(a-pa LOO ta mide)
Trade Name(s): Erleada®
Apalutamide is the generic name for the trade name drug Erleada. In some cases, health care professionals may use the trade name Erleada when referring to the generic drug name apalutamide.
Apalutamide is classified as a novel hormone therapy, specifically known as an anti-androgen or an androgen receptor inhibitor. (For more detail, see "How Apalutamide Works" below)
What Apalutamide Is Used For
- Treatment of non-metastatic castration-resistant prostate cancer (prostate cancer that is resistant to medical or surgical treatments that lower testosterone) that has not metastasized (spread to other areas of the body).
- Treatment of metastatic castration-sensitive prostate cancer (mCSPC).
Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.
How Apalutamide Is Given
- Tablets come in one dosage: 60 mg.
- The recommended daily dose of Apalutamide is 240 mg (four 60 mg tablets).
- Apalutamide is a tablet taken by mouth once daily.
- Take with or without food at the same time each day.
- Swallow whole, do not chew, break, or crush the tablet.
- If you miss a dose, take it as soon as you remember that day. If you miss taking your dose for the entire day, go back to taking your regular dose the next day. Do not take 2 doses at the same time.
- Store apalutamide at room temperature (68-77 degrees F or 20-15 degrees C).
- Keep the container closed tightly, dry, and out of reach of children.
The amount of apalutamide that you will receive depends on many factors, including your general health or other health problems. Your doctor will determine your exact dosage and schedule.
Important things to remember about the side effects of Apalutamide:
- Most people will not experience all of the side effects listed.
- Apalutamide side effects are often predictable in terms of their onset, duration, and severity.
- Apalutamide side effects will improve after therapy is complete.
- Apalutamide side effects may be quite manageable. There are many options to minimize or prevent the side effects.
The following side effects are common (occurring in greater than 30%) for patients taking Apalutamide:
These are less common side effects (occurring in 10-29%) for patients receiving Apalutamide:
These are rare but serious side effects of Apalutamide:
A rare but potentially serious side effect reported with Apalutamide is seizures. If you have a seizure history, consult a physician before starting therapy.
Not all side effects are listed above. Side effects that are very rare (occurring in less than about 10 percent of patients) are not listed here. But you should always inform your health care provider if you experience any unusual symptoms.
When to Contact Your Doctor or Health Care Provider
Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:
- Fever of 100.4º F (38º C) or higher, chills (possible signs of infection)
- If you experience a seizure
The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:
- Diarrhea (4-6 episodes in a 24-hour period)
- Swelling in the arms or legs
- If you develop a significant skin rash while taking Apalutamide
- Extreme fatigue (unable to carry on self-care activities)
- Signs of infection including mouth sores (painful redness, swelling or ulcers), painful urination, coughing up mucous
- If you experience dizziness or falls
Always inform your health care provider if you experience any unusual symptoms.
- Before starting apalutamide treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.). There could be drug interactions with apalutamide.
- Apalutamide may decrease the effectiveness of wafarin. Your INR may need to be checked more frequently.
- Discuss with your doctor if you have a history of seizures.
- Do not receive any kind of immunization or vaccination without your doctor's approval while taking apalutamide.
- Apalutamide is not approved for use in women and cannot be given during pregnancy.
- Pregnancy category X: Apalutamide may cause fetal harm when given to a pregnant woman. This drug must not be given to a pregnant woman or a woman who intends to become pregnant.
- For both men and women: Use contraceptives, and do not conceive a child (get pregnant) while taking apalutamide. Barrier methods of contraception, such as condoms, are recommended for up to 3 months after last dose of apalutamide.
- In general alcohol consumption should be kept to a minimum or avoided all together
- Drink at least two to three quarts of fluid every day, unless instructed otherwise by your doctor.
- Wash your hands often.
- You may be at risk of infection so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your health care provider.
Monitoring and Testing While Taking Apalutamide
You will be checked regularly by your doctor while you are taking Apalutamide, to monitor side effects and check your response to therapy. Periodic blood work will be obtained to monitor your complete blood count (CBC), thyroid function, as well as other organs (kidney and liver) will also be ordered by your doctor.
How Apalutamide Works
Normally in prostate cells there are androgen receptors. Androgens (such as testosterone) bind with these receptors to promote growth of these cells. Cancer of the prostate depends on the male hormone testosterone or related androgens for its growth. If the amounts of androgens are reduced it is possible to slow down or shrink the cancer.
Androgen signaling inhibitors interfere with the ability of the receptors to bind with the androgens. By doing so, this helps decrease the ability of the prostate cancer cells to grow and multiply. Apalutamide also prevents the androgens from working within the prostate cancer cells, and can ultimately lead to cancer cell death.
Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.