Nubeqa

Class: Hormonal therapy

Generic Name: darolutamide

Trade Name: Nubeqa®

How is this drug used? Nubeqa is used for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC).

What is the mechanism of action? Nubeqa interferes with the ability of male hormones to bind to their receptors within a cell, and also reduces the ability of the receptors to enter the nucleus and stimulate cell growth.

How is Nubeqa given (administered)? Nubeqa is taken orally (by mouth) twice daily with food. Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had a surgical removal of both testicles.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Nubeqa. Blood may be drawn to check for side effects and to monitor functions of some organ systems. Patients may also undergo physical examinations or other measures to assess side effects and response to therapy.

What are the most common side effects of treatment with Nubeqa?

  • Fatigue
  • Pain in extremities
  • Rash

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

  • Pay careful attention to the physician’s instructions and discuss side effects with your physician.
  • Swallow Nubeqa capsules whole.

Are there any special precautions patients should be aware of before starting treatment?

  • Patients should inform their physician about all medical conditions, including history of kidney or liver problems
  • Patients should inform their physician of any other medication or supplement they are taking (whether prescription or over-the-counter).
  • Talk to your doctor if your partner is pregnant or planning to become pregnant. If a man’s sexual partner is not pregnant but could become pregnant, a condom and another effective form of birth control should be used during treatment and for one month after treatment ends. Nubeqa may cause fertility problems, talk to your physician if you have concerns about fertility.
  • Nubeqa is not for use in women, and may cause harm to an unborn baby if taken by a pregnant woman.

When should patients notify their physician?

Tell your doctor if you experience any side effects that bother you or don’t go away.

What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Last updated 8/25/2019.

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