Description
Apalutamide is used to treat patients with metastatic castration-sensitive prostate cancer (prostate cancer that responds to medical or surgical treatments that lower testosterone and has spread to other parts of the body), and 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).
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
Apalutamide 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 apalutamide 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.
- Atazanavir
- Fostemsavir
- Isavuconazonium Sulfate
- Lenacapavir
- Lonafarnib
- Lopinavir
- Mavacamten
- Nirmatrelvir
- Ombitasvir
- Pacritinib
- Paritaprevir
- Praziquantel
- Ritonavir
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.
- Abiraterone Acetate
- Abiraterone Acetate, Micronized
- Abrocitinib
- Acalabrutinib
- Adagrasib
- Afatinib
- Alpelisib
- Amiodarone
- Apixaban
- Aripiprazole
- Atogepant
- Avacopan
- Avapritinib
- Bedaquiline
- Belumosudil
- Benzhydrocodone
- Berotralstat
- Betrixaban
- Bictegravir
- Boceprevir
- Bortezomib
- Brigatinib
- Buprenorphine
- Cabozantinib
- Cannabidiol
- Capivasertib
- Capmatinib
- Clarithromycin
- Clopidogrel
- Clozapine
- Cobicistat
- Codeine
- Conivaptan
- Copanlisib
- Crizotinib
- Cyclosporine
- Dabigatran Etexilate
- Daridorexant
- Darolutamide
- Desogestrel
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 or tumor, history of or
- Diabetes or
- Dyslipidemia (high cholesterol in the blood) or
- Heart disease, history of or
- Hypertension (high blood pressure) or
- Lung problems or
- Seizures, history of or
- Stroke, history of—Use with caution. May cause side effects to become worse.
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.
If you cannot swallow the tablet whole:
- Place all the prescribed dose of tablets in a cup. Do not crush or split the tablet.
- For one 240 mg tablet: Add 2 teaspoons (10 mL) of non-carbonated water to make sure the tablet is completely covered in water.
- For 60 mg tablets (prescribed dose of 240 mg, 180 mg, or 120 mg): Add 4 teaspoons (20 mL) of non-carbonated water to make sure the tablets are completely covered in water.
- Wait for 2 minutes until the tablet has broken up, then stir the mixture well.
- Add 2 tablespoons (30 mL) of orange juice, applesauce, or non-carbonated water to the cup and stir the mixture.
- Swallow the mixture right away.
- Rinse the cup with enough non-carbonated water to make sure you that you take your full dose and drink it right away.
- Do not store this mixture.
You may also give the tablet through feeding tube:
- For one 240 mg tablet: Place the tablet in the barrel of the syringe (at least 20 mL syringe) and draw up 10 mL of non-carbonated water.
- For 60 mg tablets (prescribed dose of 240 mg, 180 mg, or 120 mg): Place all the prescribed dose of tablets in the barrel of the syringe (at least 50 mL syringe) and draw up 20 mL of non-carbonated water.
- Wait for 10 minutes and shake the syringe well until the tablet is completely broken up.
- Attach the syringe to the feeding tube and give the mixture right away.
- Add non-carbonated water into the same syringe and flush through the feeding tube.
- Repeat this step until no pieces of tablet are left in the syringe or feeding tube.
You may take this medicine with or without 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 metastatic castration-sensitive prostate cancer and castration-resistant prostate cancer:
- Adults—The usual dose is 240 milligrams (mg) (one 240 mg tablet or four 60 mg tablets) once a day. Your doctor may adjust your dose as tolerated.
- Children—Use is not recommended.
- For metastatic castration-sensitive prostate cancer and castration-resistant 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 this medicine in its original package.
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. Apalutamide 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 3 months after the last dose. If a pregnancy occurs while you are using this medicine, tell your doctor right away.
Do not donate sperm during treatment with this medicine and for 3 months after your last dose.
Do not stop using this medicine, even for a short time, without first asking your doctor.
This medicine may increase your risk of having heart or blood vessel problems, including a heart attack or stroke. Tell your doctor right away if you have chest pain that may spread to your arms, jaw, back, or neck, faintness, headache, nausea, vomiting, trouble breathing, trouble seeing or speaking, or unusual sweating.
This medicine may cause dizziness, tiredness, seizures, and an increase risk for falls and fractures. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
Serious skin reactions (eg, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), or toxic epidermal necrolysis), which can be life-threatening can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, severe acne or a skin rash, sore throat, sores or ulcers on the skin, mouth, or lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness with this medicine.
This medicine may cause lung or breathing problems (eg, interstitial lung disease or pneumonitis). check with your doctor right away if you have chest pain, chills cough, fever, general feeling of discomfort or illness, thickening of bronchial secretions, or trouble breathing.
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
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- blurred vision
- constipation
- depressed mood
- difficulty with moving
- dizziness
- dry skin and hair
- falls
- feeling cold
- hair loss
- headache
- hoarseness or husky voice
- joint pain
- muscle cramp, pain, and stiffness
- nervousness
- pain in the legs
- pounding in the ears
- rapid weight gain
- slow or fast heartbeat
- tingling of the hands or feet
- unusual tiredness or weakness
- unusual weight gain or loss
- weight gain
Less common
- Bloody urine
- chest pain, discomfort, or tightness
- decreased urine output
- dilated neck veins
- irregular breathing or heartbeat
- nausea
- pain in the shoulders, arms, jaw, or neck
- sweating
- trouble breathing
- vomiting
Incidence not known
- Blistering, peeling, or loosening of the skin
- chills
- cough
- diarrhea
- fever
- general feeling of discomfort or illness
- itching
- joint or muscle pain
- red irritated eyes
- red skin lesions, often with a purple center
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- swollen glands
- thickening of bronchial secretions
- unusual bleeding or bruising
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
- Decreased appetite
- decreased weight
- diarrhea
- feeling of warmth
- itching, skin rash
- redness of the face, neck, arms, and occasionally, upper chest
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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