Dosing and Administration Guide for ARZERRA INDICATIONS for ARZERRA (ofatumumab) In combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate For extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL For the treatment of patients with CLL refractory to fludarabine and alemtuzumab IMPORTANT SAFETY INFORMATION for ARZERRA (ofatumumab) WARNING: HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY Hepatitis B Virus (HBV) reactivation can occur in patients receiving CD20-directed cytolytic antibodies, including ARZERRA, in some cases resulting in fulminant hepatitis, hepatic failure, and death Progressive Multifocal Leukoencephalopathy (PML) resulting in death can occur in patients receiving CD20-directed cytolytic antibodies, including ARZERRA Please see additional Important Safety Information on pages To learn more, please visit www.hcp.novartis.com/ products/arzerra.
Welcome Understanding the Difference Between First-Line, Extended Treatment Following Two or More Lines of Therapy, and FA-Refractory Dosing for ARZERRA This guide is designed to be used as a quick reference for the proper dosing of ARZERRA in the treatment of first-line CLL, extended treatment following two or more lines of therapy, and CLL that is refractory to fludarabine and alemtuzumab (FA). For your convenience, dosing instructions specific to each indication are organized separately: first-line CLL in the first section (page 4), extended treatment after at least two lines of therapy in the second section (page 8), and FA-refractory CLL in the third section (page 12). General information about product handling is covered in the fourth section (page 18). If you have any questions regarding ARZERRA or would like to schedule an in-service program, please contact Novartis Pharmaceuticals Corporation or visit us at www.hcp.novartis.com/products/arzerra. Table of Contents Dosing for ARZERRA Plus Chlorambucil for First-Line CLL...4 Dosing Recommendations... 4 Premedication... 5 Infusion Rates... 6 Dosing for ARZERRA for Extended Treatment of Patients With CLL After at Least Two Lines of Therapy......... 8 Dosing Recommendations... 8 Premedication... 9 Infusion Rates... 10 Dosing for ARZERRA for CLL Refractory to Fludarabine and Alemtuzumab...12 Dosing Recommendations... 12 Premedication... 13 Infusion Rates... 14 Infusion Rate Dose Modifications for Infusion Reactions... 16 Product Handling...18 Preparation of Solution... 18 Administration... 19 How Supplied... 20 Storage... 21 Support and Resources.... 22 Indications and Important Safety Information...24 2 3
Dosing for ARZERRA Plus Chlorambucil for First-Line CLL 1 Dosing for ARZERRA Treatment should be continued for a minimum of 3 cycles until best response* or a maximum of 12 cycles Cycle 1 300 mg Day 1 Day 8 1000 mg Cycles 2 up to 12 Day 1 of each 28-day cycle 1000 mg Median infusion time: 5.2 hours for Cycle 1, Day 1 Chlorambucil: and 4.2 to 4.4 hours for subsequent infusions 10 mg/m 2 orally days 1-7 of each 28-day cycle 1 Please note: The chlorambucil dosing information seen here was evaluated in the pivotal trial, but is not a recommendation from the Dosage and Administration section of the Prescribing Information 2 In the pivotal trial 1 : Cycle 1 Cycles 2 through 6 Median number of cycles completed was 6 Dosing Recommendations 1 Day 1 300 mg Day 8 1000 mg Day 1 of each 28-day cycle 1000 mg Administer ARZERRA in an environment where facilities to adequately monitor and treat infusion Median infusion time: 5.3 hours for Cycle 1, Day 1 reactions and are 4.1 to available 4.2 hours for subsequent infusions Prepare according to instructions on page 18 Administer as an intravenous (IV) infusion according to the schedule outlined above Do not administer as an IV push or bolus or as a subcutaneous injection Weekly Every 4 Weeks Premedicate before each infusion Weeks 1-8 Dose 1 4 Weeks 12, 16, 20, 24 * The pivotal trial defined best response as 2 consecutive response assessments of stable disease, partial response, or complete response. 