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Darolutamide tablets

What is this medicine?

DAROLUTAMIDE (DAR oh LOO ta mide) blocks the effect of the male hormone called testosterone. This medicine is used for certain types of prostate cancer.

How should I use this medicine?

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. Take this medicine 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.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

  • chest pain or chest tightness

  • signs and symptoms of infection like fever or chills; cough; sore throat; pain or trouble passing urine

  • signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin

  • signs of worsening heart failure like breathing problems; swelling in your legs and feet

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

  • signs of decreased red blood cells - unusually weak or tired, feeling faint or lightheaded, falls

What may interact with this medicine?

This medicine may interact with the following medications:

  • antiviral medicines for HIV or AIDS

  • certain antibiotics like clarithromycin and telithromycin

  • certain medicines for fungal infections like ketoconazole, itraconazole, and posaconazole

  • certain medicines for seizures like carbamazepine, phenobarbital, phenytoin

  • rifampin

  • rosuvastatin

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.

Where should I keep my medicine?

Keep out of the reach of children.

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

What should I tell my health care provider before I take this medicine?

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

  • an unusual or allergic reaction to darolutamide, other medicines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

Men should not father a child while taking this medicine and for 1 week 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.

This medicine has caused reduced sperm counts in some men. This may interfere with the ability to father a child. You should talk to your doctor or health care professional if you are concerned about your fertility.

Avoid taking products that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your doctor. These medicines may hide a fever.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

Author: StayWell Custom Communications
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