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.

Demonstrated Safety Profile

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

Adverse Reactions

Safety across pooled ASCLEPIOS I and II studies1

Adverse reactions in patients with RMS with an incidence of at least 5% with KESIMPTA and a greater incidence than teriflunomide.

Adverse Reactions chart Adverse Reactions chart

Includes the following: nasopharyngitis, upper respiratory tract infection, influenza, sinusitis, pharyngitis, rhinitis, viral upper respiratory infection, tonsillitis, acute sinusitis, pharyngotonsillitis, laryngitis, pharyngitis streptococcal, viral rhinitis, sinusitis bacterial, tonsillitis bacterial, viral pharyngitis, viral tonsillitis, chronic sinusitis, nasal herpes, tracheitis.

In clinical trials, systemic injection reactions with Kesimpta occurred most commonly within 24 hours of the first injection, but were also observed with later injections.

The overall rate of infections and serious infections in patients treated with KESIMPTA was similar to patients who were treated with teriflunomide (51.6% vs 52.7%, and 2.5% vs 1.8%, respectively).1

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Tolerability Profile

Safety across pooled ASCLEPIOS I and II studies1,2

  • In the Phase 3 pivotal clinical studies, 51.6% of KESIMPTA-treated patients experienced at least one infection compared to 52.7% of teriflunomide-treated patients
  • Injection-related reactions (systemic) and injection-site reactions (local) were reported in 21% and 11% of patients treated with KESIMPTA, respectively compared to 15% and 6% in the teriflunomide treated patients
  • The incidence of injection-related reactions (systemic) was highest with the first injection (14.4%), decreasing significantly with subsequent injections (4.4% with second, <3% from third injection)
  • Injection-related reactions were mostly (99.8%) mild to moderate in severity. Two (0.2%) KESIMPTA-treated RMS patients reported serious injection-related reactions

Treatment Discontinuations

Pooled data from ASCLEPIOS I and II studies

  • Pooled data from both clinical trials show that treatment discontinuation rates due to adverse events were similar between KESIMPTA (5.7%) and teriflunomide (5.2%)2
  • The most common cause of discontinuation in patients treated with KESIMPTA was low IgM (3.3%), defined in trial protocols as IgM at 10% below the LLN1
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Immunoglobulin Levels in Phase 3 Clinical Studies

Average IgG/IgM levels remained within reference range and comparable to teriflunomide in Phase 3 clinical studies3

Immunoglobulin G

No decline in IgG was observed at the end of the ASCLEPIOS trials.1,3*

Immunoglobulin M

In 14.3% of patients in RMS Phase 3 clinical studies, treatment with KESIMPTA resulted in a decrease in IgM that reached a value below 0.34 g/dL.1

The decrease in mean levels of IgM The decrease in mean levels of IgM

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.1

Average IgG levels remained well within the reference ranges (patients aged between 16-19 years: 5.49-15.84 g/L; patients aged >19 years: 7.00-16.00 g/L). Average IgM levels remained well within the reference ranges (patients aged between 16-19 years: 0.23-2.59 g/L; patients aged >19 years: 0.40-2.30 g/L).3

*Serum IgG/IgM levels were monitored at baseline, Weeks 4 and 12, and every 12 weeks thereafter (KESIMPTA, n=946; teriflunomide, n=936).3

Study Design

ASCLEPIOS I and II were 2 identical, double-blind, active comparator-controlled, parallel-group, multicenter, Phase 3 studies in patients with RMS, approximately 40% of whom were DMT treatment naïve. Patients were randomized to double-dummy subcutaneous KESIMPTA (20 mg every 4 weeks) or oral teriflunomide (14 mg daily) for up to 30 months. Primary endpoint was ARR. Key MRI endpoints were number of Gd+ T1 lesions, and annualized rate of new or enlarging T2 lesions. A key clinical endpoint was reduction in risk of 3-month CDP. Treatment duration was variable based on end of study criteria. Maximum duration 120 weeks, median duration 85 weeks.1

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Dosing & Administration>

ARR=annualized relapse rate; CDI=confirmed disability improvement; CDP=confirmed disability progression; DMT=disease-modifying therapy; Gd+=gadolinium-enhancing; IgG=immunoglobulin G; IgM=immunoglobulin M; LLN=lower limit of normal; RMS=relapsing multiple sclerosis.

References:

1. Kesimpta [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2020.
2. Data on file. OMB157G (ofatumumab). Summary of clinical safety. Novartis Pharmaceuticals Corp; East Hanover, NJ. January 2020.
3. de Seze J, Bar-Or A, Correale J, et al. Effect of ofatumumab on serum immunoglobulin levels and infection risk in relapsing multiple sclerosis patients from the phase 3 ASCLEPIOS I and II trials. Poster presented at the 6th Congress of the European Academy of Neurology; May 23-26, 2020; Virtual Congress.

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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