1 Please 300 mgsee Doses Important 2000 mgsafety Doses Information 2000 mg on pages 2-8 9-12 Administer first and second infusions over 6.5 hours; Premedication 1 Patients should receive all of the following premedication agents 30 minutes to 2 hours prior to each infusion of ARZERRA Oral acetaminophen 1000 mg (or equivalent) plus Oral or IV antihistamine (diphenhydramine 50 mg or cetirizine 10 mg or equivalent) plus IV corticosteroid (prednisolone 50 mg or equivalent) Corticosteroid may be reduced or omitted for subsequent infusions if a grade 3 or greater infusion-related adverse event did not occur during the first 2 infusions Infusion reactions may occur despite premedication After Cycle 1, ARZERRA is dosed in 28-day cycles. IMPORTANT SAFETY INFORMATION Infusion Reactions ARZERRA can cause serious, including fatal, infusion reactions manifesting as bronchospasm, dyspnea, laryngeal edema, pulmonary edema, flushing, hypertension, hypotension, syncope, cardiac events, back pain, abdominal pain, pyrexia, rash, urticaria, angioedema, cytokine release syndrome, and anaphylactoid/anaphylactic reactions. 5 First-Line CLL Dosing
Dosing for ARZERRA Plus Chlorambucil for First-Line CLL 1 Infusion Rates Infusion initiation rates for ARZERRA Dose Initial 300-mg dose 3.6 12 Subsequent infusions of 1000 mg Infusion Initiation Rates mg/hour ml/hour 25 25 Initiate infusion at a rate of 12 mg/hour if a grade 3 or greater infusion-related adverse event was experienced during the previous infusion In the absence of an infusion-related adverse event, the rate of infusion may be increased every 30 minutes as described in the Infusion Rate Table to the right. Do not exceed the infusion rates in the following Infusion Rate Table Infusion Reactions (cont d) Administer ARZERRA in an environment where facilities to adequately monitor and treat infusion reactions are available. Premedicate with acetaminophen, an antihistamine, and a corticosteroid. Infusion reactions may occur despite premedication. Interrupt ARZERRA for infusion reactions of any severity and initiate appropriate medical treatment. If an anaphylactic reaction occurs, immediately and permanently discontinue ARZERRA. Infusion rates for ARZERRA Interval After Start of Infusion (min) Initial 300-mg Dose a (ml/hour) Subsequent Infusions b (ml/hour) 0-30 12 25 31-60 25 50 61-90 50 100 91-120 100 200 121-150 200 400 151-180 300 400 >180 400 400 a Initial 300 mg: Median durations of infusions=4.8 to 5.2 hours. b Subsequent infusions of 1000 mg: Median durations of infusions=4.2 to 4.4 hours. Hepatitis B Virus (HBV) Reactivation HBV reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, has occurred in patients treated with ARZERRA. Screen all patients for HBV infection before initiating ARZERRA. Monitor patients with evidence of current or prior HBV infection for clinical and laboratory signs of hepatitis or HBV reactivation during and for several months following treatment with ARZERRA. HBV reactivation has been reported for at least 12 months following completion of therapy. In ARZERRA-treated patients who develop reactivation of HBV, immediately discontinue ARZERRA and any concomitant chemotherapy, and institute appropriate treatment. 6 7
Dosing for ARZERRA for Extended Treatment of Patients With CLL After at Least Two Lines of Therapy 1 What Is Extended Treatment? Patients who achieve a partial or complete response to therapy may continue to have a leukemic burden, which could lead to progression. At the time of the efficacy analysis in the clinical trial, the median follow-up was 19.4 months with the ARZERRA arm and 18.7 months with the observation arm. The event rate (progressed or died) was 33% in the ARZERRA arm and 51% in the observation arm. Dosing for ARZERRA Single-agent ARZERRA for a maximum of 2 years Cycle 1 300 mg Day 1 Day 8 1000 mg 7 Weeks Later and Every 8 Weeks 1000 mg Dosing Recommendations 1 Administer ARZERRA in an environment where facilities to adequately monitor and treat infusion reactions are available Prepare according to instructions on page 18 Administer as an IV infusion according to the schedule outlined above Do not administer as an IV push or bolus or as a subcutaneous injection Premedicate before each infusion HBV Infection Fatal infection due to hepatitis B in patients who have not been previously infected has been observed with ARZERRA. Monitor patients for clinical and laboratory signs of hepatitis. Premedication 1 Patients should receive all of the following premedication agents 30 minutes to 2 hours prior to each infusion of ARZERRA Oral acetaminophen 1000 mg (or equivalent) plus Oral or IV