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Rx Item-Evomela MELPHALAN Inj 50Mg Vial By Spectrum Pharma

Evomela MELPHALAN Inj 50Mg Vial By Spectrum Pharma Item No.:RX527887 NDC No.68152010900 UPC No.:3-68152-10900-3 368152-109003 368152109003  NDC No. 68152-0109-00 UPC/GTIN No. MPN 010900 Evomela MELPHALAN Inj 50Mg Vial By Spectrum Pharma Item No.:RX527887 NDC No.68152010900 UPC No.:3-68152-10900-3 368152-109003 368152109003  NDC No. 68152-0109-00 UPC/GTIN No. MPN 010900 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 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-Evomela MELPHALAN Inj 50Mg Vial By Spectrum Pharma

$2400.00$2285.71

Evomela MELPHALAN Inj 50Mg Vial By Spectrum Pharma Item No.:RX527887 NDC No.68152010900 UPC No.:3-68152-10900-3 368152-109003 368152109003 NDC No. 68152-0109-00 UPC/GTIN No. MPN 010900 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. Rx527887 Status Ac - Active
Item No. 3527887
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For: Multiple Myeloma

Evomela (melphalan) is an alkylating agent used as a high-dose conditioning treatment prior to stem cell transplantation in patients with multiple myeloma (MM), and for the palliative treatment of patients with MM for whom oral therapy is not appropriate. These highlights do not include all the information needed to use EVOMELA® safely and effectively. See full prescribing information for EVOMELA.

EVOMELA (melphalan) for injection, for intravenous use.
Initial U.S. Approval: 1964
WARNING: SEVERE BONE MARROW SUPPRESSION, HYPERSENSITIVITY, AND LEUKEMOGENICITY
See full prescribing information for complete boxed warning.


Severe bone marrow suppression with resulting infection or bleeding may occur. Controlled trials comparing intravenous (IV) melphalan to oral melphalan have shown more myelosuppression with the IV formulation. Monitor hematologic laboratory parameters. (5.1)

Hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received the IV formulation of melphalan. Discontinue treatment with Evomela for serious hypersensitivity reactions. (5.4)

Melphalan produces chromosomal aberrations in vitro and in vivo. Evomela should be considered potentially leukemogenic in humans. (5.5)

RECENT MAJOR CHANGES

Dosage and Administration (2.4) 09/2017
INDICATIONS AND USAGE

Evomela is an alkylating drug indicated for:


use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma. (1.1)

the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. (1.2)

DOSAGE AND ADMINISTRATION


For Conditioning Treatment, the recommended dose of Evomela is 100 mg/m2/day administered over 30 minutes by intravenous infusion for 2 consecutive days (Day -3 and Day -2) prior to autologous stem cell transplantation (ASCT, Day 0). (2.1)

For Palliative Treatment, the recommended dose of Evomela is 16 mg/m2 administered as a single intravenous infusion over 15-20 minutes at 2-week intervals for 4 doses, then, after adequate recovery from toxicity, at 4-week intervals. (2.2)

DOSAGE FORMS AND STRENGTHS

For Injection: 50 mg per vial, lyophilized powder in a single-dose vial for reconstitution. (3)
CONTRAINDICATIONS


History of serious allergic reaction to melphalan

WARNINGS AND PRECAUTIONS


Gastrointestinal toxicity: Nausea, vomiting, diarrhea or oral mucositis may occur; provide supportive care using antiemetic and antidiarrheal medications as needed. (2.1, 5.2)

Embryo-fetal toxicity: Can cause fetal harm. Advise of potential risk to fetus and to avoid pregnancy. (5.6, 8.1, 8.3)

Infertility: Melphalan may cause ovarian function suppression or testicular suppression. (5.7)

ADVERSE REACTIONS

Most common adverse reactions observed in at least 50% of patients treated with Evomela are neutrophil count decreased, white blood cell count decreased, lymphocyte count decreased, platelet count decreased, diarrhea, nausea, fatigue, hypokalemia, anemia, and vomiting. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Acrotech at 1-888-292-9617 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
USE IN SPECIFIC POPULATIONS


Nursing mothers: Advise women against breastfeeding while being treated with Evomela. (8.3)

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

Revised: 8/2019

Evomela MELPHALAN Inj 50Mg Vial By Spectrum Pharma Item No.:RX527887 NDC No.68152010900 UPC No.:3-68152-10900-3 368152-109003 368152109003  NDC No. 68152-0109-00 UPC/GTIN No. MPN 010900
RX ITEM-Evomela Inj 50Mg Vial By Spectru
Evomela MELPHALAN Inj 50Mg Vial By Spectrum Pharma Item No.:RX527887 NDC No.68152010900 UPC No.:3-68152-10900-3 368152-109003 368152109003 NDC No. 68152-0109-00 UPC/GTIN No. MPN 010900

Evomela MELPHALAN Inj 50Mg Vial By Spectrum Pharma Item No.:RX527887 NDC No.68152010900 UPC No.:3-68152-10900-3 368152-109003 368152109003  NDC No. 68152-0109-00 UPC/GTIN No. MPN 010900
Evomela Inj 50Mg Vial By Spectrum Pharma
Evomela MELPHALAN Inj 50Mg Vial By Spectrum Pharma Item No.:RX527887 NDC No.68152010900 UPC No.:3-68152-10900-3 368152-109003 368152109003 NDC No. 68152-0109-00 UPC/GTIN No. MPN 010900

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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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

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