ZIRABEV- bevacizumab-bvzr injection, solution

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Pfizer Laboratories Div Pfizer Inc

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

ZIRABEV (bevacizumab-bvzr) injection is a clear to slightly opalescent, colorless to pale brown, sterile solution for intravenous infusion supplied in a carton containing one single-dose vial 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.

Estat d'Autorització:

Biologic Licensing Application

Fitxa tècnica

ZIRABEV- BEVACIZUMAB-BVZR INJECTION, SOLUTION
PFIZER LABORATORIES DIV PFIZER INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZIRABEV SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZIRABEV.
ZIRABEV™ (BEVACIZUMAB-BVZR) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2019
ZIRABEV (BEVACIZUMAB-BVZR) IS BIOSIMILAR TO AVASTIN (BEVACIZUMAB).
RECENT MAJOR CHANGES
Warnings and Precautions, Infusion-Related Reactions (5.9)
02/2023
INDICATIONS AND USAGE
ZIRABEV is a vascular endothelial growth factor inhibitor indicated
for the treatment of:
•
•
Limitations of Use: ZIRABEV is not indicated for adjuvant treatment of
colon cancer. (1.1)
•
•
•
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DOSAGE AND ADMINISTRATION
Withhold for at least 28 days prior to elective surgery. Do not
administer ZIRABEV for 28 days following
major surgery and until adequate wound healing. (2.1)
Metastatic colorectal cancer. (2.2)
•
•
•
First-line non−squamous non−small cell lung cancer. (2.3)
•
Recurrent glioblastoma. (2.4)
•
Metastatic renal cell carcinoma. (2.5)
•
Persistent, recurrent, or metastatic cervical cancer. (2.6)
•
Stage III or IV epithelial ovarian, fallopian tube or primary
peritoneal cancer following initial surgical
resection. (2.7)
•
Platinum-resistant recurrent epithelial ovarian, fallopian tube or
primary peritoneal cancer. (2.7)
•
*
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)
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 cel