Beizray Email
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Please see full Prescribing Information, including Boxed
WARNING, and Important Safety
Information below
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IMPORTANT SAFETY INFORMATION |
WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA,
HYPERSENSITIVITY REACTIONS, and FLUID RETENTION
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Treatment-related mortality associated with BEIZRAY is increased in patients with abnormal
liver function, in patients receiving higher doses, and in patients with non-small cell
lung carcinoma and a history of prior treatment with platinum-based chemotherapy who
receive BEIZRAY as a single agent at a dose of 100 mg/m2.
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Avoid the use of BEIZRAY in patients with bilirubin > upper limit of normal (ULN), or to
patients with AST and/or ALT >1.5 x ULN concomitant with alkaline phosphatase >2.5 x ULN.
Patients with elevations of bilirubin or abnormalities of transaminase concurrent with
alkaline phosphatase are at increased risk for the development of severe neutropenia,
febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin
toxicity, and toxic death. Patients with isolated elevations of transaminase >1.5 x ULN
also had a higher rate of febrile neutropenia. Measure bilirubin, AST or ALT, and alkaline
phosphatase prior to each cycle of BEIZRAY.
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Do not administer BEIZRAY to patients with neutrophil counts of <1500 cells/mm3. Monitor blood
counts frequently as neutropenia may be severe and result in
infection.
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Do not administer BEIZRAY to patients who have a history of severe hypersensitivity
reactions to docetaxel. Severe hypersensitivity reactions have been reported in patients
despite dexamethasone premedication. Hypersensitivity reactions require immediate
discontinuation of the BEIZRAY infusion and administration of appropriate therapy.
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Severe fluid retention occurred in 6.5% (6/92) of patients despite use of dexamethasone
premedication. It was characterized by one or more of the following events: poorly
tolerated peripheral edema, generalized edema, pleural effusion requiring urgent drainage,
dyspnea at rest, cardiac tamponade, or pronounced abdominal distention (due to ascites).
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Please see additional Important Safety Information below |
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INDICATIONS
BEIZRAY is a microtubule inhibitor indicated for:
Breast Cancer (BC): single agent for locally advanced or metastatic BC after
chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable
node-positive BC
Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic
NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or
metastatic untreated NSCLC
Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic
castration-resistant prostate cancer
Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced
GC, including the gastroesophageal junction
Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil
for induction treatment of locally advanced SCCHN
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Beizray has National Medicare MAC coverage
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AL, GA, NC, MS, SC, TN, VA, WV
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CT, IL, MA,
ME, MN, NH,
NY, RI, VT, WI
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AR, CO, DC,
DE, IA, MD,
NJ, NM, OK,
PA, TX
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AK, AZ, CA,
HI, ID, MT, ND,
NV, OR, SD,
UT, WA, WY
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IA, IN, KS, MI,
MO, NE
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FL
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KY, OH
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J-code: J9174
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For support with ordering, please contact your
dedicated representative.
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ZySupportTM offers a full
suite of solutions to support access and reimbursement with the resources
to help your patients get started and stay on their prescribed Zydus medication.
Our reimbursement experts are available to help assist with coverage, prior authorization,
appeals, co-pay support, and more to help patients start and stay on their prescribed Zydus
medicines — regardless of insurance type.*
*Terms and conditions apply
Zydus and its agents make no guarantee regarding reimbursement for any service or item. The
accurate completion of reimbursement- or coverage-related documentation is the responsibility of
the healthcare provider and patient. For eligibility requirements, please contact a patient
assistance specialist.
