Description
Darolutamide is used to treat patients with non-metastatic castration-resistant prostate cancer (prostate cancer that is resistant to medical or surgical treatments that lower testosterone and has not yet spread to other parts of the body). It is also used in combination with docetaxel to treat metastatic hormone-sensitive prostate cancer (prostate cancer that responds to medical or surgical treatments that lower testosterone and has spread to other parts of the body).
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Darolutamide is not indicated for use in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of darolutamide in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bacillus of Calmette and Guerin Vaccine, Live
- Dengue Tetravalent Vaccine, Live
- Elagolix
- Grazoprevir
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Monkeypox Vaccine
- Typhoid Vaccine
- Varicella Virus Vaccine
- Yellow Fever Vaccine
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abametapir
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Alpelisib
- Apalutamide
- Atogepant
- Atorvastatin
- Avacopan
- Axitinib
- Berotralstat
- Bosentan
- Capmatinib
- Carbamazepine
- Cariprazine
- Cerivastatin
- Cholera Vaccine
- Clarithromycin
- Conivaptan
- Docetaxel
- Ebola Zaire Vaccine, Live
- Eluxadoline
- Exemestane
- Fedratinib
- Fexinidazole
- Fexofenadine
- Fluvastatin
- Fosphenytoin
- Glecaprevir
- Glyburide
- Influenza Virus Vaccine, Live
- Irinotecan
- Itraconazole
- Letermovir
- Lovastatin
- Methotrexate
- Momelotinib
- Nateglinide
- Omaveloxolone
- Paclitaxel
- Paritaprevir
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Mavacamten
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Brain injury, history of or
- Brain tumors, history of or
- Diabetes or
- Dyslipidemia (high cholesterol in the blood) or
- Heart disease or
- Hypertension (high blood pressure) or
- Seizures, history of—Use with caution. May make these conditions worse.
- Kidney disease, severe and not receiving dialysis or
- Liver disease, moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have questions.
Swallow the tablet whole. Do not break, crush, or chew it. Take it with food.
Your doctor may give you other medicines (eg, a gonadotropin-releasing hormone) unless you had a surgery to lower the amount of testosterone in your body.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For castration-resistant prostate cancer and hormone-sensitive prostate cancer:
- Adults—600 milligrams (two 300 mg tablets) 2 times a day. Your doctor may adjust your dose as needed and tolerated.
- Children—Use is not recommended.
- For castration-resistant prostate cancer and hormone-sensitive prostate cancer:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep the bottle tightly closed after you first open it.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.
Women and children should not use this medicine. Darolutamide may also cause birth defects if the father is using it when his sexual partner becomes pregnant. You must use an effective method of birth control during treatment with this medicine and for 1 week after the last dose. If a pregnancy occurs while you are using this medicine, tell your doctor right away.
This medicine may cause ischemic heart disease. Check with your doctor right away if you have chest pain or discomfort, irregular heartbeat, nausea or vomiting, pain in the shoulders, arms, jaw, or neck, sweating, or trouble breathing.
Seizures can occur while you are using this medicine. Tell your doctor right away if you have loss of consciousness.
If you plan to have children, talk with your doctor before using this medicine. Some men using this medicine have become infertile (unable to have children).
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Black, tarry stools
- bleeding gums
- blood in the urine
- bloody nose
- blurred vision
- coughing or spitting up blood
- difficulty in breathing or swallowing
- dizziness
- frequent urination
- headache
- increased menstrual flow or vaginal bleeding
- lower abdominal or stomach cramping
- nausea and vomiting
- nervousness
- nosebleeds
- painful urination
- paralysis
- pounding in the ears
- prolonged bleeding from cuts
- red or dark brown urine
- red or black, tarry stools
- slow, fast, or irregular heartbeat
- vomiting of blood or material that looks like coffee grounds
- unusual bleeding or bruising
Less common
- Blood in the urine
- chest pain or discomfort
- pain in the shoulders, arms, jaw, or neck
- painful or difficult urination
- seizures
- sweating
- trouble breathing
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Constipation
- decreased appetite
- increased weight
- pain in the arms or legs
- rash
- unusual tiredness or weakness
Less common
- Chest pain or tightness
- cough
- fever or chills
- muscle or bone pain
- sneezing
- sore throat
Rare
- Diarrhea
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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