Beizray - Now Available
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The first and only FDA approved Docetaxel+Albumin injection
(Supplied as a Kit)*
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Please see full Prescribing Information, including Boxed Warning
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*Also supplied individually as an 80 mg/4 mL single dose vial
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WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION
See full prescribing information for complete boxed warning.
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- Treatment-related mortality increases with abnormal liver function, at higher doses, and in patients with NSCLC and prior platinum-based therapy receiving BEIZRAY at 100 mg/m²
- Avoid use of BEIZRAY if bilirubin > ULN, or if AST and/or ALT > 1.5 × ULN concomitant with alkaline phosphatase > 2.5 × ULN. LFT elevations increase risk of severe or life-threatening complications. Obtain LFTs before each treatment cycle
- Do not administer BEIZRAY to patients with neutrophil counts < 1500 cells/mm³. Obtain frequent blood counts to monitor for neutropenia
- Severe hypersensitivity, including fatal anaphylaxis, has been reported in patients who received dexamethasone premedication. Severe reactions require immediate discontinuation of BEIZRAY and administration of appropriate therapy
- Contraindicated if history of severe hypersensitivity reactions to docetaxel
- Severe fluid retention may occur despite dexamethasone
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Please see additional Important Safety Information Below
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Beizray has been assigned a permanent HCPCS J-code: J9174, effective July 1, 2025.
HCPCS Code: J9174
Description: Injection, docetaxel, albumin-bound, 1 mg
Effective Date: July 1, 2025
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J9174
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This permanent J-code is now included on the CMS HCPCS Quarterly Update Crosswalk, which means it is recognized in the official coding tables used by Medicare and other payers for claims adjudication.
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Contact a representative to learn more
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Beizray is supplied as a docetaxel + albumin kit*
NDC 70710-2091-3: 80 mg kit
NDC 70710-2093-4: 160 mg kit
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(Not actual size of product)
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BEIZRAY 80 mg kit contains:
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- One single-dose vial of BEIZRAY: 80 mg/4 mL
- One single-dose vial of IV Solution Stabilizer (50 mL, 25% Albumin Human USP solution)
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BEIZRAY 160 mg kit contains:
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- Two single-dose vials of BEIZRAY: 80 mg/4 mL each
- One single-dose vial of IV Solution Stabilizer (50 mL, 25% Albumin Human USP solution)
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*Also supplied individually as an 80 mg/4 mL single dose vial
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Beizray has demonstrated bioequivalence to Taxotere and uses albumin, the body's most abundant carrier protein, to transport Docetaxel1,2
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WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION
See full prescribing information for complete boxed warning.
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- Treatment-related mortality increases with abnormal liver function, at higher doses, and in patients with NSCLC and prior platinum-based therapy receiving BEIZRAY at 100 mg/m²
- Avoid use of BEIZRAY if bilirubin > ULN, or if AST and/or ALT > 1.5 × ULN concomitant with alkaline phosphatase > 2.5 × ULN. LFT elevations increase risk of severe or life-threatening complications. Obtain LFTs before each treatment cycle
- Do not administer BEIZRAY to patients with neutrophil counts < 1500 cells/mm³. Obtain frequent blood counts to monitor for neutropenia
- Severe hypersensitivity, including fatal anaphylaxis, has been reported in patients who received dexamethasone premedication. Severe reactions require immediate discontinuation of BEIZRAY and administration of appropriate therapy
- Contraindicated if history of severe hypersensitivity reactions to docetaxel
- Severe fluid retention may occur despite dexamethasone
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Please see additional Important Safety Information.
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INDICATIONS
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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
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IMPORTANT SAFETY INFORMATION
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CONTRAINDICATION
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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.
