Yonsa

Yonsa is a prescription medication used in combination with methylprednisolone to treat a condition known as metastatic castration-resistant prostate cancer (CRPC), prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels. Many early-stage prostate cancers need normal levels of testosterone to grow, but castrate-resistant prostate cancers do not.

Yonsa belongs to a group of drugs called cytochrome P450 17 (CYP17) inhibitor, a substance that blocks the activity of proteins involved in sex hormone production. Yonsa works by reducing androgen production in the body. Androgens are male hormones that can promote tumor growth in the prostate gland.

This medication comes in tablet form and is taken once daily, with or without food. Do not chew, divide, or break Yonsa tablets. Swallow tablets whole.

Common side effects of Yonsa include joint swelling, hot flushes, and diarrhea. Yonsa can also cause dizziness or lightheadedness. Do not drive or operate heavy machinery until you know how Yonsa affects you.

Yonsa is a prescription medicine used with methylprednisolone to treat prostate cancer that has spread to other parts of the body and no longer responds to medical or surgical treatment that lowers testosterone. 

It is not known if Yonsa is safe and effective in children.

Do not take Yonsa if you:

• are pregnant or may become pregnant. Yonsa may harm your unborn baby.
• are female. 

Yonsa is not for use in women.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Yonsa. See the “Yonsa Precautions” section.

Common side effects of Yonsa include:

• weakness
• joint swelling or pain
• muscle pain
• swelling in your legs or feet
• hot flushes
• diarrhea
• vomiting
• cough
• high blood pressure
• shortness of breath
• trouble sleeping
• urinary tract infection
• bruising
• indigestion
• blood in the urine
• constipation
• upper respiratory tract infection
• low red blood cells (anemia)
• low blood potassium levels
• high blood sugars
• high blood cholesterol and triglycerides
• changes in liver function blood tests
• certain other abnormal blood tests

Yonsa may affect fertility in males and may affect your ability to father a child. Talk to your healthcare provider if this is a concern for you.

This is not a complete list of Yonsa side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), delavirdine (Rescriptor), and nefazodone
• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), and St John's wort
• medications that use an enzyme CYP2C8 such as amiodarone (Cordarone), cabazitaxel (Jevtana), carbamazepine (Tegretol), chloroquine (Aralen), diclofenac (Voltaren), ibuprofen (Advil), paclitaxel (Taxol), rosiglitazone (Avandia), repaglinide (Prandin), treprostinil (Tyvaso)
• medications that use the enzyme CYP2D6 such as desipramine, dextromethorphan, atomoxetine

This is not a complete list of Yonsa drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Yonsa including:

• High blood pressure, low blood potassium levels, and fluid retention. Tell your healthcare provider if you get any of the following symptoms:
  • dizziness
  • confusion
  • fast heartbeats
  • feel faint or lightheaded
  • headache
  • muscle weakness
  • pain in your legs
  • swelling in your legs or feet

• Adrenal problems may happen if you stop taking methylprednisolone, get an infection, or are under stress.

• Liver problems. You may develop changes in liver function blood tests. Your healthcare provider will do blood tests to check your liver before treatment with Yonsa and during treatment with Yonsa. Liver failure may occur, which can lead to death. Tell your healthcare provider if you notice any of the following changes:

  • yellowing of the skin or eyes
  • darkening of the urine
  • severe nausea or vomiting

Do not drive or operate heavy machinery until you know how Yonsa affects you.

Do not take Yonsa if you:

• are allergic to Yonsa or to any of its ingredients
• are pregnant
• Are female

No known food interactions

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Yonsa, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Yonsa tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have heart problems
• have liver problems
• have a history of adrenal problems
• have a history of pituitary problems
• have a partner who is pregnant or may become pregnant.
  • Men who are sexually active with a woman who may become pregnant must use effective birth control during treatment and for at least 3 weeks after the final dose of Yonsa.
  • Men who are sexually active with a woman who is pregnant must use a condom.

Talk with your healthcare provider if you have questions about birth control.

Tell your healthcare provider about all the medicines you take, including prescription and over-the counter medicines, vitamins, and herbal supplements. Yonsa can interact with many other medicines.

You should not start or stop any medicine before you talk with the healthcare provider that prescribed Yonsa.

Know the medicines you take. Keep a list of them with you to show to your healthcare provider and pharmacist when you get a new medicine.

Men who are sexually active with a woman who may become pregnant must use effective birth control during treatment and for at least 3 weeks after the final dose of Yonsa.

Men who are sexually active with a woman who is pregnant must use a condom.

In animal studies, pregnant animals were given Yonsa, and some babies had problems. There are no well-controlled studies in humans, but based on the findings from animal studies and the mechanism of action, Yonsa is contraindicated for use in women.

Do not take Yonsa if you:

• are pregnant or may become pregnant. Yonsa may harm your unborn baby.
• are female.

Yonsa is not for use in women.

• Women who are pregnant or who may become pregnant should not touch Yonsa tablets (or come in contact with any form of Yonsa) if broken, crushed, or damaged without protection, such as gloves.

Yonsa is not for use in women. It is not known if Yonsa crosses into human milk.

Take Yonsa and methylprednisolone exactly as your healthcare provider tells you.

• Take your prescribed dose of Yonsa 1 time a day. Take your prescribed dose of methylprednisolone 2 times a day.
• Yonsa contains abiraterone acetate. Yonsa and other medicines that contain abiraterone acetate may not be the same.
  • Do not switch between Yonsa and other medicines that contain abiraterone acetate unless your healthcare provider tells you to.
  • Follow your healthcare provider’s instructions carefully if you are switching between Yonsa and another medicine that contains abiraterone acetate.
  • Do not take Yonsa and other medicines that contain abiraterone acetate on the same day.
  • If you do not have enough Yonsa to take your full dose or if you have any other questions about Yonsa, talk with your healthcare provider or pharmacist.
• Your healthcare provider may change your dose of Yonsa if needed.
• Do not stop taking your prescribed dose of Yonsa or methylprednisolone without talking with your healthcare provider first.
• Take Yonsa with or without food.
• Swallow Yonsa tablets whole with water. Do not crush or chew tablets.
• If you miss a dose of Yonsa or methylprednisolone, take your prescribed dose the following day. If you miss more than 1 dose, tell your healthcare provider right away.
• If you are receiving gonadotropin-releasing hormone (GnRH) therapy, you should continue your therapy during treatment with Yonsa and methylprednisolone.
• If you take too much Yonsa, call your healthcare provider or go to the nearest hospital emergency room right away.
• Your healthcare provider will do blood tests to check for side effects.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended dose of Yonsa for the treatment of spreading prostate cancer that is resistant to testicle removal is 500 mg (four 125 mg tablets) in combination with 4 mg methylprednisolone twice a day.

Your doctor may decide to lower your dose if you have liver problems:

• Starting dose of 125 mg is recommended for patients with baseline moderate liver impairment. If patient develops liver damage during treatment, hold Yonsa until recovery and start at a reduced dose.
• Discontinue Yonsa in case of severe liver damage.

Your dose may be altered if you are taking other medications that interact with Yonsa.

If you take too much Yonsa, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Yonsa at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Yonsa and all medicines out of the reach of children.