I don't want RMS to hold me back. I need a treatment
that works for me, and fits into my life.

Walt: husband, dad, aeronautical engineer, KESIMPTA patient*

Take a different approach to relapsing MS

SEE POWERFUL EFFICACY1
ASCLEPIOS I and II Study Design

*Actual KESIMPTA patient who was compensated for their time. Individual results may vary.

ASCLEPIOS I and II Study Design

*Actual KESIMPTA patient who was compensated for their time. Individual results may vary.

ESTABLISHED SAFETY PROFILE IN PIVOTAL
TRIALS,
WHICH INCLUDED
TREATMENT-NAÏVE PATIENTS1,2

SEE SAFETY

Not representative
of a patient.

1 MINUTE A MONTH
WHEN THE PATIENT IS
READY TO ADMINISTER3

SEE DOSING AND ADMINISTRATION

As per stability technical specification data, when the patient is ready to inject, it typically takes less than 1 minute a month to administer. Once-monthly dosing begins after the initial dosing period, which consists of 20 mg subcutaneous doses at weeks 0, 1, and 2. Please see Instructions for Use for more detailed instructions on the preparation and administration of KESIMPTA.

80% OF COMMERCIAL PATIENTS
RECEIVE THEIR FIRST BRIDGE
DOSE IN 5 DAYS4

DOWNLOAD START FORM

Based on prescription and dispense data as of November 2022.

YOUR ELIGIBLE, COMMERCIALLY
INSURED PATIENTS PAY AS LITTLE
AS A $0 COPAY

SEE $0 OFFER

Limitations apply. Offer not valid under Medicare, Medicaid, or any other federal or state health insurance program. Patients with commercial insurance coverage for KESIMPTA may receive up to $18,000 in annual copay benefits. Novartis reserves the right to rescind, revoke, or amend this program without notice. See complete Terms & Conditions at start.kesimpta.com.

RAPID AND SUSTAINED
B-CELL DEPLETION
OVER THE STUDIED DOSING PERIOD1,5,6

EXPLORE MECHANISM OF ACTION

The precise mechanism by which KESIMPTA exerts its therapeutic effects is unknown.

See ASCLEPIOS I and II Study Design

MOA=mechanism of action; RMS=relapsing multiple sclerosis.

References: 1. Kesimpta [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp. 2. Data on file. OMB157G (ofatumumab). Statistical Overview. Novartis Pharmaceuticals Corp; East Hanover, NJ. January 2020. 3. Data on file. Injection time. Novartis Pharmaceuticals Corp; East Hanover, NJ. June 2020. 4. Data on file. Program data. Novartis Pharmaceuticals Corp; East Hanover, NJ. November 2022. 5. Hauser SL, Bar-Or A, Cohen JA, et al. B-cell depletion and efficacy outcomes with ofatumumab: subgroup analysis from the pooled phase 3 ASCLEPIOS I and II trials. P7.1-013. Poster presented at: American Academy of Neurology Annual Meeting; May 4-10, 2019; Philadelphia, PA. 6. Hauser SL, Bar-Or A, Cohen JA, et al; for the ASCLEPIOS I and ASCLEPIOS II trial groups. Ofatumumab versus teriflunomide in multiple sclerosis supplemental appendix. N Engl J Med. 2020;383(6):546-557.

IMPORTANT SAFETY INFORMATION

Contraindication: KESIMPTA is contraindicated in patients with active hepatitis B virus infection.

WARNINGS AND PRECAUTIONS

Infections: An increased risk of infections has been observed with other anti-CD20 B-cell depleting therapies. KESIMPTA has the potential for an increased risk of infections

INDICATION

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.

SEE IMPORTANT SAFETY INFORMATION

INDICATION

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.

IMPORTANT SAFETY INFORMATION

Contraindication: KESIMPTA is contraindicated in patients with active hepatitis B virus infection.