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BEIZRAYTM (docetaxel) injection is
supplied as follows:
NDC 70710‑2091‑3
BEIZRAY 80 mg kit contains:
- One single-dose vial of BEIZRAY:
80 mg/4 mL; a clear and colorless liquid
- One single-dose vial of IV Solution Stabilizer (50 mL of 25% Albumin Human USP solution for infusion; a clear and slightly viscous solution)
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NDC 70710‑2093‑4
BEIZRAY 160 mg kit contains:
- Two single-dose vials of BEIZRAY: 80 mg/4 mL each; a clear and colorless liquid
- One single-dose vial of IV Solution Stabilizer (50 mL of 25% Albumin Human USP solution for infusion; a clear and slightly viscous solution)
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NDC 70710‑2092‑8
BEIZRAY carton containing one single-dose vial:*
- 20 mg/mL; a clear and colorless liquid
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*Beizray is also supplied
in an 80
mg/4 mL single-dose vial (not available in the
U.S.)
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IMPORTANT SAFETY INFORMATION (continued)
CONTRAINDICATIONS
BEIZRAY is contraindicated in patients with:
- neutrophil counts of <1500 cells/mm3
- a history of severe hypersensitivity reactions to docetaxel. Severe reactions, including
anaphylaxis, have occurred.
WARNINGS AND PRECAUTIONS
Toxic Deaths, Hepatotoxicity, Neutropenia, Hypersensitivity Reactions, and Fluid Retention (See BOXED
WARNING).
Second primary malignancies: In patients treated with
BEIZRAY-containing regimens, monitor for delayed AML, MDS, NHL, and renal cancer.
Cutaneous reactions: Reactions including erythema of the
extremities with edema followed by desquamation may occur. Severe cutaneous adverse reactions have been
reported. Severe skin toxicity may require dose adjustment or permanent treatment discontinuation.
Neurologic reactions: Reactions including paresthesia, dysesthesia,
and pain may occur. Severe neurosensory symptoms require dose adjustment or discontinuation if
persistent.
Eye disorders: Cystoid macular edema (CME) has been reported and
requires treatment discontinuation.
Asthenia: Severe asthenia may occur and may require treatment
discontinuation.
Embryo-fetal toxicity: Can cause fetal harm. Advise patients of the
potential risk to a fetus and to use effective contraception.
Alcohol content: The alcohol content in a dose of BEIZRAY Injection
may affect the central nervous system. This may include impairment of a patient's ability to drive or use
machines immediately after infusion.
Tumor lysis syndrome: Tumor lysis syndrome has been reported.
Patients at risk should be well hydrated and closely monitored during treatment.
Transmissible Infectious Agents:BEIZRAY final infusion solution
contains albumin derived from human blood, which has a theoretical risk of viral transmission.
ADVERSE REACTIONS
The most serious adverse reactions from BEIZRAY are Toxic Deaths, Hepatic Impairment, Hematologic Effects,
Enterocolitis and Neutropenic Colitis, Hypersensitivity Reactions, Fluid Retention, Second Primary
Malignancies, Cutaneous Reactions, Neurologic Reactions, Eye Disorders, Asthenia, Alcohol Content, Tumor
Lysis Syndrome.
The most common adverse reactions across all docetaxel indications are infections, neutropenia, anemia,
febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation,
anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis,
alopecia, skin reactions, and myalgia. Incidence varies depending on the indication.
To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779
or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
REFERENCES:
- Moman RN, Gupta N, Varacallo MA. Physiology, Albumin. In: StatPearls [Internet]. Treasure Island
(FL): StatPearls Publishing; 2025 Jan.
- BeizrayTM (docetaxel)
Prescribing Information. Zydus Pharmaceuticals.
- Center for Drug Evaluation and Research Clinical Review, Beizray. https://www.accessdata.fda.gov/drugsatfda_docs/
nda/2025/218711Orig1s000MedR.pdf
Please see
full Prescribing Information, including Boxed WARNING
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BeizrayTM is a
trademark of Zhuhai Beihai Biotech Co., Ltd.
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Non‑Zydus USA brands are trademarks or registered trademarks of their respective owners.
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© 2026 Zydus Pharmaceuticals (USA) Inc. All rights reserved.
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US-BEI-2600021 05/26
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Beizray.us
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