KESIMPTA ofatumumab 20 mg/.4mL Injection, Solution, 1 syringe — NDC 0078-1007-68 (Billing 00078-1007-68)

1 INDICATIONS AND USAGE KESIMPTA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. KESIMPTA is a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. ( 1 )

2 DOSAGE AND ADMINISTRATION Before initiating KESIMPTA, screen for Hepatitis B virus (HBV) and obtain serum quantitative immunoglobulins, aminotransferases, alkaline phosphatase, and bilirubin. ( 2.1 ) Administer KESIMPTA by subcutaneous injection only. ( 2.2 , 2.3 ) Initial Dosing: 20 mg administered at Weeks 0, 1, and 2. ( 2.2 ) Subsequent Dosing: 20 mg administered monthly starting at Week 4. ( 2.2 )

2.1Assessments Prior to First Dose of KESIMPTA Hepatitis B Virus Screening Prior to initiating KESIMPTA, perform Hepatitis B virus (HBV) screening. KESIMPTA is contraindicated in patients with active HBV confirmed by positive results for Hepatitis B surface antigen [HBsAg] and anti-HBV tests. For patients who are negative for HBsAg and positive for Hepatitis B core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult liver disease experts before starting and during treatment with KESIMPTA [see Warnings and Precautions (5.1)] .

Serum Immunoglobulins Prior to initiating KESIMPTA, perform testing for quantitative serum immunoglobulins [see Warnings and Precautions (5.3)] . For patients with low serum immunoglobulins, consult immunology experts before initiating treatment with KESIMPTA. Vaccinations Because vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation until B-cell repletion, administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of KESIMPTA for live or live-attenuated vaccines, and whenever possible, at least 2 weeks prior to initiation of KESIMPTA for inactivated vaccines [see Warnings and Precautions (5.1)] .

Liver Function Tests Prior to initiating KESIMPTA, obtain serum aminotransferases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]), alkaline phosphatase, and bilirubin levels [see Warnings and Precautions (5.4)] .

2.2Recommended Dosage The recommended dosage of KESIMPTA is: initial dosing of 20 mg by subcutaneous injection at Weeks 0, 1, and 2, followed by subsequent dosing of 20 mg by subcutaneous injection once monthly starting at Week 4. Missed Doses If an injection of KESIMPTA is missed, it should be administered as soon as possible without waiting until the next scheduled dose. Subsequent doses should be administered at the recommended intervals.

2.3Administration Instructions Administer by subcutaneous injection only. KESIMPTA is intended for patient self-administration by subcutaneous injection. Administer KESIMPTA in the abdomen, thigh, or outer upper arm subcutaneously.

Do not give injection into moles, scars, stretch marks, or areas where the skin is tender, bruised, red, scaly, or hard. The first injection of KESIMPTA should be performed under the guidance of a healthcare professional [see Warnings and Precautions (5.2)] . KESIMPTA Sensoready ® pens and syringes are for one-time use only and should be discarded after use.

See Instructions for Use for complete administration instructions.

2.4Preparation of KESIMPTA The KESIMPTA “Instructions for Use” for each presentation contains more detailed instructions on the preparation of KESIMPTA. Before administration, remove KESIMPTA Sensoready Pen or KESIMPTA prefilled syringe from the refrigerator and allow KESIMPTA to reach room temperature for about 15 to 30 minutes. DO NOT remove the needle cover while allowing the prefilled syringe to reach room temperature.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the liquid contains visible particles or is cloudy.

3 DOSAGE FORMS AND STRENGTHS KESIMPTA is a clear to slightly opalescent, and colorless to slightly brownish-yellow solution available as follows: Injection: 20 mg/0.4 mL in a single-dose prefilled Sensoready Pen Injection: 20 mg/0.4 mL in a single-dose prefilled syringe Injection: 20 mg/0.4 mL solution in a single-dose prefilled Sensoready ® Pen ( 3 ) Injection: 20 mg/0.4 mL solution in a single-dose prefilled syringe ( 3 )

17 PATIENT COUNSELING INFORMATION Advise the patient to read FDA-approved patient labeling (Medication Guide and Instructions for Use). Infections Advise patients to contact their healthcare provider for any signs of infection during treatment or after the last dose. Signs include fever, chills, constant cough, or dysuria [see Warnings and Precautions (5.1)] .

Advise patients that KESIMPTA may cause reactivation of hepatitis B infection and that monitoring will be required if they are at risk [see Warnings and Precautions (5.1)] . Advise patients that PML has happened with an intravenous form of ofatumumab administered at a higher intravenous dosage in patients with CLL, as well as with drugs that are similar to KESIMPTA, and may happen with KESIMPTA. Inform the patient that PML is characterized by a progression of deficits and usually leads to death or severe disability over weeks or months.