antihistamine (diphenhydramine 50 mg or cetirizine 10 mg or equivalent) plus IV corticosteroid (prednisolone 50 mg or equivalent) Corticosteroid may be reduced or omitted for subsequent infusions if a grade 3 or greater infusion-related adverse event did not occur during the first 2 infusions Infusion reactions may occur despite premedication Progressive Multifocal Leukoencephalopathy (PML) PML resulting in death has occurred with ARZERRA. Consider PML in any patient with new onset of or changes in pre-existing neurological signs or symptoms. If PML is suspected, discontinue ARZERRA and initiate evaluation for PML, including neurology consultation. Extended CLL Treatment Dosing 8 9
Dosing for ARZERRA for Extended Treatment of Patients With CLL After at Least Two Lines of Therapy 1 Infusion Rates Infusion initiation rates for ARZERRA Dose Initial 300-mg dose 3.6 12 Subsequent infusions of 1000 mg Infusion Initiation Rates mg/hour ml/hour 25 25 Initiate infusion at a rate of 12 mg/hour if a grade 3 or greater infusion-related adverse event was experienced during the previous infusion In the absence of an infusion-related adverse event, the rate of infusion may be increased every 30 minutes as described in the Infusion Rate Table to the right. Do not exceed the infusion rates in the following Infusion Rate Table Infusion rates for ARZERRA Interval After Start of Infusion (min) Initial 300-mg Dose a (ml/hour) Subsequent Infusions b (ml/hour) 0-30 12 25 31-60 25 50 61-90 50 100 91-120 100 200 121-150 200 400 151-180 300 400 >180 400 400 a Initial 300 mg: Median durations of infusions=4.8 to 5.2 hours. b Subsequent infusions of 1000 mg: Median durations of infusions=4.2 to 4.4 hours. Tumor Lysis Syndrome (TLS) TLS, including the need for hospitalization, has occurred in patients treated with ARZERRA. Patients with high tumor burden and/or high circulating lymphocyte counts (>25 x 10 9 /L) are at greater risk. Consider TLS prophylaxis with anti-hyperuricemics and hydration prior to infusion of ARZERRA. For treatment of TLS, administer aggressive intravenous hydration and anti-hyperuricemic agents, correct electrolyte abnormalities, and monitor renal function. Cytopenias Severe cytopenias, including neutropenia, thrombocytopenia, and anemia, can occur with ARZERRA. Pancytopenia, agranulocytosis, and fatal neutropenic sepsis have occurred in patients who received ARZERRA in combination with chlorambucil. Grade 3 or 4 late-onset neutropenia and/or prolonged neutropenia were reported in ARZERRA-treated patients. Monitor complete blood counts at regular intervals during and after conclusion of therapy, and increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias. 10 11
Day 1 300 mg Day 8 1000 mg Day 1 of each 28-day cycle Dosing for ARZERRA 1000 for mg CLL Refractory to Fludarabine and Alemtuzumab 1 Median infusion time: 5.3 hours for Cycle 1, Day 1 and 4.1 to 4.2 hours for subsequent infusions Dosing for ARZERRA ARZERRA is administered as 12 infusions over a 24-week period Weekly Every 4 Weeks Premedication Patients should receive all of the following premedication agents 30 minutes to 2 hours prior to each infusion of ARZERRA Weeks 1-8 Weeks 12, 16, 20, 24 Oral Acetaminophen Oral or IV Antihistamine IV Corticosteroid Dose 1 12 300 mg Doses 2-8 2000 mg Doses 9-12 2000 mg Administer first and second infusions over 6.5 hours; administer subsequent infusions (3-12) over 4 hours Dosing Recommendations Administer ARZERRA in an environment where facilities to adequately monitor and treat infusion reactions are available Prepare according to instructions on page 18 Administer as an IV infusion according to the schedule outlined above Do not administer as an IV push or bolus or as a subcutaneous injection Premedicate before each infusion Immunizations Do not administer live viral vaccines to patients who have recently received ARZERRA. 1000 mg Diphenhydramine 50 mg or cetirizine 10 mg or equivalent plus Prednisolone 100 mg or equivalent a a Do not reduce corticosteroid dose for Infusions 1, 2, and 9. Corticosteroid dose may be reduced as follows: Infusions 3 through 8: Corticosteroid may be reduced or omitted with subsequent infusions if a grade 3 or greater infusion reaction did not occur with the preceding infusion(s) Infusions 10 through 12: Prednisolone may be given at reduced dose of 50 mg to 100 mg (or equivalent) if a Grade 3 or greater infusion-related adverse event did not occur with Infusion 9 Infusion reactions may occur despite premedication In a study of FA-refractory patients (study 2), 88% of patients received at least 8 infusions of ARZERRA and 54% received all 12 infusions. 13 FA-Refractory CLL Dosing
