Apalutamide

What is apalutamide used for?

• Apalutamide is used to treat prostate cancer.
• Apalutamide may be given to you for other reasons. Talk to your doctor.

Before taking apalutamide, tell your doctor:

• If you are allergic to apalutamide; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are a woman. This medicine is not approved for use in women. This medicine may cause harm to an unborn baby or loss of an unborn baby if it is taken during pregnancy. If you are a woman using apalutamide, talk with your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take apalutamide with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take apalutamide?

• Tell all of your health care providers that you take apalutamide. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Some people have had seizures while taking apalutamide. The chance of seizures may be raised if you have certain brain blood vessel problems, take other drugs that may raise the chance of seizures, or if you have ever had seizures, brain injury, stroke, or brain cancer. Avoid tasks or actions where passing out may cause harm to you or others. Talk with your doctor.
• The chance of falling is raised with apalutamide. Falls may lead to very bad problems like broken bones. Talk to your doctor about the chance of falling and broken bones while taking apalutamide.
• High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor.
• Heart disease has happened with apalutamide in some people. Rarely, this has been deadly. If you have questions, talk with the doctor.
• This medicine may cause high cholesterol and triglyceride levels. Talk with the doctor.
• If you have high blood sugar (diabetes), talk with your doctor. This medicine may raise blood sugar.
• Check your blood sugar as you have been told by your doctor.
• This medicine may be used with other drugs to treat your health condition. If you are also taking other drugs, talk with your doctor about the risks and side effects that may happen.
• If you are 65 or older, use apalutamide with care. You could have more side effects.
• This medicine is found in semen. Do not donate semen while you take apalutamide and for 3 months after your last dose.
• This medicine may affect being able to father a child. Talk with the doctor.
• If you are a man and have sex with a female who could get pregnant, protect her from pregnancy during treatment and for 3 months after your last dose.
• If you are a man and your sex partner gets pregnant while you take apalutamide or within 3 months after your last dose, call your doctor right away.
• If you are having sex and your partner is pregnant, use a condom while taking apalutamide and for 3 months after your last dose.

How is apalutamide best taken?

Use apalutamide as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Swallow whole. Do not chew, break, or crush.
• Take apalutamide at the same time of day.
• Keep taking apalutamide as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If you do not think about the missed dose until the next day, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of apalutamide that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Signs of high potassium levels like a heartbeat that does not feel normal; feeling confused; feeling weak, lightheaded, or dizzy; feeling like passing out; numbness or tingling; or shortness of breath.
• Signs of low thyroid levels like constipation; not able to handle cold; memory problems; mood changes; or a burning, numbness, or tingling feeling that is not normal.
• Chest pain or pressure.
• Shortness of breath.
• Seizures.
• Swelling in the arms or legs.
• Bone pain.
• Low white blood cell counts have happened with apalutamide. This may lead to a higher chance of getting an infection. Call your doctor right away if you have signs of infection like fever, chills, or sore throat.

What are some other side effects of apalutamide?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling tired or weak.
• Joint pain.
• Not hungry.
• Weight loss.
• Hot flashes.
• Diarrhea.
• Upset stomach.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out apalutamide?

• Store at room temperature protected from light. Store in a dry place. Do not store in a bathroom.
• Store in the original container. Do not take out the antimoisture cube or packet.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer information use and disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about apalutamide, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take apalutamide or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to apalutamide. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.