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Drug profile of Abirapro

Abirapro tablets are containing an active component known as Abiraterone acetate which exhibits anti-tumor activity against prostate cancer.

Abirapro is a derivative of androstene, which involves in the prohibition process of steroid 17 alpha hydroxylase and containing anti-neoplastic activity.

 Abiraterone acetate is an oral tablet which is an active acetate ester form of steroidal compound known as Abiraterone with anti-androgenic activity.

Abiraterone acetate is involved by interfering with testosterone activity by inhibiting the synthesis.

Brand name: Abirapro

Active substance: Abiraterone acetate

Strength: 250mg

Mfg: Glenmark

Pack: 120 tablets in a container

Classified as: Anti-neoplastic agent


Prescribing information of Abirapro

The most important indication of Abirapro tablets is;

Metastatic castration resistance prostate cancer

Metastatic high risk castration sensitive prostate cancer


Involved in the treatment of metastatic castration resistance prostate cancer patients who are not responding prior chemotherapy regimen called docetaxel in concomitant with prednisolone.


For the treatment of metastatic CRPC in grown-up men who are asymptomatic or somewhat symptomatic after disappointment of androgen deprivation treatment in whom chemotherapy isn't clinically shown, with prednisone or prednisolone

Mechanism of Abirapro

Abirapro consisting of Abiraterone acetate is a prodrug form which get altered into Abiraterone inside the body after oral administration.

Abiraterone, an active form which expels its action on androgen biosynthesis by inhibiting an enzyme called 17 alpha hydroxylase/C17, 20-lyase (CYP17).

This enzyme is essential for androgen biosynthesis which is expressed in testicular, adrenal & prostatic cancer cells.

A CYP17 enzyme activates two consecutive reactions;

  1. Transformation of pregnenolone & progesterone to their 17 alpha hydroxy derivatives with the help of 17 alpha hydroxylase.
  2. Production of dehydroepiandrosterone & androstenedione, relatively by CYP17, 20 lyase activity.

DHEA & androstenedione are androgens which as messenger of testosterone.

Abiraterone involved in inhibiting this CYP17 which may also leads to cause elevation of mineralocorticoid formation by adrenals.

Androgen deprivation treatment such as gonadotrophin releasing hormone agonist or orchiectomy may decrease the androgen production in the testes not in adrenals or tumor.

 Abirapro is used to reduce testosterone level and will affect the growth of tumor cells.


Maximum plasma concentration of Abirapro is reaches within 2 hours after drug intake.

The systemic exposure of Abirapro elevates while administered with meals.

Food should not be taken for at least 2 hours earlier the dose of Abirapro or at least one hour after the dose of Abirapro.


Abirapro is largely bound to human plasma protein with >99%.

Volume of distribution of Abiraterone is 19669 ± 13358L


Abiraterone acetate is undergone hydrolysis and leads to change into Abiraterone which is an active form.

Two major circulating metabolite of Abiraterone is;

Abiraterone sulphate

N-oxide Abiraterone sulphate


The terminal mean half life of Abirapro is 12 ± 5 hours.

88% of metabolite is excreted through feces; 5% in urine.

The component present in feces is an unchanged form of Abiraterone.

When to take the Abirapro

Abirapro tablet should be administered on an empty stomach and food not taken for at least 2 hour before the dose or 1 hour after the dose.

Dosage regimens of Abirapro

In advanced CRPC:

The prescribed dose of Abirapro is 1000mg should be administered as a once daily with 5mg of prednisolone should be given two times a day

In advanced high risk CSPC:

The prescribed dose of Abirapro is 1000mg should be administered as a once daily with 5mg of prednisolone should be given two times a day

Dose alteration:

In liver impairment patients:

In moderate hepatic damage patients, the dose of Abirapro should be reduced to 250mg as a single dose.

In moderate liver damaged patients, AST & ALT level should be monitored frequently.

In severe liver damaged patients, Abirapro should not be recommended.


Patient suffered with liver toxicity, during the treatment Abirapro should be postponed and provide supportive measures.

Therapy should be resumed at reduced dose of 750mg as a single dose.

If liver toxicities reappear with the dose of 750mg, should be retreated with 500mg single dose followed with LFT.

Discontinue the Abirapro therapy permanently, if patients may have current elevation of AST & ALT.

Concurrent use of Abirapro with CYP3A4 inducers:

In case concurrent use of Abirapro 250mg with CYP3A4 inducers, the frequency of Abirapro tablets should be increased to two times a day, it may only occur in co administration time.

If co administration discontinues, then frequency changes to once daily.

Abirapro caused side effects


Joint pain, swelling or discomfort

Hot flush







Urinary tract infection


Lab abnormalities:


Increasing alkaline phosphatase





Increased AST, AST



Post marketing reports:

Non infectious pneumonitis

Myopathy, involving rhabdomyolysis

Fulminant hepatitis, acute hepatic failure leads to death

Drug- drug interaction

The concomitant use of Abirapro with CYP3A4 inducers like rifampin, causes decreasing the exposure of Abiraterone.

To avoid this condition, increases the dose of Abirapro for reducing the problems.

Abirapro is an inhibitor of CYP2D6 & CYP2C8, when administering 30mg of dextromethorphan with Abirapro 100mg & 5mg of prednisolone causes increasing the AUC & Cmax of dextromethorphan (CYP2D6 substrate).

Avoid the co administration of CYP2D6 substrate with Abirapro.

In combination of Abirapro with pioglitazone, causes increasing the systemic exposure of pioglitazone.

Food drug interaction

Consuming food with Abirapro, leads to elevate the level of Abirapro in the body.

Risk factors like, increased blood pressure, water retention, hypokalemia

Food should not be taken at least 2 hours before or 1 hour after the dose of Abirapro

Possible contraindications

Abirapro is contraindicated to pregnant & lactating women

Hypersensitivity reactions may occur due to patients is contraindicating to the component present in the Abirapro tablets.

Safety measures

Hypertension, hypokalemia & fluid retention:

Abirapro inhibits CYP17, causes increasing the mineralocorticoid levels leads to hypokalemia, hypertension & retention of fluids.

Concurrent use of Abirapro with corticosteroid leads to diminish adrenocorticotrophic hormone which concludes as reduction in extent & harshness of these adverse effects.

 Control the blood pressure and correct the level of potassium and fluids if required.

Adrenocortical insufficiency:

Adrenocortical deficiency occurs during the therapy of Abirapro with prednisolone.

In this condition, treatment should be interrupt or discontinue.

Monitor the signs & symptoms occurred due to this condition.

Elevation of dose of corticosteroids occurs in both before and during the treatment.

Hepatic toxicities:

In post marketing studies, due to Abirapro therapy hepatic toxicity may occur due to acute hepatic injury leads to death.

Increasing AST, bilirubin, ALT may leads to this condition.

Patients may undergo Hepatic function test frequently before or during the treatment.

Pregnancy and lactation

Pregnancy category: X

Abirapro should not be used in pregnancy condition

Breast feeding should not be allowed.

The potency of Abirapro tablets has not been evaluated in pediatric patients.

No drug safety evaluated in geriatric patients above 65 years of age.

Storage and handling

Abirapro tablet container should be stored at 20oC to 25oC

Keep the container free from moisture, heat & light

Missed dose

Missed dose of Abirapro tablets should be avoided.

Consult with medical oncologist and follow the instructions

Follow the regular dosing schedule

Over dosage

The over dose of Abirapro has no specific antidote.

Provide supportive measures

Monitor the patients for arrhythmia, cardiac failure & determines liver function to reduce the liver injuries.

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