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General Medication Fact Sheet for Besponsa
| Field | Information |
|---|---|
| Medication Name | Besponsa |
| Generic Name | Inotuzumab Ozogamicin |
| Boxed/Label Warning | Severe hepatotoxicity, including hepatic veno-occlusive disease (VOD); increased risk of post-hematopoietic stem cell transplant (HSCT) VOD; myelosuppression; infusion-related reactions; and prolonged QT interval. |
| Purpose | Treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults. |
| Mechanism of Action | An antibody-drug conjugate (ADC) composed of a monoclonal antibody targeting CD22, a protein found on ALL cells, linked to calicheamicin, a cytotoxic agent. Upon binding to CD22, Besponsa is internalized into the cell, releasing calicheamicin, which induces DNA double-strand breaks, resulting in cell death. |
| Dosage Forms | Lyophilized powder for intravenous infusion |
| Available Strengths | 1 mg |
| Dosage Frequency | Administered as an intravenous infusion on days 1, 8, and 15 of a 21- to 28-day cycle. |
| Common Side Effects | Fever, nausea, headache, neutropenia, thrombocytopenia, infection, fatigue, abdominal pain. |
| Serious Side Effects | Hepatic veno-occlusive disease (VOD), myelosuppression (including neutropenia, thrombocytopenia, anemia), infusion-related reactions, QT prolongation, tumor lysis syndrome. |
| Drug Interactions | Drugs that inhibit or induce CYP3A4 or P-gp may alter inotuzumab ozogamicin exposure. Avoid concomitant use with strong CYP3A4 inhibitors. Exercise caution with QT-prolonging drugs. |
| Important Notes | Premedication for infusion-related reactions is recommended. Monitor for signs and symptoms of VOD, myelosuppression, and QT prolongation. Consider dose modifications or discontinuation for severe toxicities. |
| Storage | Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F) until time of use. Protect from light. |
| Missed Dose | Contact your healthcare provider immediately for instructions if you miss a scheduled infusion. Do not attempt to adjust the dosing schedule on your own. |
| Alternatives | Blinatumomab (Blincyto), Clofarabine, Chemotherapy regimens (e.g., Hyper-CVAD), Stem cell transplant. |
Besponsa Alternatives
| Medication | Mechanism of Action | Notes |
|---|---|---|
| Blinatumomab (Blincyto) | Bispecific T-cell engager (BiTE) antibody that binds to CD19 on leukemia cells and CD3 on T cells, activating T cells to kill leukemia cells. | Indicated for relapsed or refractory B-cell precursor ALL. |
| Clofarabine | Purine nucleoside antimetabolite that inhibits DNA synthesis and induces cell death. | Used in the treatment of relapsed or refractory ALL in pediatric and adult patients. |
| Chemotherapy regimens (e.g., Hyper-CVAD) | Combination chemotherapy regimens using various cytotoxic agents. | Traditional treatment approach for ALL, often used in combination with other therapies. |
| Stem cell transplant | Procedure to replace damaged or destroyed bone marrow with healthy stem cells. | May be considered for patients with relapsed or refractory ALL after achieving remission. |
Besponsa Side Effects
| Common Side Effects | Serious Side Effects |
|---|---|
| Fever | Hepatic veno-occlusive disease (VOD) |
| Nausea | Myelosuppression (Neutropenia, Thrombocytopenia, Anemia) |
| Headache | Infusion-related reactions |
| Fatigue | QT prolongation |
| Abdominal pain | Tumor lysis syndrome |
| Infection | Hemorrhage |
Besponsa Dosage Guide
| Condition | Starting Dose | Maintenance Dose | Administration Notes |
|---|---|---|---|
| Relapsed or Refractory B-cell ALL | 1.8 mg/m² | 1.8 mg/m² on days 1, 8, and 15 of each 21- to 28-day cycle. | Administer as an intravenous infusion over 1 hour. Premedicate for infusion-related reactions. Dosing adjustments may be necessary based on toxicities. Consult with a healthcare professional for personalized dosage adjustments. |
Besponsa Price With And Without Insurance
| Purchase Context | Estimated Price |
|---|---|
| With Insurance | $5,000 – $15,000 |
| Without Insurance (U.S.) | $17,000 – $18,000 |
| From Canada | $22689.20 |
