Description
Enzalutamide is used to treat castration-resistant prostate cancer (prostate cancer that is resistant to medical or surgical treatments that lower testosterone), metastatic castration-sensitive prostate cancer (prostate cancer that has spread to other parts of the body and responds to a hormone therapy or surgical treatment to lower testosterone), and non-metastatic castration-sensitive prostate cancer (prostate cancer that has spread to other parts of the body and responds to a hormone therapy or surgical treatment to lower testosterone) in patients who are at high risk of cancer spreading to other parts of the body. It works to stop the growth of cancer cells by blocking the effects of androgen hormones (eg, testosterone). Enzalutamide is an antiandrogen cancer medicine.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
- Capsule, Liquid Filled
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
Appropriate studies have not been performed on the relationship of age to the effects of enzalutamide 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 enzalutamide in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.
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.
- Artemether
- Atazanavir
- Bacillus of Calmette and Guerin Vaccine, Live
- Boceprevir
- Colchicine
- Daclatasvir
- Dasabuvir
- Delamanid
- Dengue Tetravalent Vaccine, Live
- Doravirine
- Elbasvir
- Fostemsavir
- Grazoprevir
- Isavuconazole
- Isavuconazonium
- Lenacapavir
- Lonafarnib
- Lorlatinib
- Lumefantrine
- Lurasidone
- Mavacamten
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Nifedipine
- Nirmatrelvir
- Pacritinib
- Praziquantel
- Ranolazine
- Ritonavir
- 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
- Abemaciclib
- Abiraterone Acetate
- Abiraterone Acetate, Micronized
- Acalabrutinib
- Acoramidis
- Adagrasib
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Alfentanil
- Alpelisib
- Amiodarone
- Apalutamide
- Apixaban
- Apremilast
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Astemizole
- Atogepant
- Atrasentan
- Avacopan
- Avapritinib
- Avatrombopag
- Axitinib
- Bedaquiline
- Belumosudil
- Benzhydrocodone
- Bictegravir
- Bortezomib
- Bosentan
- Bosutinib
- Brigatinib
- Buprenorphine
- Cabozantinib
- Cannabidiol
- Capivasertib
- Capmatinib
- Carbamazepine
- Cariprazine
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.
- Ospemifene
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 tumor, history of or
- Diabetes or
- Dyslipidemia (high cholesterol in the blood) or
- Hypertension (high blood pressure) or
- Seizures, history of or
- Stroke, history of or
- Transient ischemic attack, recent—Use with caution. May cause side effects to become worse.
Proper Use
Take this medicine only as directed by your doctor. 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 any questions.
Take your medicine at the same time each day with or without food.
Swallow the capsule whole with enough water. Do not chew, dissolve, or open it.
Swallow the tablet whole with enough water. Do not crush, break, or chew it.
If you are taking 2 cancer medicines, follow your doctor's instructions on when to take them.
Your doctor may give you other medicines (eg, 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 (capsules and tablets):
- For prostate cancer:
- Adults—160 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated.
- Children—Use and dose must be determined by your doctor.
- For 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
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
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.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.
Women should not use this medicine, especially women who are pregnant or able to become pregnant. This medicine can harm an unborn baby. It can also cause birth defects if the father is using it when his sexual partner becomes pregnant. Men with female partners must use a condom together with a second effective form of birth control during treatment with this medicine and for 3 months after the last dose. If a pregnancy occurs while you are using this medicine, tell your doctor right away.
This medicine may cause dizziness, tiredness, muscle weakness, seizures (very rare), and an increased risk for falls and fractures. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
This medicine may cause a nerve problems called posterior reversible encephalopathy syndrome (PRES). Check with your doctor right away if you have seizures, headache, confusion, unusual drowsiness, dullness, tiredness, weakness, feeling of sluggishness, or blurred vision.
This medicine may cause serious allergic reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a fast heartbeat, fever, joint pain, stiffness, or swelling, rash, redness of the skin, swelling of the eyelids, face, tongue, lips, hands, or feet, tightness in the chest, or trouble with breathing or swallowing.
Enzalutamide may cause heart problems including ischemic heart disease. Check with your doctor right away if you have chest pain or discomfort or pain or discomfort in the arms, jaw, back, or neck.
This medicine may cause trouble swallowing or choking due to it's size, which can be life-threatening and require immediate medical attention. Talk to your doctor if you have concerns about this.
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 (eg, St. John's wort) 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
- Back pain
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blood in the urine
- blurred vision
- chest pain
- chills
- cough with mucus
- difficulty with breathing
- dizziness
- fever
- loss of bladder or bowel control
- nervousness
- painful or difficult urination
- pounding in the ears
- slow or fast heartbeat
- sore throat
- tingling of the hands or feet
- unable to move the legs
- unusual weight gain or loss
Less common
- Anxiety
- confusion or excitement
- depression
- fainting
- falling
- lightheadedness
- loss of memory
- memory or attention span problems
- nightmares or vivid dreams
- rapid, shallow breathing
Rare
- Seizures
Incidence not known
- Black, tarry stools
- blistering, peeling, or loosening of the skin
- chest tightness
- choking
- diarrhea
- headache
- hives, itching, skin rash
- hoarseness
- irritation
- joint pain, stiffness, or swelling
- red irritated eyes
- red skin lesions, often with a purple center
- redness of the skin
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- swelling of the eyelids, face, lips, hands, or feet
- swollen glands
- trouble breathing or swallowing
- unusual bleeding or bruising
- unusual drowsiness, tiredness, weakness, or feeling of sluggishness
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
- Body aches or pain
- bone pain
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- diarrhea
- difficulty having a bowel movement
- difficulty with moving
- dry throat
- ear congestion
- feeling of constant movement of self or surroundings
- feeling of warmth
- lack or loss of strength
- loss of voice
- muscle pain, stiffness, or weakness
- pain or tenderness around the eyes and cheekbones
- sensation of spinning
- stuffy or runny nose
- tender, swollen glands in the neck
- trouble sleeping
Less common
- Bloody nose
- dry skin
- frequent urination
- pale-colored urine
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.
DRG-20075790
