alemtuzumab (Rx)

Brand and Other Names:Campath, Lemtrada
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

Available only from a restricted distribution program

injectable solution

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

Chronic Lymphocytic Leukemia (Campath)

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

Gradually escalate to maximum recommended single dose of 30 mg (typically over 3-7 days)

Escalation is required at initiation of dosing or if dose is held ≥7 days during treatment

Escalation strategy

  • Administer 3 mg IV qDay until infusion reactions are Grade ≤2, THEN
  • Administer 10 mg IV qDay until infusion reactions are Grade ≤2, THEN
  • Administer 30 mg IV 3x/week (on alternate days [eg, Mon-Wed-Fri])
  • Duration of treatment: 12 weeks (including escalation periods)
  • Not to exceed 30 mg/dose OR 90 mg/week

Multiple Sclerosis (Lemtrada)

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

Recommended dose is administered as 2 separate treatment courses

First course: 12 mg/day IV on 5 consecutive days (60 mg total dose)

Second course: 12 mg/day IV on 3 consecutive days (36 mg total dose)

Subsequent courses: Administer 12 mg/day IV on 3 consecutive days (36 mg total dose) as needed, at least 12 months after last dose of any prior treatment courses

Kidney Transplantation (Off-label)

Campath only

In numerous phase 3 clinical trials, use has achieved steroid-sparing effects including improved glycemic stability

Careful patient selection is required

Long-term follow-up results from the 3C trial (NCT01120028) is pending regarding alemtuzumab’s role in reducing calcineurin inhibitor exposure by using a more potent induction regimen

Dosage modifications (Campath)

Withhold therapy during serious infection or other serious adverse reactions until resolution

Discontinue therapy for autoimmune anemia or autoimmune thrombocytopenia

No dosage adjustment necessary for lymphopenia

Delay between doses (≥7 days): Initiate therapy at 3 mg; escalate to 10 mg, and then to 30 mg as tolerated

ANC <250 cells/mcL and/or platelet count ≤25,000 cells/mcL

  • First occurrence: Withhold therapy, resume at 30 mg when ANC ≥500 cells/mcL and platelet count ≥50,000 cells/mcL
  • Second occurrence: Withhold therapy, resume at 10 mg when ANC ≥500 cells/mcL and platelet count ≥50,000 cells/mcL
  • Third occurrence: Discontinue therapy

Patients with ≥50% decrease from baseline (ANC ≤250 cells/mcL and/or a platelet count ≤25,000 cells/mcL)

  • First occurrence: Withhold therapy, resume at 30 mg upon return to baseline
  • Second occurrence: Withhold therapy, resume at 10 mg upon return to baseline
  • Third occurrence: Discontinue therapy

Dosing Considerations

Before initiating

  • Complete any necessary immunizations ≥6 weeks
  • Determine whether patients have a history of varicella or were vaccinated for varicella zoster virus (VZV); if not, test for antibodies to VZV and consider vaccination for those who are antibody-negative; postpone initiating treatment until 6 weeks after VZV vaccination
  • Perform tuberculosis screening according to local guidelines
  • Instruct to avoid potential sources of Listeria monocytogenes (see Cautions)

Laboratory testing and monitoring

  • Conduct laboratory tests (ie, CBC with differential, serum creatinine, urinalysis with urine cell counts) at baseline and at periodic intervals for 48 months following the last treatment course
  • Test thyroid function (eg, TSH) before treatment and q3mo thereafter

Safety and efficacy not established

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Adverse Effects

>10% (Campath)

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%)

>10% (Lemtrada)

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%)

1-10% (Campath)

Chest/back pain (10%)

Dyspepsia (10%)

Insomnia (10%)

Bronchospasm (9%)

Constipation (9%)

Depression (7%)

Epistaxis (7%)

Moniliasis (8%)

Pancytopenia (5%)

Somnolence (5%)

1-10% (Lemtrada)

Paresthesia (10%)

Dizziness (10%)

Abdominal pain (10%)

Flushing (10%)

Vomiting (10%)

Cough (9%)

Chills (9%)

Dysgeusia (8%)

Influenza (8%)

Dermatitis (8%)

Dyspepsia (8%)

Blood in urine (8%)

Dyspnea (8%)

Tachycardia (8%)

Anxiety (7%)

Muscular weakness (7%)

Bronchitis (7%)

Chest discomfort (7%)

Muscle spasm (6%)

Myalgia (6%)

Decreased CD4 and CD8 lymphocytes (6%)

Asthenia (5%)

Infusion reactions, serious (3%)

Infections, serious (3%)

Immune thrombocytopenia (2%)

HPV infection (2%)

<1% (Lemtrada)

Pneumonitis (0.5%)

Glomerular nephropathies (0.3%)

Thyroid cancer (0.3%)

Melanoma (0.3%)

Active/latent tuberculosis (0.3%)

Hemolytic anemia (0.2%)

Pancytopenia (0.2%)

Neutropenia (0.1%)

