VEGZELMA- bevacizumab-adcd injection, solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

BEVACIZUMAB (UNII: 2S9ZZM9Q9V) (BEVACIZUMAB - UNII:2S9ZZM9Q9V)

Disponibil de la:

CELLTRION USA, Inc.

Calea de administrare:

INTRAVENOUS

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

VEGZELMA, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first- or second-line treatment of patients with metastatic colorectal cancer (mCRC). VEGZELMA, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with mCRC who have progressed on a first-line bevacizumab product-containing regimen. Limitations of Use : VEGZELMA is not indicated for adjuvant treatment of colon cancer [see Clinical Studies (14.2)]. VEGZELMA, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non–squamous non–small cell lung cancer (NSCLC). VEGZELMA is indicated for the treatment of recurrent glioblastoma (GBM) in adults. VEGZELMA, in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma (mRCC). VEGZELMA, in combination with paclitaxel and ci

Rezumat produs:

VEGZELMA (bevacizumab-adcd) injection is a clear to opalescent, colorless to pale brown, sterile solution for intravenous infusion supplied in a single-dose vial pakcaged within cartons in the following strengths and packaging configurations: Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton until time of use to protect from light. Do not freeze or shake the vial or carton.

Statutul autorizaţiei:

Biologic Licensing Application

Caracteristicilor produsului

VEGZELMA- BEVACIZUMAB-ADCD INJECTION, SOLUTION
CELLTRION USA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VEGZELMA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VEGZELMA.
VEGZELMA (BEVACIZUMAB-ADCD) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2022
VEGZELMA (BEVACIZUMAB-ADCD) IS BIOSIMILAR TO AVASTIN (BEVACIZUMAB).
INDICATIONS AND USAGE
VEGZELMA is a vascular endothelial growth factor inhibitor indicated
for the treatment of:
Metastatic colorectal cancer, in combination with intravenous
fluorouracil-based chemotherapy for first-
or second-line treatment. (1.1)
Metastatic colorectal cancer, in combination with
fluoropyrimidine-irinotecan- or fluoropyrimidine-
oxaliplatin-based chemotherapy for second-line treatment in patients
who have progressed on a first-
line bevacizumab product-containing regimen. (1.1)
Limitations of Use: VEGZELMA is not indicated for adjuvant treatment
of colon cancer. (1.1)
Unresectable, locally advanced, recurrent or metastatic non-squamous
non-small cell lung cancer, in
combination with carboplatin and paclitaxel for first-line treatment.
(1.2)
Recurrent glioblastoma in adults. (1.3)
Metastatic renal cell carcinoma in combination with interferon alfa.
(1.4)
Persistent, recurrent, or metastatic cervical cancer, in combination
with paclitaxel and cisplatin, or
paclitaxel and topotecan. (1.5)
Epithelial ovarian, fallopian tube, or primary peritoneal cancer:
in combination with carboplatin and paclitaxel, followed by VEGZELMA
as a single agent, for stage III
or IV disease following initial surgical resection (1.6)
in combination with paclitaxel, pegylated liposomal doxorubicin, or
topotecan for platinum-resistant
recurrent disease who received no more than 2 prior chemotherapy
regimens (1.6)
in combination with carboplatin and paclitaxel or carboplatin and
gemcitabine, followed by
VEGZELMA as a single agent, for platinum-sensitive recurrent disease
(1.6)
DOSAGE AND ADMINISTRATION
Withhold for