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This information is intended for US health care professionals only.
This information is intended for US health care professionals only.
Douglas Jeffery, MD, and Stephanie Niemi-Olson, FNP
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Stephanie Niemi-Olson, FNP, and Douglas Jeffery, MD, share their family planning approaches for women taking KESIMPTA in light of scarce data on DMTs in pregnancy and breastfeeding.
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Stephanie
* How do you incorporate family planning into choice of therapy? How do you advise patients on the risks of disease-modifying therapy, or DMT, exposure during pregnancy?
* As we know, two-thirds of people with multiple sclerosis are female. When I work with patients to choose a therapy for their treatment goals, family planning receives special attention in my practice. However, there is a paucity of data on how RMS treatments can affect pregnancy and breastfeeding.
Let's look at what we know for KESIMPTA. Dr Jeffery, how do you have this conversation with your patients?
Dr Jeffery
Thanks, Stephanie. I appreciate it when my younger patients on KESIMPTA tell me they want to start a family, but in my experience, they rarely bring it up themselves. Because of this, I tend to initiate the conversation, because if they are considering pregnancy, we also have to consider nutrition, what other drugs they may be taking, etc, so I can effectively manage them.
Stephanie
* That's why I have that family planning conversation with the patient before starting any RMS medications, including KESIMPTA, which is indicated for the treatment of relapsing forms of MS, or RMS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
* You can see Important Safety Information on KESIMPTA within this video and on the adjacent panel. The full Prescribing Information is also linked in the adjacent panel with the Important Safety Information.
To me, planning a pregnancy means using contraception until the patient decides to start trying, and up to 6 months after their last dose of KESIMPTA. My practice recommends patients stop taking KESIMPTA when they're ready to conceive, for safety purposes.
Stephanie
* The KESIMPTA prescribing information recommends using effective contraception for at least 6 months after stopping KESIMPTA before trying to get pregnant.
Dr Jeffery
* I take a similar approach.
* I see my patients every 3 months when they are off medication and trying to conceive. In my practice, we monitor and treat for relapse in that time frame before they get pregnant.
* As mentioned, I would not have a patient who wants to become pregnant taking KESIMPTA. However, there are times when my patients become pregnant and it's unplanned. For these patients, I would tell them to stop taking KESIMPTA right away and that we will monitor them regularly.
* I have to bring up that there's potential harm to the fetus based on animal data. In humans, there was some B-cell depletion and lymphocytopenia reported in infants exposed to anti-CD20 B-cell–depleting antibodies other than KESIMPTA during pregnancy, and those effects were transient.
* I also mention that there is a safety database that monitors pregnancy outcomes after exposure to KESIMPTA during pregnancy and I share the available registry data with my patients.
Stephanie
* All good points. I also have my patients discontinue KESIMPTA during pregnancy because there are no adequate data on the developmental risk associated with the use of KESIMPTA in pregnant women.
* My patients' main concerns are whether KESIMPTA is safe, if it will cause birth defects, or if it will affect the baby's immune system. I tell the person that we will enroll them in the safety database and share the data that you mentioned.
* In my practice, depending on how nervous our patients are, we will see them a little extra, every 3 months or so. I tell my pregnant patients we will do exams to make sure there are no physical changes, talk to them about their symptoms, and address any concerns about relapses.
I also recommend they follow up with a high-risk OB/GYN for extra monitoring.
Dr Jeffery
* If the patient is very nervous, sharing the data we have and offering the reassurance that we will remain vigilant tends to help ease those concerns. So Stephanie, after your patient's baby is born, how do you guide patients who want to breastfeed?
Stephanie
* There are a lot of unknowns here. Though human IgG is excreted in human milk, there are no data on the presence of KESIMPTA in human milk or its effects on the breastfed infant, and no data on the potential to lead to B-cell depletion in the infant. There are also no data on the degree of KESIMPTA absorption by the infant, for example through the GI tract.
* Instead, we have to balance the risk of relapse with that of breastfeeding while taking DMT, so what we decide ultimately depends on what the patient wants and needs. I do typically recommend to women with RMS who want to breastfeed to do so. But for safety purposes, in my practice, we typically decide to restart medication after they're done breastfeeding.
* However, some women don't want to risk another relapse and prefer to restart KESIMPTA right away after delivery. Others want to be very careful and prefer to restart medication after they've done breastfeeding and monitor for relapses in the meantime. In that case, if there is a relapse, I would recommend immediately restarting KESIMPTA.
Either way, we recommend follow-up with magnetic resonance imaging, or MRI, after delivery to monitor disease activity during breastfeeding.
