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What is Erleada, and how does it work?
Erleada is a prescription medicine used for the treatment of prostate cancer:
- that has spread to other parts of the body and still responds to a medical or surgical treatment that lowers testosterone, OR
- that has not spread to other parts of the body and no longer responds to a medical or surgical treatment that lowers testosterone.
It is not known if Erleada is safe and effective in females.
It is not known if Erleada is safe and effective in children.
What are the side effects of Erleada?
Erleada may cause serious side effects including:
- Heart Disease. Blockage of the arteries in the heart that can lead to death has happened in some people during treatment with Erleada. Your healthcare provider will monitor you for signs and symptoms of heart problems during your treatment with Erleada. Call your healthcare provider or go to the nearest emergency room right away if you get chest pain or discomfort at rest or with activity, or shortness of breath during your treatment with Erleada.
- Fractures and falls. Erleada treatment can cause bones and muscles to weaken and may increase your risk for falls and fractures. Falls and fractures have happened in people during treatment with Erleada. Your healthcare provider will monitor your risks for falls and fractures during treatment with Erleada.
- Seizure. Treatment with Erleada may increase your risk of having a seizure. You should avoid activities where a sudden loss of consciousness could cause serious harm to yourself or others. Tell your healthcare provider right away if you have a loss of consciousness or seizure. Your healthcare provider will stop Erleada if you have a seizure during treatment.
The most common side effects of Erleada include:
- feeling very tired
- joint pain
- rash. Tell your healthcare provider if you get a rash.
- decreased appetite
- weight loss
- hot flash
Erleada may cause fertility problems in males, which may affect the ability to father children. Talk to your healthcare provider if you have concerns about fertility. Do not donate sperm during treatment with Erleada and for 3 months after the last dose of Erleada.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Erleada.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the dosage for Erleada?
- The recommended dose of Erleada is 240 mg (four 60 mg tablets) administered orally once daily. Swallow the tablets whole. Erleada can be taken with or without food.
- Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had a bilateral orchiectomy.
- If a patient experiences a greater than or equal to Grade 3 toxicity or an intolerable side effect, hold dosing until symptoms improve to less than or equal to Grade 1 or original grade, then resume at the same dose or a reduced dose (180 mg or 120 mg), if warranted.
Alternate Method Of Administration
For patients who have difficulty swallowing tablets whole, the recommended dose of Erleada tablets may be mixed in applesauce.
- Mix whole Erleada tablets in 4 ounces (120 mL) of applesauce by stirring. Do not crush the tablets.
- Wait 15 minutes, stir the mixture.
- Wait another 15 minutes, stir the mixture until tablets are dispersed (well mixed with no chunks remaining).
- Using a spoon, swallow the mixture right away.
- Rinse the container with 2 ounces (60 mL) of water and immediately drink the contents. Repeat the rinse with 2 ounces (60 mL) of water a second time to ensure the whole dose is taken.
Consume the mixture within one hour of preparation. Do not store Erleada that is mixed with applesauce.
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What drugs interact with Erleada?
Effect Of Other Drugs On Erleada
Strong CYP2C8 Or CYP3A4 Inhibitors
- Co-administration of a strong CYP2C8 or CYP3A4 inhibitor is predicted to increase the steady-state exposure of the active moieties (sum of unbound apalutamide plus the potency-adjusted unbound N-desmethyl-apalutamide).
- No initial dose adjustment is necessary however, reduce the Erleada dose based on tolerability.
- Mild or moderate inhibitors of CYP2C8 or CYP3A4 are not expected to affect the exposure of apalutamide.
Effect Of Erleada On Other Drugs
CYP3A4, CYP2C9, CYP2C19 And UGT Substrates
- Erleada is a strong inducer of CYP3A4 and CYP2C19, and a weak inducer of CYP2C9 in humans.
- Concomitant use of Erleada with medications that are primarily metabolized by CYP3A4, CYP2C19, or CYP2C9 can result in lower exposure to these medications.
- Substitution for these medications is recommended when possible or evaluate for loss of activity if medication is continued.
- Concomitant administration of Erleada with medications that are substrates of UDP-glucuronosyl transferase (UGT) can result in decreased exposure.
- Use caution if substrates of UGT must be co-administered with Erleada and evaluate for loss of activity.
P-gp, BCRP Or OATP1B1 Substrates
- Apalutamide was shown to be a weak inducer of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), and organic anion transporting polypeptide 1B1 (OATP1B1) clinically.
- At steady-state, apalutamide reduced the plasma exposure to fexofenadine (a P-gp substrate) and rosuvastatin (a BCRP/OATP1B1 substrate).
- Concomitant use of Erleada with medications that are substrates of P-gp, BCRP, or OATP1B1 can result in lower exposure of these medications.
- Use caution if substrates of P-gp, BCRP or OATP1B1 must be co-administered with Erleada and evaluate for loss of activity if medication is continued.
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Is Erleada safe to use while pregnant or breastfeeding?
- The safety and efficacy of Erleada have not been established in females.
- Based on its mechanism of action, Erleada can cause fetal harm and loss of pregnancy.
- There are no human data on the use of Erleada in pregnant women.
- Erleada is not indicated for use in females, so animal embryo-fetal developmental toxicology studies were not conducted with apalutamide.
- The safety and efficacy of Erleada have not been established in females.
- There are no data on the presence of apalutamide or its metabolites in human milk, the effect on the breastfed child, or the effect on milk production.