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WARNINGS AND PRECAUTIONS
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Toxic Deaths
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Breast Cancer
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BEIZRAY administered at 100 mg/m² was associated with deaths considered possibly or probably related to treatment in 2.0% (19/965) of metastatic breast cancer patients, both previously treated and untreated, with normal baseline liver function and in 11.5% (7/61) of patients with various tumor types who had abnormal baseline liver function (AST and/or ALT >1.5 times ULN together with AP >2.5 times ULN). Among patients dosed at 60 mg/m2, mortality related to treatment occurred in 0.6% (3/481) of patients with normal liver function, and in 3 of 7 patients with abnormal liver function. Approximately half of these deaths occurred during the first cycle. Sepsis accounted for the majority of the deaths.
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Non-small Cell Lung Cancer
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BEIZRAY administered at a dose of 100 mg/m2 in patients with locally advanced or metastatic non-small cell lung cancer who had a history of prior platinum-based chemotherapy was associated with increased treatment-related mortality (14% and 5% in two randomized, controlled studies). There were 2.8% treatment-related deaths among the 176 patients treated at the 75 mg/m2 dose in the randomized trials. Among patients who experienced treatment-related mortality at the 75 mg/m2 dose level, 3 of 5 patients had an ECOG PS of 2 at study entry.
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Hepatic Impairment
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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.
Avoid 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.
For patients with isolated elevations of transaminase >1.5 x ULN, consider BEIZRAY dose modifications. Measure bilirubin, AST or ALT, and alkaline phosphatase prior to each cycle of BEIZRAY therapy.
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Hematologic Effects
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Perform frequent peripheral blood cell counts on all patients receiving BEIZRAY. Do not retreat patients with subsequent cycles of BEIZRAY until neutrophils recover to a level >1500 cells/mm3. Avoid retreating patients until platelets recover to a level >100,000 cells/mm3.
A 25% reduction in the dose of BEIZRAY is recommended during subsequent cycles following severe neutropenia (<500 cells/mm3) lasting 7 days or more, febrile neutropenia, or a grade 4 infection in a BEIZRAY cycle.
Neutropenia (<2000 neutrophils/mm3) occurs in virtually all patients given 60 mg/m2 to 100 mg/m2 of BEIZRAY and grade 4 neutropenia (<500 cells/mm3) occurs in 85% of patients given 100 mg/m2 and 75% of patients given 60 mg/m2. Frequent monitoring of blood counts is, therefore, essential so that dose can be adjusted. BEIZRAY should not be administered to patients with neutrophils <1500 cells/mm3. Hypersensitivity reactions may occur within a few minutes following initiation of a BEIZRAY infusion. If minor reactions such as flushing or localized skin reactions occur, interruption of therapy is not required. All patients should be premedicated with an oral corticosteroid prior to the initiation of the infusion of BEIZRAY.
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Fluid Retention
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Severe fluid retention has been reported following BEIZRAY therapy. Patients should be premedicated with oral corticosteroids prior to each BEIZRAY administration to reduce the incidence and severity of fluid retention. Patients with pre-existing effusions should be closely monitored from the first dose for the possible exacerbation of the effusions. When fluid retention occurs, peripheral edema usually starts in the lower extremities and may become generalized with a median weight gain of 2 kg.
Among 92 breast cancer patients premedicated with 3-day corticosteroids, moderate fluid retention occurred in 27.2% and severe fluid retention in 6.5%. The median cumulative dose to onset of moderate or severe fluid retention was 819 mg/m2. Nine of 92 patients (9.8%) of patients discontinued treatment due to fluid retention: 4 patients discontinued with severe fluid retention; the remaining 5 had mild or moderate fluid retention. The median cumulative dose to treatment discontinuation due to fluid retention was 1021 mg/m2. Fluid retention was completely, but sometimes slowly, reversible with a median of 16 weeks from the last infusion of BEIZRAY to resolution (range: 0 to 42+ weeks). Patients developing peripheral edema may be treated with standard measures,
e.g., salt restriction, oral diuretic(s).
