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Abirapro Dosage |
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Generic name: Abirapro 125mg
Dosage form: tablet
Medically reviewed on June 5, 2018.
The recommended dose of Abirapro is 500 mg (four 125 mg tablets) administered orally once daily in combination with methylprednisolone 4 mg administered orally twice daily.
To avoid medication errors and overdose, be aware that Abirapro (Abirapro) tablets may have different dosing and food effects than other Abirapro products. Patients receiving Abirapro should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.
Abirapro tablets can be taken with or without food. The tablets should be swallowed whole with water. Do not crush or chew tablets.
Hepatic Impairment
In patients with baseline moderate hepatic impairment (Child-Pugh Class B), reduce the recommended dose of Abirapro to 125 mg once daily. In patients with moderate hepatic impairment monitor ALT, AST, and bilirubin prior to the start of treatment, every week for the first month, every two weeks for the following two months of treatment and monthly thereafter. If elevations in ALT and/or AST greater than 5X upper limit of normal (ULN) or total bilirubin greater than 3X ULN occur in patients with baseline moderate hepatic impairment, discontinue Abirapro and do not re-treat patients with Abirapro.
Do not use Abirapro in patients with baseline severe hepatic impairment (Child-Pugh Class C).
Hepatotoxicity
For patients who develop hepatotoxicity during treatment with Abirapro (ALT and/or AST greater than 5X ULN or total bilirubin greater than 3X ULN), interrupt treatment with Abirapro. Treatment may be restarted at a reduced dose of 375 mg once daily following return of liver function tests to the patient’s baseline or to AST and ALT less than or equal to 2.5X ULN and total bilirubin less than or equal to 1.5X ULN. For patients who resume treatment, monitor serum transaminases and bilirubin at a minimum of every two weeks for three months and monthly thereafter.
If hepatotoxicity recurs at the dose of 375 mg once daily, re-treatment may be restarted at a reduced dose of 250 mg once daily following return of liver function tests to the patient’s baseline or to AST and ALT less than or equal to 2.5X ULN and total bilirubin less than or equal to 1.5X ULN.
If hepatotoxicity recurs at the reduced dose of 250 mg once daily, discontinue treatment with Abirapro.
Permanently discontinue Abirapro for patients who develop a concurrent elevation of ALT greater than 3 x ULN and total bilirubin greater than 2 x ULN in the absence of biliary obstruction or other causes responsible for the concurrent elevation.
Avoid concomitant strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital) during Abirapro treatment.
If a strong CYP3A4 inducer must be co-administered, increase the Abirapro dosing frequency to twice a day only during the co-administration period (e.g., from 500 mg once daily to 500 mg twice a day). Reduce the dose back to the previous dose and frequency, if the concomitant strong CYP3A4 inducer is discontinued.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medical Disclaimer
Other brands: Abirapro
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Tell your doctor about all your current medicines. Many drugs can interact with Abirapro, especially:
other prostate cancer medicines, especially radium Ra 223 (may increase your risk of fractures while you are taking Abirapro); or
pioglitazone or repaglinide to treat diabetes (may cause severe low blood sugar hypoglycemia while you are taking Abirapro.
This list is not complete and many other drugs may affect Abirapro. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Abirapro drug interactions (more detail)
Interactions With Other Drugs: Potential for Other Drugs To Affect Abirapro Exposures: In a clinical pharmacokinetic interaction study of healthy subjects pre-treated with a strong CYP3A4 inducer (rifampicin 600 mg daily for 6 days) followed by a single dose of Abirapro 1,000 mg, the mean plasma AUC∞ of Abirapro was decreased by 55%. Strong inducers of CYP3A4 (eg, phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarbital) during treatment with Abirapro are to be avoided or used with careful evaluation of clinical efficacy.
In a separate clinical pharmacokinetic interaction study of healthy subjects, co-administration of ketoconazole, a strong inhibitor of CYP3A4, had no clinically meaningful effect on the pharmacokinetics of Abirapro.
Potential of Abirapro to Affect Exposures to Other Drugs: Abirapro is an inhibitor of the hepatic drug-metabolizing enzymes CYP2D6 and CYP2C8. In the clinical study to determine the effects of Abirapro (plus prednisone) on a single dose of the CYP2D6 substrate dextromethorphan, the systemic exposure (AUC) of dextromethorphan was increased by approximately 200%. The AUC24 for dextrorphan, the active metabolite of dextromethorphan, increased approximately 33%.
Caution is advised when Abirapro is administered with drugs activated by or metabolized by CYP2D6, particularly with drugs that have a narrow therapeutic index. Dose reduction of narrow therapeutic index drugs metabolized by CYP2D6 should be considered.
In the same study to determine the effects of Abirapro (plus prednisone) on a single dose of the CYP1A2 substrate theophylline, no increase in systemic exposure of theophylline was observed.
In a CYP2C8 drug-drug interaction trial in healthy subjects, the AUC of pioglitazone was increased by 46% and the AUCs for M-III and M-IV, the active metabolites of pioglitazone, each decreased by 10%, when pioglitazone was given together with a single dose of Abirapro 1,000 mg. Although these results indicate that no clinically meaningful increases in exposure are expected when Abirapro is combined with drugs that are predominantly eliminated by CYP2C8, patients should be monitored for signs of toxicity related to a CYP2C8 substrate with a narrow therapeutic index if used concomitantly with Abirapro.
Effect of Food on Abirapro: Administration of Abirapro with food significantly increases the absorption of Abirapro. The efficacy and safety of Abirapro given with food has not been established. Abirapro must not be taken with food.
Incompatibilities: Not applicable.
Users | % | ||
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Once in a day | 1 | 100.0% |
Users | % | ||
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201-500mg | 2 | 100.0% |
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Information checked by Dr. Sachin Kumar, MD Pharmacology
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