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
Please see full
Prescribing Information, including Medication Guide.
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