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RX ITEM-Zytiga 250Mg Tab 120 By J O M Pharma

item No.:RX119166 NDC No.57894015012 57894-150-12 5789415012 UPC No.:357894150121 NDC No.57894-0150-12 UPC/GTIN No.3-57894-15012-1 MPN 15012  NDC Code(s): 57894-150-12, 57894-150-25, 57894-184-12, 578BRAND: ZYTIGA NDC: 57894-0150-12,57894015012 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 250Mg Tab 120 By J O M Pharma

$13064.42$11999.00

item No.:RX119166 NDC No.57894015012 57894-150-12 5789415012 UPC No.:357894150121 NDC No.57894-0150-12 UPC/GTIN No.3-57894-15012-1 MPN 15012 NDC Code(s): 57894-150-12, 57894-150-25, 57894-184-12, 57894-195-06,
57894-195-15
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.Rx119166 Zytiga 250mg Ta

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Clinical Information
Gen. Code and Des.
67349 abiraterone acetate ORAL TABLET 250 MG
Strength
250 mg
Dose Form
TABLET
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
10000000 ANTINEOPLASTIC AGENTS
Active Ingredients
13721 abiraterone acetate 154229182
Inactive Ingredients
2432 lactose 64044515

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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item No.:RX119166 NDC No.57894015012 57894-150-12 5789415012 UPC No.:357894150121 NDC No.57894-0150-12 UPC/GTIN No.3-57894-15012-1 MPN 15012  NDC Code(s): 57894-150-12, 57894-150-25, 57894-184-12, 578
RX ITEM-Zytiga 250Mg Tab 120 By J O M Ph
item No.:RX119166 NDC No.57894015012 57894-150-12 5789415012 UPC No.:357894150121 NDC No.57894-0150-12 UPC/GTIN No.3-57894-15012-1 MPN 15012 NDC Code(s): 57894-150-12, 57894-150-25, 57894-184-12, 578

BRAND: ZYTIGA NDC: 57894-0150-12,57894015012 UPC: 3-57894-15012-1,357894150121 J/O/M Pharma Services
Zytiga 250Mg Tab 120 By J O M Pharma
BRAND: ZYTIGA NDC: 57894-0150-12,57894015012 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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