Dr Jeffery
* You're right that we technically don't have enough information about the safety of breastfeeding while people are on KESIMPTA.
* We do have to be careful about breastfeeding while taking KESIMPTA, though in my experience, I tend to start patients back on KESIMPTA after delivery. This is because relapsing MS disease activity begins to increase postpartum and returns to prepregnancy rates approximately 4-6 months postpartum.
Ultimately, it's a judgment call. According to the Prescribing Information, the developmental and health benefits of breastfeeding for the child should be considered along with the clinical need for KESIMPTA.
Stephanie
* It's definitely a decision that should be made in consultation with the patient.
* Dr Jeffery, I think you'd agree that another pressing concern patients have is how KESIMPTA affects the risk of infections. What do you tell patients who are worried about these things?
IMPORTANT SAFETY INFORMATION
Infections
* Delay KESIMPTA administration in patients with an active infection until the infection is resolved. Vaccination with live-attenuated or live vaccines is not recommended during treatment with KESIMPTA and after discontinuation, until B-cell repletion
Injection-Related Reactions
* Management for injection-related reactions depends on the type and severity of the reaction
Reduction in Immunoglobulins
* Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with KESIMPTA until B-cell repletion. Consider discontinuing KESIMPTA if a patient develops a serious opportunistic infection or recurrent infections if immunoglobulin levels indicate immune compromise
Fetal Risk
* May cause fetal harm based on animal data. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for at least 6 months after the last dose.
KESIMPTA Important Safety Information | Click here for full Prescribing Information, including Medication Guide.
KESIMPTA Important Safety Information | Click here for full Prescribing Information, including Medication Guide. ▾
IMPORTANT SAFETY INFORMATION
Contraindications: KESIMPTA is contraindicated in patients with active hepatitis B virus (HBV) infection, or history of hypersensitivity to ofatumumab, or life-threatening injection-related reaction to KESIMPTA. Hypersensitivity reactions have included anaphylaxis and angioedema.
WARNINGS AND PRECAUTIONS
Infections: Serious, including life-threatening or fatal, bacterial, fungal, and new or reactivated viral infections have been observed during and following completion of treatment with anti-CD20 B-cell depleting therapies.
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.
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
Contraindications: KESIMPTA is contraindicated in patients with active hepatitis B virus (HBV) infection, or history of hypersensitivity to ofatumumab, or life-threatening injection-related reaction to KESIMPTA. Hypersensitivity reactions have included anaphylaxis and angioedema.
Warnings and Precautions
Infections: Serious, including life-threatening or fatal, bacterial, fungal, and new or reactivated viral infections have been observed during and following completion of treatment with anti-CD20 B-cell depleting therapies. 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 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 and Hypersensitivity Reactions: KESIMPTA can result in systemic injection-related reactions and hypersensitivity reactions, which may be serious or life-threatening. 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.
In the post-marketing setting, additional systemic injection-related reactions and hypersensitivity reactions have been reported, including anaphylaxis, angioedema, pruritus, rash, urticaria, erythema, bronchospasm, throat irritation, oropharyngeal pain, dyspnea, pharyngeal or laryngeal edema, flushing, hypotension, dizziness, nausea, and tachycardia. Most cases were not serious and occurred with the first injection. Symptoms of systemic injection-related reactions may be clinically indistinguishable from acute hypersensitivity reactions.
The first injection of KESIMPTA should be performed under the guidance of an appropriately trained health care professional. If systemic injection-related reactions occur, initiate appropriate therapy. Patients who experience symptoms of systemic injection-related reactions or hypersensitivity reactions with KESIMPTA should be instructed to seek immediate medical attention. If local 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.
Liver Injury: Clinically significant liver injury, without findings of viral hepatitis, has been reported in the post-marketing setting. Signs of liver injury have occurred weeks to months after administration. Patients treated with KESIMPTA found to have an alanine aminotransferase or aspartate aminotransferase greater than 3 times the upper limit of normal (ULN) with serum total bilirubin greater than 2 times the ULN are potentially at risk for severe drug-induced liver injury.
Obtain liver function tests prior to initiating treatment. Monitor for signs and symptoms of hepatic injury during treatment, including new or worsening fatigue, anorexia, nausea, vomiting, right upper abdominal discomfort, dark urine, or jaundice. If symptoms of liver injury are reported, measure serum aminotransferases, alkaline phosphatase, and bilirubin levels. Discontinue KESIMPTA if liver injury is present and an alternative etiology is not identified.
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: 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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