Abiraterone acetate

What is Abiraterone acetate?

• Abiraterone acetate (Zytiga) is a CYP17 inhibitor used to treat prostate cancer.

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Abiraterone acetate

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What are the uses of this medicine?

• Zytiga is a prescription medicine that is used along with prednisone. Zytiga is used to treat men with prostate cancer that has spread to other parts of the body.

How does this medicine work?

• Zytiga lowers the amount of androgens (male hormones), such as testosterone, made by the body.
• This may stop the growth of cancer cells that need androgens to grow.
• Zytiga is a type of antiandrogen.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Avoid concomitant strong CYP3A4 inducers during Zytiga treatment. If a strong CYP3A4 inducer must be co-administered, increase the Zytiga dosing frequency.
• Avoid co-administration of Zytiga with CYP2D6 substrates that have a narrow therapeutic index. If an alternative treatment cannot be used, exercise caution and consider a dose reduction of the concomitant CYP2D6 substrate.

Is this medicine FDA approved?

• Abiraterone acetate was described in 1995, and approved for medical use in the United States and Europe in 2011.

How should this medicine be used?

Recommended dosage: Metastatic CRPC:

• The recommended dose of Zytiga is 1,000 mg (two 500 mg tablets or four 250 mg tablets) orally once daily with prednisone 5 mg orally twice daily.

Metastatic High-risk CSPC:

• The recommended dose of Zytiga is 1,000 mg (two 500 mg tablets or four 250 mg tablets) orally once daily with prednisone 5 mg administered orally once daily.

Administration:

• Take your prescribed dose of Zytiga 1 time a day.
• Your healthcare provider may change your dose if needed.
• Do not change or stop taking your prescribed dose of Zytiga or prednisone without talking with your healthcare provider first.
• Take Zytiga tablets as a single dose one time a day on an empty stomach. Do not eat food 2 hours before and 1 hour after taking Zytiga.
• Do not take Zytiga with food. Taking Zytiga with food may cause more of the medicine to be absorbed by the body than is needed and this may cause side effects.
• Swallow Zytiga tablets whole. Do not crush or chew tablets.
• Take Zytiga tablets with water.
• If you miss a dose of Zytiga or prednisone, take your prescribed dose the following day. If you miss more than 1 dose, tell your healthcare provider right away.
• Your healthcare provider will do blood tests to check for side effects.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Film-Coated Tablet 500 mg
• Uncoated Tablet 250 mg

This medicine is available in fallowing brand namesː

• Zytiga

What side effects can this medication cause?

The most common side effects of this medicine include:

• feeling very tired
• joint pain
• high blood pressure
• nausea
• swelling in your legs or feet
• low blood potassium levels
• hot flushes
• diarrhea
• vomiting
• infected nose, sinuses, or throat (cold)
• cough
• headache
• low red blood cells (anemia)
• high blood cholesterol and triglycerides
• high blood sugar levels
• certain other abnormal blood tests

Zytiga may cause serious side effects including:

• High blood pressure (hypertension), low blood potassium levels (hypokalemia), fluid retention (edema)
• Adrenal problems
• Severe liver problems
• Increased risk of bone fracture and death
• Severe low blood sugar (hypoglycemia)

What special precautions should I follow?

• Zytiga may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition. Monitor patients for hypertension, hypokalemia, and fluid retention at least once a month. Control hypertension and correct hypokalemia before and during treatment with Zytiga. Closely monitor patients with cardiovascular disease. Control hypertension and correct hypokalemia before treatment. Monitor blood pressure, serum potassium and symptoms of fluid retention at least monthly.
• Adrenal insufficiency occurred in 0.3% of patients taking Zytiga. Monitor for symptoms and signs of adrenocortical insufficiency. Monitor for symptoms and signs of adrenocortical insufficiency. Increased dosage of corticosteroid may be indicated before, during and after stressful situations.
• Zytiga-associated severe hepatic toxicity, including fulminant hepatitis, acute liver failure and deaths. Can be severe and fatal. Monitor liver function and modify, interrupt, or discontinue Zytiga dosing as recommended.
• Zytiga plus prednisone/prednisolone is not recommended for use in combination with radium Ra 223 dichloride outside of clinical trials.
• The safety and efficacy of Zytiga have not been established in females. Based on animal reproductive studies and mechanism of action, Zytiga can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception.
• Severe hypoglycemia has been reported when Zytiga was administered to patients with pre-existing diabetes receiving medications containing thiazolidinediones (including pioglitazone) or repaglinide. Monitor blood glucose in patients with diabetes and assess if antidiabetic agent dose modifications are required.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Human experience of overdose with Zytiga is limited.

Treatment of overdosage:

• There is no specific antidote.
• In the event of an overdose, stop Zytiga, undertake general supportive measures, including monitoring for arrhythmias and cardiac failure and assess liver function.

Can this medicine be used in pregnancy?

• The safety and efficacy of Zytiga have not been established in females.
• Based on findings from animal studies and the mechanism of action, Zytiga can cause fetal harm and potential loss of pregnancy.

Can this medicine be used in children?

• Safety and effectiveness of Zytiga in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: abiraterone acetate
• Inactive ingredients:
• 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, silicified microcrystalline cellulose, and sodium lauryl sulfate. The film-coating contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate.

Who manufactures and distributes this medicine?

500 mg Tablets Manufactured by: Patheon France S.A.S., Bourgoin Jallieu, France

250 mg Tablets

• Manufactured by: Patheon Inc., Mississauga, Canada
• Manufactured for: Janssen Biotech, Inc., Horsham, PA

What should I know about storage and disposal of this medication?

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

• Dailymed label info on Abiraterone acetate
• FDA Abiraterone acetate

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