adverse reactions. Monitor patients more frequently for Darolutamide adverse reactions and modify Darolutamide dosage as needed.BCRP (Breast Cancer Resistant Protein) 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.
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The safety and efficacy of Darolutamide have not been established in females. Based on its mechanism of action, Darolutamide can cause fetal harm and loss of pregnancy. Animal embryo-fetal developmental toxicology studies were not conducted with Darolutamide. There are no human data on the use of Darolutamide in pregnant females.
Darolutamide can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception.
Cytotoxic Chemotherapy
Do not store above 25°C temperature. Keep away from light and wet place. Keep out of reach of children.