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Alemtuzumab

    Brands

    DEA Class;  Rx

    Common Brand Names; Campath, Lemtrada

    •  Antineoplastics, Monoclonal Antibody; 
    • Multiple Sclerosis Treatments

    Humanized monoclonal antibody against the CD52 antigen
    One product, Lemtrada, is used for relapsing forms of multiple sclerosis (MS) but is reserved for those with inadequate response to 2 or more drugs due to risk for serious side effects
    The product used for B-cell chronic lymphocytic leukemia, Campath, is only available through a restricted access distribution program

    Indicated as a single agent for treatment of B-cell chronic lymphocytic leukemia (B-CLL)

    Indicated for relapsing forms of multiple sclerosis (MS); owing to its safety profile, reserve for patients who have an inadequate response to ≥2 other drugs for MS

    Campath: None

    Lemtrada

    • Patients infected with HIV,

    • Hypersensitivity or anaphylactic reactions to alemtuzumab or excipients

    • Active infection

    • Rigors (86%)
    • Fever (85%)
    • Neutropenia (85%)
    • Anemia (80%)
    • Thrombocytopenia (72%)
    • Nausea (54%)
    • Vomiting (41%)
    • Rash (40%)
    • Fatigue (34%)
    • Dyspnea (26%)
    • Cough (25%)
    • Headache (24%)
    • Pruritus (24%)
    • Sepsis (24%)
    • Skeletal pain (24%)
    • Diarrhea (22%)
    • Anorexia (20%)
    • Excessive sweating (19%)
    • Pneumonia (16%)
    • Dysthesias (15%)
    • Stomatitis (14%)
    • Asthenia (13%)
    • Edema (13%)
    • Dizziness (12%)
    • Abdominal pain (11%)
    • Herpes simplex (11%)
    • Hypertension (11%)
    • Myalgias (11%)
    • Tachycardia, SVT (11%)
    • Infusion reactions, all (92%)
    • Infections, all (71%)
    • Rash (53%)
    • Headache (52%)
    • Pyrexia (29%)
    • Nasopharyngitis (25%)
    • Nausea (21%)
    • Urinary tract infection (19%)
    • Fatigue (18%)
    • Insomnia (16%)
    • Upper respiratory tract infection (16%)
    • Herpes viral infection (16%)
    • Urticaria (16%)
    • Pruritus (14%)
    • Thyroid gland disorders (13%)
    • Fungal infection (13%)
    • Arthralgia (12%)
    • Pain in extremity (12%)
    • Back pain (12%)
    • Diarrhea (12%)
    • Sinusitis (11%)
    • Oropharyngeal pain (11%)

    Therapy associated with moderate emetic potential in adults in the oncology setting; may recommend antiemetics to prevent nausea and vomiting

    Leukoencephalopathy (PML) reported; withhold therapy immediately for symptoms suggestive of PML

    Unknown whether drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity; administer to a pregnant woman only if clearly needed

    No data on presence of alemtuzumab in human milk, effects on the breastfed infant, or effects of the drug on milk production

    Lemtrada: Alemtuzumab was detected in the milk of lactating huCD52 transgenic mice administered drug

    Adults

    Treatment of chronic lymphocytic leukemia (Campath): Single doses > 30 mg IV or cumulative weekly doses > 90 mg IV are not recommended.
    Treatment of relapsing multiple sclerosis (Lemtrada): 12 mg/dose IV.

    Geriatric

    Treatment of chronic lymphocytic leukemia (Campath): Single doses > 30 mg IV or cumulative weekly doses > 90 mg IV are not recommended.
    Treatment of relapsing multiple sclerosis (Lemtrada): 12 mg/dose IV.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Available only from a restricted distribution program

    Alemtuzumab 

    injectable solution

    • 10mg/mL (Lemtrada; 1.2mL/vial [12mg/1.2mL])
    • 30mg/mL (Campath; 1mL/vial)