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Why is this medication prescribed?

In men who have not responded to prior medical therapies, darolutamide is used to treat specific types of prostate cancer (cancer that starts in the prostate, a male reproductive gland), which has not spread to other parts of the body. In conjunction with docetaxel, dalolutamide is also used to treat certain forms of prostate cancer (cancer that starts in the prostate [a male reproductive gland]) in men whose cancer has progressed to other parts of the body. Darolutamide belongs to a group of drugs known as androgen receptor inhibitors. In order to prevent the growth and spread of cancer cells, it blocks the effects of androgen, a hormone produced by male reproductive organs.

How should this medicine be used?

Darolutamide is available as an oral tablet. It is typically taken twice daily with food. Darolutamide should be taken every day at around the same time(s). Ask your doctor or chemist to explain any instructions on your prescription label that you are unsure about following. When recommended, take darolutamide as prescribed. Never take it in larger or less amounts or more frequently than directed by your doctor.

Do not chew, break, or crush the tablets; instead, swallow them whole.

In the event that you encounter severe adverse effects while undergoing therapy, your doctor could advise you to temporarily stop taking darolutamide or reduce your dose. During your darolutamide treatment, be careful to discuss your feelings with your doctor.

You must continue taking this drug during your darolutamide therapy if your doctor has given it to treat your prostate cancer, such as goserelin (Zoladex), histrelin (Supprelin LA, Vantas), leuprolide (Eligard, Lupron), or triptorelin (Trelstar).

Darolutamide should still be taken even if you feel fine. Without consulting your doctor, do not discontinue taking darolutamide.

For a copy of the manufacturer’s information for the patient, ask your chemist or doctor.

Other uses for this medicine

Ask your doctor or chemist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking darolutamide,

  • If you have an allergy to darolutamide, any other drugs, or any of the substances in darolutamide tablets, inform your doctor right away. Get a list of the ingredients from your chemist.
  • Inform your doctor and chemist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • Please let your doctor know if you are taking any herbal supplements, especially St. John’s Wort.
  • Inform your doctor about any kidney, liver, heart, high blood pressure, diabetes, high cholesterol, or history of seizures you may have if any of these conditions exist or have ever existed in you.
  • Darolutamide should only be used in men, as you are aware. In particular, women who are breastfeeding or who may become pregnant shouldn’t take this drug. Darolutamide may be harmful to the foetus if consumed by pregnant women. A pregnant woman who takes darolutamide needs to contact her doctor right away. Both of you must use birth control during treatment and for one week following your last dose if your female partner is not currently pregnant but could become pregnant.
  • You should be aware that this drug may reduce male fertility. You shouldn’t, however, believe that your female spouse can’t get pregnant while you’re receiving therapy.

What special dietary instructions should I follow?

While using this medication, avoid grapefruit and grapefruit juice.

What should I do if I forget a dose?

If you miss a dosage, take it as soon as you recall. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

Darolutamide could have negative effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Extreme fatigue
  • Hand, foot, leg, or arm pain

Certain adverse effects can be very harmful. Call your doctor right away if any of these symptoms occur to you:

  • Hand, foot, leg, or arm pain
  • Rash
  • Urinary blood
  • Fast and/or shallow breathing, cough, and fever
  • Chest pressure or a discomfort in the chest
  • Seizures

Further negative effects of darolutamide are possible. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Keep it away from excessive heat and moisture at room temperature (not in the bathroom).

Although many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning.

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your chemist or the garbage/recycling agency in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medications website at for additional information.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Moreover, information can be found online at Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

What other information should I know?

Keep all of your appointments with your physician and the lab. To monitor how your body is responding to darolutamide, your doctor may request specific lab tests.

No one else should take your medication. Any queries you may have regarding prescription refills should be directed to your chemist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Nubeqa®
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