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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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Douglas Jeffery, MD, and Stephanie Niemi-Olson, FNP, share how they explain to their patients how select adverse events such as PML and cancer risk are managed during therapy with KESIMPTA.
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Stephanie
When I start a patient on KESIMPTA for relapsing multiple sclerosis, or RMS, I typically review the common adverse events and the relevant warnings and precautions, including infections, hepatitis B virus, progressive multifocal leukoencephalopathy, vaccination, injection-related reactions, reduction in immunoglobulins, fetal risk, and rare side effects. However, I've noticed that my patients often have difficulty estimating the likelihood of experiencing some of these rare side effects, and that estimation may influence their treatment choices. I believe it is important to provide my patients with an accurate risk assessment and encourage them to remain vigilant so that they feel their care plan adequately addresses these concerns.
Dr Jeffery
* In my experience, cancer and progressive multifocal leukoencephalopathy, or PML, are 2 rare side effects that patients, when researching disease-modifying therapy, or DMT, typically come across and ask me about.
* Stephanie, what do you tell your patients about these risks?
Stephanie
* Well cancer risk is one of the most common questions I get about DMT side effects, especially since there is an overall higher risk of skin cancer here in Arizona where I practice.
I let patients know that the KESIMPTA Phase 3 studies did report some risk of cancer. Neoplasms were reported in 0.5% or 5 total patients taking KESIMPTA, and 0.4% or 4 total patients taking teriflunomide.
Stephanie
* As a reminder, 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.
You can see Important Safety Information on KESIMPTA within this video and on the adjacent panel.
Stephanie
* The other important thing is to remind patients to do their due diligence with cancer screening to catch it early. I highly recommend patients to remember to get their skin and breast cancer exams per standard guidelines, especially if breast cancer runs in their family. And if the patient is an older male, I also recommend them to get their prostate exams done.
As for PML, we usually begin discussing the risks in broad strokes in the first couple of visits. But after patients have been on medications for a while, they tend to bring up PML themselves because by then they have already read about it. I try to reassure them by explaining how we monitor for it and encourage patients to bring back questions and keep the lines of communication open.
Dr Jeffery
* When patients bring up PML, I explain to them that there have been no reported cases of PML occurring on KESIMPTA. PML resulting in death was seen in CLL at substantially higher intravenous doses than the recommended dose in relapsing MS but for a shorter duration of treatment.
* Stephanie, you mentioned that you also monitor for PML. How do you monitor for PML in your practice?
Stephanie
* When I begin screening patients to start them on a DMT, I explain all the tests I am running. In my own practice, I like to know what their titer levels for John Cunningham virus, or JCV, are, regardless of which DMT is being considered, so that we can be aware of their potential risk of having PML.
* That is also when I tell them that JCV is quite common and that PML may happen. JCV infection resulting in PML has also been observed in patients treated with other anti-CD20 antibodies and other MS therapies.
However, even if they are JCV positive, we would continue to offer KESIMPTA while still being conscious of their risk of PML. If the patient comes in with new or unusual symptoms, and we know that there is a high JCV count in the background, then we do an MRI and look for evidence of PML. According to the KESIMPTA Prescribing Information, at the first sign or symptom suggestive of PML, withhold KESIMPTA and perform an appropriate diagnostic evaluation.
Dr Jeffery
I like your explanation, Stephanie. We've been talking a lot about how we address our patients' safety concerns, but my younger patients who want to start a family tend to have a different set of questions and considerations when it comes to KESIMPTA. I'd love to hear your perspective on how you manage relapsing MS during pregnancy...
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 six 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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