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Rx Item-Mylotarg GEMTUZUMAB OZOGAMICIN 4.5Mg Powder Vial 1X1 Ea By Pfizer Pharma

Item No.:RX00008-4510-01/c NDC No.8451001 00008-4510-01 0008451001 00008451001 UPC No.:300084510014 NDC No. 00008-4510-01 UPC/GTIN No. 3-00084-51001-4 300084-510014 300084510014 MPN 51001MYLOTARG 4.5MG POWDER VIAL 1X1 EA by Pfizer PharmaMYLOTARG 4.5MG POWDER VIAL 1X1 EA by Pfizer PharmaMYLOTARG 4.5MG POWDER VIAL 1X1 EA by Pfizer PharmaMYLOTARG 4.5MG POWDER VIAL 1X1 EA by Pfizer PharmaMYLOTARG 4.5MG POWDER VIAL 1X1 EA by Pfizer PharmaMYLOTARG 4.5MG POWDER VIAL 1X1 EA by Pfizer PharmaWant 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-Mylotarg GEMTUZUMAB OZOGAMICIN 4.5Mg Powder Vial 1X1 Ea By Pfizer Pharma

$10754.78$10242.65

Item No.:RX00008-4510-01/c NDC No.8451001 00008-4510-01 0008451001 00008451001 UPC No.:300084510014 NDC No. 00008-4510-01 UPC/GTIN No. 3-00084-51001-4 300084-510014 300084510014 MPN 51001 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. Rx00008-4510-01 MYLOTARG, 4.5MG POWDER VIAL 1X1 EA by Pfizer Ph

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For: Acute Myeloid Leukemia Mylotarg (gemtuzumab ozogamicin) is a D33-directed antibody-drug conjugate indicated for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and the treatment of relapsed or refractory CD33-positive AML in adults and in pediatric patients 2 years and older. MYLOTARG (gemtuzumab ozogamicin) for Injection is a white to off-white lyophilized cake or powder supplied in a carton (NDC 0008-4510-01) containing one 4.5 mg single-dose vial [see Dosage and Administration (2)]. 16.1 Storage and Handling Refrigerate (2�"8°C; 36�"46°F) MYLOTARG vials and store in the original carton to protect from light. DO NOT FREEZE. MYLOTARG is a cytotoxic drug. Follow applicable special handling and disposal procedures.1 These highlights do not include all the information needed to use MYLOTARG safely and effectively. See full prescribing information for MYLOTARG. MYLOTARG™ (gemtuzumab ozogamicin) for injection, for intravenous use Initial U.S. Approval: 2000 WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. Hepatotoxicity, including severe or fatal hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), has been reported in association with the use of MYLOTARG. (5.1, 6.1) RECENT MAJOR CHANGES Dosage and Administration, Recommended Dosage (2.2) 4/2018 Dosage and Administration, Instructions for Reconstitution, Dilution, and Administration (2.4) 4/2018 INDICATIONS AND USAGE MYLOTARG is a CD33-directed antibody-drug conjugate indicated for: treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults (1.1). treatment of relapsed or refractory CD33-positive AMLin adults and in pediatric patients 2 years and older (1.2). DOSAGE AND ADMINISTRATION Newly-diagnosed, de novo AML (combination regimen): �" Induction: 3 mg/m2 (up to one 4.5 mg vial) on Days 1, 4, and 7 in combination with daunorubicin and cytarabine (2.2). �" Consolidation: 3 mg/m2 on Day 1 (up to one 4.5 mg vial) in combination with daunorubicin and cytarabine. (2.2). Newly-diagnosed AML (single-agent regimen): �" Induction: 6 mg/m2 (not limited to one 4.5 mg vial) on Day 1 and 3 mg/m2 (not limited to one 4.5 mg vial) on Day 8 (2.2). �" Continuation: For patients without evidence of disease progression following induction, up to 8 continuation courses of MYLOTARG 2 mg/m2 (not limited to one 4.5 mg vial) on Day 1 every 4 weeks (2.2). Relapsed or refractory AML(single-agent regimen): �" 3 mg/m2 (up to one 4.5 mg vial) on Days 1, 4, and 7 (2.2). Premedicate with a corticosteroid, antihistamine, and acetaminophen 1 hour prior to MYLOTARG (2.1). DOSAGE FORMS AND STRENGTHS For Injection: 4.5 mg as a lyophilized cake or powder in a single-dose vial for reconstitution and dilution (3). CONTRAINDICATIONS Hypersensitivity to MYLOTARG or any of its components (4). WARNINGS AND PRECAUTIONS Infusion related reactions (including anaphylaxis): Premedicate with a corticosteroid, acetaminophen, and diphenhydramine. Monitor patients during and for at least 1 hour after the end of the infusion. Interrupt the infusion, administer steroids or antihistamines, or permanently discontinue treatment as necessary (2.1, 5.2, and 6). Hemorrhage: Severe, including fatal, hemorrhage may occur when MYLOTARG is used at recommended doses. Monitor platelet counts frequently (5.3 and 6.1). Embryo-fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception (5.6, 8.1, and 8.3). ADVERSE REACTIONS The most common adverse reactions (greater than 15%) were hemorrhage, infection, fever, nausea, vomiting, constipation, headache, increased AST, increased ALT, rash, and mucositis (6). To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed (8.2). See 17 for PATIENT COUNSELING INFORMATION. Revised: 4/2018

Item No.:RX00008-4510-01/c NDC No.8451001 00008-4510-01 0008451001 00008451001 UPC No.:300084510014 NDC No. 00008-4510-01 UPC/GTIN No. 3-00084-51001-4 300084-510014 300084510014 MPN 51001
RX ITEM-Mylotarg 4.5Mg Powder Vial 1X1 E
Item No.:RX00008-4510-01/c NDC No.8451001 00008-4510-01 0008451001 00008451001 UPC No.:300084510014 NDC No. 00008-4510-01 UPC/GTIN No. 3-00084-51001-4 300084-510014 300084510014 MPN 51001

MYLOTARG 4.5MG POWDER VIAL 1X1 EA by Pfizer Pharma
00008-4510-01
MYLOTARG 4.5MG POWDER VIAL 1X1 EA by Pfizer Pharma

MYLOTARG 4.5MG POWDER VIAL 1X1 EA by Pfizer Pharma
00008-4510-01
MYLOTARG 4.5MG POWDER VIAL 1X1 EA by Pfizer Pharma

MYLOTARG 4.5MG POWDER VIAL 1X1 EA by Pfizer Pharma
00008-4510-01
MYLOTARG 4.5MG POWDER VIAL 1X1 EA by Pfizer Pharma

MYLOTARG 4.5MG POWDER VIAL 1X1 EA by Pfizer Pharma
00008-4510-01
MYLOTARG 4.5MG POWDER VIAL 1X1 EA by Pfizer Pharma

MYLOTARG 4.5MG POWDER VIAL 1X1 EA by Pfizer Pharma
00008-4510-01
MYLOTARG 4.5MG POWDER VIAL 1X1 EA by Pfizer Pharma

MYLOTARG 4.5MG POWDER VIAL 1X1 EA by Pfizer Pharma
00008-4510-01
MYLOTARG 4.5MG POWDER VIAL 1X1 EA by Pfizer Pharma

Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com
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Want to do Research on this Med or need a large quantity? Email Details with quantity required to:[email protected]

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
AmericanPharmaWholesale.com
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.