Drug Interaction:
No formal drug-drug interaction studies have been conducted with ARZERRA
Indication:
Proprietary Name- Arzerra Inj
Established Name - Ofatumumab- CD -20 directed cytolytic monoclonal antibody
Applicant- Glaxo Group Limited D/B/A GlaxoSmithKline
Indication-
Treatment of Chronic Lymphocytic leukemia
Dosage-
Recommended dose 12 dose administered as
300mg initial dose, followed by 1 week later
2000mg weekly for 7 doses, followed by 1 week later
2000mg every 4 weeks for 4 doses
Approved by FDA on 26-10-2010 (Ref- FDA approved List- 2010)
Proprietary Name- ARZERRA I.V. INFUSION*
Established Name- Oftatumumab
Applicant- GLAXOSMITHKLINE
Indication- In combination with Chlorambutil for the treatment of previously
untreated patients with chronic lymphocytic leukemia (CLL)
for whom fludarbine-therapy is considered in appropiate
Approval Date- 17/4/2014
Approved by U.S.FDA (Ref- FDA approved List- 2014)
Adverse Reaction:
Most common adverse reactions (.10%) were neutropenia, pneumonia, pyrexia,
cough, diarrhea, anemia, fatigue, dyspnea, rash, nausea, bronchitis,
and upper respiratory tract infections.
Contra-Indications:
CONTRAINDICATIONS
None.
-WARNINGS AND PRECAUTIONS
.
Infusion Reactions: Premedicate with an intravenous corticosteroid (as appropriate),
an oral analgesic, and an oral or intravenous antihistamine.
Monitor patients closely during infusions. Interrupt infusion if infusion reactions occur.
.
Cytopenias: Monitor blood counts at regular intervals for neutropenia and
thrombocytopenia.
.
Progressive Multifocal Leukoencephalopathy (PML):
Monitor neurologic function and discontinue ARZERRA if PML is suspected.
.
Hepatitis B Reactivation: Screen high-risk patients.
Discontinue ARZERRA in patients who develop viral hepatitis or reactivatio
of viral hepatitis.
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE-
ARZERRA (ofatumumab) is a CD20-directed cytolytic monoclonal
antibody indicated for the treatment of patients with chronic lymphocytic
leukemia (CLL) refractory to fludarabine and alemtuzumab.
The effectiveness of ARZERRA is based on the demonstration of durable
objective responses. No data demonstrate an improvement in disease
related symptoms or increased survival with ARZERRA.
DOSAGE AND ADMINISTRATION
Dilute and administer as an intravenous infusion. Do not administer as an
intravenous push or bolus.
Recommended dose and schedule is 12 doses administered as follows:
300 mg initial dose, followed 1 week later by
2,000 mg weekly for 7 doses, followed 4 weeks later by
2,000 mg every 4 weeks for 4 doses.
Premedicate with oral acetaminophen, oral or intravenous antihistamine,
and intravenous corticosteroid.
DOSAGE FORMS AND STRENGTHS
100 mg/5 mL single-use vial.
Patient Information:
Advise patients to contact a healthcare professional for any of the following:
1.Signs and symptoms of infusion reactions including fever, chills, rash,
or breathing problems within 24 hours of infusion
2.Bleeding, - easy bruising, petechiae, pallor, worsening weakness, or fatigue
3.Signs of infections including fever and cough
4.New neurological symptoms such as confusion, dizziness or loss of balance,
difficulty talking or walking, or vision problems
5.Symptoms of hepatitis including worsening fatigue or yellow discoloration
of skin or eyes
6.New or worsening abdominal pain or nausea
7.Use during Pregnancy or nursing
•
Periodic monitoring for blood counts
[see Warnings and Precautions (5.2)]
•
Avoiding vaccination with live viral vaccines
[see Warnings and Precautions (5.6)]
Pharmacology/ Pharmacokinetics:
1 Mechanism of Action
Ofatumumab binds specifically to both the small and large extracellular loops
of the CD20 molecule. The CD20 molecule is expressed on normal
B lymphocytes (pre-B- to mature B-lymphocyte) and on B-cell CLL.
The CD20 molecule is not shed from the cell surface and is not internalized
following antibody binding
2. Pharmacokinetics
Pharmacokinetic data were obtained from 146 patients with refractory CLL who
received a 300-mg initial dose followed by 7 weekly and 4 monthly infusions of
2,000 mg.
The Cmax and AUC(0-‡) after the 8th infusion in Study 1 were approximately 40%
and 60% higher than after the 4th infusion in Study 2.
The mean volume of distribution at steady-state (Vss) values ranged from
1.7 to 5.1 L. Ofatumumab is eliminated through both a target-independent route
and a B cell-mediated route.
Ofatumumab exhibited dose-dependent clearance in the dose range of 100 to 2,000 mg.
Due to the depletion of B cells, the clearance of ofatumumab decreased substantially
after subsequent infusions compared to the first infusion.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
.1 Pregnancy
Pregnancy Category C:
There are no adequate or well-controlled studies of ofatumumab
in pregnant women.ARZERRA should be used during pregnancy only
if the potential benefit to the mother justifies the potential risk to the fetus.
2. Nursing Mothers
It is not known whether ofatumumab is secreted in human milk; however human
IgG is secreted in human milk. Published data suggest that neonatal and infant
consumption of breast milk does not result in substantial absorption of these
maternal antibodies into circulation.
Because the effects of local gastrointestinal and limited systemic exposure
to ofatumumab are unknown, caution should be exercised
when ARZERRA is administered to a nursing woman.
3. Pediatric Use
Safety and effectiveness of ARZERRA have not been established in children.
4. Geriatric Use
Clinical studies of ARZERRA did not include sufficient numbers of subjects
aged 65 and over to determine whether they respond differently from younger
subjects
Manufacturer Details