WARNINGS AND PRECAUTIONS

Infections: An increased risk of infections has been observed with other anti-CD20 B-cell depleting therapies. KESIMPTA has the potential for an increased risk of infections including serious bacterial, fungal, and new or reactivated viral infections; some have been fatal in patients treated with other anti-CD20 antibodies. The overall rate of infections and serious infections in KESIMPTA-treated patients was similar to teriflunomide-treated patients (51.6% vs 52.7%, and 2.5% vs 1.8%, respectively). The most common infections reported by KESIMPTA-treated patients in relapsing MS (RMS) trials included upper respiratory tract infection (39%) and urinary tract infection (10%). Delay KESIMPTA administration in patients with an active infection until resolved.

Consider the potential increased immunosuppressive effects when initiating KESIMPTA after an immunosuppressive therapy or initiating an immunosuppressive therapy after KESIMPTA.

Hepatitis B Virus: Reactivation: No reports of hepatitis B virus (HBV) reactivation in patients with MS treated with KESIMPTA. However, HBV reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, has occurred in patients treated with ofatumumab at higher intravenous doses for chronic lymphocytic leukemia (CLL) than the recommended dose in MS and in patients treated with other anti-CD20 antibodies.

Infection: KESIMPTA is contraindicated in patients with active hepatitis B disease. Fatal infections caused by HBV in patients who have not been previously infected have occurred in patients treated with ofatumumab at higher intravenous doses for CLL than the recommended dose in MS. Perform HBV screening in all patients before initiation of KESIMPTA. Patients who are negative for HBsAg and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], should consult liver disease experts before starting and during KESIMPTA treatment.

Progressive Multifocal Leukoencephalopathy: No cases of progressive multifocal leukoencephalopathy (PML) have been reported for KESIMPTA in RMS clinical studies; however, PML resulting in death has occurred in patients being treated with ofatumumab at higher intravenous doses for CLL than the recommended dose in MS. In addition, JC virus infection resulting in PML has also been observed in patients treated with other anti-CD20 antibodies and other MS therapies. If PML is suspected, withhold KESIMPTA and perform an appropriate diagnostic evaluation. If PML is confirmed, KESIMPTA should be discontinued.

Vaccinations: Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines at least 4 weeks and, whenever possible at least 2 weeks prior to starting KESIMPTA for inactivated vaccines. The safety of immunization with live or live-attenuated vaccines following KESIMPTA therapy has not been studied. Vaccination with live or live-attenuated vaccines is not recommended during treatment and after discontinuation until B-cell repletion.

Vaccination of Infants Born to Mothers Treated with KESIMPTA During Pregnancy. For infants whose mother was treated with KESIMPTA during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines. If the B-cell count has not recovered in the infant, do not administer the vaccine as having depleted B-cells may pose an increased risk in these infants.

Injection-Related Reactions: Injection-related reactions with systemic symptoms occurred most commonly within 24 hours of the first injection, but were also observed with later injections. There were no life-threatening injection reactions in RMS clinical studies.

The first injection of KESIMPTA should be performed under the guidance of an appropriately trained health care professional. If injection-related reactions occur, symptomatic treatment is recommended.

Reduction in Immunoglobulins: As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Monitor the levels of quantitative serum immunoglobulins during treatment, especially in patients with opportunistic or recurrent infections and after discontinuation of therapy until B-cell repletion. Consider discontinuing KESIMPTA therapy if a patient with low immunoglobulins develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins.

Fetal Risk: Based on animal data, KESIMPTA can cause fetal harm due to B-cell lymphopenia and reduce antibody response in offspring exposed to KESIMPTA in utero. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. Advise females of reproductive potential to use effective contraception while receiving KESIMPTA and for at least 6 months after the last dose.

Most common adverse reactions (>10%) are upper respiratory tract infection, headache, injection-related reactions, and local injection-site reactions.

Please see full Prescribing Information, including Medication Guide.

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