Beizray follows the same dosing as docetaxel across indicated tumor types

Recommended Dosage

• The recommended BEIZRAY dosage is 75 mg/m² administered 1 hour after doxorubicin 50 mg/m² and cyclophosphamide 500 mg/m² every 3 weeks for 6 courses.
• Prophylactic G-CSF may be used to mitigate the risk of hematological toxicities.

Dosage Adjustments during Treatment

BEIZRAY in combination with doxorubicin and cyclophosphamide should be administered when the neutrophil count is ≥1,500 cells/mm³.

Recommended Dosage

• The recommended dosage of BEIZRAY is 60 mg/m² to 100 mg/m² administered intravenously over 1 hour every 3 weeks.

Dosage Adjustments during Treatment

• Conversely, patients who are dosed initially at 60 mg/m² and who do not experience febrile neutropenia, neutrophils <500 cells/mm³ for more than 1 week, severe or cumulative cutaneous reactions, or severe peripheral neuropathy during BEIZRAY therapy may tolerate higher doses.
• Patients who develop ≥ grade 3 peripheral neuropathy should have BEIZRAY treatment discontinued entirely.

Recommended Dosage

• The recommended dosage of BEIZRAY monotherapy is 75 mg/m² administered intravenously over 1 hour every 3 weeks.

In patients previously treated with chemotherapy, a dosage of 100 mg/m² is not recommended because this dosage was associated with increased hematologic toxicity, infection, and 
treatment-related mortality in randomized controlled trials.

Dosage Adjustments during Treatment

Recommended Dosage

• For chemotherapy-naive patients, the recommended dosage of BEIZRAY is 75 mg/m² administered intravenously over 1 hour immediately followed by cisplatin 75 mg/m² over 30–60 minutes every 3 weeks.

Dosage Adjustments during Treatment

Premedication

• Given the concurrent use of prednisone, the recommended premedication regimen is oral dexamethasone 8 mg at 12 hours, 3 hours, and 1 hour before the BEIZRAY infusion

Recommended Dosage

• The recommended dosage of BEIZRAY is 75 mg/m² every 3 weeks as a 1-hour intravenous infusion.
• Recommend concomitant use of 5 mg of prednisone orally twice daily continuously.

Dosage Adjustments during Treatment
BEIZRAY should be administered when the neutrophil count is ≥1,500 cells/mm³.

Recommended Dosage

• The recommended dosage of BEIZRAY is 75 mg/m² as a 1-hour intravenous infusion
• Followed by cisplatin 75 mg/m², as a 1 to 3 hour intravenous infusion (both on day 1 only)
• Followed by fluorouracil 750 mg/m² per day given as a 24-hour continuous intravenous infusion for 5 days, starting at the end of the cisplatin infusion.
• Repeat treatment every 3 weeks.
• Must receive premedication with antiemetics and appropriate hydration for cisplatin administration.

Dosage Adjustments during Treatment
See dose modifications for Gastric or Head and Neck Cancer

Premedication

• Must receive premedication with antiemetics and appropriate hydration (prior to and after cisplatin administration).
• Prophylaxis for neutropenic infections should be administered.
• All patients treated on the BEIZRAY containing arms of the TAX323 and TAX324 studies received prophylactic antibiotics.

Recommended Dosage

• For the induction treatment of locally advanced inoperable SCCHN, the recommended dose of BEIZRAY is 75 mg/m² as a 1-hour intravenous infusion
• Followed by cisplatin 75 mg/m² intravenously over 1 hour, on day 1,
• Followed by fluorouracil as a continuous intravenous infusion at 750 mg/m² per day for 5 days.
• This regimen is administered every 3 weeks for 4 cycles.
• Following chemotherapy, patients should receive radiotherapy.

Dosage Adjustments during Treatment

See dose modifications for Gastric or Head and Neck Cancer

Premedication

• Must receive premedication with antiemetics and appropriate hydration (prior to and after cisplatin administration).
• Prophylaxis for neutropenic infections should be administered.
• All patients treated on the BEIZRAY containing arms of the TAX323 and TAX324 studies received prophylactic antibiotics.

