Erleada

The active ingredient in Erleada is apalutamide. It works by targeting and blocking the androgen receptor, which inhibits the growth of cancer cells and delays their ability to spread to other parts of the body (metastasis). Erleada is sometimes taken alone or in combination with a treatment called androgen deprivation therapy (ADT).

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Erleada. However, the following is a synopsis of the general guidelines for the use of Erleada:

• It is typically taken once daily at the same time every day
• Take Erleada tablets whole unless instructed by your healthcare provider
• Your doctor may recommend that you mix the tablet(s) in applesauce to dissolve them if you are having difficulty swallowing. Do not start doing this without speaking to your healthcare provider first
• You can take your dose of Erleada with or without food. It is usually recommended that you take your medication with food if you develop nausea or a stomach ache after taking the medication.
• If you miss a dose, do not take two doses at once. Instead, take the missed dose as soon as you can on the same day. The next day, return to your normal schedule
• Speak to your doctor about whether you are currently taking a gonadotropin-releasing hormone (GnRH) analog therapy. If you are not, it may be recommended that you start the therapy while taking Erleada
• Your provider will likely order prostate-specific antigen (PSA) tests for you to check your cancer’s response to treatment.

The most common side effects of Erleada seen in clinical trials as compared to placebo include:

• Joint pain
• Fatigue, or generally feeling very tired
• Falling
• Skin rash (typically treated with a topical corticosteroid)
• Decreased appetite
• High blood pressure (hypertension)
• Weight loss
• Diarrhea
• Fractures
• Hot flash (hot flush)
• Low thyroid hormone levels (hypothyroidism)

Some individuals may experience serious side effects while using Erleada. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Mini-stroke, stroke, or worsening heart disease
• Some people have experienced bleeding in a specific part of the brain or blockages in the arteries in the heart while taking Erleada.
• Call your healthcare provider immediately if you experience any of the following:
• Dizziness, trouble walking, loss of balance or coordination
• Weakness of the arm, face, or leg (most likely on one side of the body)
• Shortness of breath
• Discomfort or chest pain in your chest at rest or with activity
• Difficulty talking or understanding
• Difficulty seeing in one or both of your eyes
• Seizure
• Speak to your doctor about your risk level and what activities you should avoid while taking Erleada. In general, activities where a lack of consciousness could take place should be avoided.
• Falls and fractures
• Severe skin reactions
• These skin reactions could be life-threatening or could lead to death.
• Seek medical attention if you develop any of the following symptoms:
• Swollen lymph nodes
• Flu-like symptoms or a fever
• Severe rash or a rash that continues to spread or worsen
• Peeling or blistering skin
• Sores or blisters on your mouth, nose, throat, eyes or genital area

These are not all of the possible side effects of Erleada. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Erleada, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• High blood pressure
• History of heart disease
• Diabetes
• Dyslipidemia (an abnormal amount of cholesterol or fat in your body)
• History of stroke, brain tumors, brain injury, or seizures
• A partner who is pregnant plans to become pregnant or is breastfeeding

Erleada (apalutamide) is a medication used to treat prostate cancer. Its contraindications include:

• Known allergy to apalutamide or any of its ingredients.
• Severe liver impairment (Child-Pugh class C).

Erleada (apalutamide) may start to show effects within a few weeks of treatment, but it typically takes several months to see significant results in controlling prostate cancer. The full benefits are often assessed after a few months of consistent use, and your doctor will monitor your response through regular tests. Always follow your doctor's guidance for treatment and evaluation.

When Erleada is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Sensitive substrates of CYP2C19, CYP3A4, UGT, CYP2C9, BCRP, P-gp, or OATP1B1
• Coadministration may result in a drop in the activity of these medications or a change in Erleada’s ability to fight cancer.

This is not an extensive list of the drug interactions that may exist with Erleada. Talk to your healthcare provider about any questions you have about other drugs that may interact with your Erleada treatment.

Erleada comes in tablet form, in 60 mg and 240 mg strengths.

Store at room temperature, which is considered between 20 °C to 25 °C (68 °F to 77 °F). Some excursions are permitted between 15 °C to 30 °C (59 °F to 86 °F).

Keep Erleada in the original package, as it will protect it from light and moisture.

Erleada is manufactured by Janssen Biotech, Inc.

There are lower-cost generics available for the brand name Erleada.

To stop taking Erleada (apalutamide), consult your doctor first, as discontinuing the medication without guidance may affect your treatment plan. Your doctor may adjust your therapy or suggest alternatives based on your condition. Do not stop taking Erleada abruptly without medical advice.

It has not been proven that Erleada is safe and effective in females. Erleada may affect a male’s ability to be fertile, or their ability to father children. However, if you are a male who is using Erleada, and you have a partner who could become pregnant, it is recommended that you use contraception (effective birth control) while taking Erleada and for at least three months after you have finished your last dose of Erleada.

There is evidence that Erleada can cause embryo-fetal toxicity. This toxicity includes a loss of pregnancy or harm to an unborn baby. Do not donate sperm while taking Erleada or for three months after finishing treatment with Erleada.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you. It is unknown if Erleada is found in breast milk.