Zytiga 250 mg Tablet

Zytiga 250 mg Tablet Uses, Dosage, Side Effects, Food Interaction and all others data.

Zytiga 250 mg Tablet
Uses
Dosage
Side Effect
Precautions
Interactions
Uses during Pregnancy
Uses during Breastfeeding
Accute Overdose
Food Interaction
Half Life
Volume of Distribution
Clearance
Interaction With other Medicine
Contradiction
Storage

Trade Name	Zytiga 250 mg Tablet
Generic	Abiraterone Acetate
Weight	250 mg
Type	Tablet
Therapeutic Class	Cytotoxic Chemotherapy
Manufacturer	UniMed UniHealth (Mfg. by: Janssen-Cilag)
Available Country	Bangladesh
Last Updated:	September 24, 2024 at 5:38 am

Uses

Zytiga 250 mg Tablet is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC). Metastatic high-risk castration-sensitive prostate cancer (CSPC).

Dosage

Zytiga 250 mg Tablet dosage

Recommended Dose For Metastatic CRPC: The recommended dose of Zytiga 250 mg Tablet is 1,000 mg (two 500 mg tablets or four 250 mg tablets) orally once daily with Prednisone 5 mg orally twice daily. Recommended Dose For Metastatic High-Risk CSPC: The recommended dose of Zytiga 250 mg Tablet is 1,000 mg (two 500 mg tablets or four 250 mg tablets) orally once daily with Prednisone 5 mg administered orally once daily. Patients receiving Zytiga 250 mg Tablet should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. Zytiga 250 mg Tablet must be taken on an empty stomach, at least one hour before or at least two hours atier a meal. The tablets should be swallowed whole with water. Do not crush or chew tablets.Dose Modification: For patients with baseline moderate hepatic impairment (Child-Pugh Class B), reduce the Zytiga 250 mg Tablet starting dose to 250 mg once daily. For patients who develop hepatotoxicity during treatment, hold Zytiga 250 mg Tablet until recovery. Retreatment may be initated at a reduced dose. Zytiga 250 mg Tablet should be discontinued if patients develop severe hepatotoxicity. Avoid concomitant strong CYP3A4 inducers (e.g., Phenytoin, Carbamazepine, Rifampin, Rifabutin, Rifapentine, Phenobarbital) during Zytiga 250 mg Tablet treatment. If a strong CYP3A4 inducer must be co-administered, increase the Zytiga 250 mg Tablet dosing frequency to twice a day only during the co-administration period (e.g., from 1,000 mg once daily to 1,000 mg twice a day). Reduce the dose back to the previous dose and frequency, if the concomitant strong CYP3A4 inducer is discontinued. Or, as directed by the registered physician. Pediatric Use: The safety and effectiveness in pediatric patients have not been established.

Side Effects

The most common adverse reactions are fatigue, arthalgia, hypertension, nausea, edema, hypokalemia, hot flush, diarrhea, vomiting, upper respiratory infection, cough, and headache.

Precaution

Zytiga 250 mg Tablet may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition. Patients should be monitored for hypertension, hypokalemia, and fluid retention at least once a month. Hypertension and hypokalemia should be controlled and corrected before and during treatment with Abiraterone. Patients should be monitored for symptoms and signs of adrenocortical insufficiency. Serum transaminases (ALT and AST) and bilirubin levels should be measured prior to starting treatment with Abiraterone, every two weeks for the first three months of treatment and monthly thereatier.

Interaction

Drugs That Inhibit Or Induce CYP3A4 Enzymes: Based on in vitro data, Zytiga 250 mg Tablet is a substrate of CYP3A4. In a dedicated drug interaction trial, co-administration of Rifampin, a strong CYP3A4 inducer, decreased exposure of Abiraterone by 55%. Avoid concomitant strong CYP3A4 inducers during Zytiga 250 mg Tablet treatment. If a strong CYP3A4 inducer must be co-administered, increase the Zytiga 250 mg Tablet dosing frequency. In a dedicated drug interaction trial, co-administration of ketoconazole, a strong inhibitor of CYP3A4, had no clinically meaningful effect on the pharmacokinetics of Abiraterone.Effects Of Abiraterone On Drug Metabolizing Enzymes: Zytiga 250 mg Tablet is an inhibitor of the hepatic drug-metabolizing enzymes CYP2D6 and CYP2C8. In a CYP2D6 drug-drug interaction trial, the Cmax and AUC of Dextromethorphan (CYP2D6 substrate) were increased 2.8- and 2.9-fold, respectively, when Dextromethorphan was given with Zytiga 250 mg Tablet 1,000 mg daily and Prednisone 5 mg twice daily. Avoid co-administration of Zytiga 250 mg Tablet with substrates of CYP2D6 with a narrow therapeutic index (e.g., Thioridazine). If alternative treatments cannot be used, consider a dose reduction of the concomitant CYP2D6 substrate drug. In a CYP2C8 drug-drug interaction trial in healthy subjects, the AUC of Pioglitazone (CYP2C8 substrate) was increased by 46% when Pioglitazone was given together with a single dose of 1,000 mg Zytiga 250 mg Tablet. Therefore, patients should be monitored closely for signs of toxicity related to a CYP2C8 substrate with a narrow therapeutic index if used concomitantly with Zytiga 250 mg Tablet.

Pregnancy & Breastfeeding use

The safety and efficacy of Abiraterone have not been established in females. Based on findings from animal studies and the mechanism of action, Abiraterone can cause fetal harm and potential loss of pregnancy. There are no human data on the use of Abiraterone in pregnant women. The safety and efficacy of Abiraterone have not been established in females. There is no information available on the presence of abiraterone acetate in human milk, or on the effects on the breastfed child or milk production.

Contraindication

Hypersensitivity to the Abiraterone acetate or to any of the excipients of Abiraterone.

Acute Overdose

There is no specific antidote. In the event of an overdose, Zytiga 250 mg Tablet should be stopped, general supportive measures are undertaken, including monitoring for arrhythmias and cardiac failure and assess liver function.