ARZERRA- ofatumumab injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OFATUMUMAB (UNII: M95KG522R0) (OFATUMUMAB - UNII:M95KG522R0)

Available from:

Novartis Pharmaceuticals Corporation

INN (International Name):

OFATUMUMAB

Composition:

OFATUMUMAB 20 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Chronic Lymphocytic Leukemia (CLL) ARZERRA (ofatumumab) is indicated: - in combination with chlorambucil, for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate [see Clinical Studies (14.1)] - in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed CLL [see Clinical Studies (14.2)] - for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL [see Clinical Studies (14.3)] - for the treatment of patients with CLL refractory to fludarabine and alemtuzumab [see Clinical Studies (14.4)] None. Risk Summary ARZERRA may cause fetal B-cell depletion based on findings from animal studies and the drug’s mechanism of action [see Clinical Pharmacology (12.1)] . There are no data on ARZERRA use in pregnant women to inform a drug-associated risk. However, there are clinical considerations [see Clinical Considerations] . No terato

Product summary:

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.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

ARZERRA- OFATUMUMAB INJECTION, SOLUTION
NOVARTIS PHARMACEUTICALS CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ARZERRA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ARZERRA.
ARZERRA (OFATUMUMAB) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2009
WARNING: HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL
LEUKOENCEPHALOPATHY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
HEPATITIS B VIRUS (HBV) REACTIVATION, IN SOME CASES RESULTING IN
FULMINANT HEPATITIS,
HEPATIC FAILURE, AND DEATH. (5.2)
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML) RESULTING IN DEATH.
(5.4)
RECENT MAJOR CHANGES
Indications and Usage, Extended Treatment in CLL (1)
1/2016
Indications and Usage, Relapsed CLL (1)
8/2016
Dosage and Administration, Recommended Dosage Regimen (2.1)
1/2016
Dosage and Administration, Administration (2.2)
8/2016
Dosage and Administration, Pre-medication (2.4)
1/2016
INDICATIONS AND USAGE
ARZERRA (ofatumumab) is a CD20-directed cytolytic monoclonal antibody
indicated for the treatment of
chronic lymphocytic leukemia (CLL) (1):
in combination with chlorambucil, for the treatment of previously
untreated patients with CLL for whom
fludarabine-based therapy is considered inappropriate.
in combination with fludarabine and cyclophosphamide for the treatment
of patients with relapsed CLL.
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.
DOSAGE AND ADMINISTRATION
Dilute and administer as an intravenous infusion. Do not administer
subcutaneously or as an
intravenous push or bolus. (2.1)
Previously untreated CLL in combination with chlorambucil recommended
dosage and schedule is:
300 mg on Day 1 followed by 1,000 mg on Day 8 (Cycle 1)
1,000 mg on Day 1 of subsequent 28-day cycles for a minimum of 3
cycles until best response or a