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Second Primary Malignancies
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Second primary malignancies, notably acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), non-Hodgkin's lymphoma (NHL), and renal cancer, have been reported in patients treated with docetaxel-containing regimens. These adverse reactions may occur several months or years after docetaxel-containing therapy.
Treatment-related AML or MDS has occurred in patients given anthracyclines and/or cyclophosphamide, including use in adjuvant therapy for breast cancer. In the adjuvant breast cancer trial (TAX316) AML occurred in 3 of 744 patients who received BEIZRAY, doxorubicin and cyclophosphamide (TAC) and in 1 of 736 patients who received fluorouracil, doxorubicin, and cyclophosphamide. In TAC-treated patients, the risk of delayed myelodysplasia or myeloid leukemia requires hematological follow-up. Monitor patients for second primary malignancies.
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Cutaneous Reactions
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Localized erythema of the extremities with edema followed by desquamation has been observed. In case of severe skin toxicity, an adjustment in dosage is recommended. The discontinuation rate due to skin toxicity was 1.6% (15/965) for metastatic breast cancer patients. Among 92 breast cancer patients premedicated with 3-day corticosteroids, there were no cases of severe skin toxicity reported and no patient discontinued BEIZRAY due to skin toxicity.
Severe cutaneous adverse reactions (SCARs) such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with docetaxel treatment. Patients should be informed about the signs and symptoms of serious skin manifestations and monitored closely. Permanent treatment discontinuation should be considered in patients who experience SCARs.
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Neurologic Reactions
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Severe neurosensory symptoms (e.g., paresthesia, dysesthesia, pain) were observed in 5.5% (53/965) of metastatic breast cancer patients and resulted in treatment discontinuation in 6.1%. When these symptoms occur, dosage must be adjusted. If symptoms persist, treatment should be discontinued. Patients who experienced neurotoxicity in clinical trials and for whom follow-up information on the complete resolution of the event was available had spontaneous reversal of symptoms with a median of 9 weeks from onset (range: 0 to 106 weeks). Severe peripheral motor neuropathy mainly manifested as distal extremity weakness occurred in 4.4% (42/965).
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Eye Disorders
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Cystoid macular edema (CME) has been reported in patients treated with docetaxel. Patients with impaired vision should undergo a prompt and comprehensive ophthalmologic examination. If CME is diagnosed, BEIZRAY treatment should be discontinued and appropriate treatment initiated. Alternative non-taxane cancer treatment should be considered.
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Asthenia
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Severe asthenia has been reported in 14.9% (144/965) of metastatic breast cancer patients but has led to treatment discontinuation in only 1.8%. Symptoms of fatigue and weakness may last a few days up to several weeks and may be associated with deterioration of performance status in patients with progressive disease.
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Embryo-Fetal Toxicity
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Based on findings from animal reproduction studies and its mechanism of action, BEIZRAY can cause fetal harm when administered to a pregnant woman. Available data from case reports in the literature and pharmacovigilance with docetaxel use in pregnant women are not sufficient to inform the drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, administration of docetaxel to pregnant rats and rabbits during the period of organogenesis caused embryo-fetal toxicities, including intrauterine mortality, at doses as low as 0.02 and 0.003 times the recommended human dose based on body surface area, respectively.
Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Verify pregnancy status in females of reproductive potential prior to initiating BEIZRAY. Advise females of reproductive potential to use effective contraception during treatment and for 2 months after the last dose of BEIZRAY. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 4 months after the last dose of BEIZRAY.
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Alcohol Content
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Cases of intoxication have been reported with some formulations of docetaxel due to the alcohol content. The alcohol content in a dose of BEIZRAY may affect the central nervous system and should be taken into account for patients in whom alcohol intake should be avoided or minimized. Consideration should be given to the alcohol content in BEIZRAY on the ability to drive or use machines immediately after the infusion. Each administration of BEIZRAY Injection at 100 mg/m2 delivers 4.0 g/m2 of ethanol. For a patient with a BSA of 2.0 m2, this would deliver 8.0 grams of ethanol. Other docetaxel products may have a different amount of alcohol.
