Alemtuzumab
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];
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Overview
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Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Alemtuzumab FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Alemtuzumab in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Alemtuzumab in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Alemtuzumab FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Alemtuzumab in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Alemtuzumab in pediatric patients.
Contraindications
There is limited information regarding Alemtuzumab Contraindications in the drug label.
Warnings
There is limited information regarding Alemtuzumab Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Alemtuzumab Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Alemtuzumab Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Alemtuzumab Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Alemtuzumab in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Alemtuzumab in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Alemtuzumab during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Alemtuzumab in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Alemtuzumab in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Alemtuzumab in geriatric settings.
Gender
There is no FDA guidance on the use of Alemtuzumab with respect to specific gender populations.
Race
There is no FDA guidance on the use of Alemtuzumab with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Alemtuzumab in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Alemtuzumab in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Alemtuzumab in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Alemtuzumab in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Alemtuzumab Administration in the drug label.
Monitoring
There is limited information regarding Alemtuzumab Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Alemtuzumab and IV administrations.
Overdosage
There is limited information regarding Alemtuzumab overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Alemtuzumab Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Alemtuzumab Mechanism of Action in the drug label.
Structure
There is limited information regarding Alemtuzumab Structure in the drug label.
Pharmacodynamics
There is limited information regarding Alemtuzumab Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Alemtuzumab Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Alemtuzumab Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Alemtuzumab Clinical Studies in the drug label.
How Supplied
There is limited information regarding Alemtuzumab How Supplied in the drug label.
Storage
There is limited information regarding Alemtuzumab Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
{{#ask: Label Page::Alemtuzumab |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Alemtuzumab Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Alemtuzumab interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Alemtuzumab Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Alemtuzumab Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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Media |
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Evidence Based Medicine |
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Clinical Trials |
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Ongoing Trials on Alemtuzumab at Clinical Trials.gov Clinical Trials on Alemtuzumab at Google
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Guidelines / Policies / Govt |
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US National Guidelines Clearinghouse on Alemtuzumab
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News |
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Commentary |
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Definitions |
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Patient Resources / Community |
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Patient resources on Alemtuzumab Discussion groups on Alemtuzumab Patient Handouts on Alemtuzumab Directions to Hospitals Treating Alemtuzumab Risk calculators and risk factors for Alemtuzumab
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Causes & Risk Factors for Alemtuzumab |
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Overview
Alemtuzumab (marketed as Campath or Campath-1H) is a monoclonal antibody used in the treatment of chronic lymphocytic leukemia (CLL) and T-cell lymphoma.
Alemtuzumab targets CD52, a protein present on the surface of mature lymphocytes, but not on the stem cells from which these lymphocytes were derived. It is used as second line therapy for CLL. It was approved by the Food and Drug Administration for patients who have been treated with alkylating agents and who have failed fludarabine therapy.
A significant complication of therapy with alemtuzumab is that it significantly increases the risk for opportunistic infections, in particular, reactivation of cytomegalovirus.
Alemtuzumab is also used in some conditioning regimens for bone marrow transplantation and kidney transplantation. It is also used under clinical trial protocols for treatment of some autoimmune diseases, such as multiple sclerosis.
Description
Alemtuzumab is a recombinant DNA-derived humanized monoclonal antibody (Campath-1H) that is directed against the 21-28 kD cell surface glycoprotein, CD52.
Indications and Use
Alemtuzumab is indicated for the treatment of B-cell chronic lymphocytic leukemia (B-CLL) in patients who have been treated with alkylating agents and who have failed fludarabine therapy.
Contraindications and precautions
Alemtuzumab is contraindicated in patients who have active systemic infections, underlying immunodeficiency (e.g., seropositive for HIV), or known Type I hypersensitivity or anaphylactic reactions to Campath or to any one of its components.
Adverse reactions
Alemtuzumab has been associated with infusion-related events including hypotension, rigors, fever, shortness of breath, bronchospasm, chills, and/or rash. In post-marketing reports, the following serious infusion-related events were reported: syncope, pulmonary infiltrates, ARDS, respiratory arrest, cardiac arrhythmias, myocardial infarction and cardiac arrest. The cardiac adverse events have resulted in death in some cases.
History
The origins of alemtuzumab date back to Campath-1 which was derived from the mouse antibodies raised against human lymphocyte proteins by Herman Waldmann and colleagues.[1] The name "Campath" derives from the pathology department of Cambridge University.
Initially, Campath-1 was not ideal for therapy because patients could, in theory, react against the foreign rat protein determinants of the antibody. To circumvent this problem, Greg Winter and his colleagues humanised Campath-1, by extracting the hypervariable loops that had specificity for CD52 and grafted it onto a human antibody framework. This became known as Campath-1H and serves as the basis for alemtuzumab.[2]
References
- ↑ Hale G, Bright S, Chumbley G, Hoang T, Metcalf D, Munro AJ, Waldmann H. Removal of T cells from bone marrow for transplantation: a monoclonal antilymphocyte antibody that fixes human complement. Blood 1983;62:873-82. PMID 6349718.
- ↑ Riechmann L, Clark M, Waldmann H, Winter G. Reshaping human antibodies for therapy. Nature 1988;332:323-7. PMID 3127726.