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Pregnancy Category: C
Pharmacologic: monoclonal antibodies
Pharmacologic: monoclonal antibodies
Treatment of B-cell chronic lymphocytic leukemia in patients who have been treated with alkylating agents and in which fludarabine therapy has failed.
Binds to the CD52 antigen found on the surface of B- and T-lymphocytes and other white blood cells; resulting in lysis.
Lysis of leukemic cells with eventual improvement in hematologic parameters.
Absorption: IV administration results in complete bioavailability.
Distribution: Binds to CD52 receptors.
Metabolism and Excretion: Unknown.
Half-life: 12 days.
Time/action profile (hematologic parameters)
|IV||unknown||2–4 mos‡||7–11 mos‡‡|
Contraindicated in: Hypersensitivity;Systemic infections;Underlying immunodeficiency, including HIV infection; Lactation: Discontinue breast-feeding during and for 3 mos following last dose of alemtuzumab.
Use Cautiously in: Patients with ischemic heart disease or in patients on antihypertensive medications;Women and men with reproduction potential should use contraception during treatment and for 6 mos after therapy; Obstetric: Should be administered only if clearly needed.
Adverse Reactions/Side Effects
Central nervous system
- abdominal pain
Fluid and Electrolyte
- neutropenia (life-threatening)
- pancytopenia/marrow hypoplasia (life-threatening)
- anemia (most frequent)
- lymphopenia (most frequent)
- thrombocytopenia (most frequent)
- back pain
- skeletal pain
- infusion-related events (most frequent)
Drug-Drug interactionAdditive bone marrow depression with other antineoplastics or radiation therapy.May ↓ antibody response to and increase the risk of adverse reactions to live-virus vaccines.
Intravenous (Adults) 3 mg/day initially, as tolerated increase dose to 10 mg/day and then 30 mg/day given three times weekly for up to 12 weeks; single doses should not exceed 30 mg or more than 90 mg/wk.
Solution for injection (requires further dilution): 30 mg/3 mL in single-use ampules
- Monitor for infusion reactions (hypotension, rigors, fever, shortness of breath, bronchospasm, chills, rash). Premedicate with an oral antihistamine and acetaminophen 30 min prior to initial dose, dose increases, and as clinically indicated. Monitor BP and hypotensive symptoms in patients with ischemic heart disease with extra care. Antihistamines, acetaminophen, antiemetics, meperidine, corticosteroids, and incremental dose escalation have been used to prevent and treat infusion-related reactions. Initiate therapy at lowest dose and increase gradually. If therapy is interrupted for 7 or more days, reinstitute with gradual dose escalation.
- Lab Test Considerations: Obtain CBC and platelet counts weekly during therapy and more frequently if worsening anemia, neutropenia, or thrombocytopenia is observed. For first occurrence of ANC <250 cells/mm3 and/or platelet count <25,000 cells/mm3, withhold alemtuzumab therapy. When ANC >500 cells/mm3 and platelet count is >50,000 cells/mm3, resume at same dose. If delay of 7 days or more occurred initiate therapy at 3 mg and escalate to 10 mg and then to 30 mg as tolerated. For second occurrence of ANC <250 cells/mm3 and/or platelet count <25,000 cells/mm3, withhold alemtuzumab. When ANC >500 cells/mm3 and platelet count >50,000 cells/mm3, resume therapy at 10 mg. If delay is 7 days or more, initiate therapy at 3 mg and escalate to 10 mg only. For third occurrence of ANC <250 cells/mm3 and/or platelet count <25,000 cells/mm3, discontinue alemtuzumab therapy permanently. For a decrease of ANC and/or platelet count of 50% of baseline value in patients initiating therapy with a baseline ANC of <500 cells/mm3 and/or a baseline platelet count of 25,000 cells/mm3, withhold therapy. When baseline levels return, resume therapy. If delay is 7 days or more, initiate therapy at 3 mg and escalate to 10 mg and 30 mg as tolerated.
- Assess CD4 counts after treatment until recovery to ≥200 cells cells/mm3.
Potential Nursing DiagnosesRisk for infection (Side Effects)
Risk for injury (Adverse Reactions)
- high alert: Fatalities have occurred with chemotherapeutic agents. Before administering, clarify all ambiguous orders; double check single, daily, and course-of-therapy dose limits; have second practitioner independently double check original order, calculations, and infusion pump settings. Alemtuzumab should only be administered under the supervision of a physician experienced in the use antineoplastic therapy.
- Administer via IV only. Inspect solution for particulate matter or discoloration. Do not administer solutions that contain particulate matter or are discolored.
- pH: 6.8–7.4.
- Withdraw necessary amount from ampule into syringe. Filter with a sterile low-protein binding, non–fiber-releasing 5 micron filter prior to dilution.
- Intermittent Infusion: Diluent: Dilute with 100 mL of 0.9% NaCl or D5W. Gently invert bag to mix. Dispose of syringe and unused drug product according to institutional guidelines. Use within 8 hr of dilution. Store at room temperature or in refrigerator. Protect solution from light.
- Rate: Administer over 2 hr.
- Y-Site Incompatibility: No data is available regarding mixing with other solutions and medications. Do not add to or infuse simultaneously with other solutions or medications.
- Inform patient and family of purpose of alemtuzumab.
- Caution patient to avoid immunizations with a live virus due to immunosuppression.
- Improvement in hematologic parameters in patients with B-cell chronic lymphocytic leukemia.
alemtuzumabA humanised monoclonal antibody against leukocyte antigen CD52, used to manage B-cell CLL in patients treated with alkylating agents who have failed fludarabine therapy.
Post-infusion infection, severe thrombocytopenia and/or neutropenia leading to treatment discontinuation or death.