ARZERRA (Page 6 of 6)

14.3 Extended Treatment in CLL

The efficacy of ARZERRA as extended treatment in CLL was evaluated in a randomized, parallel arm, open-label trial. In this trial, 474 patients who were in complete or partial response after at least two lines of prior therapy, were randomized to receive ARZERRA as intravenous infusions (300 mg on Day 1 followed 1 week later by 1,000 mg on Day 8 followed 7 weeks later by 1,000 mg and every 8 weeks thereafter for up to a maximum of 2 years) or observation.

In the overall trial population, the median age was 65 years (range: 33 to 87 years), 68% were male, and 96% were white. Most patients were in partial remission (81%), had two prior treatments (70%), and had received chemoimmunotherapy (80%) as prior therapy. The main efficacy outcome was progression-free survival (PFS) as assessed by the investigator.

At the time of the efficacy analysis, 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. The investigator-assessed median PFS was 29.4 months in the ARZERRA arm and 15.2 months in the observation arm (hazard ratio: 0.50 with 95% confidence interval [0.38, 0.66]; P <0.0001).

Figure 3. Kaplan-Meier Estimates of Investigator-assessed Progression-free Survival

Figure 2
(click image for full-size original)

14.4 Refractory CLL

Study 4 was a single-arm, multicenter trial in 154 patients with relapsed or refractory CLL. ARZERRA was administered by intravenous infusion according to the following schedule: 300 mg (Week 0), 2,000 mg weekly for 7 infusions (Weeks 1 through 7), and 2,000 mg every 4 weeks for 4 infusions (Weeks 12 through 24). Patients with CLL refractory to fludarabine and alemtuzumab (n = 59) comprised the efficacy population. Drug refractoriness was defined as failure to achieve at least a partial response to, or disease progression within 6 months of, the last dose of fludarabine or alemtuzumab. The main efficacy outcome was durable objective tumor response rate. Objective tumor responses were determined using the 1996 NCI-WG Guidelines for CLL.

In patients with CLL refractory to fludarabine and alemtuzumab, the median age was 64 years (range: 41 to 86 years), 75% were male, and 95% were white. The median number of prior therapies was 5; 93% received prior alkylating agents, 59% received prior rituximab, and all received prior fludarabine and alemtuzumab. Eighty-eight percent of patients received at least 8 infusions of ARZERRA and 54% received 12 infusions.

The investigator-determined overall response rate in patients with CLL refractory to fludarabine and alemtuzumab was 42% (99% CI: 26, 60) with a median duration of response of 6.5 months (95% CI: 5.8, 8.3). There were no complete responses. Anti-tumor activity was also observed in additional patients in Study 4 and in a multicenter, open-label, dose-escalation study (Study 5) conducted in patients with relapsed or refractory CLL.

16 HOW SUPPLIED/STORAGE AND HANDLING

ARZERRA (ofatumumab) 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 ofatumumab in 5 mL of solution or 1,000 mg ofatumumab in 50 mL of solution.

ARZERRA is available as follows:

Carton Contents

NDC

3 single-use 100 mg/5 mL vials

Vial: NDC 0078-0669-61

Carton of 3 vials: NDC 0078-0669-13

1 single-use 1,000 mg/50 mL vial

Vial and Carton: NDC 0078-0690-61

Store ARZERRA refrigerated between 2° to 8°C (36° to 46°F). Do not freeze. Vials should be protected from light.

17 PATIENT COUNSELING INFORMATION

Advise patients to contact a healthcare professional for any of the following:

  • Signs and symptoms of infusion reactions including fever, chills, rash, or breathing problems within 24 hours of infusion [see Warnings and Precautions (5.1), Adverse Reactions (6.1)]
  • Symptoms of hepatitis including worsening fatigue or yellow discoloration of skin or eyes [see Warnings and Precautions (5.2, 5.3)]
  • New neurological symptoms such as confusion, dizziness or loss of balance, difficulty talking or walking, or vision problems [see Warnings and Precautions (5.4)]
  • Bleeding, easy bruising, petechiae, pallor, worsening weakness, or fatigue [see Warnings and Precautions (5.6)]
  • Signs of infections including fever and cough [see Warnings and Precautions (5.6), Adverse Reactions (6.1)]
  • Pregnancy- Advise pregnant women of potential fetal B-cell depletion [see Use in Specific Populations (8.1, 8.2)]

Advise patients of the need for:

  • Monitoring and possible need for treatment if they have a history of hepatitis B infection (based on the blood test) [see Warnings and Precautions (5.2)].
  • Periodic monitoring for blood counts [see Warnings and Precautions (5.6)]
  • Avoiding vaccination with live viral vaccines [see Warnings and Precautions (5.7)]

Manufactured by:
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936
US License 1244
At
Glaxo Group Ltd
Brentford, Middlesex, UK

© Novartis

T2016-73August 2016

Principal Display Panel

NDC 0078-0669-13

Arzerra®

(ofatumumab)

Injection, for Intravenous Infusion

100 mg/5 mL(20mg/mL)

Rx only

For Intravenous Infusion Only.

Must Be Diluted Prior To Administration.

Contains 3 vials

Single-Use Vials — Discard Unused Portion

Novartis

arzerra principal display panel
(click image for full-size original)

Principal Display Panel

NDC 0078-0690-61

Arzerra®

(ofatumumab)

Injection, for Intravenous Infusion

1000 mg/50 mL(20mg/mL)

Rx only

For Intravenous Infusion Only.

Must Be Diluted Prior To Administration.

Contains 1 vial

Single-Use Vials — Discard Unused Portion

Novartis

arzerra principal display panel
(click image for full-size original)
ARZERRA ofatumumab injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0669
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OFATUMUMAB (OFATUMUMAB) OFATUMUMAB 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ARGININE
HYDROCHLORIC ACID
EDETATE DISODIUM
POLYSORBATE 80
SODIUM ACETATE
SODIUM CHLORIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0669-13 3 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE (0078-0669-61)
1 NDC:0078-0669-61 5 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (0078-0669-13)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125326 02/01/2016
ARZERRA ofatumumab injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0690
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OFATUMUMAB (OFATUMUMAB) OFATUMUMAB 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ARGININE
HYDROCHLORIC ACID
EDETATE DISODIUM
POLYSORBATE 80
SODIUM ACETATE
SODIUM CHLORIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0690-61 50 mL in 1 VIAL, SINGLE-USE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125326 02/01/2016
Labeler — Novartis Pharmaceuticals Corporation (002147023)

Revised: 06/2020 Novartis Pharmaceuticals Corporation

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