• Monitor for infusion reactions (hypotension, rigors, fever, shortness of breath, swelling in mouth or throat, difficulty breathing, weakness, abnormal heart rate [fast, slow, or irregular], chest pain, rash, facial drooping, sudden severe headache, weakness on one side of the body, difficulty with speech, neck pain, urticaria, bleeding in the lung, chest tightness/pain or discomfort, heart attack, and stroke or tears in blood vessels supplying the brain) for at least 2 hr following infusion. Withhold for Grade 3 or 4 infusion reactions. Reactions may occur 1–3 days after infusion. 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.
• Obtain a baseline ECG. Monitor vital signs before and periodically during infusion.
• Monitor for signs and symptoms of stroke (neck pain, weakness on one side, facial droop, difficulty with speech, sudden severe headache) especially during 3 days following infusion.
• Perform baseline and yearly skin exams. May cause increased risk of malignancies (thyroid cancer, melanoma, lymphoproliferative disorders).
• Determine history of varicella or varicella zoster virus (VZV) vaccination. If no history, test patient for antibodies to VZV. Consider vaccination if antibody-negative. Postpone treatment until 6 wk after VZV vaccination.
• Monitor for signs and symptoms of infection (fever, swollen glands, sore throat, cough, dyspnea, chest pain, chills, fatigue, loss of appetite, rash, weakness, sore muscles) prior to, periodically during, and for at least 2 mo following therapy. Hold therapy in patients with active infections.
• Assess for tuberculosis with a tuberculin skin test. If positive, tuberculosis should be treated prior to therapy.
• Monitor for signs and symptoms of immune thrombocytopenia (ITP) (easy bruising, petechiae, spontaneous mucocutaneous bleeding [epistaxis, hemoptysis], heavier than normal or irregular menstrual bleeding) periodically during and after therapy is completed. If ITP is suspected, immediately obtain CBC and begin treatment.
• Monitor for signs of PML (progressive weakness on one side of the body or clumsiness of limbs; disturbance of vision; changes in thinking, memory, and orientation leading to confusion and personality changes). Initiate evaluation for PML (neurological consultation, brain MRI, lumbar puncture) if signs occur. Discontinue alemtuzumab if PML is suspected.
• Assess for signs and symptoms of viral infections periodically during therapy. Administer antiviral prophylaxis for herpetic viral infections starting on the first day of each treatment course and continue for at least 2 mo following therapy or until CD4+ lymphocyte count is ≥200 cells per microliter, whichever occurs later.
• Monitor for signs and symptoms of acute acalculous cholecystitis (abdominal pain, abdominal tenderness, fever, nausea, vomiting, leukocytosis, abnormal liver enzymes). May lead to high morbidity and mortality rates if not diagnosed early and treated. If acute acalculous cholecystitis is suspected, evaluate and treat promptly.
• Monitor for signs and symptoms of adult-onset Still's disease (fever, arthritis, rash, leukocytosis in the absence of infections, malignancies, other rheumatic conditions) during therapy. Discontinue alemtuzumab if no other explanation for symptoms can be found.
• Monitor for signs and symptoms of AIE (subacute onset of memory impairment, altered mental status, psychiatric symptoms, neurological findings, seizures). If AIE is confirmed by the presence of neural autoantibodies or no other explanation for symptoms is found, discontinue alemtuzumab.
• Monitor for signs and symptoms of immune-mediated colitis (diarrhea, abdominal pain, mucus or blood in stool, with or without fever). Corticosteroids may be needed.

Lab Test Considerations:

• Verify negative pregnancy test before starting therapy.
  • Obtain CBC with differential and platelet count prior to start of therapy and monthly thereafter until 48 mo after last infusion. May cause severe and prolonged lymphopenia. If ANC <250 cells/mm³ and/or platelet count ≤25,000 cells/mm³ and 1st occurrence: hold therapy. Resume at 30 mg when ANC ≥500 cells/mm³ and platelet count ≥50,000 cells/mm³. For 2nd occurrence: Hold therapy. Resume at 10 mg when ANC ≥500 cells/mm³ and platelet count ≥50,000 cells/mm³. For 3rd occurrence: discontinue alemtuzumab. If ANC ≥50% decrease from baseline in patients starting therapy with baseline ANC <250 cells/mm³ and/or platelet count ≤25,000 cells/mm³ and 1st occurrence, hold therapy. Resume at 30 mg upon return to baseline values. For 2nd occurrence: Hold therapy. Resume at 10 mg upon return to baseline values. For 3rd occurrence: Discontinue alemtuzumab.
  • Measure serum creatinine levels, urinalysis with urine cell counts, and urine protein to creatinine ratio before starting therapy. Continue to monitor serum creatinine and urinalysis with urine cell counts on a monthly basis during therapy and for 48 mo after last dose of alemtuzumab.
  • Monitor thyroid function tests (thyroid stimulating hormone levels) prior to start of therapy and every 3 mo up to 48 mo after last dose.
  • Monitor AST, ALT, and total bilirubin prior to and periodically during and up to 48 mo after last dose.