Vepotolizumab (POLIVY) Instructions

1. Generic name: Vepotolizumab

Product name:POLIVY

All names: polotuzumab, polatuzumab vedotin-piiq, vibrotuzumab for injection, Urova, Baoaining,

2. Indications:

1. Previously untreated diffuse largeB-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL):

Vepotuzumab (POLIVY) may be used in combination with rituximab products, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of previously untreated diffuse large B-cell lymphoma, unspecified or high-grade B-cell lymphoma, and adult patients with an International Prognostic Index score of 2 or higher.

2. Relapsed or refractory diffuse largeB-cell lymphoma (DLBCL), not otherwise specified (NOS):

Vepotuzumab in combination with bendamustine and rituximab is indicated for the treatment of adult patients with diffuse largeB-cell lymphoma, not otherwise specified, who have relapsed or been refractory after at least two prior therapies.

3. Usage and dosage:

1. Recommended dosage:

(1)For patients with previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), or high-grade B-cell lymphoma (HGBL):

The recommended dose of velpotuzumab is 1.8 mg/kg in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone as an intravenous infusion every 21 days for 6 cycles, with velpotuzumab, cyclophosphamide, doxorubicin, and rituximab administered in any order on day 1 after prednisone, with prednisone administered on days 1-5 of each cycle.

(2) For patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS):

The recommended dose of velpotuzumab is1.8 mg/kg, used in combination with bendamustine and rituximab products, as an intravenous infusion every 21 days for a total of 6 cycles. Administer velpotuzumab, bendamustine, and rituximab products in any order on Day 1 of each cycle. The recommended dose of bendamustine when administered with velpotuzumab and rituximab products is 90 mg/m2/day on Days 1 and 2. The recommended intravenous dose of rituximab product is 375 mg/m2 on Day 1 of each cycle.

(3) For all designated patients: If not already premedicated, take antihistamines and fever-reducing medications at least 30 minutes before administration to prevent potential infusion-related reactions. If you miss a scheduled dose of vepotuzumab, give it as soon as possible. Adjust the dosing schedule to maintain an interval of 21 days between two doses.

2. Dosage adjustment:

The starting dose of vepotuzumab is1.8mg/kg. If adverse reactions occur, the first dose reduction level is1.4mg/kg, The second dose reduction level is 1mg/kg, If 1mg/kg is not tolerated, consider discontinuing vepotuzumab. If the primary cause is lymphoma, a delay or dose reduction may not be necessary.

3. Recommended preventive drugs:

Prevention of Pneumocystis pneumonia and herpes viruses during treatment with vepotuzumab. Prophylactic granulocyte colony-stimulating factor (G-CSF) should be administered to neutropenic patients receiving velpotuzumab plus R-CHP. For neutropenic patients receiving velpotuzumab plus bendamustine and rituximab products, consider prophylactic G-CSF for tumor lysis syndrome prevention in patients with an increased risk of tumor lysis syndrome.

4. Adverse reactions:

Vepotuzumab affects the production of blood cells. The most common side effects of combining bendamustine and rituximab are anemia (low red blood cell count), thrombocytopenia (low platelet count), neutropenia ( Severe side effects include febrile neutropenia (low white blood cell count with fever), fever, and pneumonia. Vepotolizumab should not be given to patients with serious infections.

5. Storage:

Vepotolizumab is an injectable formulation. Store refrigerated in the original carton at 2°C to 8°C (36°F to 46°F) to avoid light. Do not use beyond the expiration date shown on the carton. Do not freeze and do not shake. If necessary, refrigerate unused reconstituted polyethylene solution at 2°C to 8°C (36°F to 46°F) for 48 hours or at room temperature (9°C to 25°C, 47°F to 77°F) for up to 8 hours before diluting. If cumulative storage time exceeds 48 hours before dilution, discard vial.

6. Special groups:

1. Women: Due to the possibility of serious adverse reactions in breastfed children, it is recommended that women of reproductive potential use effective contraceptive measures during vepotuzumab treatment and within 3 months after the last dose; they should not breastfeed during vepotuzumab treatment and within 2 months after the last dose.

2. Men: Based on the results of genotoxicity studies, it is recommended that men who are female partners of reproductive potential use effective contraceptive measures during treatment with vepotuzumab and within 5 months after the last dose.

7. Mechanism of action:

Vepotuzumab is a CD79b-directed antibody-drug conjugate with activity against dividing B cells.小分子MMAE是一种抗有丝分裂剂，通过一个可裂解的接头与抗体共价连接。 The monoclonal antibody binds CD79b, a B cell-specific surface protein that is a component of the B cell receptor. Upon binding to CD79b, velpotuzumab is internalized and the linker is cleaved by lysosomal proteases to enable intracellular delivery of MMAE. MMAE binds to microtubules and kills dividing cells by inhibiting cell division and inducing apoptosis.