Saturday, May 30, 2020

Yonsa Package Insert

Patients receiving YONSA should also receive a gonadotropin-releasing hormone GnRH analog concurrently or. Only YONSA is FDA-approved to treat mCRPC at a 500 mg dose 1.

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YONSA 500 mg four 125 mg tablets administered orally once daily in combination with methylprednisolone 4 mg administered orally twice daily.

Yonsa package insert. How to use Yonsa. Castration-resistant refers to disease progression following either surgical or medically induced methods of castration. The recommended dosage is 250 mg orally twice daily.

Yonsa may cause hypertension hypokalemia and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition 1. Sun Pharmaceutical Industries Inc. Yonsa while maintaining optimal therapeutic outcomes.

YONSA is indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer. Based on animal reproductive studies and mechanism of action Yonsa can. Prior approval is required to ensure the safe clinically appropriate and cost effective use of Yonsa while maintaining optimal therapeutic outcomes.

Yonsa may cause hypertension hypokalemia and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition 1. 2 DOSAGE AND ADMINISTRATION. Read the Patient Information Leaflet if available from your pharmacist before you start taking abiraterone and each time you get a refill.

The NCCN Drugs and Biologics Compendium NCCN Compendium. Accessed January 6 2020. In patients with cancer receiving hormonal agents biologic products or radiotherapy unless also receiving.

Yonsa abiraterone is a CYP17 inhibitor indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer CRPC. Accessed July 19 2020. Sun Pharmaceutical Industries Inc.

YONSA taken in combination with methylprednisolone is the only abiraterone acetate with no food restrictions giving patients the flexibility to take it with or without food 12. 4 15 Limitations of Use Epogenhas not been shown to improve quality of life fatigue or patient well-being. Prior approval is required to ensure the safe clinically appropriate and cost effective use of Yonsa while maintaining optimal therapeutic outcomes.

See full prescribing information for dosage adjustments by indication for patients with moderate or severe hepatic impairment or severe renal impairment26. Policy History Date Action June 2018 Addition to PA September 2018 Annual review Keywords This policy was approved by the FEP Pharmacy and Medical Policy Committee on. Individual is using the alternative agent Zytiga abiraterone acetate with prednisone for CRPC.

Yonsa abiraterone acetate is an ultramicrosize formulation of the oral CYP17 inhibitor abiraterone acetate approved as Zytiga used in combination with methylprednisolone for the treatment of metastatic castration-resistant prostate cancer. Yonsa is a CYP17 inhibitor indicated in combination with methylprednisolone for the treatment of patients with metastatic castration resistant prostate cancer CRPC 1. The recommended dosage of Yonsa is 500 mg four 125 mg tablets orally once daily in combination with methylprednisolone 4 mg orally twice daily.

The recommended dosage is 280 mgm 2 orally twice daily based on body surface area. Letters Reviews Labels Patient Package Insert Notes Url. Epogen is not indicatedfor use.

If you have any questions ask your. Requests for Yonsa abiraterone acetate may not be approved for the following. The NCCN Drugs Biologics Compendium 2020 National Comprehensive Cancer Network Inc.

Policy History Date Action June 2018 Addition to PA September 2018 Annual review June 2019 Annual review Keywords This policy was approved by the FEP Pharmacy and Medical Policy Committee on. Approval Type 5 - New Formulation or New Manufacturer STANDARD. The formulation was designed to improve oral bioavailability and reduce food effects 3.

Patients receiving Yonsa should also receive a gonadotropin-releasing hormone GnRH analog concurrently or should have had bilateral orchiectomy. Sun Pharmaceutical Industries Inc. Yonsa should be swallowed whole with water.

Yonsa while maintaining optimal therapeutic outcomes. To avoid medication errors and overdose be aware that Yonsa tablets may have different dosing and food effects than other abiraterone products. Label PDF Letter PDF Review.

These Highlights Do Not Include All The Information Needed To Use Yonsa Safely And Effectively See Full Prescribing Information For Yonsa Yonsa Abiraterone Acetate Tablets For Oral Useinitial U S Approval 2011

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