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:

• bone problems
• brain tumor
• diabetes
• head injury
• heart disease
• high blood pressure
• high cholesterol
• history of stroke
• seizures
• an unusual or allergic reaction to apalutamide, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush or chew this medicine. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine 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 and skip your missed dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• artemether
• certain antivirals for HIV or hepatitis like atazanavir, daclatasvir, doravirine, elbasvir; grazoprevir, fostemsavir, lopinavir, nelfinavir, paritaprevir, rilpivirine, ritonavir, and tipranavir
• certain medicines for fungal infections like isavuconazonium and voriconazole
• lorlatinib
• lurasidone
• praziquantel
• ranolazine

This medicine may interact with the following medications:

• gemfibrozil
• certain medicines for fungal infections like ketoconazole and itraconazole
• fexofenadine
• midazolam
• omeprazole
• rosuvastatin
• 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 medicine should not be used in women. Men should not father a child while taking this medicine and for 3 months after stopping it. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.

Due to a risk of seizures, use caution when engaging in activities that could result in serious harm to yourself or others if you pass out.

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
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• 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
• Increase in blood pressure
• 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.

Store between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

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.