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The following safety information highlights potential risks and necessary precautions when using Nubeqa (darolutamide). It is important to read these warnings carefully and discuss any concerns with your healthcare provider.

• Heart Artery Blockage: Nubeqa can infrequently lead to blockage of the heart's arteries, potentially resulting in a heart attack. Monitoring for heart-related symptoms is recommended during treatment. Contact your healthcare provider immediately if you experience chest pain, discomfort, or shortness of breath, as these may indicate heart problems. Be aware of additional risk factors such as high blood sugar, high blood pressure, and high cholesterol.

• Seizure Risk: There is a rare possibility of seizures occurring with Nubeqa usage, sometimes as soon as five weeks after starting treatment. Inform your healthcare provider if you have a history of seizures, are at risk for seizures, or are on medications that could increase this risk. It's crucial to make loved ones and caregivers aware of this potential so they can assist you in seeking medical help if needed. Discontinue Nubeqa and notify your provider immediately if you suspect a seizure, as a medication change may be necessary. Early seizure signs can include unusual tastes or smells, anxiety, nausea, or sensations of fluttering.

• Potential Harm to Unborn Babies: Nubeqa may cause harm to unborn children. If your partner can become pregnant, it is advised to use birth control, such as condoms, during treatment and for one week following the last dose. Contact your healthcare provider immediately if your partner becomes pregnant during this period.

There are no known contraindications for Nubeqa at this time. Always consult with your healthcare provider for personalized advice and follow their recommendations.

When taking this medication, you may experience some common side effects such as tiredness, weakness, nausea, or pain in your arms, legs, hands, or feet. While these are typically mild, it's important to consult your healthcare provider if they persist or worsen. Additionally, you might notice higher liver lab results, lower white blood cell counts, or increased tiredness, which occur in some individuals. Keep an eye on your blood pressure, as this medication may cause an increase, potentially leading to headaches or dizziness.

There are other side effects to be mindful of, including lower red blood cell counts, higher blood sugar levels, and changes in liver function. Some patients report lower blood calcium levels, constipation, decreased appetite, rash, persistent bleeding, weight gain, and a general feeling of fatigue. If you experience any of these, especially if they become severe, it's advisable to contact your healthcare provider.

Rare but serious side effects require immediate medical attention. These include symptoms of a heart attack, such as chest pain, shortness of breath, or unusual sweating, as well as seizures. Additionally, this medication may lower your immune response, increasing your risk of infections. Seek medical help if you notice signs of an infection like a persistent sore throat, fever, or chills. A severe allergic reaction, though rare, is also possible, indicated by symptoms such as rash, swelling, severe dizziness, or trouble breathing. Always reach out to your healthcare provider if you notice any side effects not listed here.