Yonsa

Use Yonsa (abiraterone acetate) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

All products:

• This medicine is taken with a steroid drug like prednisone. Take the steroid drug with Yonsa (abiraterone acetate) as you have been told by your doctor.
• Take with a full glass of water.
• Swallow whole. Do not chew, break, or crush.
• To gain the most benefit, do not miss doses.
• Keep taking Yonsa (abiraterone acetate) as you have been told by your doctor or other health care provider, even if you feel well.

Zytiga:

• Take Yonsa (abiraterone acetate) on an empty stomach. Take 1 hour before or 2 hours after a meal.

Yonsa:

• Take with or without food.

What do I do if I miss a dose?

• If you miss a dose, wait until the next day to take your normal dose.
• Do not take 2 doses at the same time or extra doses.
• If you miss 2 doses, call your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
• Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• A fast heartbeat.
• Shortness of breath.
• A big weight gain.
• Swelling.
• Feeling very tired or weak.
• Bruising.
• Very bad and sometimes deadly liver problems have happened with Yonsa (abiraterone acetate). Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Yonsa (abiraterone acetate), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Yonsa tablets should not be handled by a woman who is pregnant or who may become pregnant. This medicine can harm an unborn baby or cause miscarriage.

You should not use Yonsa if you are allergic to it.

Tell your doctor if you have ever had:

• liver disease;

• heart problems;

• low levels of potassium in your blood; or

• problems with your adrenal gland or pituitary gland.

Yonsa is not for use by women or children.

Yonsa can harm an unborn baby or cause miscarriage. Yonsa tablets should not be handled by a woman who is pregnant or who may become pregnant. If this cannot be avoided, the woman should wear latex gloves.

Yonsa can also harm an unborn baby if the father is taking this medicine at the time of conception or during pregnancy.

Use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 weeks after your last dose. Use a condom plus another form of effective birth control to prevent pregnancy.

Yonsa should also not be used by a woman who is breast-feeding a baby.

Yonsa is not approved for use by anyone younger than 18 years old.

Applies to abiraterone: oral tablet

Along with its needed effects, abiraterone (the active ingredient contained in Yonsa) 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 while taking abiraterone:

More Common

• Bladder pain
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody or cloudy urine
• blurred vision
• bone fracture
• chest pain or discomfort
• decreased urine
• difficult, burning, or painful urination
• dizziness
• dry mouth
• fainting
• fast, pounding, or irregular heartbeat or pulse
• feeling of warmth
• frequent urge to urinate
• headache
• increased thirst
• increased urge to urinate during the night
• lightheadedness, dizziness, or fainting
• loss of appetite
• lower back or side pain
• mood changes
• muscle pain or cramps
• nausea
• nervousness
• numbness or tingling in the hands, feet, or lips
• pain or swelling in the arms or legs without any injury
• passing urine more often
• pounding in the ears
• rapid weight gain
• redness of the face, neck, arms, and occasionally, upper chest
• seizures
• slow heartbeat
• sudden sweating
• swelling
• swelling with pits or depressions on the skin
• unusual tiredness or weakness
• unusual weight gain or loss
• vomiting
• waking to urinate at night

Less Common

• Arm, back, or jaw pain
• chest tightness or heaviness
• clay colored stools
• cool, sweaty skin
• dark urine
• decreased appetite
• decreased urine output
• difficulty with breathing
• dilated neck veins
• extreme tiredness or weakness
• fever
• headache
• irregular breathing
• itching skin or rash
• stomach pain or tenderness
• sweating
• weakness
• weight gain
• yellow eyes or skin

Rare

• Darkening of the skin
• diarrhea
• mental depression

Some side effects of abiraterone 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

• Belching
• body aches or pain
• chills
• cough
• difficulty with moving
• ear congestion
• heartburn
• indigestion
• joint pain
• loss of voice
• muscle cramps, spasms, or stiffness
• muscle or bone pain
• nasal congestion
• runny nose
• sneezing
• sore throat
• stomach discomfort or upset
• swelling or stiffness of the joints

For Healthcare Professionals

Applies to abiraterone: oral tablet

Endocrine

Uncommon (0.1% to 1%): Adrenocortical insufficiency[Ref]

Hepatic

Very common (10% or more): Elevated ALT (up to 41.9%), elevated AST (up to 37.3%)

Common (1% to 10%): Elevated total bilirubin

Postmarketing reports: Fulminant hepatitis, acute liver failure and death[Ref]

Cardiovascular

Very common (10% or more): Hot flush (up to 22.3%), hypertension (up to 21.6%)

Common (1% to 10%): Arrhythmia, chest pain/chest discomfort, angina pectoris, atrial fibrillation, tachycardia, myocardial infarction/ischemia, cardiac failure (e.g., congestive heart failure, left ventricular dysfunction, decreased ejection fraction)

Frequency not reported: QT prolongation[Ref]

Musculoskeletal

Very common (10% or more): Joint swelling/discomfort (up to 30.3%), muscle discomfort (up to 26.2%), contusion (up to 13.3%)

Common (1% to 10%): Groin pain, fractures, falls

Postmarketing reports: Rhabdomyolysis, myopathy[Ref]

Hematologic

Very common (10% or more): Lymphopenia (up to 38.2%), anemia[Ref]

Metabolic

Very common (10% or more): Hypertriglyceridemia (up to 62.5%), hyperglycemia (up to 56.6%), hypernatremia (up to 32.8%), hypokalemia (up to 28.3%), fluid retention/edema (up to 26.7%), hypophosphatemia (up to 23.8%), elevated alkaline phosphatase, hypercholesterolemia[Ref]

Renal

Frequency not reported: Renal failure[Ref]

Other

Very common (10% or more): Fatigue (up to 39.1%)

Common (1% to 10%): Sepsis, pyrexia[Ref]

Respiratory

Very common (10% or more): Cough (up to 17.3%), upper respiratory tract infection (up to 12.7%), dyspnea (up to 11.8%), nasopharyngitis (up to 10.7%)

Postmarketing reports: Non-infectious pneumonitis, allergic alveolitis[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (up to 12%), hematuria (up to 10.3%)

Common (1% to 10%): Urinary frequency, nocturia[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 13.5%)[Ref]

Gastrointestinal

Very common (10% or more): Constipation (up to 23.1%), diarrhea (up to 21.6%), dyspepsia (up to 11.1%), vomiting[Ref]

Dermatologic

Common (1% to 10%): Rash[Ref]