Erleada is a prescription medicine used for the treatment of prostate cancer that has spread to other parts of the body and still responds to a medical or surgical treatment that lowers testosterone, or that has not spread to other parts of the body and no longer responds to a medical or surgical treatment that lowers testosterone.
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Prostate cancer is the most common cancer in men after skin cancer. Risk factors include age, family history, ethnicity, and diet. Prostate cancer is diagnosed by digital rectal exam, prostate specific antigen (PSA) test, and prostate biopsy. Symptoms may include frequent need to urinate, incontinence, pain, blood in the urine, fatigue, and more. Prognosis and treatment depend on cancer staging. Watchful waiting, surgery, radiation, cryotherapy, and other management strategies are available. Research and clinical trials strive to find new and better treatments for prostate cancer.
Prostate Cancer (Prostatic Cancer) Symptoms and Causes
Difficulty with urination – frequency, weak stream, trouble getting started, etc. – is usually the first sign of prostate cancer. But these and other early symptoms of prostatic cancer can also come from benign prostate conditions, so diagnostic testing is important, including PSA tests and digital rectal exam.
How Is Prostate Cancer Diagnosed?
Prostate cancer is largely a disease of men over 40, so it’s around this age doctors recommend the first prostate screening. The first exam is a blood test to determine if there are abnormal prostate specific antigen (PSA) levels in your blood – PSA is produced by the prostate. If the PSA is high, your doctor will perform a digital rectal exam, during which the doctor feels your prostate from inside your rectum with a gloved finger. Other diagnostic tests include an endoscopic biopsy of tumor tissue for analysis in a lab.
Prostate Cancer Staging and Prognosis
The prognosis for prostate cancer, as with any cancer, depends on how advanced the cancer has become, according to established stage designations. The patient's PSA score at diagnosis, as well as their Gleason score (the grading system used to determine the aggressiveness of prostate cancer) determines the prognosis and final stage designation. Prostate cancer has a high survival rate in general, but your chances depend on the stage of the cancer.
Early-Stage Prostate Cancer Treatment
If prostate cancer is detected early and appears to be slow-growing, invasive procedures, chemotherapy, radiation and other approaches can sometimes do more harm than good. Many prostate cancer treatments come with side effects, like incontinence or impotence, so it’s in the patient’s interest to put off invasive treatments as long as is medically safe. Active surveillance is where doctors "watch and wait" for changes that could prompt medical intervention.
Prostate Cancer Treatment: Radical Prostatectomy Surgery
Radical prostatectomy, or surgical removal of the entire prostate gland, isn’t typically the first choice in prostate cancer treatment. Sometimes a radical approach is necessary to keep the cancer from metastasizing, however. Some cases are too severe or diagnosed too late for drugs or radiation to have much effect. In these cases, treatment teams may opt for a radical prostatectomy, despite potential side effects like impotence and incontinence.
Prostate Cancer Treatment: Chemotherapy, Bone-Targeted and Immune Therapy
Doctors may introduce chemotherapy and immune therapy if other measures fail to cure a case of prostate cancer. However, unlike with other forms of cancer, chemotherapy isn’t the first choice for early prostate cancer. Immune therapy uses the body's own immune system to attack the prostate tumor, while bone-targeted therapy aims to preserve bone and prevent metastasis.
Prostate Cancer Treatment: Radiation, Brachytherapy and Radiopharmaceuticals
Radiation treatment for prostate cancer is a powerful tool at doctors’ disposal. Using radiation vs. surgery or other invasive treatments to kill cancer cells may still cause side effects, but ideally they are less severe. Radiation therapy can be performed via external beam therapy (EBRT) or the placement of radioactive seeds into the prostate (prostate brachytherapy) or using radioactive drugs (radiopharmaceuticals).
Prostate Cancer Treatment: Hormonal Therapy
Prostate cancer is highly sensitive to, and dependent on, the level of the male hormone testosterone, which drives the growth of prostate cancer cells. Testosterone belongs to a family of hormones called androgens, and today front-line hormonal therapy for advanced and metastatic prostate cancer is called androgen deprivation therapy (ADT).
Prostate Cancer Treatment: Focal Therapy and Other Experimental Treatments
Several new and experimental treatments for prostate cancer are under study, including treatments that use ultrasound, lasers, tissue-freezing gas, and new ways of administering radiation. These new methods are types of focal therapy, that is, treatment focused on the cancer cells in the prostate, rather than systemic therapy that administers medications or other treatments to the whole body with the aim of treating the prostate.
Prostate Cancer Facts
Prostate cancer is a leading cause of cancer and cancer death in males; in some men, identifying it early may prevent or delay metastasis and death from prostate cancer. The prostate is a walnut-shaped gland that is a part of the male reproductive system that wraps around the male urethra at it exits the bladder. Prostate cancer is common in men over 50 years of age, with the risk of developing prostate cancer increases with aging.
What Are the 5 Warning Signs of Prostate Cancer?
Prostate cancer rarely produces symptoms in the early stage; however, few signs can help in detecting prostate cancer.
The early signs of prostate cancer
Prostate cancer in its early stages usually causes no signs and symptoms. Screening can help detect the cancer early.
Can Prostate Cancer Be Completely Cured?
Prostate cancer is the second most common cancer in men. Due to routine screening of prostate-specific antigen (PSA) levels in the United States, nearly 90% of prostate cancers get detected in early stages. When found early, there are several treatment options available and prostate cancer has a high chance of getting cured.
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.