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Tumor Lysis Syndrome
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Tumor lysis syndrome has been reported with docetaxel. Patients at risk of tumor lysis syndrome (e.g., with renal impairment, hyperuricemia, bulky tumor) should be closely monitored prior to initiating BEIZRAY and periodically during treatment. Correction of dehydration and treatment of high uric acid levels are recommended prior to initiation of treatment.
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Transmissible Infectious Agents
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BEIZRAY final infusion solution contains human albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries a remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob Disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin.
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ADVERSE REACTIONS
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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.
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Clinical Trials Experience
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Adverse events occurring in at least 5% of patients with various tumor types
Adverse reactions occurring in breast cancer patients, both treated and untreated with chemotherapy, with normal liver function tests at baseline who were treated with docetaxel 100 mg/m2 and those occurring in patients with various tumor types who had normal or elevated liver function tests at baseline who were treated with docetaxel 100 mg/m2 were neutropenia <2000 cells/mm3 (96% all tumor types with normal liver function tests, 96% all tumor types with elevated liver function tests, 99% breast cancer with normal liver function tests, respectively), neutropenia <500 cells/mm3 (75%, 88%, 86%, respectively), leukopenia <4000 cells/mm3 (96%, 98%, 99%, respectively), leukopenia <1000 cells/mm3 (32%, 47%, 44%, respectively), thrombocytopenia <100,000 cells/mm3 (8%, 25%, 9%,
respectively), anemia <11 g/dL (90%, 92%, 94%, respectively), anemia <8 g/dL (9%, 31%, 8%, respectively), severe febrile neutropenia (11%, 26%, 12%, respectively), infections (severe; 6%, 16%, 6%, respectively), infections (any; 22%, 33%, 22%, respectively), fever in the absence of infection (severe; 2%, 8%, 2%, respectively), fever in the absence of infection (any; 31%, 41%, 35%, respectively), hypersensitivity reactions regardless of premedication (severe; 4%, 10%, 3%, respectively), hypersensitivity reactions regardless of premedication (any; 21%, 20%, 18%, respectively), hypersensitivity reactions with 3-day premedication (sever; 2%, 0%, 2%, respectively), hypersensitivity reactions with 3-day premedication (any; 15%, 33%, 15%, respectively), fluid retention regardless of
premedication (severe; 7%, 8%, 9%, respectively), fluid retention regardless of premedication (any; 47%, 39%, 60%, respectively, fluid retention with 3-day premedication (severe; 7%, 33%, 7%, respectively), fluid retention with 3-day premedication (any; 64%, 67%, 64%, respectively), neurosensory (severe; 4%, 0%, 6%, respectively), neurosensory (any; 49%, 34%, 58%, respectively), cutaneous (severe; 5%, 10%, 5%, respectively), cutaneous (any; 48%, 54%, 47%, respectively), nail changes (severe; 3%, 5%, 4%, respectively), nail changes (any; 31%, 23%, 41%, respectively), gastrointestinal (severe; 5%, 5%, 6%, respectively), nausea (39%, 38%, 42%, respectively), vomiting (22%, 23%, 23%, respectively), diarrhea (39%, 33%, 43%, respectively), stomatitis (severe; 6%, 13%, 7%, respectively),
stomatitis (any; 42%, 49%, 52%, respectively), alopecia (76%, 62%, 74%, respectively), asthenia (severe; 13%, 25%, 15%, respectively), asthenia (any; 62%, 53%, 66%, respectively), myalgia (severe; 2%, 2%, 2%, respectively), myalgia (any; 19%, 16%, 21%, respectively), arthralgia (9%, 7%, 8%, respectively), and infusion site reactions (4%, 3%, 4%, respectively). Septic death (2%, 5%, 1%, respectively) and non-septic death (1%, 7%, 1%, respectively) also occurred.
