Erleada

Erleada is used to treat prostate cancer that has spread to other parts of the body (metastatic) and still responds to a medical or surgical treatment that lowers testosterone.

Erleada is also used to treat prostate cancer that has not spread to other parts of the body, after surgery or other treatments did not work or have stopped working.

Erleada belongs to a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of cancer cells.

This medicine is not approved for use in women or children.

Take Erleada exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

You may take Erleada with or without food but take it the same way each time.

Erleada is usually taken once per day. Follow your doctor's dosing instructions very carefully.

You may be given another medication while you are on Erleada, unless you have had surgery to remove your testicles. Keep using this medicine for as long as your doctor has prescribed.

Swallow the tablet whole and do not crush, chew, or break it.

You may need frequent medical tests, and your cancer treatments may be delayed based on the results.

Your condition may get worse if you stop using this medicine. Ask your doctor before stopping the medicine.

Store at room temperature away from moisture, heat, and light. Keep the medicine in the original container, along with the packet or canister of moisture-absorbing preservative.

If you cannot swallow tablets whole

Your dose can be dispersed in water. Do not crush or split the tablets.

• Put your whole dose in a cup. For one 240 mg tablet, add about 2 teaspoons (10 mL) of still water. For 60 mg tablets, add about 4 teaspoons (20 mL) of still water. Make sure the tablets are fully covered.
• Wait 2 minutes until the tablets have broken up and spread out, then stir.
• Add 2 tablespoons (30 mL) of orange juice, applesauce, or more still water, and stir again.
• Swallow the mixture straight away.
• Rinse the cup with water and drink it immediately, so you get the full dose.

Do not use carbonated water, and do not store the mixture for later.

Taking Erleada through a feeding tube

Erleada can be given through a feeding tube that is 8 French or larger.

• Take the plunger out of the syringe. Use at least a 20 mL syringe for one 240 mg tablet, or at least a 50 mL syringe for 60 mg tablets.
• Put your whole dose into the barrel of the syringe and replace the plunger. Do not crush or split the tablets.
• Draw up 10 mL of still water for a 240 mg tablet, or 20 mL for 60 mg tablets.
• Wait 10 minutes, then shake the syringe vigorously until the tablets have broken up completely.
• Attach the syringe to the feeding tube and give the mixture straight away.
• Refill the syringe with still water and flush the tube. Repeat until no tablet residue is left in the syringe or the tube.

Ask your doctor or pharmacist if you do not understand these instructions.

Although Erleada is not for use by women, this medicine can cause birth defects if a woman is exposed to it during pregnancy.

Erleada can cause heart attacks, strokes, seizures, severe skin reactions, and inflammation of the lungs. Some of these have been fatal. Your doctor will monitor you during treatment.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

There are no medical conditions that automatically rule out treatment with Erleada. However, to make sure Erleada is safe for you, tell your doctor if you have ever had:

• a head injury or brain tumor;
• a seizure;
• a stroke;
• heart disease, high blood pressure;
• diabetes;
• lung problems;
• liver problems;
• thyroid problems; or
• high cholesterol or triglycerides.

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.

Use birth control if your sex partner is able to get pregnant. Men using Erleada should use condoms during treatment. Keep using birth control for at least 3 months after your last dose.

Tell your doctor right away if a pregnancy occurs.

It may be harder for you to get a woman pregnant while you are using this medicine. Do not donate sperm while you are taking Erleada, and during the 3 months after your last dose.

Apalutamide can weaken your bones. You may be more likely to have a broken bone while taking Erleada. Talk with your doctor about ways to keep your bones healthy.

Erleada can also cause an underactive thyroid. Your doctor may check your thyroid levels during treatment and start or adjust thyroid medicine if needed.

