Apo-Abiraterone

Apo-Abiraterone

abiraterone

Manufacturer:

Apotex

Distributor:

Hind Wing
Concise Prescribing Info
Contents
Abiraterone acetate
Indications/Uses
In combination w/ prednisone for the treatment of metastatic prostate cancer in adults w/ mild or no symptoms after treatment w/ androgen deprivation therapy (ADT) that does not work; or had cancer treatment w/ docetaxel after treatment of ADT that does not work.
Dosage/Direction for Use
Adult 1,000 mg/day (two 500-mg tab or four 250-mg tab once daily).
Administration
Should be taken on an empty stomach: Do not eat any solid or liqd food 2 hr before & at least 1 hr after taking the tab. Swallow whole w/ water, do not break.
Contraindications
Hypersensitivity. Pregnancy & lactation.
Special Precautions
Patients w/ high BP, low blood K & irregular heartbeats; DM; heart failure, heart attack, artery blood clots or other heart problems; liver problems; adrenal (hormonal) problems; current or previous surgery; severe trauma or infections. Risk of liver failure; hypoglycemia; muscle problems including rhabdomyolysis. Perform regular blood tests prior to therapy, every 2 wk for the 1st 3 mth while on therapy, & every mth after. Check BP & blood sugar levels, & perform physical exam before, during & at the end of treatment. Male patients should use condom w/ another effective birth control method. Continue using condom until 1 wk after the last dose. May affect male fertility. Not for use in women. May cause fetal harm. Women who are pregnant or may be pregnant should not handle abiraterone tab w/o protective gloves. Do not use in patients <18 yr.
Adverse Reactions
Joint swelling or pain, muscle pain, hot flushes, cough, diarrhea, fatigue, constipation, vomiting, insomnia, high BP, stomach upset/indigestion, flu-like symptoms, wt gain, frequent urination, blood in urine, bone fractures including ribs, rash & skin wounds, falls, bruising, headache, depression.
Drug Interactions
Potential interaction w/ antiepileptics eg, phenytoin, carbamazepine, phenobarb; antibacterials eg, rifampicin, rifabutin; St. John's wort; antidiabetics eg, pioglitazone, repaglinide; antitussives eg, dextromethorphan.
MIMS Class
Cancer Hormone Therapy
ATC Classification
L02BX03 - abiraterone ; Belongs to the class of other hormone antagonists and related agents. Used in the treatment of metastatic castration-resistant prostate cancer.
Presentation/Packing
Form
Apo-Abiraterone FC tab 250 mg
Packing/Price
60's
Form
Apo-Abiraterone FC tab 500 mg
Packing/Price
60's
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