Classifications: biologic response modifier; monocolonal antibody; antineoplastic; Therapeutic: antineoplastic; monoclonal antibody
Pregnancy Category: C
30 mg/mL injection
Monoclonal antibody that attaches to CD52 cell surface antigens expressed on a variety of leukocytes, including normal and
malignant B and T lymphocytes, monocytes, and some granulocytes. Proposed mechanism of action is antibody-dependent lysis
of leukemic cells following binding to cell surface antigens.
Initiates antibody dependent cell lysis, thus inhibiting cell proliferation in chronic lymphocytic leukemia.
Treatment of B-cell chronic lymphocytic leukemia in patients who have failed fludarabine therapy.
Treatment of mycosis fungoides, non-Hodgkin's lymphoma.
Type I hypersensitivity to alemtuzumab or its components, hamster protein hypersensitivity; serious infection or exposure
to viral infections (i.e., herpes or chickenpox), HIV infection, dental work; infection; pregnancy (category C), lactation.
History of hypersensitivity to other monoclonal antibodies; ischemic cardiac disease, angina, coronary artery disease; dental
disease; history of varicella disease; females of childbearing age. Safety and efficacy in children are not established.
Route & Dosage
|B-Cell Chronic Lymphocytic Leukemia
Adult: IV Start with 3 mg/d, when that is tolerated, increase dose over next 37 d to 10 mg/d; when 10 mg/d is tolerated, increase
to maintenance dose of 30 mg/d (give 30 mg/d 3 times/wk). Single dose should not exceed 30 mg; cumulative dose should not exceed 90 mg/wk
First time ANC falls below 250/mcL or platelet count falls below 25,000/mcL
Second time ANC below 250/mcL or platelet count falls below 25,000 mcL
- Stop therapy until ANC is at least 500 mcL and platelet count is at least 50,000 mcL, resume at previous dose
- If therapy is stopped for 7 or more days, re-start at 3 mg and taper up
Third time ANC below 250/mcL or platelet count falls below 25,000 mcL*Patients starting therapy with baseline ANC <500 mcL or baseline platelet count <25,000 mcL who experience a 50% decrease
from baseline should stop therapy until values return to baseline then resume at previous dose. If therapy is stopped for
7 or more days, re-start at 3 mg and taper up.
- Stop therapy until ANC is at least 500 mcL and platelet count is at least 50,000 mcL, resume at 10 mg dose
- If therapy is stopped for 7 or more days, re-start at 3 mg and taper up, do not exceed 10 mg
- Note: Premedication with antihistamines, acetaminophen, antiemetics, and corticosteroids prior to infusion may reduce the severity
of adverse side effects.
PREPARE: IV Infusion: Do NOT shake ampule prior to use. Withdraw required dose into a syringe with a sterile, low-protein binding, non-fiber releasing
5 micron filter. Inject into 100 mL NS or D5W. Gently invert bag to mix. Infuse within 8 h of mixing. Protect from light.
Discard any unused solution. Use within 8 h of mixing.
ADMINISTER: IV Infusion: Infuse each dose over 2 h. Do NOT give single doses >30 mg or cumulative weekly doses >90 mg.
INCOMPATIBILITIES Solution/additive: Do not infuse or mix with other drugs.
- Store at 2°8° C (36°46° F). Discard if ampule has been frozen. Protect from direct light.
Adverse Effects (≥1%) Body as a Whole: Infusion reactions (rigors, fever, nausea, vomiting, hypotension, rash, shortness of breath, bronchospasm, chills), fatigue,
pain, sepsis, asthenia, edema, herpes simplex, myalgias, malaise
, moniliasis, temperature change sensation, coma, seizures. CNS: Headache, dysesthesias, dizziness, insomnia, depression
, tremor, somnolence, cerebrovascular accident, subarachnoid hemorrhage. CV: Hypotension, tachycardia, hypertension, cardiac failure, arrhythmias, MI. GI: Diarrhea, nausea, vomiting, stomatitis, abdominal pain, dyspepsia, anorexia, constipation
. Hematologic: Neutropenia, anemia, thrombocytopenia,
purpura, epistaxis, pancytopenia. Respiratory: Dyspnea, cough, bronchitis, pneumonia, pharyngitis,
bronchospasm, rhinitis. Skin: Rash, urticaria, pruritus, increased sweating. Other:
Risk of opportunistic infections.
Additive risk of bleeding with anticoagulants
s, platelet inhibitors
increased risk of opportunistic infections with fludarabine. Herbal: Feverfew, garlic, ginger, ginkgo
may increase risk of bleeding.
Steady-state levels in approximately 6 wk. Half-Life:
Assessment & Drug Effects
- Monitor for acute infusion-related events, including hypotension, rigors, fever, shortness of breath, bronchospasm, chills,
and/or rash. If such a reaction occurs, the infusion should be discontinued and the physician notified.
- Withhold drug and notify physician if absolute neutrophil count <250/mcL or platelet count ≤25,000/mcL.
- Monitor BP closely during infusion period. Careful monitoring of BP and hypotensive symptoms is especially important in patients
with ischemic heart disease and those on antihypertensives.
- Discontinue infusion and notify physician immediately if any of the following occurs: hypotension, fever, chills, shortness
of breath, bronchospasm, or rash.
- Withhold drug during any serious infection. Therapy may be reinstituted following resolution of the infection.
- Lab tests: CBS with differential and platelet counts weekly or more frequently in the presence of anemia, thrombocytopenia,
or neutropenia; periodic blood glucose, serum electrolytes, and alkaline phosphatase.
- Monitor diabetics closely for loss of glycemic control.
- Monitor for S&S of dehydration especially with severe vomiting.
Patient & Family Education
- Do not accept immunizations with live viral vaccines during therapy or if therapy has been recently terminated.
- Use effective methods of contraception to prevent pregnancy during therapy and for at least 6 mo following therapy.
- Report any of the following to physician immediately: unexplained bleeding, fever, sore throat, flu-like symptoms, S&S of
an infection, difficulty breathing, significant GI distress, abdominal pain, fluid retention, or changes in mental status.
- Diabetics should monitor blood glucose levels carefully since loss of glycemic control is a possible adverse reaction.