Instruct the patient of the importance of contacting their healthcare provider if they develop any symptoms suggestive of PML. Inform the patient that typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes [see Warnings and Precautions (5.1)] . Vaccinations Advise patients to complete any required live or live-attenuated vaccinations at least 4 weeks and, whenever possible at least 2 weeks, prior to initiation of KESIMPTA for inactivated vaccines.

Administration of live-attenuated or live vaccines is not recommended during KESIMPTA treatment and until B-cell recovery [see Warnings and Precautions (5.1)] . Injection-Related Reactions and Hypersensitivity Reactions Inform patients about the signs and symptoms of injection-related reactions and hypersensitivity reactions. Inform patients that injection-related reactions generally occur within 24 hours and predominantly following the first injection.

A hypersensitivity reaction may occur with any injection, and any new or worsening symptoms with subsequent KESIMPTA injections should prompt consideration of a hypersensitivity reaction. Advise patients to seek immediate medical attention if they experience signs or symptoms of a severe or life-threatening injection-related reaction or hypersensitivity reaction, and to contact their healthcare provider if they experience any signs or symptoms of an injection-related reaction or hypersensitivity reaction [see Warnings and Precautions (5.2)] .

Liver Injury Inform patients that liver injury has been reported with anti-CD20 B-cell depleting therapies, including KESIMPTA. Instruct patients treated with KESIMPTA to promptly report any symptoms that may indicate liver injury, including fatigue, anorexia, nausea, vomiting, right upper abdominal discomfort, dark urine, or jaundice. A blood test should be obtained before patients start therapy, and during treatment as clinically indicated [see Warnings and Precautions (5.4)] .

Contraception Advise females of childbearing potential to use effective contraception while receiving KESIMPTA and for 6 months after the last treatment of KESIMPTA [see Warnings and Precautions (5.5) and Use in Specific Populations (8.3)] . Pregnancy Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.5) and Use in Specific Populations (8.1, 8.3)] . Pregnancy Exposure Registry Instruct patients that if they are pregnant or plan to become pregnant while taking KESIMPTA, they should inform their healthcare provider.

Encourage patients to enroll in the MotherToBaby Pregnancy Study in Multiple Sclerosis if they become pregnant while taking KESIMPTA [see Use in Specific Populations (8.1)] . Instruction on Injection Technique Patients or caregivers should be instructed by a healthcare professional on how to administer KESIMPTA [see Instructions for Use] .… [Excerpted — this section continues on DailyMed.]

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 4/2026 MEDICATION GUIDE KESIMPTA ® (KEY-simp-ta) (ofatumumab) injection, for subcutaneous use What is the most important information I should know about KESIMPTA?

KESIMPTA can cause serious side effects, including: Infections. Serious infections, which can be life-threatening or cause death, can happen during treatment with KESIMPTA. If you have an active infection, your healthcare provider should delay your treatment with KESIMPTA until your infection is gone.

KESIMPTA taken before or after other medicines that weaken the immune system may increase your risk of getting infections. Tell your healthcare provider right away if you have any infections or get any symptoms, including painful and frequent urination, nasal congestion, runny nose, sore throat, fever, chills, cough, or body aches. Hepatitis B virus (HBV) reactivation.

Before starting treatment with KESIMPTA, your healthcare provider will do blood tests to check for HBV. If you have ever had HBV infection, the HBV may become active again during or after treatment with KESIMPTA. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems, including liver failure or death.

You should not receive KESIMPTA if you have active hepatitis B liver disease. Your healthcare provider will monitor you for HBV infection during and after you stop using KESIMPTA. Tell your healthcare provider right away if you get worsening tiredness or yellowing of your skin or white part of your eyes during treatment with KESIMPTA.

Progressive Multifocal Leukoencephalopathy (PML). PML may happen with KESIMPTA. PML is a rare, serious brain infection caused by a virus that may get worse over days or weeks.

PML can result in death or severe disability. Tell your healthcare provider right away if you have any new or worsening neurologic signs or symptoms. These may include weakness on one side of your body, loss of coordination in arms and legs, vision problems, changes in thinking and memory which may lead to confusion and personality changes.

Weakened immune system. KESIMPTA taken before or after other medicines that weaken the immune system could increase your risk of getting infections. What is KESIMPTA?

KESIMPTA is a prescription medicine used to treat adults with relapsing forms of multiple sclerosis (MS), including: clinically isolated syndrome relapsing-remitting disease active secondary progressive disease It is not known if KESIMPTA is safe or effective in children. Do not use KESIMPTA if you: have an active hepatitis B virus infection. have had an allergic reaction to ofatumumab or life-threatening injection-related reaction to KESIMPTA. See the end of this Medication Guide for a complete list of ingredients in KESIMPTA.

