AVASTIN- bevacizumab injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Genentech, Inc.

INN (International Name):

bevacizumab

Composition:

bevacizumab 100 mg in 4 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Avastin (bevacizumab) injection is a clear to slightly opalescent, colorless to pale brown, sterile solution for intravenous infusion supplied as single-dose vials in the following strengths: 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.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

AVASTIN- BEVACIZUMAB INJECTION, SOLUTION
GENENTECH, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AVASTIN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AVASTIN.
AVASTIN (BEVACIZUMAB) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2004
RECENT MAJOR CHANGES
Indications and Usage (1.1)
9/2022
Dosage and Administration (2.2)
9/2022
Warnings and Precautions, Infusion-Related Reactions (5.9)
9/2022
INDICATIONS AND USAGE
Avastin 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: Avastin 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 Avastin 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 Avastin as
a single agent, for platinum-se