Progression Free Survival in Previously Untreated B-CLL Patients1

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1
Log-rank test adjusted for Rai Stage (I-II vs. III-IV).
14.2 Previously Treated B-CLL Patients
Campath was eva luated in three multicenter, open-label, single arm studies of 149 patients with B-CLL previously treated with alkylating agents, fludarabine, or other chemotherapies. Patients were treated with the recommended dose of Campath, 30 mg intravenously, three times per week for up to 12 weeks. Partial response rates of 21 to 31% and complete response rates of 0 to 2% were observed.
15 REFERENCES
1 American Association of Blood Banks, America’s Blood Centers, American Red Cross. Circular of Information for the Use of Human Blood and Blood Components. July 2002.
16 HOW SUPPLIED/STORAGE AND HANDLING
Campath (alemtuzumab) is supplied in single-use clear glass vials containing 30 mg of alemtuzumab in 1 mL of solution. Each carton contains three Campath vials (NDC 50419-357-03) or one Campath vial (NDC 50419-357-01).
Store Campath at 2-8°C (36-46°F). Do not freeze. If accidentally frozen, thaw at 2-8°C before administration. Protect from direct sunlight.
17 PATIENT COUNSELING INFORMATION
Cytopenias: Advise patients to report any signs or symptoms such as bleeding, easy bruising, petechiae or purpura, pallor, weakness or fatigue [see WARNINGS AND PRECAUTIONS (5.1) and ADVERSE REACTIONS (6.1)].
Infusion Reactions: Advise patients of the signs and symptoms of infusion reactions and of the need to take premedications as prescribed [see WARNINGS AND PRECAUTIONS (5.2) and OVERALL ADVERSE REACTIONS (6.1)].
Infections: Advise patients to immediately report symptoms of infection (e.g. pyrexia) and to take prophylactic anti-infectives for PCP (trimethoprim/sulfamethoxazole DS or equivalent) and for herpes virus (famciclovir or equivalent) as prescribed [see WARNINGS AND PRECAUTIONS (5.3) and ADVERSE REACTIONS (6.1)].
Advise patients that irradiation of blood products is required [see WARNINGS AND PRECAUTIONS (5.3)].
Advise patients that they should not be immunized with live viral vaccines if they have recently been treated with Campath [see WARNINGS AND PRECAUTIONS (5.5)].
Advise male and female patients with reproductive potential to use effective contraceptive methods during treatment and for a minimum of 6 months following Campath therapy [see NONCLINICAL TOXICOLOGY (13.1)].
U.S. Patents: 5,846,534; 6,569,430
Manufactured by: Genzyme Corporation, Cambridge, MA 02142
Distributed by: Bayer HealthCare Pharmaceuticals Inc., Wayne, NJ 07470
Package Label – Principal Display Panel – 1-Pack Carton
NDC 50419-357-01
1 Single-Use 1 mL Vial
Campath
Alemtuzumab
For Intravenous Use Only
30 mg/mL
No US Standard of Potency
Must be further diluted prior to IV administration
Single-Use Vial, Discard Unused Portion
See package insert