Get emergency medical help if you have signs of an allergic reaction to Erleada (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Serious side effects

Erleada may cause serious side effects including:

• Heart disease, stroke, or mini-stroke. Bleeding in the brain or blockage of the arteries in the heart or in part of the brain have happened in some people during treatment with Erleada and can lead to death. Your healthcare provider will monitor you for signs and symptoms of heart or brain problems during your treatment with Erleada. Call your healthcare provider or get medical help right away if you get: chest pain or discomfort at rest or with activity shortness of breath numbness or weakness of the face, arm, or leg, especially on one side of the body trouble talking or understanding trouble seeing in one or both eyes dizziness, loss of balance or coordination, or trouble walking
• 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.
• Severe skin reactions. Treatment with Erleada may cause severe skin reactions that can lead to death or be life-threatening. Stop taking Erleada and tell your healthcare provider or get medical help right away if you develop any of these signs or symptoms of a severe skin reaction: severe rash or rash that continues to get worse fever or flu-like symptoms swollen lymph nodes blisters or sores in the mouth, throat, nose, eyes, or genital area blistering or peeling of the skin
• Lung problems. Treatment with Erleada may cause inflammation of the lungs that can lead to death or be life-threatening. Stop taking Erleada and tell your healthcare provider or get medical help right away if you develop any new or worsening symptoms of lung problems, including: shortness of breath cough fever.

Common side effects

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
• fall
• weight loss
• high blood pressure
• hot flash
• diarrhea
• fracture

Your healthcare provider may reduce your dose, temporarily stop, or permanently stop treatment with Erleada if you have certain side effects.

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 the FDA at 1-800-FDA-1088.

The cost for prescription drugs varies depending on your insurance plan and which pharmacy you use. Refer to our Erleada price guide page for more information about the cost of Erleada.

You may also be eligible for an Erleada savings card or Erleada coupon. Ask your doctor or pharmacist if you qualify.

Usual Adult Dose for Prostate Cancer:

240 mg orally once a day

Dose in severe liver impairment:

120 mg orally once a day (Child-Pugh Class C). No dose change is needed for mild or moderate liver impairment (Child-Pugh Class A or B).

Comments:

• Patients should receive a gonadotropin-releasing hormone (GnRH) analog concurrently or have had a bilateral orchiectomy.
• For severe or intolerable side effects, treatment is withheld and then restarted at the same dose or at a reduced dose of 180 mg or 120 mg once daily once symptoms improve.
• Treatment is stopped permanently for a seizure, a confirmed severe skin reaction, or severe lung inflammation.

Uses:

• For the treatment of metastatic castration-sensitive prostate cancer (mCSPC)
• For the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC)

Take the missed dose on the same day you remember it. Take your next dose at the regular time and stay on your once-daily schedule. Do not take two doses in one day.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Apalutamide can cause seizures. Avoid activities that could be dangerous if you have an unexpected seizure.

Erleada speeds up the way the body breaks down many other medicines, which can make them less effective or stop them working altogether. It is a strong inducer of the liver enzymes CYP3A4 and CYP2C19, a weak inducer of CYP2C9, and it also increases the activity of several drug transporters (P-gp, BCRP, and OATP1B1).

In studies, taking Erleada reduced blood levels of:

• midazolam, a sedative, by 92%;
• omeprazole, a stomach acid medicine, by 85%;
• S-warfarin, a blood thinner, by 46%;
• rosuvastatin, a cholesterol medicine, by 41%; or
• fexofenadine, an antihistamine, by 30%.

These are examples rather than a complete list. Your doctor may switch you to a different medicine where possible, or monitor you for signs that a medicine has stopped working.

Some medicines also affect Erleada itself. Strong inhibitors of the enzymes CYP2C8 or CYP3A4, such as gemfibrozil or ketoconazole, can raise Erleada levels in the body, and your doctor may lower your Erleada dose.

Other drugs may interact with apalutamide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use. Do not start or stop any medicine without checking first.

Interference with digoxin blood tests

Erleada can interfere with some laboratory tests that measure digoxin levels in the blood, giving a result that is falsely high. If you take digoxin, tell your doctor you are taking Erleada so the laboratory can use a suitable test method.

Active ingredient: apalutamide.

Inactive ingredients: 240 mg film-coated tablets: colloidal anhydrous silica, croscarmellose sodium, hydroxypropyl methylcellulose-acetate succinate, silicified microcrystalline cellulose, and magnesium stearate. The coating contains glyceryl monocaprylocaprate, iron oxide black, polyvinyl alcohol, talc, titanium dioxide, and vinyl alcohol grafted copolymer.

60 mg film-coated tablets: colloidal anhydrous silica, croscarmellose sodium, hydroxypropyl methylcellulose-acetate succinate, magnesium stearate, microcrystalline cellulose, and silicified microcrystalline cellulose. The coating contains iron oxide black, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

Manufactured for: Janssen Products, LP, Horsham, PA 19044, USA.