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RX ITEM-Zelboraf 240Mg Tab 112 By Genentech

NDC 50242-0090-02 UPC/GTIN No.3-50242-09002-5 Mfg.Part No.9002BRAND: ZELBORAF  NDC: 50242-0090-02,50242009002 UPC: 3-50242-09002-5,350242090025 Genentech, Inc. USAOnly 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-Zelboraf 240Mg Tab 112 By Genentech

$6076.45$6076.45

item No.:RX464248 NDC No.50242009002 UPC No.:350242090025 NDC No.50242-0090-02 UPC/GTIN No.3-50242-09002-5 MPN 9002 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.Rx464248 Zelboraf 240mg Tab 112 by Genentech Item No.3464248 NDC No.50242009002 UPC No.350242090025 Other Name Zelboraf Therapeutic Clas

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ZELBORAF- vemurafenib tablet, film coated
Genentech, Inc.

1 INDICATIONS AND USAGE

ZELBORAF ® is indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.
Limitation of Use: ZELBORAF is not indicated for treatment of patients with wild-type BRAF melanoma

DOSAGE AND ADMINISTRATION

2.1 Patient Selection


Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment with ZELBORAF [see Warnings and Precautions (5.2)]. Information on FDA-approved tests for the detection of BRAF V600 mutations in melanoma is available at https://www.fda.gov/CompanionDiagnostics.

2.2 Recommended Dose
The recommended dose of ZELBORAF is 960 mg (four 240 mg tablets) orally every 12 hours with or without a meal. A missed dose can be taken up to 4 hours prior to the next dose.

Treat patients with ZELBORAF until disease progression or unacceptable toxicity occurs.

Do not take an additional dose if vomiting occurs after ZELBORAF administration, but continue with the next scheduled dose.

Do not crush or chew the tablets.

2.3 Dose Modifications
For New Primary Cutaneous Malignancies: No dose modifications are recommended.

For Other Adverse Reactions:

Permanently discontinue ZELBORAF for any of the following:

Grade 4 adverse reaction, first appearance (if clinically appropriate) or second appearance
QTc prolongation > 500 ms and increased by > 60 ms from pre-treatment values [see Warnings and Precautions (5.5) ]
Withhold ZELBORAF for NCI-CTCAE (v4.0) intolerable Grade 2 or greater adverse reactions.

Upon recovery to Grade 01, restart ZELBORAF at a reduced dose as follows:

720 mg twice daily for first appearance of intolerable Grade 2 or Grade 3 adverse reactions
480 mg twice daily for second appearance of Grade 2 (if intolerable) or Grade 3 adverse reactions or for first appearance of Grade 4 adverse reaction (if clinically appropriate)
Do not dose reduce to below 480 mg twice daily.

3 DOSAGE FORMS AND STRENGTHS

Tablet: 240 mg.

DESCRIPTION

ZELBORAF (vemurafenib) is a kinase inhibitor available as 240 mg tablets for oral use. Vemurafenib has the chemical name propane-1-sulfonic acid {3-[5-(4-chlorophenyl)-1H-pyrrolo[2,3-b]pyridine-3-carbonyl]-2,4-difluoro-phenyl}-amide. It has the molecular formula C23 H18 ClF2 N3 O3 S and a molecular weight of 489.9
Mechanism of Action
Vemurafenib is a low molecular weight, orally available inhibitor of some mutated forms of BRAF serine-threonine kinase, including BRAF V600E. Vemurafenib also inhibits other kinases in vitro such as CRAF, ARAF, wild-type BRAF, SRMS, ACK1, MAP4K5, and FGR at similar concentrations. Some mutations in the BRAF gene including V600E result in constitutively activated BRAF proteins, which can cause cell proliferation in the absence of growth factors that would normally be required for proliferation. Vemurafenib has anti-tumor effects in cellular and animal models of melanomas with mutated BRAF V600E.

NDC 50242-0090-02 UPC/GTIN No.3-50242-09002-5 Mfg.Part No.9002
RX ITEM-Zelboraf 240Mg Tab 112 By Genent
NDC 50242-0090-02 UPC/GTIN No.3-50242-09002-5 Mfg.Part No.9002

BRAND: ZELBORAF  NDC: 50242-0090-02,50242009002 UPC: 3-50242-09002-5,350242090025 Genentech, Inc. USA
Zelboraf 240Mg Tab 112 By Genentech
BRAND: ZELBORAF NDC: 50242-0090-02,50242009002 UPC: 3-50242-09002-5,350242090025 Genentech, Inc. USA

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
VEMURAFENIB ORAL TABLET 2
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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