Before using KESIMPTA, tell your healthcare provider about all of your medical conditions, including if you: have or think you have an infection, including HBV or PML. See “What is the most important information I should know about KESIMPTA?” have ever taken, currently take, or plan to take medicines that affect your immune system. These medicines could increase your risk of getting an infection. have a history of liver problems. have had a recent vaccination or are scheduled to receive any vaccinations.

You should receive any required ‘live’ or ‘live-attenuated’ vaccines at least 4 weeks before you start treatment with KESIMPTA . You should not receive ‘live’ or ‘live-attenuated’ vaccines while you are being treated with KESIMPTA and until your healthcare provider tells you that your immune system is no longer weakened. Whenever possible, you should receive any ‘non-live’ vaccines at least 2 weeks before you start treatment with KESIMPTA .

Talk to your healthcare provider about vaccinations for your baby if you used KESIMPTA during your pregnancy. are pregnant, think that you might be pregnant, or plan to become pregnant. It is not known if KESIMPTA wi… [Excerpted — this section continues on DailyMed.]

This Instructions for Use has been approved by the U.S. Food and Drug Administration. Revised: 9/2022 INSTRUCTIONS FOR USE KESIMPTA ® [KEY-simp-ta] (ofatumumab) injection, for subcutaneous use Sensoready ® Pen This Instructions for Use contains information on how to inject KESIMPTA Sensoready Pen.

Be sure that you read, understand, and follow this Instructions for Use before injecting KESIMPTA. Your healthcare provider should show you how to prepare and inject KESIMPTA the right way using the Sensoready Pen before you use it for the first time. Talk to your healthcare provider if you have any questions before you use KESIMPTA for the first time.

Important Information You Need to Know Before Injecting KESIMPTA Sensoready Pen. Do not use the KESIMPTA Sensoready Pen if either the seal on the outer carton or the seal on the KESIMPTA Sensoready Pen is broken. Keep the KESIMPTA Sensoready Pen in the sealed outer carton until you are ready to use it.

Do not shake the KESIMPTA Sensoready Pen. If you drop your KESIMPTA Sensoready Pen, do not use it if it looks damaged, or if you dropped it with the cap removed. Throw away (dispose of) the used KESIMPTA Sensoready Pen right away after use.

Do not re-use a KESIMPTA Sensoready Pen. See “How should I dispose of used KESIMPTA Sensoready Pens?” at the end of this Instructions for Use. How should I store KESIMPTA Sensoready Pen?

Store your carton of KESIMPTA Sensoready Pen in a refrigerator, between 36°F to 46°F (2°C to 8°C). Keep KESIMPTA Sensoready Pen in the original carton until ready to use to protect from light. If needed, KESIMPTA Sensoready Pen may be stored for up to 7 days at room temperature, up to 86°F (30°C).

Write the date taken out of the refrigerator in the space provided on the carton. If stored below 86°F (30°C), unused KESIMPTA may be returned to the refrigerator and must be used within the next 7 days. If this KESIMPTA is not used within those 7 days, then discard the medicine.

Do not freeze KESIMPTA Sensoready Pen. Keep KESIMPTA Sensoready Pen and all medicines out of the reach of children. KESIMPTA Sensoready Pen parts (see Figure A): Figure A The KESIMPTA Sensoready Pen is shown with the cap removed.

Do not remove the cap until you are ready to inject. What you need for your injection: Included in the carton: A new KESIMPTA Sensoready Pen ( see Figure B ). Figure B Not included in the carton ( see Figure C ): 1 alcohol wipe 1 cotton ball or gauze Sharps disposal container See “How should I dispose of used KESIMPTA Sensoready Pens?” at the end of this Instructions for Use.

Figure C Before your injection Take the KESIMPTA Sensoready Pen out of the refrigerator 15 to 30 minutes before injecting to allow it to reach room temperature. Step 1. Important safety checks before you inject ( see Figure D ): Look through the viewing window.

The liquid should be clear to slightly cloudy. Do not use if the liquid contains visible particles or is cloudy. You may see a small air bubble, which is normal.

Look at the expiration date (EXP) on your KESIMPTA Sensoready Pen. Do not use your pen if the expiration date has passed. Contact your pharmacist or healthcare provider if your pen fails any of these checks.

Figure D Step 2. Choose your injection site: The recommended site is the front of the thighs. You may also use the lower stomach area (lower abdomen), but not the area 2 inches around the navel (belly button) ( 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. If a caregiver or healthcare provider is giving you your injection, they may also inject into your outer upper arm ( see Figure F ).

Figure E Figure F (Caregiver and healthcare provider only) Step 3. Clean your injection site: Wash your hands with soap and water. Using a circular motion, clean the injection site with the alcohol wipe.

Leave it to dry before injecting ( see Figure G ). Do not touch the cleaned area again before inject… [Excerpted — this section continues on DailyMed.]