Abione Tablet Uses, Dosage and Side Effects

Description and Composition of Abione Tablet

Abione Tablet belongs to a class of drugs known as anti-androgens and is used for the treatment of prostate cancer. It contains Abiraterone acetate as its active pharmaceutical ingredient. In addition to this, it contains other ingredients called inactive pharmaceutical ingredients or excipients in sufficient quantities.

 Abiraterone

Pharmacology

Abione Tablet is converted in vivo to abiraterone. Abiraterone selectively inhibits 17a-hydroxylase/C17,20-lyase (CYP17), which is expressed in and required for androgen biosynthesis in testicular, adrenal and prostatic tumour tissues. This inhibits the conversion of pregnenolone and progesterone into testosterone precursors, DHEA and androstenedione, respectively. CYP17 inhibition also increases mineralocorticoid production by the adrenals. After oral administration on an empty stomach, it takes approximately 2 hours to reach peak plasma concentrations. Food significantly increases the absorption of abiraterone acetate. Plasma protein binding is 99.8%. Mean plasma half-life is approximately 15 hours. Abiraterone inhibits CYP2D6 and CYP2C8 enzymes.

Uses or Indications of Abione Tablet

Abione Tablet is used in combination with prednisone or prednisolone for the treatment of newly diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHS PC) in adult men in combination with androgen deprivation therapy (ADT), metastatic castration-resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated and mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

Dosage of Abione Tablet

Adult, by mouth, 1,000 mg as a single daily dose.

Dosage of prednisone or prednisolone:

  • For mHSPC, 5 mg prednisone or prednisolone daily.
  • For mCRPC, 10 mg prednisone or prednisolone daily.

It is used also for medical castration with luteinising hormone releasing hormone analogue should be continued during treatment in patients not surgically castrated.

Hepatic impairment: Pre-existing mild hepatic impairment: No dose adjustment.

Moderate hepatic impairment: Use with caution.

Severe hepatic impairment: Do not use

NOTE:

Patients receiving abiraterone should also receive a gonadotropin-releasing hormone analogue concurrently or should have had bilateral orchiectomy.

Women who are pregnant or women who may be pregnant should not handle abiraterone uncoated, broken, crushed, or damaged tablets without protection e.g., gloves.

Patients with a significant risk for congestive heart failure: Consider assessing cardiac function (e.g., echocardiogram) before initiating abiraterone. Treat cardiac failure and optimize cardiac function before initiating abiraterone. Correct and control hypertension, hypokalaemia and fluid retention. During treatment, monitor blood pressure, serum potassium, fluid retention (weight gain, peripheral oedema), and other signs and symptoms of congestive heart failure every two weeks for three months, then monthly thereafter. Correct abnormalities. Assess cardiac function as clinically indicated.

If abiraterone is continued after corticosteroids are stopped, monitor for symptoms of mineralocorticoid excess.

Monitor for symptoms and signs of adrenocortical insufficiency. Patients may require increased doses of corticosteroids before, during and after stressful situations.

Monitor serum transaminase levels before starting abiraterone, every two weeks for the first three months of treatment, and monthly thereafter. If clinical symptoms or signs suggestive of hepatotoxicity develop, immediately measure serum transaminases. If at any time the ALT or AST rises above 5 times the upper limit of normal (ULN), immediately hold abiraterone and closely monitor liver function. Abiraterone can be reinitiated only after liver function tests return to the patient’s baseline and at a reduced dose. If severe hepatotoxicity (ALT or AST 20 times the ULN) develops anytime while on abiraterone, discontinue treatment and do not reinitiate.

Patients with diabetes who are taking pioglitazone or repaglinide (CYP2C8 substrates): Risk of hypoglycaemia; Monitor blood glucose and consider dose adjustments if required.

Administration: How to Use Abione Tablet

Abione Tablet is taken by mouth. Take on an empty stomach, at least one hour before or at least two hours after a meal. Swallow tablets whole with water. Do not crush or chew tablets.

