Monograph Details
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Neoplasms
> Monoclonal antibodies
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MYLOTARG |
| Manufacturer |
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Wyeth Pharmaceuticals |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Humanized IgG4, kappa antibody, recombinant. |
| Generic Name |
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Gemtuzumab ozogamicin 5mg/vial; pwd for IV infusion after reconstitution and dilution; preservative-free. |
| Indications |
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Treatment of patients with CD33 positive acute myeloid leukemia in first relapse who are ≥60yrs old and are not candidates for other chemotherapy. |
| Children |
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Not recommended. |
| Adults |
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Pretreat with diphenhydramine and acetaminophen; methylprednisolone may reduce infusion-related symptoms. 9mg/m2 infused over 2 hours. Treat for a total of 2 doses with 14 days between each dose. |
| Contraindications |
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Nursing mothers. |
| Precautions |
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Withhold treatment if dyspnea or significant hypotension occurs; monitor until resolves. Discontinue if anaphylaxis, pulmonary edema, or acute respiratory distress syndrome occurs. Symptomatic intrinsic lung disease. High peripheral blast counts (WBCs ≥30,000/µL): consider leukoreduction or leukapheresis before administering. Hepatic or renal impairment. Monitor CBCs, platelets, electrolytes, hepatic function. Ensure adequate hydration. Product is light sensitive. Pregnancy (Cat.D): not recommended. |
| Adverse Reactions |
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Infusion reactions (eg, fever, chills), GI upset, headache, dyspnea, myelosuppression, neutropenia, anemia, thrombocytopenia, leukopenia, infections, bleeding, mucositis, electrolyte imbalances, rash, hypotension, hypertension, hyperglycemia, pulmonary events, hepatotoxicity (eg, veno-occlusive disease), tumor lysis syndrome; others. |
| How Supplied |
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Single-use vials—1 |
| Additional Resources |
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• Related Prescribing Note |
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