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ARZERRA- ofatumumab injection, solution


  1. Advise Patients To Contact A Healthcare Professional For Any Of The Following:
  2. Advise Patients Of The Need For:
  3. Revised: 9/2019document Id:

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

T2016-73
August 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.

Contains3vials

Single-Use Vials - Discard Unused Portion

Novartis

arzerra principal display panel

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.

Contains1vial

Single-Use Vials - Discard Unused Portion

Novartis

arzerra principal display panel
ARZERRA
ofatumumab injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0078-0669
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OFATUMUMAB(UNII: M95KG522R0) (OFATUMUMAB - UNII:M95KG522R0)OFATUMUMAB20 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
ARGININE(UNII: 94ZLA3W45F)
HYDROCHLORIC ACID(UNII: QTT17582CB)
EDETATE DISODIUM(UNII: 7FLD91C86K)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SODIUM ACETATE(UNII: 4550K0SC9B)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
WATER(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0078-0669-133 in 1 CARTON02/01/2016
1NDC:0078-0669-615 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA12532602/01/2016
ARZERRA
ofatumumab injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0078-0690
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OFATUMUMAB(UNII: M95KG522R0) (OFATUMUMAB - UNII:M95KG522R0)OFATUMUMAB20 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
ARGININE(UNII: 94ZLA3W45F)
HYDROCHLORIC ACID(UNII: QTT17582CB)
EDETATE DISODIUM(UNII: 7FLD91C86K)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SODIUM ACETATE(UNII: 4550K0SC9B)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
WATER(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0078-0690-6150 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product02/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA12532602/01/2016
Labeler -Novartis Pharmaceuticals Corporation (002147023)

Revised: 9/2019document Id: 

bd8b549b-504e-4b95-85f9-70d3ac3ea643Set id: 77785ce3-e8df-4ca1-8f8e-6c418c6a17deVersion: 5Effective Time: 20190916Novartis Pharmaceuticals Corporation



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