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Rx Item-Arzerra 100mg ofatumumab Sdv 3X5ml by Novartis

RX512645 512645 10162695 RX10162695 NDC No. 00078-0669-13 0078-0669-13 00078066913 0078066913 UPC/GTIN No.3-00780-66913-9 300780669139 300780-669139 MPN 3512645Novartis Pharma Corp RX512645 512645 10162695 RX10162695 NDC No. 00078-0669-13 0078-0669-13 00078066913 0078066913 UPC/GTIN No.3-00780-66913-9 300780669139 300780-669139 MPN 3512645Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Arzerra 100mg ofatumumab Sdv 3X5ml by Novartis

$2172.13$2099.00

RX512645 512645 10162695 RX10162695 NDC No. 00078-0669-13 0078-0669-13 00078066913 0078066913 UPC/GTIN No.3-00780-66913-9 300780669139 300780-669139 MPN 3512645 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX Item. Rx Item No.Rx512645 Status Ac - Active
Item No 3512645
Selling Size 3X5 ml
Selling Uom Ea

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Clinical Information
Gen. Code and Des.
65775 ofatumumab INTRAVEN VIAL 100 MG/5ML
GCN and Des.
27827 ofatumumab INTRAVEN VIAL 100 MG/5ML
Strength
100MG
Dose Form
VIAL (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
10000000 ANTINEOPLASTIC AGENTS
Active Ingredients
13301 ofatumumab 679818598
Inactive Ingredients
2551 polysorbates 9005645
3785 edetic acid 60004
756 sodium acetate 127093

hese 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 maximum of 12 cycles. (2.1)
Relapsed CLL in combination with fludarabine and cyclophosphamide 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 maximum of 6 cycles (2.1)
Extended treatment in CLL recommended dosage and schedule is:
300 mg on Day 1 followed by
1,000 mg 1 week later on Day 8, followed by
1,000 mg 7 weeks later and every 8 weeks thereafter for up to a maximum of 2 years. (2.1)
Refractory CLL recommended dosage and schedule is:
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. (2.1)
Administer where facilities to adequately monitor and treat infusion reactions are available. (2.2)
Pre-medicate with acetaminophen, antihistamine, and corticosteroid. (2.4)

DOSAGE FORMS AND STRENGTHS

100 mg/5 mL single-use vial for intravenous infusion. (3)
1,000 mg/50 mL single-use vial for intravenous infusion. (3)

CONTRAINDICATIONS

None. (4)
WARNINGS AND PRECAUTIONS

Infusion Reactions: Pre-medicate with corticosteroid, acetaminophen, and an antihistamine. Monitor patients during infusions. Interrupt infusion if infusion reactions occur. (2.3, 2.4, 5.1)
Tumor Lysis Syndrome: Anticipate TLS in high-risk patients; pre-medicate with anti-hyperuricemics and hydration. (5.5)
Cytopenias: Neutropenia, anemia, and thrombocytopenia occur. Late-onset and prolonged neutropenia can also occur. Monitor complete blood counts at regular intervals. (5.6)

ADVERSE REACTIONS

Previously Untreated CLL: Common adverse reactions (≥10%) were infusion reactions and neutropenia. (6)
Relapsed CLL: Common adverse reactions (>10%) were infusion reactions, neutropenia, leukopenia and febrile neutropenia. (6)
Extended Treatment in CLL: Common adverse reactions (≥10%) were infusion reactions, neutropenia, and upper respiratory tract infection. (6)
Refractory CLL: Common adverse reactions (≥10%) were neutropenia, pneumonia, pyrexia, cough, diarrhea, anemia, fatigue, dyspnea, rash, nausea, bronchitis, and upper respiratory tract infections. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS

Pregnancy: May cause fetal B-cell depletion. (8.1)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 8/2016

RX512645 512645 10162695 RX10162695 NDC No. 00078-0669-13 0078-0669-13 00078066913 0078066913 UPC/GTIN No.3-00780-66913-9 300780669139 300780-669139 MPN 3512645
Arzerra 100mg Sdv 3X5ml by Novartis
RX512645 512645 10162695 RX10162695 NDC No. 00078-0669-13 0078-0669-13 00078066913 0078066913 UPC/GTIN No.3-00780-66913-9 300780669139 300780-669139 MPN 3512645

Novartis Pharma Corp RX512645 512645 10162695 RX10162695 NDC No. 00078-0669-13 0078-0669-13 00078066913 0078066913 UPC/GTIN No.3-00780-66913-9 300780669139 300780-669139 MPN 3512645
Arzerra 100mg ofatumumab
Novartis Pharma Corp RX512645 512645 10162695 RX10162695 NDC No. 00078-0669-13 0078-0669-13 00078066913 0078066913 UPC/GTIN No.3-00780-66913-9 300780669139 300780-669139 MPN 3512645

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
AmericanPharmaWholesale.com
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.