Alemtuzumab

Intravenous
Subcutaneous
Class
Biologic agents
Subclass
Anti-CD52 monoclonal antibodies
Substance name
Alemtuzumab
Brand names
Lemtrada®
Common formulations
Concentrate for injectable solution
Dosage and administration
Adults patients
B-cell chronic lymphocytic leukemia
•
Start at: 3-10 mg IV q24h, administered over 2 hours, until infusion-related reactions are grade ≤ 2 (escalation period)
•
Maintenance: 30 mg IV 3× per week for a total of 12 weeks
Multiple sclerosis • Relapsing-remitting disease or secondary progressive
•
Start at: 12 mg IV q24h, administered over 4 hours, for 5 days (first course)
•
Maintenance: 12 mg IV q24h for 3 days (second course) 12 months after the first course, repeated as needed after at least 12 months after the last dose
T-cell prolymphocytic leukemia • Off-label
•
Start at: 3-10 mg IV q24h for the first week (escalation period)
•
Maintenance: 30 mg IV 3× per week
Other off-label uses
•
Treatment of acute GvHD (corticosteroid-refractory), after allo-SCT
•
Treatment of idiopathic hypereosinophilic syndrome (severe, refractory)
•
Treatment of large granular lymphocytic leukemia
•
Prevention of heart transplant rejection
•
Prevention of pancreas transplant rejection
Indications for use
Labeled indications
Adults
•
Treatment of B-cell chronic lymphocytic leukemia
•
Treatment of multiple sclerosis (relapsing-remitting disease or secondary progressive)
Off-label indications
Adults
•
Treatment of T-cell prolymphocytic leukemia
•
Treatment of acute GvHD (corticosteroid-refractory), after allo-SCT
•
Treatment of idiopathic hypereosinophilic syndrome (severe, refractory)
•
Treatment of large granular lymphocytic leukemia
•
Prevention of heart transplant rejection
•
Prevention of pancreas transplant rejection
Safety risks
Boxed warnings
Autoimmune disorders
•
Maintain a high level of suspicion, as alemtuzumab has been associated with an increased risk of serious autoimmune conditions, including immune thrombocytopenia and anti-GBM disease. Monitor CBCs with differential, serum creatinine levels, and urinalysis with urine cell counts before initiating treatment and then at monthly intervals until 48 months after the last dose of alemtuzumab.
•
Obtain thyroid function tests before initiation of treatment and every 3 months thereafter until 48 months after the last infusion. Use in patients with ongoing thyroid disorder only if the potential benefit justifies the potential risks.
Cytopenias
•
Maintain a high level of suspicion, as alemtuzumab has been associated with an increased risk of autoimmune cytopenias, including anemia, thrombocytopenia, neutropenia, pancytopenia, and prolonged myelosuppression.
Infusion-related reactions
•
Maintain a high level of suspicion, as alemtuzumab can cause serious and life-threatening infusion reactions. Administer alemtuzumab in a setting with appropriate equipment and personnel to manage anaphylaxis or serious infusion reactions. Premedicate patients receiving alemtuzumab for multiple sclerosis with high-dose corticosteroids immediately before infusion and for the first 3 days of each treatment course. Premedicate patients receiving alemtuzumab for chronic lymphocytic leukemia with diphenhydramine and acetaminophen 30 minutes before the first infusion and each dose escalation. Monitor patients for 2 hours after each infusion.
Malignancies
•
Maintain a high level of suspicion, as alemtuzumab has been associated with an increased risk of malignancies, including thyroid cancer, melanoma, and lymphoproliferative disorders. Use caution in patients with pre-existing or ongoing malignancies.
Stroke, cervicocephalic arterial dissection
•
Maintain a high level of suspicion, as serious and life-threatening stroke, including ischemic and hemorrhagic, has been reported within 3 days of alemtuzumab administration.
Contraindications
Hypersensitivity to alemtuzumab or its components
HIV infection
Use of live vaccines
Warnings and precautions
Acute cholecystitis
•
Maintain a high level of suspicion, as alemtuzumab has been associated with an increased risk of acute acalculous cholecystitis.
Adult-onset Still's disease
•
Maintain a high level of suspicion, as adult-onset Still's disease has occured in patients receiving alemtuzumab.
