Apalutamide Tablets

What is this medication?

APALUTAMIDE (A puh LOO tuh mide) treats prostate cancer. It works by blocking the effect of testosterone and other hormones in your body, which may slow or stop cancer cells from spreading or growing.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): ERLEADA

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Brain tumor
• Diabetes
• Head injury
• Heart disease
• High blood pressure
• High cholesterol
• Osteoporosis, weak bones
• Seizures
• Stroke
• An unusual or allergic reaction to apalutamide, other medications, foods, dyes, or preservatives
• If you or your partner are pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the tablets whole. If you cannot swallow tablets whole, talk to your care team about how to mix it with applesauce, water, or juice. You can take it with or without food. If it upsets your stomach, take it with food. Your care team may change your dose or tell you to stop taking this medication if you get side effects. Do not change your dose or stop taking it unless your care team tells you to.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Artemether; Lumefantrine
• Certain antivirals for HIV or hepatitis
• Isavuconazonium
• Lonafarnib
• Lorlatinib
• Lurasidone
• Mavacamten
• Pacritinib
• Praziquantel
• Ranolazine
• Voriconazole

This medication may also interact with the following:

• Gemfibrozil
• Itraconazole
• Ketoconazole
• Midazolam
• Omeprazole
• Rifampin
• Warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

This medication may make you feel generally unwell. This is not uncommon as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your care team tells you to stop.

Using this medication for a long time may weaken your bones. The risk of bone fractures may be increased. Talk to your care team about your bone health.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. You may also notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms.

Heart attacks and strokes have been reported with the use of this medication. Get emergency help if you develop signs or symptoms of a heart attack or stroke. Talk to your care team about the risks and benefits of this medication.

If your partner can get pregnant, use a condom during sex while taking this medication and for 3 months after the last dose. Tell your care team right away if you think your partner might be pregnant. This medication can cause serious birth defects.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.

Do not donate sperm while taking this medication and for 3 months after the last dose.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Dry cough, shortness of breath or trouble breathing
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Increase in blood pressure
• Rash, fever, and swollen lymph nodes
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Seizures
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Fatigue
• Hot flashes
• Joint pain
• Loss of appetite

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original packaging. Protect from moisture. Keep the container tightly closed. Do not throw out the packet in the container. It keeps the medication dry. Protect from light. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.