Abiron Tablet
Abiraterone
250mg
Ziska Pharmaceuticals Ltd.
| Pack size | 28’s pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 520.00 AED |
Indications
Abiron Tablet is used for:
Prostate cancer
Adult Dose
Oral
Prostate cancer
Adult:
Metastatic, castration-resistant prostate cancer:
1 g (two 500-mg tablets or four 250-mg tablets) once daily, in combination w/ prednisolone (5 mg PO q12hr).
Metastatic high-risk castration-sensitive prostate cancer
Indicated in combination with prednisone for patients with metastatic high-risk castration-sensitive prostate cancer (CSPC)
1000 mg (two 500-mg tablets or four 250-mg tablets) PO qDay with prednisone 5 mg PO q12hr
Child Dose
Renal Dose
Renal impairment
Mild-to-severe: No dosage adjustment necessary
Administration
Should be taken on an empty stomach. Take at least 1 hr before or 2 hr after meals. Swallow whole, do not chew/crush.
Contra Indications
Severe hepatic impairment (Child-Pugh Class C). Pregnancy and lactation.
Precautions
Mineralocorticoid excess: Closely monitor patients with cardiovascular disease. Control hypertension and correct hypokalemia before treatment.
Adrenocortical insufficiency: Monitor for symptoms and signs of adrenocortical insufficiency. Increased dosage of corticosteroids may be indicated before, during and after stressful situations.
Hepatotoxicity: Can be severe and fatal. Monitor liver function and modify, interrupt, or discontinue Abiraterone dosing as recommended.
Increased fractures and mortality in combination with radium Ra 223 dichloride: Use of Abiraterone plus prednisone/prednisolone in combination with radium Ra 223 dichloride is not recommended.
Embryo-Fetal Toxicity: Abiraterone can cause fetal harm. Advise males with female partners of reproductive potential to use effective contraception.
Hypoglycemia: Severe hypoglycemia has been reported in patients with pre-existing diabetes who are taking medications containing thiazolidinediones (including pioglitazone) or repaglinide.
Monitoring Parameter
Monitor blood pressure, serum potassium concentration, and fluid balance before treatment, and at least monthly during treatment.
Monitor liver function before treatment, then every 2 weeks for the first 3 months of treatment, then monthly thereafter—interrupt treatment if serum alanine aminotransferase or aspartate aminotransferase greater than 5 times the upper limit and discontinue permanently if 20 times the upper limit.
Monitor blood glucose in patients with diabetes and assess if antidiabetic agent dose modifications are required.
Pregnancy-Lactation
Pregnancy
Based on findings from animal studies and mechanism of action, abiraterone is contraindicated for use in pregnant women because drug can cause fetal harm and potential loss of pregnancy
Not indicated for use in females
There are no human data regarding use in pregnant women
In animal reproduction studies, oral administration of abiraterone acetate to pregnant rats during organogenesis caused adverse developmental effects at maternal exposures ~>0.03 times the human exposure (AUC) at the recommended dose
Contraception
Advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 weeks after the final dose of abiraterone
Infertility
Based on animal studies, may impair reproductive function and fertility in males of reproductive potential
Lactation
Not indicated for women
No information is available on the presence of abiraterone acetate in human milk, or on the effects on the breastfed child or milk production
Interactions
Increased risk of hypokalaemia w/ K-lowering drugs (e.g. thiazide diuretics). Risk of tumour progression w/ spironolactone. Decreased exposure w/ strong CYP3A4 inducers (e.g. rifampicin). Increased plasma concentration w/ potent CYP3A4 inhibitors e.g. ketoconazole. Increased risk of QT prolongation w/ antiarrhythmics (e.g. quinidine, amiodarone), antipsychotics, moxifloxacin, methadone. May increase exposure to drugs that are metabolised or activated by CYP2D6 (e. g. desipramine, venlafaxine, metoprolol), esp those w/ narrow therapeutic index.
Contraindicated (2)
mavacamten
ombitasvir/paritaprevir/ritonavir & dasabuvir (DSC)
Serious - Use Alternative (13)
apalutamide
bosutinib
edoxaban
etrasimod
ivosidenib
metoclopramide intranasal
palifermin
pomalidomide
sofpironium topical
spironolactone
topotecan
tucatinib
venetoclax
Adverse Effects
Side effects of Abiraterone :
Adverse drug reactions are for abiraterone with prednisone
>10% (All grades)
Hypertriglyceridemia (63%)
Hyperglycemia, nonfasting (57%)
Increased ALT (11-46%)
Fatigue (39%)
Lymphopenia (20-38%)
Increased AST (15-37%)
Hypertension (8.5-37%)
Hypernatremia (33%)
Joint swelling/discomfort (30%)
Hypokalemia (17-30%)
Edema (25-27%)
Muscle discomfort (26%)
Hypophosphatemia (24%)
Constipation (23%)
Hot flush (15-22%)
Diarrhea (18-22%)
Hot flush (19%)
Cough (6.5-17%)
Increased total bilirubin (6.6-16%)
Insomnia (14%)
Contusion (13%)
Upper respiratory tract infection (5.4-13%)
Urinary tract infection (7-12%)
Dyspnea (12%)
Nasopharyngitis (11%)
Dyspepsia (6.1-11%)
>10% (Grade 3 or 4)
Hypertension (1.3-20%)
1-10%
All grades
Hematuria (10%)
Pyrexia (8.7%)
Rash (8.1%)
Headache (7.5%)
Urinary frequency (7.2%)
Arrhythmia (7.2%)
Groin pain (6.6%)
Nocturia (6.2%)
Falls (5.9%)
Fractures (5.9%)
Chest pain or chest discomfort (3.8%)
Cardiac failure (2.3%)
Grade 3 or 4
Lymphopenia (4.1-8.7%)
Hypophosphatemia (7.2%)
Hyperglycemia, nonfasting (6.5%)
Increased ALT (1.4-6.1%)
Hypokalemia (2.8-10%)
Increased AST (2.1-4.4%)
Joint swelling/discomfort (2-4.2%)
Muscle discomfort (3%)
Dyspnea (2.4%)
Fatigue (2.2%)
Urinary tract infection (1-2.1%)
Edema or cardiac failure(1.9%)
Fractures (1.4%)
Hematuria (1.3%)
Arrhythmias (1.1%)
<1%
Grade 3 or 4
Diarrhea (0.6-0.9%)
Pyrexia (0.6%)
Chest pain or discomfort (0.5%)
Hypertriglyceridemia (0.4%)
Groin pain (0.4%)
Constipation (0.4%)
Edema (0.4%)
Hyponatremia (0.4%)
Urinary frequency (0.3%)
Hot flush (0.2-0.3%)
Headache (0.3%)
Upper respiratory tract (0.2%)
Insomnia (0.2%)
Increased total bilirubin (0.1-0.2%)
Mechanism of Action
Abiraterone suppresses testosterone production through selective and irreversible inhibition of 17 alpha-hydroxylase/C17, 20-lyase (CYP17), an enzyme required for androgen biosynthesis in testicular, adrenal, and prostatic tumour tissues.
Note
Abiron 250mg Tablet manufactured by Ziska Pharmaceuticals Ltd.. Its generic name is Abiraterone. Abiron is availble in Bangladesh.
Farmaco BD drug index information on Abiron Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.