Dosing for ARZERRA for CLL Refractory to Fludarabine and Alemtuzumab 1 Infusion Rates Infusion initiation rates for ARZERRA Infusion rates for ARZERRA Infusion Infusion 1 (300 mg) Infusion 2 (2000 mg) Infusions 3 through 12 (2000 mg) Infusion Initiation Rates mg/hour ml/hour 3.6 12 24 12 50 25 Interval After Start of Infusion (min) Infusions 1 and 2 a (ml/hour) Subsequent Infusions b (ml/hour) 0-30 12 25 31-60 25 50 61-90 50 100 91-120 100 200 >120 200 400 Initiate infusion at a rate of 12 mg/hour if a grade 3 or greater infusion-related adverse event was experienced during the previous infusion In the absence of an infusion-related adverse event, the rate of infusion may be increased every 30 minutes as described in the Infusion Rate Table to the right. Do not exceed the infusion rates in the following Infusion Rate Table a Infusions 1 and 2 (300 mg and 2000 mg): Median duration of infusions=6.8 hours. b Subsequent infusions of 2000 mg: Median durations of infusions=4.2 to 4.4 hours. Most Common Adverse Reactions Previously untreated CLL:( 10%, all grades) were infusion reactions (67% for ARZERRA plus chlorambucil vs 0% for chlorambucil) and neutropenia (27% vs18%). Extended treatment therapy in CLL: Common adverse reactions ( 10%) were infusion reactions, neutropenia, and upper respiratory infection. Most Common Adverse Reactions (cont d) In the single-arm refractory CLL clinical trial, the most common adverse reactions ( 10%, all grades) were neutropenia, pneumonia, pyrexia, cough, diarrhea, anemia, fatigue, dyspnea, rash, nausea, bronchitis, and upper respiratory tract infections. The most common serious adverse reactions were infections (including pneumonia and sepsis), neutropenia, and pyrexia. 14 15
Infusion Rate Dose Modifications for Infusion Reactions 1 Infusion Rate Dose Modifications Interrupt infusion for infusion reactions of any severity. Treatment can be resumed at the discretion of the treating physician. The following infusion rate modifications can be used as a guide If the infusion reaction resolves or remains less than or equal to grade 2, resume infusion with the following modifications according to the initial grade of the infusion reaction Grade 1 or 2: Infuse at one-half of the previous infusion rate After resuming the infusion, the infusion rate may be increased according to the Infusion Rate Tables on pages 6-7, 10-11, and 14-15 based on patient tolerance Consider permanent discontinuation of ARZERRA if the severity of the infusion reaction does not resolve to less than or equal to grade 2 despite adequate clinical intervention Permanently discontinue therapy for patients who develop an anaphylactic reaction to ARZERRA Infusion Rate Dose Modifications Grade 3 or 4: Infuse at a rate of 12 ml/hour Infusion reactions occur more frequently with the first 2 infusions. Laboratory Abnormalities In the previously untreated CLL clinical trial, post-baseline hematologic laboratory abnormalities (all grades) occurring with 5% incidence in patients receiving ARZERRA plus chlorambucil, and also 2% more than patients receiving chlorambucil, were leukopenia (67% for ARZERRA plus chlorambucil vs 28% for chlorambucil), neutropenia (66% vs 56%), and lymphopenia (52% vs 20%). 16 17
Product Handling 1 Preparation and Administration Do not shake product Inspect parenteral drug products visually for particulate matter and discoloration prior to administration. ARZERRA should be a clear to opalescent, colorless solution. The solution should not be used if discolored or cloudy, or if foreign particulate matter is present Preparation of Solution 300-mg dose: Withdraw and discard 15 ml from a 1000-mL bag of 0.9% Sodium Chloride Injection, USP. Withdraw 5 ml from each of 3 single-use, 100-mg vials of ARZERRA and add to the bag 1000-mg dose*: Withdraw and discard 50 ml from a 1000-mL bag of 0.9% Sodium Chloride Injection, USP. Withdraw 50 ml from 1 single-use, 1000-mg vial of ARZERRA and add to the bag 2000-mg dose : Withdraw