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Drug Monographs
Treatment Regimens

Scientific Name:
ALEMTUZUMAB
Brand Name(s):
CamPath®

Drug Monograph

Pharmacology

Mechanism of Action

Alemtuzumab (Campath-1H) is a recombinant humanized monoclonal antibody directed against the CD52 antigen on most (>95%) normal lymphocytes, and T-cell & B-cell lymphoma cells.  Alemtuzumab binds to the CD52 antigen on the cell surface, activating antibody-dependent cellular cytotoxicity, complement binding, apoptosis, cellular opsonization, and antitumour T-cell activity.  Alemtuzumab has been used for chronic lymphocytic leukemia, low grade lymphomas and other non-cancerous indications.

Pharmacokinetics

Oral Absorption: no information
Distribution: no information; excretion in breast-milk unknown
Cross blood brain barrier?  no information
Vd: no information
PPB: no information
Metabolism:  no information
Excretion:  no information

Side Effects

IMMEDIATE ONSET (hours to days)
• Infusion-related reactions:   chills & rigors (80%), hypotension (16%)
• Tumor lysis syndrome:  hyperuricemia, hyperkalemia, hypocalcemia, acute renal  
   failure, elevated LDH, high fevers
• nausea (62%)

EARLY ONSET (days to weeks)
• Myelosuppression: lymphocytopenia (100%), anemia (36%), thrombocytopenia
   (22%), neutropenia (28%), oral candidiasis
• Respiratory infections: Pneumocystis carinii pneumonia, CMV pneumonia,
   pulmonary aspergillosis
• reactivation of herpes simplex, septicemia

DELAYED/LATE ONSET
• skin rash (52%)

Therapeutics

Approved Indications

Chronic lymphocytic lymphoma, B-cell, relapsed.

Routes

Intravenous infusion (over 2 hours)
Subcutaneous injection

IV Compatibility

Dextrose 5%

Dosing

Initial:
•  Begin with 3mg/day as 2-hour IV infusion; as tolerated (infusion-related toxicities <Grade 2), increase to 10mg/day, then further increase to 30mg/day when previous dose tolerated

Maintenance
:
•  30mg/day SC/IV tiw (alternate days) up to 12 weeks
•  Do not exceed single doses of >30mg or cululative doses >90mg/week
•  Premedicate with diphenhydramine and acetaminophen before each infusion

Dose Adjustment Criteria

Infusion-related reactions:
Reduce infusion rate or stop; May restart infusion at 50% of previous rate upon improvement of symptoms
Treat fever and rigors with diphenhydramine or acetaminophen plus meperidine, if indicated

Tumor Lysis SyndromeDiscontinue infusion.
Resume at a 50% rate when symptoms have completely resolved.

Antiemetic Risk

LOW RISK (Less than 10% of patients)
• No routine antiemetic pre-chemotherapy or post-chemotherapy

Contraindications

• Known type I hypersensitivity to murine (mouse) proteins • Caution in heavily pretreated patients- watch for signs of opportunistic infections

Monitoring

Clinical Monitoring

RECOMMENDED CRITERIA
• Observation for hypersensitivity reaction during and following infusion (emergency treatment readily available)
• Watch for symptoms of fever or infection

SUGGESTED CRITERIA
• Rating hypersensitivity reactions
Hypersensitivity/Allergy
0. None
1. Transient rash, fever <38oC
2. Urticaria, fever > 38oC, mild bronchospasm
3. Serum sickness, bronchospasm, requires parenteral medications
4. Anaphylaxis
Rated In Response To Patient Reaction

Extravasation Hazard

None

Significant Interactions

No information

Product Information

Commercial Product Description

Single use vials of 30mg Alemtuzumab.

Pharmaceutical Considerations

Injection:
Single-use vial containing 30mg/3mL alemtuzumab.  Store in refrigerator at 2-8oC; do not freeze.  Protect from sunlight.

Preparation
:
Do not shake ampoule.  Withdraw dose into syringe.  Filter with 5-micron filter prior to dilution.  Inject dose into 100mL NS or D5W.  Gently invert bag to mix solution. 

Diluted Solution for Injection:
Infuse over 2 hours. Store solution at room temperature or under refrigeration.  Use diluted solution within 8 hours of preparation.

Handling Risk Level

Pregnancy CPOSSIBLE HAZARDOUS DRUG
FDA Pregnancy Risk Factor C

  • Consider handling this drug using precuations outlined in CCNS Policies for Occupational Safety, Preparing Cancer Chemotherapy and Administering Cancer Chemotherapy

Note

GUIDELINES:
Treatment of Chronic Lymphocytic Leukemia
NCDF Coverage Criteria:
As a single agent in patients (excluding those with bulky adenopathy) with progressive and symptomatic CLL (1) who are refractory to both alkylator-based and fludarabine-based regimens.

Serious Warnings:

• Hematologic Toxicity: Serious and, in rare instances fatal, pancytopenia/ marrow hypoplasia, autoimmune idiopathic thrombocytopenia, and autoimmune hemolytic anemia have occurred in patients receiving MabCampath therapy. Single doses of MabCampath greater than 30 mg or cumulative doses greater than 90 mg per week should not be administered because these doses are associated with a higher incidence of pancytopenia.

• Infusion Reactions: MabCampath can result in serious, and in some instances fatal, infusion reactions.  Patients should be carefully monitored during infusions and MabCampath discontinued if indicated.  Gradual escalation to the recommended maintenance dose is required at the initiation of therapy and after interruption of therapy for seven or more days.

• Infections, Opportunistic Infections: Serious, sometimes fatal bacterial, viral, fungal, and protozoan infections have been reported in patients receiving MabCampath therapy. Prophylaxis directed against P. carinii pneumonia (PCP) and herpes virus infections has been shown to decrease, but not eliminate, the occurrence of these infections. Anti-viral prophylaxis is strongly recommended.

Availability & Funding

Administrative Information (Nova Scotia)

• CCNS Provincial Formulary Status- Advanced Level • Take Home Prescription- Restricted Use • CDHA Formulary Status: Non-Formulary • Go to "Additional Information" tab (above) for links to Provincial Formulary of Cancer Drugs • Pharmacare Formulary Status: Non-Formulary NOTE: It is recommended to limit ordering of this medication to standard preprinted order forms, for patient safety

New Cancer Drug Fund Status (Nova Scotia)

New Cancer Drug Fund (NCDF) funding approved for: • Treatment of Chronic Lymphocytic Leukemia- As a single agent in patients (excluding those with bulky adenopathy) with progressive and symptomatic CLL who are refractory to both alkylator-based and fludarabine-based regimens.



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