Apalutamide (Oral route)

Pronunciation:

a-pah-LOO-ta-mide

Brand Names:

  • Erleada

Dosage Forms:

  • Tablet

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

Apalutamide 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).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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.

Children—

Apalutamide is not indicated for use in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of apalutamide in the elderly.

Breast-feeding—

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.

Other medicines—

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 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
  • Alpelisib
  • Amiodarone
  • Apixaban
  • Betrixaban
  • Bictegravir
  • Boceprevir
  • Brigatinib
  • Cabozantinib
  • Clarithromycin
  • Cobicistat
  • Conivaptan
  • Crizotinib
  • Dabigatran Etexilate
  • Darolutamide
  • Desogestrel
  • Dienogest
  • Dronedarone
  • Drospirenone
  • Entrectinib
  • Erdafitinib
  • Estradiol
  • Ethinyl Estradiol
  • Ethynodiol
  • Etonogestrel
  • Fedratinib
  • Gemfibrozil
  • Gestodene
  • Gilteritinib
  • Glasdegib
  • Idelalisib
  • Indinavir
  • Itraconazole
  • Ketoconazole
  • Larotrectinib
  • Levonorgestrel
  • Lopinavir
  • Macitentan
  • Mestranol
  • Nefazodone
  • Nelfinavir
  • Norethindrone
  • Norgestimate
  • Norgestrel
  • Pexidartinib
  • Pitolisant
  • Posaconazole
  • Pretomanid
  • Ritonavir
  • Rivaroxaban
  • Romidepsin
  • Saquinavir
  • Telaprevir
  • Telithromycin
  • Upadacitinib
  • Voriconazole
  • Warfarin

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
  • Seizures, history of or
  • Stroke, history of or—Use with caution. May cause side effects to become worse.

Proper Use of This Medicine:

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.

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 castration-resistant prostate cancer:
      • Adults—The usual dose is 240 milligrams (mg) (four 60 mg tablets) once a day. Your doctor may adjust your dose as tolerated.
      • Children—Use is not recommended.

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 While Using This Medicine:

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 cause 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.

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 of This Medicine:

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 in 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 arms or 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 or discomfort
decreased urine output
dilated neck veins
extreme tiredness or weakness
irregular breathing or heartbeat
nausea
pain in the shoulders, arms, jaw, or neck
tightness in the chest
troubled breathing
vomiting

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.


Last Updated: 9/5/2019

The information provided herein should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. A licensed medical professional should be consulted for diagnosis and treatment of any and all medical conditions. Call 911 for all medical emergencies. Links to other sites are provided for information only -- they do not constitute endorsements of those other sites.

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The information provided herein should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. A licensed medical professional should be consulted for diagnosis and treatment of any and all medical conditions. Call 911 for all medical emergencies. Links to other sites are provided for information only -- they do not constitute endorsements of those other sites.
All rights reserved.

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