Darolutamide Tablets

What is this medication?

DAROLUTAMIDE (DAR oh LOO ta 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): NUBEQA

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

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

• Diabetes
• An unusual or allergic reaction to darolutamide, other medications, foods, dyes, or preservatives
• If you or your partner is pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a glass of water. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow tablets whole. Take this medication with food. Keep taking it unless your care team tells you to stop.

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?

• Antiviral medications for HIV or AIDS
• Certain antibiotics, such as clarithromycin, telithromycin
• Certain medications for fungal infections, such as ketoconazole, itraconazole, posaconazole
• Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin
• Rifampin
• Rosuvastatin

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?

Your condition will be monitored carefully while you are receiving this medication.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Avoid taking medications that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your care team. These medications may hide a fever.

This medication may increase blood sugar. The risk may be higher in patients who already have diabetes. Ask your care team what you can do to lower your risk of diabetes while taking this medication.

Talk to your care team if you or your partner are pregnant or think either of you might be pregnant. This medication can cause serious birth defects. If your partner can get pregnant, use a condom during sex while taking this medication and for 1 week after the last dose.

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

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
• Seizures

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

• Diarrhea
• Fatigue
• Increase in blood pressure
• Nausea
• Pain in the hands or feet

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 between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original container. 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 it 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.