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.

Dosing & Administration

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

Self-Administration at Home

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KESIMPTA offers the flexibility of a self-administered B-cell therapy, with the subcutaneous Sensoready® Pen, for a treatment that can be taken at home or anywhere1-4*

*The initial dosing period consists of 20 mg subcutaneous doses at Weeks 0, 1, and 2. KESIMPTA Sensoready® Pens must be refrigerated at 2ºC to 8ºC (36ºF to 46ºF). Keep product in the original carton to protect from light until the time of use. Do not freeze. To avoid foaming do not shake. KESIMPTA does not contain a preservative.

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A subcutaneous route of administration may offer2-4:

  • No need for an infusion center
  • Less time in the clinic
  • Decreased health care costs

Potential for decreased health care costs as measured by administration-related services in the form of deductibles, copays, and coinsurance when compared to infusion therapy.4

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Getting Started With KESIMPTA

  • The use of premedication is not required1
  • Prior to initiating KESIMPTA, perform hepatitis B virus (HBV) screening, test for quantitative serum immunoglobulins, and vaccinate (at least 4 weeks prior for live or live-attenuated vaccines and at least 2 weeks prior for inactivated vaccines)
  • The first injection should be performed under the guidance of a health care professional
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Dosing Regimen

After initial dosing, KESIMPTA is administered once monthly1

Dosing chart and Sensoready® pen. Dosing chart and Sensoready® pen.

Additional dosing information

First Dose
The first injection should be performed under the guidance of a health care professional.

Missed Doses
Administer as soon as possible without waiting until the next scheduled dose; subsequent doses should be administered at the recommended intervals.

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Health Professional Training Video

Teach patients to self-administer KESIMPTA with the Sensoready® Pen.

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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RMS=relapsing multiple sclerosis.

References:

1. Kesimpta [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2020.
2. De Cock E, Kritikou P, Sandoval M, et al. Time savings with rituximab subcutaneous injection versus rituximab intravenous infusion: a time and motion study in eight countries. PLoS One. 2016;11(6): e0157957. doi:10.1371/journal.pone.0157957.
3. Rummel M, Kim TM, Aversa F, et al. Preference for subcutaneous or intravenous administration of rituximab among patients with untreated CD20+ diffuse large B-cell lymphoma or follicular lymphoma: results from a prospective, randomized, open-label, crossover study (PrefMab). Ann Oncol. 2017;28(4):836-842.
4. Data on file. Dieguez G, Engel T, Jacobson N; for Novartis Pharmaceuticals Corporation. Site of service and cost dispersion of infused drugs: a case study of patients with multiple sclerosis. Milliman white paper. Novartis Pharmaceuticals Corp; East Hanover, NJ. December 2019.

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.