Nubeqa (darolutamide)

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Non-english packaging - English label and English insert included. Plan in advance - allow us 7 days to ship your medicine

Manufacturing site for all Nubeqa (EU/USA/everywhere): Orion Corporation, Orion Pharma 24100 Salo Finland

Information about Nubeqa (Darolutamide)

Nubeqa (generic name: darolutamide) is an oral medication used to treat prostate cancer. It is a nonsteroidal androgen receptor inhibitor that works by blocking the action of male hormones (androgens), such as testosterone, which can stimulate the growth of prostate cancer cells. Darolutamide is primarily used in combination with other treatments or as a monotherapy in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic castration-sensitive prostate cancer (mCSPC), in conjunction with other cancer therapies like androgen deprivation therapy (ADT).

Nubeqa works by blocking the androgen receptor in prostate cancer cells, preventing androgens from binding to these receptors and thereby slowing or halting the growth of the cancer.

Product Highlights

• This is a form of prostate cancer that has become resistant to hormone therapy (androgen deprivation therapy) and has not yet spread to other parts of the body (i.e., it has no detectable metastases).
• This type of prostate cancer has spread to other parts of the body but still responds to hormone deprivation therapy. Darolutamide is used alongside androgen deprivation therapy (ADT) to help manage the growth of the cancer.
• It is used in combination with other treatments like androgen deprivation therapy (ADT), and docetaxel chemotherapy for mCSPC.

Key Ingredient

• Darolutamide

Key Benefits

• Nubeqa helps slow the progression of prostate cancer by inhibiting androgen receptor activity, preventing the cancer cells from receiving the signals they need to grow.
• Compared to some other androgen receptor inhibitors, darolutamide has shown a relatively favorable side effect profile, with lower incidence of central nervous system side effects (such as fatigue, seizures, or cognitive impairment).
• Clinical trials have shown that Nubeqa can significantly prolong progression-free survival in men with nmCRPC, delaying the time before cancer spreads or worsens.
• In mCSPC, it is used alongside ADT or chemotherapy, showing potential benefits in extending survival and improving clinical outcomes.

Direction of Use

• The typical starting dose for Nubeqa is 600 mg, taken as two 300 mg tablets twice daily (morning and evening).
• It is taken orally, with or without food. The tablets should be swallowed whole with water and should not be crushed or chewed.
• For maximum benefit, Nubeqa should be taken consistently at the same times each day, and patients should adhere to the prescribed dosage.
• The duration of treatment depends on the individual’s condition, response to treatment, and the presence of side effects. Treatment may continue as long as the benefits outweigh the risks.

Safety Concerns

• Like other androgen receptor inhibitors, Nubeqa may cause cardiovascular side effects such as high blood pressure, heart failure, and other heart-related issues. Patients should be monitored for these conditions.
• Although less common than with other treatments, fatigue, and muscle weakness can occur in some patients.
• Liver function should be monitored regularly during treatment, as darolutamide can cause liver enzyme elevations, though these are usually mild and reversible.
• Prostate cancer treatments, including Nubeqa, can lead to bone density loss and increase the risk of fractures. Calcium and vitamin D supplementation, as well as monitoring for osteoporosis, is often recommended.
• Though rare, there is a potential for seizures, especially in patients with a history of seizure disorders. However, Nubeqa is less likely to cause seizures compared to other androgen receptor inhibitors.
• Nubeqa may interact with certain medications, including those that affect liver enzymes, such as CYP3A4 inhibitors or inducers. It is essential to let your doctor know about all the medications you are currently taking.

Avoid Nubeqa (Darolutamide) If

• If you are allergic to darolutamide or any of its ingredients, you should avoid using this medication.
• Nubeqa is not recommended during pregnancy, as it may harm the developing fetus. It is also not recommended for use in women as it is a medication for male-specific prostate cancer.
• Darolutamide should not be used by breastfeeding women, as its safety in lactation has not been established.
• If you have severe liver disease (e.g., cirrhosis), Nubeqa should be avoided, as it may worsen liver function.
• While the risk is relatively low, patients with a history of seizures may be at a higher risk of experiencing them while taking Nubeqa.