KESIMPTA (Page 8 of 8)

PRINCIPAL DISPLAY PANEL

NDC 0078-1007-68

Rx only

Kesimpta®
(ofatumumab)
Injection

20 mg/0.4 mL

Single-dose Prefilled Sensoready® Pen
For Subcutaneous Use Only

Sterile Solution — Contains No Preservatives

Carton contains: 1 Single-dose Prefilled Sensoready® Pen, Prescribing Information, Instructions for Use, and Medication Guide

Attention: Dispense with enclosed Medication Guide.

REFRIGERATE

NOVARTIS

PRINCIPAL DISPLAY PANEL
							NDC 0078-1007-68 
							Rx only
							Kesimpta® (ofatumumab) Injection
							20 mg/0.4 mL
							Single-dose Prefilled Sensoready® Pen For Subcutaneous Use Only
							Sterile Solution -- Contains No Preservatives
							Carton contains: 1 Single-dose Prefilled Sensoready ® Pen,
							Prescribing Information, Instructions for Use, and Medication Guide
							Attention: Dispense with enclosed Medication Guide.
							REFRIGERATE
							NOVARTIS
(click image for full-size original)

KESIMPTA ofatumumab injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-1007
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OFATUMUMAB (OFATUMUMAB) OFATUMUMAB 20 mg in 0.4 mL
Inactive Ingredients
Ingredient Name Strength
ARGININE 4.000 mg in 0.4 mL
HYDROCHLORIC ACID 5.5 mg in 0.4 mL
EDETATE DISODIUM 0.007 mg in 0.4 mL
POLYSORBATE 80 0.080 mg in 0.4 mL
SODIUM ACETATE 2.722 mg in 0.4 mL
SODIUM CHLORIDE 1.192 mg in 0.4 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-1007-68 1 SYRINGE, GLASS in 1 CARTON contains a SYRINGE, GLASS
1 0.4 mL in 1 SYRINGE, GLASS This package is contained within the CARTON (0078-1007-68)
2 NDC:0078-1007-98 1 SYRINGE, GLASS in 1 CARTON contains a SYRINGE, GLASS
2 0.4 mL in 1 SYRINGE, GLASS This package is contained within the CARTON (0078-1007-98)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125326 10/26/2009
Labeler — Novartis Pharmaceuticals Corporation (002147023)

Revised: 09/2021 Novartis Pharmaceuticals Corporation

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