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Rx Item-Abiraterone Acetate Generic Zytiga 250mg Tab 120 By Novadoz Pharma

Abiraterone Acetate Generic Zytiga 250mg Tab 120 By Novadoz Pharma.  NDC No.72205-0030-92 72205-030-92 7220503092 72205003092 UPC/GTIN No.3-72205-03092-3 372205-030923 372205030923  MPN No. 3092NDC No.00093112589 0091125-89 00093-1125-89  57894-155-12 UPC/GTIN No.300931125897 3-00931-12589-7 300931-125897 MPN No. 12589 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, LOnly Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.ABIRATERONE ACETATE 250MG
Brand Equivalent: ZYTIGA 250MG
NDC: 00093112589UPC: 300931125897
Item: 328901
Size: 120
Form: TABLET
Manufacturer: TEVAJ/O/M Pharma Services

Rx Item-Abiraterone Acetate Generic Zytiga 250mg Tab 120 By Novadoz Pharma

$11649.00$499.00

NDC No.72205-0030-92 72205-030-92 7220503092 72205003092 UPC/GTIN No.3-72205-03092-3 372205-030923 372205030923 MPN No. 3092 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, Pharmacist, PA, Physical Therapist, Podiatrist, Research Co., Uni., VA, Vet & Wholesalers In Scope Of their Practice Can Order Rx Item. Rx Item No.Rx894547 894547 Abiraterone Acetate Generic Zytiga 250mg Tab 120 By Novadoz Pharma Item

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These highlights do not include all the information needed to use ZYTIGA safely and effectively. See full prescribing information for ZYTIGA.

ZYTIGA¨ (abiraterone acetate) tablets, for oral use
Initial U.S. Approval: 2011
RECENT MAJOR CHANGES
Warnings and Precautions (5.1) 06/2019
Warnings and Precautions (5.4) 06/2019
Warnings and Precautions (5.5) 06/2019
INDICATIONS AND USAGE

ZYTIGA is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with

metastatic castration-resistant prostate cancer (CRPC). (1)
metastatic high-risk castration-sensitive prostate cancer (CSPC). (1)

DOSAGE AND ADMINISTRATION

Metastatic castration-resistant prostate cancer:

ZYTIGA 1,000 mg orally once daily with prednisone 5 mg orally twice daily. (2.1)

Metastatic castration-sensitive prostate cancer:

ZYTIGA 1,000 mg orally once daily with prednisone 5 mg orally once daily. (2.2)

Patients receiving ZYTIGA should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. ZYTIGA must be taken on an empty stomach with water at least 1 hour before or 2 hours after a meal. Do not crush or chew tablets. (2.3)

Dose Modification:

For patients with baseline moderate hepatic impairment (Child-Pugh Class B), reduce the ZYTIGA starting dose to 250 mg once daily. (2.4)
For patients who develop hepatotoxicity during treatment, hold ZYTIGA until recovery. Retreatment may be initiated at a reduced dose. ZYTIGA should be discontinued if patients develop severe hepatotoxicity. (2.4)

DOSAGE FORMS AND STRENGTHS

Film-Coated Tablet 500 mg (3)
Uncoated Tablet 250 mg (3)

CONTRAINDICATIONS

None (4)
WARNINGS AND PRECAUTIONS

Mineralocorticoid excess: Closely monitor patients with cardiovascular disease. Control hypertension and correct hypokalemia before treatment. Monitor blood pressure, serum potassium and symptoms of fluid retention at least monthly. (5.1)
Adrenocortical insufficiency: Monitor for symptoms and signs of adrenocortical insufficiency. Increased dosage of corticosteroids may be indicated before, during and after stressful situations. (5.2)
Hepatotoxicity: Can be severe and fatal. Monitor liver function and modify, interrupt, or discontinue ZYTIGA dosing as recommended. (5.3)
Increased fractures and mortality in combination with radium Ra 223 dichloride: Use of ZYTIGA plus prednisone/prednisolone in combination with radium Ra 223 dichloride is not recommended. (5.4)
Embryo-Fetal Toxicity: ZYTIGA can cause fetal harm. Advise males with female partners of reproductive potential to use effective contraception. (5.5, 8.1, 8.3)

ADVERSE REACTIONS

The most common adverse reactions (‚Č•10%) are fatigue, arthralgia, hypertension, nausea, edema, hypokalemia, hot flush, diarrhea, vomiting, upper respiratory infection, cough, and headache. (6.1)

The most common laboratory abnormalities (>20%) are anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, and hypokalemia. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech, Inc. at 1-800-526-7736 (1-800-JANSSEN) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS

CYP3A4 Inducers: Avoid concomitant strong CYP3A4 inducers during ZYTIGA treatment. If a strong CYP3A4 inducer must be co-administered, increase the ZYTIGA dosing frequency. (2.5, 7.1)
CYP2D6 Substrates: Avoid co-administration of ZYTIGA with CYP2D6 substrates that have a narrow therapeutic index. If an alternative treatment cannot be used, exercise caution and consider a dose reduction of the concomitant CYP2D6 substrate. (7.2)

USE IN SPECIFIC POPULATIONS

Do not use ZYTIGA in patients with baseline severe hepatic impairment (Child-Pugh Class C). (8.6)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 6/2019
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Abiraterone Acetate Generic Zytiga 250mg Tab 120 By Novadoz Pharma.  NDC No.72205-0030-92 72205-030-92 7220503092 72205003092 UPC/GTIN No.3-72205-03092-3 372205-030923 372205030923  MPN No. 3092
Abiraterone Acetate
Abiraterone Acetate Generic Zytiga 250mg Tab 120 By Novadoz Pharma. NDC No.72205-0030-92 72205-030-92 7220503092 72205003092 UPC/GTIN No.3-72205-03092-3 372205-030923 372205030923 MPN No. 3092

NDC No.00093112589 0091125-89 00093-1125-89  57894-155-12 UPC/GTIN No.300931125897 3-00931-12589-7 300931-125897 MPN No. 12589 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, L
Rx Item-Abiraterone Acetate Generic Zyti
NDC No.00093112589 0091125-89 00093-1125-89 57894-155-12 UPC/GTIN No.300931125897 3-00931-12589-7 300931-125897 MPN No. 12589 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, L

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
ABIRATERONE ACETATE ORAL
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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ABIRATERONE ACETATE 250MG
Brand Equivalent: ZYTIGA 250MG
NDC: 00093112589UPC: 300931125897
Item: 328901
Size: 120
Form: TABLET
Manufacturer: TEVA
ABIRATERONE ACETATE 250MG
ABIRATERONE ACETATE 250MG Brand Equivalent: ZYTIGA 250MG NDC: 00093112589UPC: 300931125897 Item: 328901 Size: 120 Form: TABLET Manufacturer: TEVA

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