Monotherapy with docetaxel for locally advanced or metastatic breast cancer after failure of prior chemotherapy
Hematologic adverse reactions (Grade 3/4) occurring in breast cancer patients previously treated with chemotherapy with normal or elevated liver function tests who were treated with docetaxel 100 mg/m2 or those with normal liver function tests who were treated with docetaxel 60 mg/m2 were neutropenia <500 cells/mm3 (84%, 94%, and 75% at 100 mg/m2 with normal liver function tests, 100 mg/m2 with elevated liver function test, and at 60 mg/m2 with normal liver function tests, respectively), thrombocytopenia <20,000 cells/mm3 (1%,17%,1%, respectively), infection (7%,33%,0%, respectively), febrile neutropenia by patient (12%,33%,0%, respectively), and febrile neutropenia by course (2%,9%,0%, respectively).
Severe non-hematologic adverse reactions occurring in breast cancer patients previously treated with chemotherapy with normal or elevated liver function tests who were treated with docetaxel 100 mg/m2 or those with normal liver function tests who were treated with docetaxel 60 mg/m2 were acute hypersensitivity reaction regardless of premedication (1%,0%, and 0% at 100 mg/m2 with normal liver function tests, 100 mg/m2 with elevated liver function test, and at 60 mg/m2 with normal liver function tests, respectively), fluid retention regardless of premedication (8%,17%,0%, respectively), neurosensory (6%,0%,0%, respectively), cutaneous (5%,17%,0%, respectively), asthenia (17%,22%,0%, respectively), diarrhea (6%,11%, NA, respectively), and stomatitis (8%, 39%, 1%, respectively).
Septic death (2%,6%,1%, respectively), and non-septic death (1%,11%,0%, respectively) also occurred.
Monotherapy trial (TAX313) comparing docetaxel 60 mg/m2, 75 mg/m2 and 100 mg/m2 in advanced breast cancer
The following adverse reactions were associated with increasing docetaxel doses: fluid retention (26%, 38%, and 46% at 60 mg/m2, 75 mg/m2, and 100 mg/m2, respectively), thrombocytopenia (7%,11%,12%, respectively), neutropenia (92%, 94%, 97% respectively), febrile neutropenia (5%,7%,14%, respectively), treatment-related grade 3 or 4 infection (2%, 3%, 7%, respectively) and anemia (87%, 94%, 97%, respectively).
Combination therapy with Docetaxel in the adjuvant treatment of breast cancer
Adverse reactions (Grade 3/4) occurring in patients with breast cancer who were treated with Docetaxel 75 mg/m2 every 3 weeks in combination with doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (TAX316) were anemia (4%), neutropenia (66%), fever in the absence of infection (1%), infection (4%), thrombocytopenia (2%), hypersensitivity reactions (1%), fluid retention (1%), neuro-cortical (1%), syncope (1%), skin toxicity (1%), nausea (5%), stomatitis (7%), vomiting (4%), diarrhea (4%), constipation (1%), taste perversion (1%), anorexia (2%), abdominal pain (1%), vasodilation (1%), asthenia (11%), myalgia (1%), and arthralgia (1%).
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch (www.fda.gov/medwatch), or call 1-800-FDA-1088.
Manufactured by:
Ningbo Shuangcheng Pharmaceutical Co., Ltd.
Ningbo, Zhejiang, 315336, China
Distributed by:
Zhuhai Beihai Biotech Co.,Ltd.
Zhuhai, Guangdong, 519090, China
Beizray™ is a trademark of Zydus Pharmaceuticals (USA) Inc
© Zydus Pharmaceuticals (USA) Inc. All rights reserved.
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Please see full
Prescribing
Information
including Boxed
Warning, at the
QR code
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REFERENCES
1. Taxotere (docetaxel) Product Information. Sanofi-Aventis.
2. Akmal M. Asrorov et al; Albumin is a reliable drug-delivering molecule: Highlighting points in cancer therapy. Medicine in Drug Discovery 22 (2024) 100186
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