General

High Alert Medication: This medication bears a heightened risk of causing significant patient harm when it is used in error.

Pronunciation
a-lem-TOO-zoo-mab

Trade Name(s)

• Campath

Pregnancy Category
Category C

Ther. class.
antineoplastics

Pharm. class.
monoclonal antibodies

Indications

Treatment of B-cell chronic lymphocytic leukemia in patients who have been treated with alkylating agents and in which fludarabine therapy has failed

Action

Binds to the CD52 antigen found on the surface of B- and T-lymphocytes and other white blood cells; resulting in lysis

Therapeutic Effect(s):
Lysis of leukemic cells with eventual improvement in hematologic parameters

Pharmacokinetics

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)

ROUTE	ONSET	PEAK	DURATION
IV	unknown	2–4 mos‡	7–11 mos‡‡

‡Median time to response
‡‡Duration of response

Contraindication/Precautions

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

• OB: Should be administered only if clearly needed

Adverse Reactions/Side Effects

CNS: depression, dizziness, drowsiness, fatigue, headache, weakness.

Resp: bronchospasm, cough, dyspnea.

CV: hypertension, hypotension, tachycardia.

GI: abdominal pain, anorexia, constipation, stomatitis.

Derm: rash, sweating.

F and E: edema.

Hemat: NEUTROPENIA, PANCYTOPENIA/MARROW HYPOPLASIA, anemia, lymphopenia, thrombocytopenia.

MS: back pain, skeletal pain.

Misc: infusion-related events, infection, sepsis.

*CAPITALS indicates life-threatening.
*italic indicates most frequent.

Interactions

Drug-Drug

• Additive bone marrow depression with other antineoplastics or radiation therapy

• May antibody response to and increase the risk of adverse reactions to live-virus vaccines

Route/Dosage

• IV (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.

Availability

• Solution for injection (requires further dilution): 30 mg/3 ml in single-use ampules

Assessment

• 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 blood pressure 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 Diagnoses

• Risk for infection (Side Effects)

• Risk for injury (Adverse Reaction)

Implementation

• 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

IV Adminstration:

• 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

Patient/Family Teaching

• Inform patient and family of purpose of alemtuzumab

• Caution patient to avoid immunizations with a live virus due to immunosuppression

Evaluation/Desired Outcomes

Improvement in hematologic parameters in patients with B-cell chronic lymphocytic leukemia

alemtuzumab is a sample topic found in Davis's Drug Guide. All other sections of this record are viewable by clicking on the index in the left column, or by clicking on "Display all Sections" in the "Content Manager".

To find other Davis's Drug Guide topics, please login or purchase a subscription.