Postmarketing Reports

Campath

  • Fatal infusion reactions
  • Cardiovascular: CHF, cardiomyopathy, decreased ejection fraction (some patients had been previously treated with cardiotoxic agents)
  • Cerebrovascular disorders: Cervicocephalic arterial dissection, stroke, including hemorrhagic and ischemic stroke
  • Gastrointestinal: Acute acalculous cholecystitis
  • Immune disorders: Goodpasture’s syndrome, Graves disease, aplastic anemia, Guillain Barre syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, serum sickness, fatal transfusion associated
  • GVHD Infections: Epstein-Barr virus (EBV) including EBV-associated lymphoproliferative disorder, progressive multifocal leukoencephalopathy (PML), reactivation of latent viruses
  • Metabolic: Tumor lysis syndrome
  • Neurologic: Optic neuropathy

Lemtrada

  • Cerebrovascular disorders: Stroke, including hemorrhagic and ischemic stroke and cervicocephalic arterial dissection
  • Gastrointestinal system disorders: Cholecystitis, including acalculous cholecystitis and acute acalculous cholecystitis
  • Immune system disorders: Guillain-Barre syndrome, hemophagocytic lymphohistiocytosis
  • Pulmonary system disorders: Pulmonary alveolar hemorrhage
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Warnings

Black Box Warnings

Infusion reactions

  • Serious infusion reactions, including fatal reactions, can occur
  • Administer in a setting with appropriate equipment and personnel to manage anaphylaxis or serious infusion reactions
  • Monitor during infusions and for 2 hr after each infusion, withhold drug for Grade 3 or 4 infusion reactions
  • Gradually escalate drug to recommended dose at initiation of therapy and after interruption of therapy for ≥7 days

Malignancies

  • May cause an increased risk of malignancies, including thyroid cancer, melanoma, and lymphoproliferative disorders
  • Perform baseline and yearly skin exams

Cytopenias (Campath)

  • Serious cytopenias, including fatal pancytopenia/marrow hypoplasia, autoimmune idiopathic thrombocytopenia, and autoimmune hemolytic anemia, can occur
  • Single doses >30 mg or cumulative doses >90 mg/week increase incidence of pancytopenia
  • Monitor CBC with differential, serum creatinine, and urinalysis at periodic intervals for 48 months after last dose

Infections (Campath)

  • Serious infections, including fatal bacterial, viral, fungal, and protozoan infections, reported
  • Administer prophylaxis against Pneumocystis jiroveci pneumonia (PCP) and herpes virus infections

Autoimmunity (Lemtrada)

  • Serious, sometimes fatal, autoimmune conditions (eg, immune thrombocytopenia, antiglomerular basement membrane disease) may occur
  • Monitor CBC with differential, serum creatinine levels, and urinalysis with urine cell counts at periodic intervals for 48 months after last dose

Stroke (Lemtrada)

  • Serious and life-threatening stroke (eg, ischemic, hemorrhagic stroke) reported within 3 days of administration
  • Advise to seek immediate medical attention if symptoms of stroke occur

REMS

  • Campath and Lemtrada are available only through restricted distribution under a Risk Evaluation Mitigation Strategy (REMS) program
  • Campath: 1-877-422-6728
  • Lemtrada: 1-855-676-6326

Contraindications

Campath: None

Lemtrada: Patients infected with HIV

Cautions

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

Campath

  • Treatment results in severe and prolonged lymphopenia along with an increased incidence of opportunistic infections
  • Prophylaxis does not eliminate these infections; routinely monitor for CMV infection during treatment and for ≥2 months following completion; withhold treatment for serious infections and during antiviral treatment for CMV infection or confirmed CMV viremia (defined as polymerase chain reaction (PCR) positive CMV in ≥2 consecutive samples obtained 1 week apart)
  • Unless an emergency, administer only irradiated blood products to avoid transfusion associated graft versus host disease
  • Hemolytic anemia, pure red cell aplasia, bone marrow aplasia, and hypoplasia reported after treatment
  • Safety of immunization with live viral vaccines has not been studied; do not administer live viral vaccines to patients who have recently therapy
  • Serious infusion reactions (pyrexia, chills/rigors, nausea, hypotension, urticaria, dyspnea, rash, emesis, bronchospasm) reported
  • Monitor thyroid stimulating hormone (TSH) at baseline and every 2-3 months during treatment