and discard 100 ml from a 1000-mL bag of 0.9% Sodium Chloride Injection, USP. Withdraw 50 ml from each of 2 single-use, 1000-mg vials of ARZERRA and add to the bag Mix diluted solution by gentle inversion Store diluted solution between 2 to 8 C (36 to 46 F) No incompatibilities between ARZERRA and polyvinylchloride or polyolefin bags and administration sets have been observed Administration Instructions Administer ARZERRA in an environment where facilities to adequately monitor and treat infusion reactions are available Do not administer as an IV push or bolus or as a subcutaneous injection Do not mix ARZERRA with, or administer as an infusion with, other medicinal products Administer using an infusion pump and an administration set Flush the IV line with 0.9% Sodium Chloride Injection, USP before and after each dose Start infusion within 12 hours of preparation Discard prepared solution after 24 hours Not actual size. Product Handling Prepare all doses in 1000 ml of 0.9% Sodium Chloride Injection, USP. *First-line and extended treatment use only. FA-refractory use only. 18 19
Product Handling 1 How Supplied Carton 3 single-use 100-mg/5-mL vials NDC Number Vial NDC 0078-0669-61 Carton of 3 vials NDC 0078-0669-13 Dosing Requirements 1 carton of 3 single-use vials (total of 3 vials), are needed for each 300-mg dose ARZERRA is a sterile, clear to opalescent, colorless, preservative-free liquid concentrate (20 mg/ml) for dilution and intravenous administration provided in single-use glass vials with a rubber stopper (not made with natural rubber latex) and an aluminum overseal. Each vial contains either 100 mg of ARZERRA in 5 ml of solution or 1000 mg of ARZERRA in 50 ml of solution. 1 single-use 1000-mg/50-mL vial Vial and Carton NDC 0078-0690-61 ARZERRA J-Code: J9302 1 carton of 1 single-use vial (total of 1 vial) is needed for each 1000-mg dose 2 cartons of 1 single-use vial (total of 2 vials) are needed for each 2000-mg dose Storage Store the vials and diluted solution of ARZERRA refrigerated between 2 to 8 C (36 to 46 F) Do not freeze Vials should be protected from light Discard prepared solution after 24 hours ARZERRA is not considered a hazardous material, so there are no biohazard requirements. Dispose per usual hospital/clinic procedures 20 21
Support and Resources Novartis Pharmaceuticals Corporation is committed to providing you with direct access to the resources you and your patients need while treating CLL with ARZERRA. Contact Information 1-888-NOW-NOVA (1-888-669-6682) Monday-Friday, 8:30 am-5:00 pm ET Customer Interaction Center Novartis Pharmaceuticals Corporation One Health Plaza East Hanover, NJ 07936-1080 Customized Medical Support You can request personalized assistance from an ARZERRA Medical Sciences Liaison by contacting Novartis Pharmaceuticals Corporation directly via the contact information provided at left. Available Now! Information about ARZERRA is available for you at www.hcp.novartis.com/products/ arzerra/ and for your patients at www.us.arzerra.com. 22 23
Indications and Important Safety Information INDICATIONS for ARZERRA (ofatumumab) In combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabinebased therapy is considered inappropriate For extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL For the treatment of patients with CLL refractory to fludarabine and alemtuzumab IMPORTANT SAFETY INFORMATION for ARZERRA (ofatumumab) WARNING: HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY Hepatitis B Virus (HBV) reactivation can occur in patients receiving CD20-directed cytolytic antibodies, including ARZERRA, in some cases resulting in fulminant hepatitis, hepatic failure, and death Progressive Multifocal Leukoencephalopathy (PML) resulting in death can occur in patients receiving CD20-directed cytolytic antibodies, including ARZERRA Infusion Reactions ARZERRA can cause serious, including fatal, infusion reactions manifesting as bronchospasm, dyspnea, laryngeal edema, pulmonary edema, flushing, hypertension, hypotension, syncope, cardiac events, back pain, abdominal pain, pyrexia, rash, urticaria, angioedema, cytokine release syndrome, and anaphylactoid/anaphylactic reactions Please see additional Important Safety Information on pages 26 and 27 and click here for full Prescribing Information, including Boxed WARNING, for