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RX ITEM-Zytiga 500Mg Tab 120 By J O M Pharma

item No.:RX652503  NDC No.57894019506  57894-195-06  5789419506     UPC No.:357894150121 NDC No.57894-0195-06 UPC/GTIN No. 3-57894-19506-1 MPN 15012BRAND: ZYTIGA NDC: 57894-0195-06 ,57894019506 UPC: 3-57894-15012-1,357894150121 J/O/M Pharma ServicesOnly 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.

RX ITEM-Zytiga 500Mg Tab 120 By J O M Pharma

$13064.42$11999.00

item No.:RX652503 NDC No.57894019506 57894-195-06 5789419506 UPC No.:357894150121 NDC No.57894-0195-06 UPC/GTIN No. 3-57894-19506-1 MPN 15012 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX item. Rx Item No.Rx652503 Zytiga 250mg Tab 120 by J/O/M Pharma Item No.652503 NDC No.57894019506 UPC No. 357894-195061 3

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HIGHLIGHTS OF PRESCRIBING INFORMATION
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

item No.:RX652503  NDC No.57894019506  57894-195-06  5789419506     UPC No.:357894150121 NDC No.57894-0195-06 UPC/GTIN No. 3-57894-19506-1 MPN 15012
RX ITEM-Zytiga 500Mg Tab 120 By J O M Ph
item No.:RX652503 NDC No.57894019506 57894-195-06 5789419506 UPC No.:357894150121 NDC No.57894-0195-06 UPC/GTIN No. 3-57894-19506-1 MPN 15012

BRAND: ZYTIGA NDC: 57894-0195-06 ,57894019506 UPC: 3-57894-15012-1,357894150121 J/O/M Pharma Services
Zytiga 500Mg Tab 120 By J O M Pharma
BRAND: ZYTIGA NDC: 57894-0195-06 ,57894019506 UPC: 3-57894-15012-1,357894150121 J/O/M Pharma Services

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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