Lemtrada

  • Autoantibody formation may occur and increase risk of serious autoimmune conditions (eg, thyroid disorders, immune thrombocytopenia, hemolytic anemia, pancytopenia, glomerular nephropathies, connective tissue disorders, and acquired hemophilia A)
  • Autoimmune hepatitis causing clinically significant liver injury, including acute liver failure requiring transplant, reported; prior to starting treatment, obtain serum transaminases (ALT and AST) and total bilirubin levels; obtain transaminase levels and total bilirubin levels periodically until 48 months after last dose
  • Infusion reactions are common (92%) and may be serious or life-threatening; premedication with corticosteroids is required and monitoring
  • May increase risk for malignancies, including thyroid cancer, melanoma, lymphoproliferative disorders, and lymphoma
  • Pneumonitis reported; advise patients to contact physician with symptoms of SOB, cough, wheezing, chest pain/tightness, or hemoptysis
  • Increased vigilance and monitoring is warranted in patients previously treated with alemtuzumab (Campath) for CLL who receive Lemtrada for MS; additive and chronic autoimmune effects may occur
  • May increase risk of acute acalculous cholecystitis; symptoms of acute acalculous cholecystitis include abdominal pain, abdominal tenderness, fever, nausea, vomiting; leukocytosis and abnormal liver enzymes are also commonly observed; if acute acalculous cholecystitis is suspected, evaluate and treat promptly
  • In postmarketing setting, cases of cervicocephalic (eg, vertebral, carotid) arterial dissection involving multiple arteries reported within 3 days of administration
  • Monitor TSH at baseline and every 3 months until 48 months after last infusion or longer or at any time during therapy if clinically indicated
  • Infections
    • Infections reported, including herpes viral infections, HPV, tuberculosis, fungal infections (especially oral and vaginal candidiasis), and listeria meningitis; patients with HBV or HCV were excluded from clinical trials
    • Avoid or adequately heat foods that are potential sources of Listeria monocytogenes (eg, deli meat, dairy products made with unpasteurized milk, soft cheeses, or undercooked meat, seafood, or poultry)
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Pregnancy & Lactation

Pregnancy

Campath: 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

Lemtrada

  • Pregnancy exposure registry (1-866-758-2990) monitors pregnancy outcomes of drug exposure during pregnancy
  • No adequate data on developmental risk associated with use in pregnant women
  • When administer during organogenesis, drug was embryolethal in pregnant huCD52 transgenic mice
  • Auto-antibodies may develop after administration; placental transfer of antithyroid antibodies resulting in neonatal Graves’ disease reported
  • Contraception
    • Women of childbearing potential should use effective contraceptive measures during treatment and for 4 months following that course of treatment
  • Infertility
    • In huCD52 transgenic mice, administration prior to and during the mating period resulted in adverse effects on sperm parameters in males and reduced number of corpora lutea and implantations in females
  • Clinical considerations
    • Alemtuzumab induces persistent thyroid disorders, untreated hypothyroidism in pregnant women increases the risk for miscarriage and may have effects on the fetus including mental retardation and dwarfism
    • In mothers with Graves’ disease, maternal thyroid stimulating hormone receptor antibodies may transfer to a developing fetus and can cause neonatal Graves’ disease

Lactation

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

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Recombinant monoclonal antibody against CD52 (lymphocyte antigen); promotes antibody-dependent lysis

Pharmacokinetics

Half-Life: 12 days

Vd: 14.1 L; largely confined to blood and interstitial space

Metabolism: unknown

Excretion: unknown

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Administration

IV Incompatibilities

Do not admix with any other drug; do not administer simultaneously in the same IV line

IV Compatibilities

0.9% NaCl

D5W

Campath: Polyvinylchloride (PVC) bags and PVC or polyethylene-lined PVC administration sets

IV Preparation

Visually inspect for particulate matter and discoloration; if particulate matter is present or solution is discolored, do use vial

Do not shake vial

Withdraw the necessary amount from the vial into a syringe

Campath

  • To prepare 3-mg or 10-mg dose, withdraw calculated amount into a 1-mL syringe calibrated in increments of 0.01 mL
  • To prepare 30-mg dose, withdraw 1 mL in either a 1-mL or 3-mL syringe

Lemtrada

  • Withdraw 1.2 mL from vial into a syringe
  • Inject syringe contents into 100 mL sterile 0.9% NaCl USP or D5W
  • Gently invert bag to mix solution

Premedication and Infection Prophylaxis

Campath

  • Premedicate with diphenhydramine 50 mg and acetaminophen 500-1000 mg PO 30 minutes before first infusion and each dose escalation
  • Administer trimethoprim/sulfamethoxazole DS PO BID 3x/week (or equivalent) for Pneumocystis jiroveci pneumonia (PCP) prophylaxis
  • Administer famciclovir 250 mg PO BID (or equivalent) as herpetic prophylaxis
  • Continue PCP and herpes viral prophylaxis for a minimum of 2 months after treatment completion or until the CD4+ count is ≥200 cells/mcL, whichever occurs later
  • Monitor CBC, platelets, CD4+ counts qWeek

Lemtrada

  • Corticosteroids: Premedication with high-dose corticosteroids (eg, 1,000 mg methylprednisolone) immediately before alemtuzumab IV infusion and for the first 3 days of each treatment course
  • Herpes prophylaxis: Administer antiviral prophylaxis for herpetic viral infections starting on the first day of each treatment course and continue for a minimum of 2 months following or until CD4+ count is ≥200 cells/microL

IV Administration

Administer by IV infusion only, do NOT give as IV push or bolus

Campath: Administer over 2 hr

Lemtrada: Administer over 4 hr; extend duration of infusion if clinically warranted

Do not shake prior to use

Storage

Unopened vials: Refrigerate at 2-8°C (36-46°F)

Diluted solution: Start infusion within 8 hr after dilution (no preservatives); may store at room temperature or refrigerate at 2-8°C (36-46°F)

Do not freeze or shake

Store in original carton to protect from light

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Formulary

FormularyPatient Discounts

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Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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Code Definition
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