Apalutamide is used to treat men with prostate cancer. This medication belongs to a class of drugs known as anti-androgens (anti-testosterone). It works by blocking the effects of testosterone to slow the growth and spread of prostate cancer.

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start taking apalutamide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily. Swallow the tablets whole. Do not cut, chew, or crush the tablets.

If you are using the 60 milligram tablets and have difficulty swallowing the tablets whole, you may mix the whole tablets in 4 ounces (120 milliliters) of applesauce. Stir the mixture but make sure not to crush the tablets. Wait 15 minutes, and then stir the mixture again. Wait another 15 minutes and stir the mixture for a third time. Make sure the tablets are well mixed with no solid chunks remaining. Swallow the mixture right away using a spoon. After taking the mixture, rinse the container with 2 ounces (60 milliliters) of water and drink the mixture right away. Repeat the rinse to make sure you take the full dose of the medication. The applesauce/drug mixture should be used within 1 hour of making. Do not store for future use.

If you are using the 240 milligram tablet and have difficulty swallowing the tablet whole, you may mix the whole tablet with water as directed. Add 2 teaspoons (10 milliliters) of water to a cup with the tablet inside. Do not split or crush the tablet. Make sure that the tablet is covered with water. Wait 2 minutes for the tablet to break up and then stir the mixture. Then add 2 tablespoons (30 milliliters) of either orange juice, applesauce, or more water to the mixture and stir. Swallow the mixture right away. After taking the mixture, rinse the cup with water and drink the water to make sure you take the full dose of the medication. Do not save any of the mixture for future use.

If you are giving this medication through a feeding tube, ask your health care professional for detailed instructions on how to properly mix and give it.

The dosage is based on your medical condition and response to treatment. Do not increase your dose or take this drug more often than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Hot flashes, tiredness, joint pain, nausea, decreased appetite, weight loss, or decreased sexual interest/ability may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including:

• signs of an underactive thyroid (such as unusual weight gain, cold intolerance, slow heartbeat, constipation)

Treatment with this medication can cause bones and muscles to weaken, which may increase your risk for falls and broken bones. Ask your doctor for details.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Get medical help right away if you have any signs of infection (such as sore throat that doesn't go away, swollen lymph nodes, chills).

Rarely, apalutamide has caused severe (sometimes fatal) lung problems (interstitial pneumonitis). Get medical help right away if you develop symptoms of lung problems (such as cough, fever).

Get medical help right away if you have any very serious side effects, including:

• symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating)
• signs of a stroke (such as weakness on one side of the body, trouble speaking, sudden vision changes, confusion)
• seizure

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

Apalutamide can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking apalutamide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• heart problems (such as coronary artery disease, heart failure, recent heart attack)
• diabetes
• high cholesterol
• high blood pressure
• stroke/transient ischemic attack (TIA)
• seizure
• increased risk for seizure (such as brain injury, stroke, brain tumor)

Since this medication may rarely cause seizures in some people, ask your doctor if you should avoid activities where a sudden loss of consciousness may cause serious harm to you or others.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication should not be used by women, especially during pregnancy or breastfeeding. It may harm an unborn or breastfeeding baby. Consult your doctor for more details.

Older adults may be at greater risk for falls while using this drug.

Men who are sexually active with a pregnant woman must use a condom during treatment and for 3 months after stopping treatment. Men with female partners of childbearing age should use reliable forms of birth control during treatment and for 3 months after stopping treatment. If your partner becomes pregnant or thinks she may be pregnant, tell the doctor right away. Do not donate sperm during treatment and for at least 3 months after stopping treatment.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Apalutamide can speed up the removal of other medications from your body, which may affect how they work. Examples of affected drugs include artemether-lumefantrine, azole antifungals (such as isavuconazonium, voriconazole), cobicistat, lurasidone, nifedipine, ranolazine, rilpivirine, certain drugs for hepatitis C (such as asunaprevir, daclatasvir, ledipasvir, sofosbuvir), among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as blood pressure, thyroid function) should be done while you are taking this medication. Keep all medical and lab appointments.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store in the original package at room temperature away from light and moisture. Do not store in the bathroom. Keep the drying agent (desiccant) in the bottle. Tightly close the bottle when not in use. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.