DAROLUTAMIDE

Darolutamide is an anti-cancer medication initially approved for treating non-metastatic, castration-resistant prostate cancer (cancer that does not spread to other parts of the body and cannot be surgically treated). Subsequently, on 05 August 2005, the FDA approved darolutamide for treating metastatic hormone-sensitive prostate cancer.

Darolutamide is used to treat non-metastatic, castration-resistant prostate cancer (prostate cancer that hasn’t spread to other body parts and does not respond to surgical treatment). It is also indicated to treat hormone-sensitive metastatic prostate cancer (cancer that spreads to other parts of the body) in combination with other anticancer medications.

Darolutamide is available as an oral tablet. It is a prescription medicine. The tablet should be taken exactly as prescribed by your healthcare provider. Swallow this medication whole with water. It can be taken with food. Do not break, crush, or chew the tablet. Your doctor will decide the frequency of the tablet based on your disease severity and other factors.

The common side effects of darolutamide are fatigue, rash, muscle pain, bone pain, pain in the arms and legs, and broken bones. Serious side effects include chest pain, pain in arms, jaw, neck, and back, lightheadedness or dizziness, shortness of breath, swelling of ankles and legs, and seizures. Even though all medicines have side effects, not everyone gets them.

Risk of ischemic heart disease is high in patients receiving this medication regularly. Regular monitoring of signs and symptoms of heart attack is necessary. Report symptoms of chest pain, pain in arms, jaw pain, and shoulder pain immediately. Darolutamide is not indicated for women, especially if they are pregnant, because it causes severe birth defects in the baby. Inform your physician if you have seizures, lung disorders, kidney problems, or heart problems, including changes in heart rhythm and hypertension, before starting the treatment with this medicine.

Inform your physician about all the prescription medicines, over-the-counter medicines, nutritional or vitamin supplements, nasal flu vaccine, and herbal products that you are currently taking or have taken before. It is advised to use contraceptives if you have a female partner with reproducing ability. Use contraceptives during the treatment and for 1 week after the last dose. If you come into contact with this medicine and are pregnant or breastfeeding, it is advisable to discuss it with your physician. Your healthcare professional may advise you to take certain blood tests to monitor the effectiveness and side effects of the therapy.

Do not take this medicine if you have an allergy to darolutamide or any ingredient in the formulation. This medicine should be taken with food. Inform your doctor if you experience symptoms of seizures, swelling in the legs, ankles, and face, abdominal pain, shortness of breath, or chest pain after taking this medicine. Notify your doctor if you are taking any antibiotics, cholesterol medications, or other prescribed medicines. Darolutamide is not indicated in children and adolescents below 18 years of age. Pregnant and breastfeeding women should not use this medication, as it is used to treat prostate cancer.

Bayer (Pty) Ltd, Patient information leaflet, [Revised on 15th March 2022], [Accessed on 8th August 2], https://www.bayer.com/sites/default/files/NUBEQA_EN_PIL.pdf#page=2 Orion Corporation, Orion Pharma, Electronics Medicine Compendium (emc), [Revised on January 2021], [Accessed on 8th August 2022], https://www.medicines.org.uk/emc/files/pil.11324.pdf Bayer HealthCare Pharmaceuticals Inc, U.S. Food and Drug Administration, [Revised on July 2019], [Accessed on 8th August 2022], https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212099Orig1s000lbl.pdf Goodman & Gilman’s, The Pharmacological Basis of Therapeutics, Natural products in cancer chemotherapy: hormones and related agents, 12th edition, 2011, 1707 - 1709.