A Milestone Moment: FDA Approves Addyi® for Hypoactive Sexual Desire Disorder in Postmenopausal Women
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Brand Name :
Yonsa, Zytiga
Synonyms :
abiraterone
Class :
Antineoplastic agents & Antiandrogens
Brand Name :
Yonsa, Zytiga
Synonyms :
abiraterone
Class :
Antineoplastic agents & Antiandrogens
Adult dosing
Dosage Forms & Strengths
Tablet, Oral
125 mg
250 mg
500 mg
Metastatic cancer:
1000
mg
Orally
once a day
in combination with prednisone 5 mg twice a day.
Or
500 mg orally once a day in combination with methyl prednisone 4 mg twice a day.
Dose Adjustments
Moderate hepatotoxicity: 125 mg once a day
Severe hepatotoxicity: discontinue the treatment
No safe dosing is established
Refer to adult dosing
when both drugs are combined, there may be a decreased effect of abiraterone by affecting hepatic or intestinal enzyme cyp3a4 metabolism
when both drugs combine abiraterone will increase effect of ifosfamide by affecting the enzyme CYP3A4 metabolism.
when both drugs are combined, there may be a decreased metabolism of paclitaxel
the effect of abiraterone is decreased by lorlatinib, by altering intestinal or hepatic CYP3A4 enzyme metabolism
Action:
It targets CYP17A1 (17α-hydroxylase/17,20-lyase). The agents that help in androgenesis like testosterone which promote the growth of the prostate cancer cells. As a result, the overall androgen production is significantly reduced in the testes, adrenal glands and the tumour tissue due to the CYP17A1 inhibition by abiraterone and thus limiting the progression of the tumour.
Frequency defined:
>10%:
Edema (25%)
Hypertension (9%)
Hot flash (15%)
Constipation (23%)
Dyspepsia (6%)
Urinary tract infection (12%)
Bruise
Increased serum alanine aminotransferase
Fatigue
Insomnia
Arthralgia
Joint swelling
1%-10%
Cardiac arrhythmia
Cardiac failure
Nocturia
Headache
Bone fracture
Fever
<1%:
Adrenocortical insufficiency
Black Box Warning
None
Contraindication /Caution:
Cautions:
Cardiovascular Disorders
Moderate Liver Impairment
Electrolyte Imbalances
Diabetes
Pregnancy/Lactation:
Pregnancy consideration: Based on animal studies, it may cause harm to patients who can become pregnant.
Lactation: Excretion of abiraterone in breast milk is not known.
Pregnancy category:
Category A: Satisfactory and well-controlled studies show no risk to the fetus in the first or later trimester.
Category B: There is no evidence of risk to the fetus found in animal reproduction studies and there are not enough studies on pregnant women.
Category C: Adverse effects on the fetus found with evidence in animal reproduction studies and no adequate evidence for an effect in humans, care must be taken for potential risks in pregnant women
Category D: There is adequate data available with sufficient evidence of human fetal risk from various platforms, but despite potential risks may be used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh risks over benefits These category drugs should be prohibited for pregnant women.
Category N: There is no data available for the drug under this category.
Pharmacology
Abiraterone is an antiandrogen class of antineoplastic drug. It is used to treat prostate cancer.
Pharmacodynamics
It targets CYP17A1 (17α-hydroxylase/17,20-lyase). The agents that help in androgenesis like testosterone which promote the growth of the prostate cancer cells. As a result, the overall androgen production is significantly reduced in the testes, adrenal glands and the tumour tissue due to the CYP17A1 inhibition by abiraterone and thus limiting the progression of the tumour.
Pharmacokinetics
Absorption
The peak plasma time is 2 hours.
Distribution
Abiraterone has a high affinity for plasma proteins, including albumin, and alpha-1 acid glycoprotein.
Metabolism
It is metabolized mainly in the liver.
Excretion and elimination
The major route of metabolism of abiraterone is through feces, which constitutes 88%, while urinary excretion accounts for 5%.
The terminal half-life of the drug is estimated to be about 12 h for abiraterone.
Administration
The route of administration is oral.
The drug can be taken with or without a meal.
Generic Name: abiraterone
Pronounced: ae-bi-ra-te-ron
Why do we use abiraterone?
Abiraterone is an antiandrogen class of antineoplastic drug. It is used to treat cancer of the prostate gland.
Abiraterone has been effective for use in combination with prednisone/prednisolone for mCRPC patients who have demonstrated progression after or during receiving chemotherapy as mentioned including at least a period of docetaxel course.
It is also employed in the treatment of mHSPC when used with prednisone or prednisolone (neoadjuvant or concurrent with initial docetaxel).
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