AIH
•
Maintain a high level of suspicion, as AIH has occured in patients receiving alemtuzumab. Obtain serum transaminases and TBIL levels before initiating treatment and then at periodic intervals until 48 months after the last dose.
Autoimmune encephalitis
•
Maintain a high level of suspicion, as autoimmune encephalitis has occured in patients receiving alemtuzumab.
Hemophagocytic lymphohistiocytosis
•
Maintain a high level of suspicion, as hemophagocytic lymphohistiocytosis has occured in patients receiving alemtuzumab.
Hemophilia A
•
Maintain a high level of suspicion, as acquired hemophilia A has occured in patients receiving alemtuzumab.
Immune-mediated colitis
•
Maintain a high level of suspicion, as immune-mediated colitis has occured in patients receiving alemtuzumab.
Infections
•
Maintain a high level of suspicion, as alemtuzumab has been associated with an increased risk of infections, including opportunistic Infections, L. monocytogenes infections, herpes virus infections, HPV infection, tuberculosis, and fungal infections. Administer prophylaxis against P. jirovecii pneumonia and herpes virus infections.
•
Maintain a high level of suspicion, as alemtuzumab has been associated with an increased risk of infections.
Pneumonitis
•
Maintain a high level of suspicion, as pneumonitis has occured in patients receiving alemtuzumab.
Progressive multifocal leukoencephalopathy
•
Maintain a high level of suspicion, as progressive multifocal leukoencephalopathy has occured in patients receiving alemtuzumab.
TTP
•
Maintain a high level of suspicion, as TTP has occured in patients receiving alemtuzumab.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
•
No guidance available. Alemtuzumab has been used for kidney transplant rejection prophylaxis. , Alemtuzumab has been associated with an increased risk of glomerular nephropathies, including anti-glomerular basement membrane disease.
Renal replacement therapy
Any modality
•
No guidance available.
Hepatic impairment
Any severity
•
No guidance available.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: B2
•
Avoid use. Evidence of fetal harm in humans.
Breastfeeding
Halt breastfeeding temporarily.
•
Advise females not to breastfeed for at least 3 months after the last dose.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
•
Anemia, serum anti-alemtuzumab antibodies, ↓ blood lymphocyte count, ↓ blood neutrophil count, ↓ platelet count, fungal infections, infections, infusion-related reactions, nasopharyngitis, arthralgia, pain in extremity, back pain, chills, diarrhea, fatigue, fever, headache, insomnia, nausea, pruritus, hypertension, skin rash, throat pain, sinusitis, thyroid disorders, urinary tract infections, upper respiratory tract infections, herpes simplex virus infection, cytomegalovirus infection, urticaria, hypotension
Common 1-10%
•
Bronchitis, immune thrombocytopenia, influenza virus infection, dermatitis, anxiety, asthenia, peripheral edema, nosebleed, neck pain, abnormal uterine bleeding, cough, dysgeusia, dyspepsia, hematuria, dyspnea, muscle spasms, myalgia, ↓ CD4 count, ↓ CD8 count, muscle weakness, chest discomfort, paresthesia, dizziness, abdominal pain, vomiting, skin flushing, skin erythema, tachycardia, tremor
Uncommon < 1%
•
Anti-glomerular basement membrane disease, thyroid cancer, melanoma, serum anti-factor VIII antibodies, pancytopenia, suicidal ideation, rheumatoid arthritis, retinal pigment epitheliopathy, diabetes mellitus type 1, vitiligo, hemolytic anemia
Unknown frequency
•
Hair loss, ↓ LVEF, thrombotic thrombocytopenic purpura, acute ischemic stroke, hemorrhagic shock, cervicocephalic arterial dissection, acute cholecystitis, autoimmune hepatitis, opportunistic infections, progressive multifocal leukoencephalopathy, vasculitis, Guillain-Barré syndrome, hemophagocytic lymphohistiocytosis, adult-onset Still's disease, autoimmune encephalitis, myasthenia gravis, Lambert-Eaton myasthenic syndrome, diffuse alveolar hemorrhage, congestive heart failure, cardiomyopathy, aplastic anemia, Graves' disease, chronic inflammatory demyelinating polyneuropathy, serum sickness, Epstein-Barr virus infection, tumor lysis syndrome, optic neuropathy
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