ARZERRA. Infusion Reactions (cont d) Administer ARZERRA in an environment where facilities to adequately monitor and treat infusion reactions are available. Premedicate with acetaminophen, an antihistamine, and a corticosteroid. Infusion reactions may occur despite premedication Interrupt ARZERRA for infusion reactions of any severity and initiate appropriate medical treatment. If an anaphylactic reaction occurs, immediately and permanently discontinue ARZERRA Hepatitis B Virus (HBV) Reactivation HBV reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, has occurred in patients treated with ARZERRA Screen all patients for HBV infection before initiating ARZERRA Monitor patients with evidence of current or prior HBV infection for clinical and laboratory signs of hepatitis or HBV reactivation during and for several months following treatment with ARZERRA. HBV reactivation has been reported for at least 12 months following completion of therapy In ARZERRA-treated patients who develop reactivation of HBV, immediately discontinue ARZERRA and any concomitant chemotherapy, and institute appropriate treatment HBV Infection Fatal infection due to hepatitis B in patients who have not been previously infected has been observed with ARZERRA. Monitor patients for clinical and laboratory signs of hepatitis 24 25 Important Safety Information
Indications and Important Safety Information (cont d) Progressive Multifocal Leukoencephalopathy (PML) PML resulting in death has occurred with ARZERRA. Consider PML in any patient with new onset of or changes in pre-existing neurological signs or symptoms If PML is suspected, discontinue ARZERRA and initiate evaluation for PML, including neurology consultation Tumor Lysis Syndrome (TLS) TLS, including the need for hospitalization, has occurred in patients treated with ARZERRA. Patients with high tumor burden and/or high circulating lymphocyte counts (>25 x 10 9 /L) are at greater risk Consider TLS prophylaxis with anti-hyperuricemics and hydration prior to infusion of ARZERRA For treatment of TLS, administer aggressive intravenous hydration and anti-hyperuricemic agents, correct electrolyte abnormalities, and monitor renal function Cytopenias Severe cytopenias, including neutropenia, thrombocytopenia, and anemia, can occur with ARZERRA. Pancytopenia, agranulocytosis, and fatal neutropenic sepsis have occurred in patients who received ARZERRA in combination with chlorambucil. Grade 3 or 4 late-onset neutropenia and/or prolonged neutropenia were reported in ARZERRAtreated patients Monitor complete blood counts at regular intervals during and after conclusion of therapy, and increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias Immunizations Do not administer live viral vaccines to patients who have recently received ARZERRA Most Common Adverse Reactions Previously untreated CLL:( 10%, all grades) were infusion reactions (67% for ARZERRA plus chlorambucil vs 0% for chlorambucil) and neutropenia (27% vs18%) Extended treatment therapy in CLL: Common adverse reactions ( 10%) were inf usion reactions, neutropenia, and upper respiratory infection In the single-arm refractory CLL clinical trial, the most common adverse reactions ( 10%, all grades) were neutropenia, pneumonia, pyrexia, cough, diarrhea, anemia, fatigue, dyspnea, rash, nausea, bronchitis, and upper respiratory tract infections. The most common serious adverse reactions were infections (including pneumonia and sepsis), neutropenia, and pyrexia Laboratory Abnormalities In the previously untreated CLL clinical trial, postbaseline hematologic laboratory abnormalities (all grades) occurring with 5% incidence in patients receiving ARZERRA plus chlorambucil, and also 2% more than patients receiving chlorambucil, were leukopenia (67% for ARZERRA plus chlorambucil vs 28% for chlorambucil), neutropenia (66% vs 56%), and lymphopenia (52% vs 20%) References: 1. ARZERRA [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2016. 2. Data on file. Novartis Pharmaceuticals Corp; 2014. Please see additional Important Safety Information on pages 24 and 25 and click here for full Prescribing 26 Information, 27
More information available at: www.hcp.novartis.com/products/arzerra 24-27 and click here for full Prescribing Information, including Boxed WARNING, for ARZERRA. 2016 Novartis 2/16 ARZ-1132022