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-...

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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.

Access and Support

Make KESIMPTA your 1st choice for RMS Make KESIMPTA your 1st choice for RMS

Tools for Your Practice

The resources you need to make KESIMPTA part of your practice

ALONGSIDE is a trademark of Novartis AG. CoverMyMeds and the CoverMyMeds logo are registered trademarks of CoverMyMeds, LLC.

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Interactive Prescribing Information

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See our educational videos about KESIMPTA and the Sensoready® Pen

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Call 1-855-537-4678 for assistance or questions about how to enroll. Support is available 8:30 am to 8:00 pm ET, Monday through Friday.

Which of your patients may be ready for KESIMPTA? 

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Which of your patients may be ready for KESIMPTA? 

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Frequently Asked Questions

How does KESIMPTA work?

The precise mechanism by which ofatumumab exerts its therapeutic effects in multiple sclerosis is unknown, but is presumed to involve binding to CD20, a cell surface antigen present on pre-B and mature B lymphocytes. Following cell surface binding to B lymphocytes, ofatumumab results in antibody-dependent cellular cytolysis and complement-mediated lysis.1

In which types of patients with RMS is KESIMPTA appropriate? 

KESIMPTA is indicated for the treatment of adult patients with relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. 

KESIMPTA was studied in a broad range of patients in two Phase 3 clinical trials.

  • Approximately 40% of patients in KESIMPTA clinical studies were DMT-treatment naïve
  • The study population included patients 18-55 years of age with an EDSS score of 0 to 5.5.1,2

What is CDP?

A key clinical outcome measured in the pivotal studies was confirmed disability progression (CDP). Disability progression was defined as an increase in EDSS of at least 1.5, 1, or 0.5 points in patients with a baseline EDSS of 0, 1 to 5, or 5.5 or greater, respectively.

Can I provide samples to any patient? 

Samples can be provided to any KESIMPTA patient, but consider your patients’ access scenario:

  • Commercially insured patients start treatment immediately with the KESIMPTA Access Card—they’ll avoid insurance delays and get a $0 copay. Remind them to use the samples provided for initial dosing and the medication they receive in the mail for their monthly dosing
  • Alongside™ KESIMPTA will work to secure coverage prior to dispensing paid product to government-insured or uninsured patients so they can get started as quickly as possible

What injection training support does Novartis offer?

As the first injection of KESIMPTA should be performed under the guidance of a health care professional, it is up to the discretion of the HCP to determine how to monitor their patients.1

Alongside KESIMPTA offers supplemental resources and flexible assistance to patients on how to administer KESIMPTA—fitting into their needs via:

  • Quick Tips for Use brochure (sent to patient’s home with Welcome Package)
  • On-demand training videos at KESIMPTA.com
  • Virtual injection training (eg, video chat) by nurses
  • In-home injection training by nurses

How can I order in-home supplemental training?

Simply check the "supplemental injection demonstration" box on the Start Form.

Were there any cases of hepatitis B observed with KESIMPTA?

No cases of hepatitis B virus (HBV) reactivation were identified in KESIMPTA clinical studies. Hepatitis B reactivation has occurred in patients treated with anti-CD20 antibodies, which in some cases resulted in fulminant hepatitis, hepatic failure, and death. Patients with active hepatitis B disease should not be treated with KESIMPTA. All patients should be screened for hepatitis B before starting KESIMPTA.

What COVID-19 safety protocols are in place for in-home injection training?

Twenty-four hours prior to the scheduled appointment, in-home nurses will call the patient to confirm the appointment, and will run through several COVID-19 screening questions:

  • Do you have a fever?
  • Do you have a cough or shortness of breath?
  • Does anyone in your household have a fever, cough, or shortness of breath?
  • In the past 2 weeks, have you been exposed to anyone who has COVID-19?

If the patient answers “Yes” to any of these questions, the appointment will be rescheduled. Nurses will also self-assess with the above questions; if the nurse answers “Yes” to any of the above questions, the appointment will be rescheduled, and the patient may be assigned to a different nurse. All nurses will be equipped with the following PPE for any in-home appointments:

  • Gown
  • Gloves
  • Alcohol wipes
  • Face masks
  • Face shields
  • Shoe covers

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DMT=disease-modifying therapy; EDSS=Expanded Disability Status Scale; MS=multiple sclerosis; RMS=relapsing multiple sclerosis; SPMS=secondary progressive multiple sclerosis.

References:

1. Kesimpta [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2020.
2. Hauser SL, Bar-Or A, Cohen JA, et al, for the ASCLEPIOS I and ASCLEPIOS II trial groups. Ofatumumab versus teriflunomide in multiple sclerosis. N Engl J Med. 2020;383(6):546-557.

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.

KESIMPTA, the KESIMPTA logo, and SENSOREADY are registered trademarks of Novartis AG.