MVASI- bevacizumab-awwb injection, solution

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Amgen Inc

Administreringssätt:

INTRAVENOUS

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

MVASI, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first- or second-line treatment of patients with metastatic colorectal cancer (mCRC). MVASI, 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 : MVASI is not indicated for adjuvant treatment of colon cancer [see Clinical Studies (14.2)]. MVASI, 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). MVASI is indicated for the treatment of recurrent glioblastoma (GBM) in adults. MVASI, in combination with interferon-alfa, is indicated for the treatment of metastatic renal cell carcinoma (mRCC). MVASI, in combination with paclitaxel and cisplatin or paclitaxel

Produktsammanfattning:

MVASI (bevacizumab-awwb) injection is a clear to slightly opalescent, colorless to pale yellow, sterile solution for intravenous infusion supplied as single-dose vials in the following strengths: 100 mg/4 mL (25 mg/mL) (NDC 55513-206-01) and 400 mg/16 mL (25 mg/mL) (NDC 55513-207-01). Each carton contains one vial. 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.

Bemyndigande status:

Biologic Licensing Application

Produktens egenskaper

MVASI- BEVACIZUMAB-AWWB INJECTION, SOLUTION
AMGEN INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MVASI SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MVASI.
MVASI (BEVACIZUMAB-AWWB) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2017
MVASI (BEVACIZUMAB-AWWB) IS BIOSIMILAR TO AVASTIN (BEVACIZUMAB)
RECENT MAJOR CHANGES
Indications and Usage (1.6)
11/2021
Dosage and Administration (2.1, 2.8)
4/2021
Dosage and Administration (2.7)
11/2021
Warnings and Precautions (5.2)
4/2021
INDICATIONS AND USAGE
MVASI 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: MVASI 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 MVASI 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