KESIMPTA: Package Insert and Label Information (Page 4 of 4)

This Instructions for Use has been approved by the U.S. Food and Drug Administration.Issued: August 2020
INSTRUCTIONS FOR USE KESIMPTA® [KEY-simp-ta](ofatumumab)injection, for subcutaneous usePrefilled Syringe
This Instructions for Use contains information on how to inject KESIMPTA Prefilled Syringe. Be sure that you read, understand, and follow this Instructions for Use before injecting KESIMPTA prefilled syringe. Your healthcare provider should show you how to prepare and inject KESIMPTA the right way before using the prefilled syringe the first time. Talk to your healthcare provider if you have any questions.Important Information You Need to Know Before Injecting KESIMPTA prefilled syringe.
  • Do not use the KESIMPTA prefilled syringe if either the seal on the outer carton or the seal of the blister is broken. Keep the KESIMPTA prefilled syringe in the sealed carton until you are ready to use it.
  • Do not shake the KESIMPTA prefilled syringe.
  • The KESIMPTA prefilled syringe has a needle guard that will be activated to cover the needle after the injection is finished. The needle guard will help to prevent needle stick injuries to anyone who handles the KESIMPTA prefilled syringe after injection.
  • Do not remove the needle cap until just before you give the injection.
  • Avoid touching the syringe guard wings before use. Touching them may cause the needle guard to be activated too early.
  • Throw away (dispose of) the used KESIMPTA prefilled syringe right away after use. Do not re-use a KESIMPTA prefilled syringe. See “How should I dispose of used KESIMPTA prefilled syringe?” at the end of these Instructions for Use.
How should I store KESIMPTA Prefilled Syringe?
  • Store your carton of the KESIMPTA prefilled syringe in a refrigerator, between 36°F to 46°F (2°C to 8°C).
  • Keep the KESIMPTA prefilled syringe in the original carton until ready to use to protect from light.
  • Do not freeze the KESIMPTA prefilled syringe.
Keep KESIMPTA Prefilled Syringe and all medicines out of the reach of children.
KESIMPTA prefilled syringe parts (see Figure A):Figure A
Figure A
(click image for full-size original)
What you need for your injection Included in the carton: A new KESIMPTA prefilled syringe.Not included in the carton (see Figure B):
  • 1 alcohol wipe
  • 1 cotton ball or gauze
  • Sharps disposal container
See “How should I dispose of used KESIMPTA prefilled syringe?” at the end of these Instructions for Use.
Figure B
Figure B
(click image for full-size original)
Prepare the KESIMPTA prefilled syringeStep 1. Find a clean, well-lit, flat work surface.Step 2. Take the carton containing the KESIMPTA prefilled syringe out of the refrigerator and leave it unopened on your work surface for about 15 to 30 minutes so that it reaches room temperature.Step 3. Wash your hands well with soap and water.Step 4. Remove the KESIMPTA prefilled syringe from the outer carton and take it out of the blister by holding the syringe guard body.Step 5. Look through the viewing window on the KESIMPTA prefilled syringe. The liquid inside should be clear to slightly cloudy. You may see a small air bubble in the liquid, which is normal. Do not use the KESIMPTA prefilled syringe if the liquid contains particles or is cloudy.Step 6. Do not use the KESIMPTA prefilled syringe if it is broken. Return the KESIMPTA prefilled syringe and the package it came in to the pharmacy.Step 7. Do not use the KESIMPTA prefilled syringe if the expiration date has passed (see Figure C). Return the expired KESIMPTA prefilled syringe and the package it came in to the pharmacy. Figure C
Figure C
(click image for full-size original)
Choose and clean the injection site
  • Areas of your body that you may use as injection sites include:
  • the front of your thighs (see Figure D)
  • the lower stomach-area (abdomen), but not the area 2 inches around your navel (belly button) (see Figure D)
  • your outer upper arms, if a healthcare provider or caregiver is giving you the injection (see Figure E).
  • Do not inject into areas where the skin is tender, bruised, red, scaly, or hard. Avoid areas with moles, scars or stretch marks.
Step 8. Using a circular motion, clean the injection site with the alcohol wipe. Leave it to dry before injecting. Do not touch the cleaned area again before injecting.
Figure D
Figure D
(click image for full-size original)
Figure E (Caregiver and healthcare provider only)
Figure E
(click image for full-size original)
Giving your injection Step 9. Carefully remove the needle cap from the KESIMPTA prefilled syringe (see Figure F). Throw away the needle cap. You may see a drop of liquid at the end of the needle. This is normal. Figure F
Figure F
(click image for full-size original)
Step 10. With one hand, gently pinch the skin at the injection site. With your other hand insert the needle into your skin at an angle of about 45 degrees as shown (see Figure G). Push the needle all the way in to make sure that you inject your full dose. Figure G
Figure G
(click image for full-size original)
Step 11. Hold the KESIMPTA prefilled syringe finger grips as shown (see Figure H). Slowly press down on the plunger head as far as it will go, so that the plunger head is completely between the syringe guard wings.Continue to press fully on the plunger head for an additional 5 seconds. Hold the syringe in place for the full 5 seconds. Figure H
Figure H
(click image for full-size original)
Step 12. Slowly release the plunger head until the needle is covered (see Figure I), and then remove the syringe from the injection site.Step 13. There may be a small amount of blood at the injection site. You can press a cotton ball or gauze over the injection site and hold it for 10 seconds. Do not rub the injection site. You may cover the injection site with a small adhesive bandage, if needed. Figure I
Figure I
(click image for full-size original)
How should I dispose of used KESIMPTA prefilled syringe? Step 14. Put your used KESIMPTA prefilled syringe in a FDA-cleared sharps disposal container right away after use (see Figure J). Do not throw away (dispose of) your used KESIMPTA prefilled syringe in your household trash. Never try to reuse your KESIMPTA prefilled syringe.If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
  • made of a heavy-duty plastic,
  • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • upright and stable during use,
  • leak-resistant, and
  • properly labeled to warn of hazardous waste inside the container.
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles, syringes and prefilled syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal.Keep the sharps container out of the reach of children. Manufactured by:Novartis Pharmaceuticals CorporationEast Hanover, NJ 07936U.S. License No.: 1244
Figure J
Figure J
(click image for full-size original)

T2020-115

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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