Pronunciation:

a-bir-A-ter-one AS-e-tate, MYE-kroe-nized

Brand Names:

• Yonsa

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antiandrogen

Uses of This Medicine:

Note: Women of childbearing potential should not use or handle abiraterone tablets without protection (eg, gloves).

Abiraterone is used in combination with methylprednisolone to treat patients with metastatic castration-resistant prostate cancer (prostate cancer that is resistant to medical or surgical treatments that lower testosterone and has already 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—

Abiraterone 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 abiraterone in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Daprodustat
• Dasabuvir
• Eliglustat
• Selexipag

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
• Acarbose
• Albiglutide
• Alogliptin
• Amiodarone
• Amphetamine
• Apalutamide
• Aripiprazole
• Atomoxetine
• Benzphetamine
• Canagliflozin
• Carbamazepine
• Carvedilol
• Cerivastatin
• Chlorpropamide
• Cilostazol
• Clarithromycin
• Clomipramine
• Clozapine
• Codeine
• Dabrafenib
• Dapagliflozin
• Desipramine
• Desloratadine
• Deutetrabenazine
• Dextroamphetamine
• Dihydrocodeine
• Domperidone
• Donepezil
• Doxepin
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Dulaglutide
• Duloxetine
• Empagliflozin
• Encainide
• Enclomiphene
• Enzalutamide
• Ertugliflozin
• Exenatide
• Fedratinib
• Fenfluramine
• Fexinidazole
• Flecainide
• Fluoxetine
• Fosphenytoin
• Glimepiride
• Glipizide
• Glyburide
• Haloperidol
• Hydroxyamphetamine
• Ifosfamide
• Iloperidone
• Imipramine
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Itraconazole
• Ivosidenib
• Linagliptin
• Liraglutide
• Lisdexamfetamine
• Lixisenatide
• Lofexidine
• Loperamide
• Lumacaftor
• Lurasidone
• Mavacamten
• Metformin
• Methamphetamine
• Methoxyphenamine
• Metoprolol
• Mexiletine
• Miglitol
• Mitotane
• Montelukast
• Naloxegol
• Nateglinide
• Nebivolol
• Nicergoline
• Nortriptyline
• Omaveloxolone
• Ondansetron
• Ospemifene
• Oxycodone
• Ozanimod
• Paclitaxel
• Paroxetine
• Perphenazine
• Phenobarbital
• Phenytoin
• Pimozide
• Pioglitazone
• Piperaquine
• Pitolisant
• Pixantrone
• Prajmaline
• Pramlintide
• Primidone
• Propafenone
• Radium Ra 223 Dichloride
• Rifampin
• Rifapentine
• Risperidone
• Rosiglitazone
• Rosuvastatin
• Saxagliptin
• Semaglutide
• Simeprevir
• Sitagliptin
• Spironolactone
• St John's Wort
• Tamoxifen
• Tamsulosin
• Thioridazine
• Timolol
• Tolazamide
• Tolbutamide
• Tolperisone
• Tolterodine
• Tramadol
• Trimipramine
• Tropisetron
• Tucatinib
• Venlafaxine
• Vernakalant
• Voglibose
• Vortioxetine
• Yohimbine
• Zuclopenthixol

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.

• Dextromethorphan
• Repaglinide

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:

• Adrenal or pituitary problems, history of or
• Heart attack, recent or
• Heart failure or
• Heart or blood vessel disease, history of or
• Heart rhythm problems (eg, ventricular arrhythmia, QT prolongation, torsades de pointes) or
• Hypertension (high blood pressure) or
• Hypokalemia (low potassium in the blood)—Use with caution. May make these conditions worse.

• Liver disease, moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Liver disease, severe—Should not be used in patients with this condition.

Proper Use of This Medicine:

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 questions.

Swallow the tablets whole with water. Do not crush or chew the tablets.

You may take this tablet with or without food.

Use only the brand of this medicine that your doctor prescribed. Different brands have different dosages and effects when taken with food.

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 (tablets):
  • For castration-resistant prostate cancer:
    • Adults—500 milligrams (mg) (four 125 mg tablets taken as a single dose) once a day, taken together with 4 mg methylprednisolone 2 times a day.
    • Children—Use is not recommended.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you missed a dose of this medicine, take your normal dose the following day. If more than one daily dose is missed, call your doctor.

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 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. Blood and urine tests will be needed to check for any unwanted effects that may be caused by this medicine.

Women and children should not use this medicine. Pregnant women or women who may become pregnant should not handle or touch the tablets without protection (eg, gloves). This medicine may also cause birth defects if the father is using it when his sexual partner becomes pregnant. You must use a condom and another effective method of birth control during treatment with this medicine and for at least 3 weeks after the last dose. If a pregnancy occurs while you are using this medicine, tell your doctor right away.

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).

You will also need to have your blood pressure measured before starting this medicine and while you are using it. If you notice any changes to your recommended blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.

Do not interrupt or stop using this medicine together with methylprednisolone without first asking your doctor. This may increase your risk of having adrenal gland problems. Talk to your doctor if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine together with methylprednisolone may increase your risk for fractures when used with a radiation treatment (eg, radium Ra 223 dichloride). Talk with your doctor about this risk.

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

Bladder pain

bloody or cloudy urine

blurred vision

body aches or pain

chills

cough

decreased urine

difficult, burning, or painful urination

dizziness

dry mouth

ear congestion

fainting

fast, slow, or irregular heartbeat

fever

fractures

frequent urge to urinate

headache

increased thirst

loss of appetite

loss of voice

lower back or side pain

mood changes

nausea or vomiting

numbness or tingling in the hands, feet, or lips

nervousness

pounding in the ears

runny or stuffy nose

seizures

slow or fast heartbeat

sneezing

sore throat

swelling

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

Less common

Chest pain, discomfort, or tightness

dilated neck veins

irregular breathing

weight gain

Incidence not known

Clay-colored stools

dark urine

diarrhea

general feeling of discomfort or illness

itching, rash

muscle cramp, spasm, pain, or stiffness

stomach pain, continuing

thickening of bronchial secretions

unpleasant breath odor

vomiting of blood

yellow eyes or skin

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

falls

feeling of warmth

groin pain

increased urge to urinate during the night

joint swelling or discomfort

redness of the face, neck, arms, and occasionally, upper chest

trouble sleeping

waking to urinate at night

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.