Class: Hormonal therapy
Generic Name: Apalutamide
Trade Name: Erleada®
How is Erleada® used? Erleada is used for the treatment of patients with castration-resistant prostate cancer that has not metastasized.
What is the mechanism of action of Erleada®? Erleada 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 Erleada given (administered)? Erleada is taken orally (by mouth) with or without food.
How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Erleada. 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 Erleada?
- Weakness or fatigue
- High blood pressure
- Weight loss
- Joint pain
- Hot flushes
- Decreases appetite
- Swelling (edema) in hands, arms, feet, or legs.
What are some of the potentially serious side effects of Erleada?
- Seizure. In a randomized study, seizure occurred in 0.2% of the patients who received Erleada.
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 Erleada 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 seizures, brain injury, stroke, or brain tumors.
- Patients should inform their physician of any other medication or supplement they are taking (whether prescription or over-the-counter).
- During treatment with Erleada and for three months after Erleada treatment ends, men who are sexually active with a pregnant woman must use a condom. 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.
- Erleada is not for use in women, and may cause harm to an unborn baby if taken by a pregnant woman.
- Because of the risk of seizure, avoid activities where sudden loss of consciousness could seriously harm you or others.
When should patients notify their physician?
Tell your doctor if you experience any side effects that bother you or don’t go away. Also tell your doctor if you have falls, trouble thinking clearly, loss of consciousness, or seizure.
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.
Important Limitations of Use
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