NAME OF DRUG
alemtuzumab

CLASSIFICATION

Monoclonal antibody

ALTERNATE NAMES

CAMPATH

INDICATIONS

• indicated in B-cell chronic lymphocytic leukemia in patients previously treated with alkylating agents and who have failed fludarabine therapy
• used as part of the conditioning regimen prior to stem cell transplantation
  

RECONSTITUTION AND STABILITY

• refrigerate; do not freeze
• protect ampoules from light
• DO NOT SHAKE ampoule prior to use
• withdraw drug using a 5 micron filter needle, add to 100mL NS or D5W; gently invert to mix
• diluted solution stable x 8 hours at room temperature (use within 8 hours of preparation); protect solution from light
   

COMPATIBILITY

• compatible with NS, D5W
• do not mix with other drugs

ROUTES OF ADMINISTRATION

• SC (off label route)
  • thought to be better tolerated than IV dosing
• IV intermittent
  • recommended route of administration
  • dilute dose in 100 mL NS or D5W and infuse over 2 hours
  • flush line with 10 mL NS at end of infusion

VH & HSC ADMINISTRATION POLICY
Restricted to Hematologists in the Stem Cell Transplant Program according to BCCA protocols

A - Not to be administered by the direct IV route
H - The IV administration rate must be controlled by an automated infusion control device


DOSAGE

Chronic Lymphocytic Leukemia

• during the first week, give 3 mg day 1, 10 mg day 2, then 30 mg day 3
• maintenance dose of 30 mg/day administered 3 times/week on alternate days (e.g. Mon/Wed/Fri) for up to 12 weeks depending on progress
• AVOID doses > 30 mg/day or cumulative weekly doses > 90 mg due to increased risk of pancytopenia

Conditioning Regimen for Stem Cell Transplant

• 20 mg IV daily x 5 days

POTENTIAL HAZARDS OF PARENTERAL ADMINISTRATION

• infusion-related adverse effects include hypotension, rigors, fever, shortness of breath, brochospasm, nausea, chills; may be prevented by pre-medication with antihistamines (e.g. diphenhydramine 50 mg) and acetaminophen 650 mg given 30 minutes prior to infusion; in cases of severe infusion-related events, pre-medicate with hydrocortisone 200mg IV
• rash – if rash occurs, consider premedications with antihistamines on days of treatment
• resuscitation equipment must be readily available including epinephrine, diphenydramine and hydrocortisone for anaphylaxis; discontinue and notify physician
• pain, redness or swelling at the site of injection

IMPORTANT IMPLICATIONS

• prolonged lymphopenia, pancytopenia, marrow hypoplasia, anemia, neutropenia, thrombycytopenia have been reported - monitor CBC and platelets at weekly intervals
• monitor blood pressure for hypotensive symptoms, especially in patients with ischemic heart disease or on antihypertensive medications
• increased risk of opportunistic infections such as CMV and PCP – patients should be monitored and receive prophylactic anti-infectives
• if dyspnea occurs, patients may be treated with a beta-2 agonist (e.g. salbutamol)
• if hypotension occurs, hydration with NS is indicated

May 2008