Contraindications

Hypersensitivity to abiraterone or any of the excipients. Severe hepatic impairment. Abiraterone with prednisone or prednisolone is contraindicated in combination with Ra-223. It is not for use in women.

Precautions

  • Diabetes.
  • Underlying medical conditions that might be compromised by elevated blood pressure, hypokalaemia (e.g., patients on cardiac glycosides), or fluid retention (e.g., patients with heart failure, severe or unstable angina pectoris, recent myocardial infarction or ventricular arrhythmia and those with severe renal impairment).
  • History of cardiovascular disease, significant risk for congestive heart failure (e.g., history of cardiac failure, uncontrolled hypertension, or cardiac events such as ischaemic heart disease).
  • Prior ketoconazole use (for prostate cancer) may reduce expected response rates

Interactions of Abione Tablet with Drugs and Foods

  • Ra-223: (Concurrent use with abiraterone and prednisone/prednisolone is contraindicated. Increases risk of fractures. Also, a trend for increased mortality among patients with asymptomatic or mildly symptomatic prostate cancer was observed in clinical trials. Do not initiate subsequent treatment with Ra-223 for at least 5 days after the last administration of abiraterone plus prednisone/prednisolone).
  • Strong CYP3A4 inducers e.g., rifampicin, phenytoin, carbamazepine, rifabutin, rifapentine, phenobarbital (Avoid concurrent use except in the absence of a therapeutic alternative).
  • Dextromethorphan (Increases dextromethorphan plasma levels because dextromethorphan is a CYP2D6 substrate).
  • Drugs metabolised by CYP2D6 e.g., metoprolol, propranolol, desipramine, venlafaxine, haloperidol, risperidone, propafenone, flecainide, codeine, oxycodone and tramadol (Abiraterone inhibits CYP2D6. Use with caution and dose adjustments may be required – especially those with a narrow therapeutic index).
  • CYP2C8 substrates e.g., pioglitazone, repaglinide (Abiraterone inhibits CYP2C8. Increases plasma levels of the CYP2C8 substrate. When used concurrently, monitor for signs of toxicity of the CYP2C8 substrate, especially those with a narrow therapeutic index).
  • Drugs metabolised by CYP2D6 e.g., metoprolol, propranolol, desipramine, venlafaxine, haloperidol, risperidone, propafenone, flecainide, codeine, oxycodone and tramadol (Abiraterone inhibits CYP2D6. Use with caution and dose adjustments may be required especially those with a narrow therapeutic index).
  • CYP2C8 substrates e.g., pioglitazone, repaglinide (Abiraterone inhibits CYP2C8. Increases plasma levels of the CYP2C8 substrate. When used concurrently, monitor for signs of toxicity of the CYP2C8 substrate, especially those with a narrow therapeutic index).
  • Drugs that prolong the QT interval or induce torsades de pointes such as quinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide, methadone, moxifloxacin, antipsychotics (Use with caution).
  • Spironolactone (Concurrent use is not recommended. Spironolactone may increase prostate specific antigen (PSA) levels)

Side Effects of Abione Tablet

Most common adverse effects are urinary tract infection, sepsis, hypokalaemia, hypertriglyceridaemia, fluid retention, cardiac failure (includes congestive heart failure, left ventricular dysfunction and decreased ejection fraction), angina pectoris, atrial fibrillation, tachycardia, hypertension, diarrhoea, dyspepsia, elevated alanine aminotransferase (ALT), elevated aspartate aminotransferase (AST), rash, haematuria, peripheral oedema, fractures (includes osteoporosis and all fractures, except pathological fractures). Other adverse effects include anaphylactic reactions, hepatotoxicity, myocardial infarction, QT prolongation, myopathy, rhabdomyolysis, allergic alveolitis.

How to Store

Store in a cool, dry place and away from sunlight. Keep away from the reach of children.

Chemical Structure

Abiraterone structure

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