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UNDERSTANDING SAFETY

Before you start any treatment, it's important to understand the safety profile and potential side effects.

PROVEN SAFETY PROFILE

KESIMPTA was studied in 2 head-to-head studies vs AUBAGIO® (teriflunomide).

• Few people stopped treatment due to side effects: comparable to AUBAGIO: 5.7% for KESIMPTA, 5.2% for AUBAGIO

• Mild to moderate injection-related reactions: 99.8% of injection-related reactions were mild to moderate. They were most common in the first injection and decreased to less than 3% after the 3rd dose

*A type of study where participants are aware of the type of treatment they're being given. Interpreting results from open-label studies can be uncertain. They are not considered representative results, since participants chose whether to stay in the trial.
^†After the original KESIMPTA studies, over 1700 people continued to participate for further evaluation, where they all took KESIMPTA. The goal of this extended study was to learn about the safety and tolerability of KESIMPTA in the long term, with a focus on injection–related reactions, malignancies, and serious infections for up to 6 years. No conclusions of clinical outcomes can be drawn. (September 25, 2023 data cut-off date.)

POTENTIAL SIDE EFFECTS 

KESIMPTA could increase the risk of serious, including life-threatening or fatal, infections:

• Hepatitis B virus (HBV) reactivation: Before starting KESIMPTA, you’ll get a blood test for HBV. If you’ve ever had HBV infection, it may become active again during or after 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, and can result in death or severe disability. While no cases of PML were reported in RMS clinical trials with KESIMPTA, it could happen.

Other serious side effects are:

• Local injection-site reactions: Symptoms include redness, pain, itching, and swelling.

• Injection-related reactions (systemic): Symptoms include fever, headache, pain in the muscles, chills, tiredness, rash, hives, trouble breathing, swelling of the face, eyelids, lips, mouth, tongue and throat, and feeling faint, or chest tightness.

• Low immunoglobulins: KESIMPTA may decrease some types of antibodies. Your doctor will do blood tests to check your immunoglobulin levels.

HERE'S WHAT'S MOST COMMON

THINGS TO TELL YOUR DOCTOR

Before you take KESIMPTA, it's important to tell your doctor if you have any infections, or if you:

• Have or think you have HBV or PML

• Have taken or plan to take medication that affects your immune system

• Had a recent vaccination or have one scheduled

• Are pregnant, think you may be, or are planning to be. There is a registry for women who become pregnant during treatment with KESIMPTA. For more information or to register, visit MotherToBaby, ↗ call 1-877-311-8972 or send an email to [email protected] ↗

• Are breastfeeding or plan to

All people shown on this webpage are living with relapsing multiple sclerosis, have taken KESIMPTA, and have been compensated for their time. 
RMS, relapsing multiple sclerosis.
^‡Limitations apply. Offer not valid under Medicare, Medicaid, or any other federal or state health insurance program. Patients with commercial insurance who are initially denied coverage may receive free KESIMPTA for up to 12 months while seeking coverage. Patients with commercial insurance who have coverage for KESIMPTA may receive up to $18,000 in annual co-pay benefits. Novartis reserves the right to rescind, revoke, or amend this program without notice. Additional limitations may apply. See complete Terms & Conditions at start.kesimpta.com.
^§2023 data on file.