Campath Demonstrated a Predictable, Manageable,
and Reversible Safety Profile
• Cytomegalovirus (CMV) infection was reported in 16% of patients treated
with Campath vs 0% of patients treated with chlorambucil with no grade 4 events2
• All patients with CMV infection recovered without sequelae1
• CMV events were manageable with no apparent effect on PFS, ORR, or CR1
• Routinely monitor patients for CMV infection during Campath treatment and
for at least 2 months following completion of treatment
• Most common infusion reactions associated with Campath were mild to
moderate in severity and declined sharply after the first week2
Now Approved as Single-agent, First-line Therapy for B-CLL*
Campath Demonstrated Superior Efficacy
Campath significantly improved progression-free survival (PFS)
100
Estimated Probability (%)
Superior Efficacy and Well Tolerated
1
chlorambucil
Campath
42% reduction in risk of disease
progression or death with
Campath (P=.0001; HR=0.58)
75
50
Median 14.6 months
(0.6-25.1)2
25
0
Median 11.7 months
(0.3-27.9)2
0
4
8
12
16
20
24
28
32
36
40
Time (Months)
HR=hazard ratio.
*B-CLL=B-cell chronic lymphocytic leukemia.
• Median PFS was nearly 3 months longer with Campath than with chlorambucil
• Median follow-up was about 25 months in both treatment arms1
• Campath achieved an 83% overall response rate (ORR) compared with 55% for chlorambucil and a complete response (CR) rate of 24% compared
with 2% for chlorambucil (P <.0001)
Please see Important Safety Information, including Boxed Warning,
on the inside and accompanying full Prescribing Information.
• The median treatment-free interval with Campath was more than double that of chlorambucil (88 weeks vs 36 weeks)1
References: 1. Hillmen P, Skotnicki AB, Robak T, et al. Alemtuzumab compared
with chlorambucil as first-line therapy for chronic lymphocytic leukemia. J Clin Oncol.
2007;25:5616-5623. 2. Data on file, Bayer HealthCare Pharmaceuticals Inc.
Manufactured by Genzyme Corporation, Cambridge, MA 02142
Distributed by Bayer HealthCare Pharmaceuticals Inc., Wayne, NJ 07470
© 2007 Bayer HealthCare Pharmaceuticals Inc., Wayne, NJ 07470
All rights reserved. 541-01-0004-07 305605 Printed in USA 12/07
Please see Important Safety Information,
including Boxed Warning, on the inside and
accompanying full Prescribing Information.
Superior Efficacy and Well Tolerated
Treat for the Recommended Duration of 12 Weeks
First Infusion
Week 1*
Week 2
Administer as an intravenous infusion
over 2 hours. Administer
3 mg/day until infusion
reactions are grade 2
Second Infusion
Then administer 10 mg/day until infusion reactions are grade 2
Third Infusion
Then administer 30 mg/day
Continue 30-mg/day therapeutic dose
(alternate days 3 times weekly)
Week 12
*Titration can take up to 3 to 7 days to accomplish.
• Median length of treatment was 11.7 weeks in first-line patients
• O
btain complete blood counts (CBCs) and platelet counts at weekly intervals during therapy and CD4 counts after therapy until recovery to 200 cells/µL
Important safety information
Campath is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).
The most commonly reported adverse reactions are infusion reactions (fever, chills, hypotension, urticaria, nausea, rash, tachycardia, dyspnea), cytopenias (neutropenia, lymphopenia, thrombocytopenia, anemia), and infections (CMV viremia, CMV infection, other infections). In clinical trials, the frequency of infusion reactions was highest in the first week of treatment. Other commonly reported adverse reactions include vomiting, abdominal pain,
insomnia and anxiety. The most commonly reported serious adverse reactions
are cytopenias, infusion reactions, and immunosuppression/infections. See “Warnings and Precautions,” and “Adverse Reactions” sections of full Prescribing Information.
WARNING: Cytopenias, Infusion Reactions, and Infections
Cytopenias: Serious, including fatal, pancytopenia/marrow hypoplasia, autoimmune idiopathic thrombocytopenia,
and autoimmune hemolytic anemia can occur in patients receiving Campath. Single doses of Campath greater than
30 mg or cumulative doses greater than 90 mg per week increase the incidence of pancytopenia [see Warnings
and Precautions (5.1)].
Infusion Reactions: Campath administration can result in serious, including fatal, infusion reactions. Carefully
monitor patients during infusions and withhold Campath for Grade 3 or 4 infusion reactions. Gradually escalate
Campath to the recommended dose at the initiation of therapy and after interruption of therapy for 7 or more days
[see DOSAGE AND ADMINISTRATION (2) and Warnings and Precautions (5.2)].
Infections: Serious, including fatal, bacterial, viral, fungal, and protozoan infections can occur in patients receiving
Campath. Administer prophylaxis against Pneumocystis jiroveci pneumonia (PCP) and herpes virus infections
[see DOSAGE AND ADMINISTRATION (2.2) and Warnings and Precautions (5.3)].
Please see accompanying full Prescribing Information.