Recommended Dosage

• For the induction treatment of patients with locally advanced (unresectable, low surgical cure, or organ preservation) SCCHN, the recommended dose of BEIZRAY is 75 mg/m² as a 1-hour intravenous infusion on day 1,
• Followed by cisplatin 100 mg/m² administered as a 30-minute to 3-hour infusion,
• Followed by fluorouracil 1000 mg/m²/day as a continuous infusion from day 1 to day 4.
• This regimen is administered every 3 weeks for 3 cycles.
• Following chemotherapy, patients should receive chemoradiotherapy.

Dosage Adjustments during Treatment

See dose modifications for Gastric or Head and Neck Cancer

BEIZRAY in combination with cisplatin and fluorouracil in gastric cancer or head and neck cancer

Patients treated with BEIZRAY in combination with cisplatin and fluorouracil must receive antiemetics and appropriate hydration according to current institutional guidelines. In both studies, G-CSF was recommended during the second and/or subsequent cycles in case of febrile neutropenia, or documented infection with neutropenia, or neutropenia lasting more than 7 days.

Do not retreat patients with subsequent cycles of BEIZRAY until neutrophils recover to a level >1,500 cells/mm³. Avoid retreating patients until platelets recover to a level >100,000 cells/mm³. Discontinue treatment if these toxicities persist.

Recommended dose modifications for toxicities in patients treated with BEIZRAY in combination with cisplatin and fluorouracil are shown in Table 1.

Table 1: Recommended Dose Modifications for Toxicities in Patients Treated with BEIZRAY in Combination with Cisplatin and Fluorouracil

Liver dysfunction: In case of AST/ALT >2.5 to ≤5 × ULN and AP ≤2.5 × ULN, or AST/ALT >1.5 to ≤5 × ULN and AP >2.5 to ≤5 × ULN, BEIZRAY should be reduced by 20%.

In case of AST/ALT >5 × ULN and/or AP >5 × ULN, BEIZRAY should be stopped.

The dose modifications for cisplatin and fluorouracil in the gastric cancer study are provided below.

Cisplatin dose modifications and delays

Peripheral neuropathy: A neurological examination should be performed before entry into the study, and then at least every 2 cycles and at the end of treatment. In the case of neurological signs or symptoms, more frequent examinations should be performed and the following dose modifications can be made according to NCI-CTCAE grade:

• Grade 2: Reduce cisplatin dose by 20%.
• Grade 3: Discontinue treatment.

Ototoxicity: In the case of grade 3 toxicity, discontinue treatment.

Nephrotoxicity: In the event of a rise in serum creatinine ≥ grade 2 (>1.5 × normal value) despite adequate rehydration, CrCl should be determined before each subsequent cycle and the following dose reductions should be considered (see Table 2).

For other cisplatin dosage adjustments, also refer to the manufacturers’ prescribing information.

Table 2: Dose Reductions for Evaluation of Creatinine Clearance

CrCl = Creatinine clearance

Fluorouracil dose modifications and treatment delays

For diarrhea and stomatitis, see Table 1.

In the event of grade 2 or greater plantar-palmar toxicity, fluorouracil should be stopped until recovery. The fluorouracil dosage should be reduced by 20%.

For other greater than grade 3 toxicities, except alopecia and anemia, chemotherapy should be delayed (for a maximum of 2 weeks from the planned date of infusion) until resolution to grade ≤1 and then recommenced, if medically appropriate.

For other fluorouracil dosage adjustments, also refer to the manufacturers’ prescribing information.

Combination Therapy with Strong CYP3A4 Inhibitors

Avoid using concomitant strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole). There are no clinical data with a dose adjustment in patients receiving strong CYP3A4 inhibitors. Based on extrapolation from a pharmacokinetic study with ketoconazole in 7 patients, consider a 50% docetaxel dose reduction if patients require coadministration of a strong CYP3A4 inhibitor.