Apalutamide

Apalutamide 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.

Apalutamide 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.

Apalutamide 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 apalutamide 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 apalutamide with or without food but take it the same way each time.

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

You may be given another medication while you are on apalutamide, 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.

Read and carefully follow the instructions below on how to prepare and take apalutamide if you cannot swallow tablets whole. This medicine may also be given through a feeding tube. Ask your doctor or pharmacist if you don't understand these instructions.

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.

Mixing tablets with water

If you cannot swallow the 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.

Giving apalutamide through a feeding tube

Apalutamide 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.

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

Apalutamide 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 apalutamide so the laboratory can use a suitable test method.

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.

Apalutamide (Erleada brand) cost will depend on your insurance plan and which pharmacy you use.

Erleada coupon or a Erleada savings card may be available that you could be eligible for. Ask your doctor or pharmacist if you qualify, or click on this link for Erleada Coupons and our price guide.

To make sure apalutamide 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; or
• high cholesterol or triglycerides.

Apalutamide can harm an unborn baby if the father is using this medicine.

• Use birth control if your sex partner is able to get pregnant. Men using apalutamide 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 apalutamide, 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 this medicine. Talk with your doctor about ways to keep your bones healthy.

Get emergency medical help if you have signs of an allergic reaction to apalutamide (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

Apalutamide 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 apalutamide and can lead to death. Your healthcare provider will monitor you for signs and symptoms of heart or brain problems during your treatment with apalutamide. 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. Apalutamide 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 apalutamide. Your healthcare provider will monitor your risks for falls and fractures during treatment with apalutamide.
• Seizure. Treatment with apalutamide 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 apalutamide if you have a seizure during treatment.
• Severe skin reactions. Treatment with apalutamide may cause severe skin reactions that can lead to death or be life-threatening. Stop taking apalutamide 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 apalutamide may cause inflammation of the lungs that can lead to death or be life-threatening. Stop taking apalutamide 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 apalutamide 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 apalutamide if you have certain side effects.

Apalutamide 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 apalutamide and for 3 months after the last dose of apalutamide.

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 apalutamide.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Prostate Cancer:

• 240 mg orally once a day.

Dosing in people with severe liver problems

The usual dose of apalutamide is 240 mg once a day. If you have severe liver problems (Child-Pugh Class C), the recommended dose is 120 mg once a day.

No dose change is needed if you have mild or moderate liver problems (Child-Pugh Class A or B).

Dose changes for side effects

Your doctor may stop apalutamide temporarily if you develop severe or intolerable side effects. Once symptoms improve, treatment may be restarted at the same dose or at a lower dose of 180 mg or 120 mg once a day.

Apalutamide may be stopped permanently if you develop:

• a severe or unexplained lung problem (interstitial lung disease or pneumonitis)
• a confirmed severe skin reaction, or another very severe skin reaction
• a seizure

Your doctor may also consider stopping apalutamide permanently after a severe heart or stroke-related event.

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.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Apalutamide 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 apalutamide 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%
• 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 apalutamide itself. Strong inhibitors of the enzymes CYP2C8 or CYP3A4, such as gemfibrozil or ketoconazole, can raise apalutamide levels in the body, and your doctor may lower your apalutamide dose.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal products. Do not start or stop any medicine without checking first.

• How long do you have to take Erleada (apalutamide) for?
• How effective is Erleada (apalutamide)?
• What type of prostate cancer is Erleada used to treat?