impta. ( 5.4 , 8.1 ) 5.1 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 of these infections have been fatal in patients treated with other anti-cd20 antibodies. in study 1 and study 2 [see clinical studies (14)] , 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). the most common infections reported by kesimpta-treated patients in the randomized clinical 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 the infection is resolved. possible increased risk of immunosuppressant effects with other immunosuppressants when initiating kesimpta after an immunosuppressive therapy or initiating an immunosuppressive therapy after kesimpta, consider the potential for increased immunosuppressive effects [see drug interactions (7.1) and clinical pharmacology (12.2)] . kesimpta has not been studied in combination with other ms therapies. hepatitis b virus reactivation there were 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 being treated with ofatumumab for chronic lymphocytic leukemia (cll) (at higher intravenous doses than the recommended dose in ms but for a shorter duration of treatment) 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 being treated with ofatumumab for cll (at higher intravenous doses than the recommended dose in ms but for a shorter duration of treatment). hbv screening should be performed in all patients before initiation of treatment with kesimpta. at a minimum, screening should include hepatitis b surface antigen (hbsag) and hepatitis b core antibody (hbcab) testing. these can be complemented with other appropriate markers as per local guidelines. for patients who are negative for hbsag and positive for hb core antibody [hbcab+] or are carriers of hbv [hbsag+], consult liver disease experts before starting and during treatment with kesimpta. these patients should be monitored and managed following local medical standards to prevent hbv infection or reactivation. progressive multifocal leukoencephalopathy progressive multifocal leukoencephalopathy (pml) is an opportunistic viral infection of the brain caused by the jc virus (jcv) that typically occurs in patients who are immunocompromised, and that usually leads to death or severe disability. although no cases of pml have been reported for kesimpta in the rms clinical studies, pml resulting in death has occurred in patients being treated with ofatumumab for cll (at substantially higher intravenous doses than the recommended dose in ms but for a shorter duration of treatment). in addition, jcv infection resulting in pml has also been observed in patients treated with other anti-cd20 antibodies and other ms therapies. at the first sign or symptom suggestive of pml, withhold kesimpta and perform an appropriate diagnostic evaluation. magnetic resonance imaging (mri) findings may be apparent before clinical signs or symptoms. typical symptoms associated with pml are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. if pml is confirmed, treatment with kesimpta should be discontinued. vaccinations administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of kesimpta for live or live-attenuated vaccines, and whenever possible, at least 2 weeks prior to initiation of kesimpta for inactivated vaccines. kesimpta may interfere with the effectiveness of 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 [see clinical pharmacology (12.2)] . vaccination of infants born to mothers treated with kesimpta during pregnancy in infants of mothers treated with kesimpta during pregnancy, do not administer live or live-attenuated vaccines before confirming the recovery of b-cell counts. depletion of b-cells in these infants may increase the risks from live or live-attenuated vaccines. inactivated vaccines may be administered, as indicated, prior to recovery from b-cell depletion, but an assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted. 5.2 injection-related reactions in study 1 and study 2, systemic and local injection reactions were reported in 21% and 11% of patients treated with kesimpta compared to 15% and 6% of patients treated with teriflunomide who received matching placebo injections, respectively [see adverse reactions (6.1) and clinical studies (14)] . injection-related reactions with systemic symptoms observed in clinical studies occurred most commonly within 24 hours of the first injection, but were also observed with later injections. symptoms observed included fever, headache, myalgia, chills, and fatigue, and were predominantly (99.8%) mild to moderate in severity. there were no life-threatening injection reactions in the rms clinical studies. local injection-site reaction symptoms observed in clinical studies included erythema, swelling, itching, and pain. only limited benefit of premedication with corticosteroids, antihistamines, or acetaminophen was observed in rms clinical studies. the first injection of kesimpta should be performed under the guidance of an appropriately trained healthcare professional. if injection-related reactions occur, symptomatic treatment is recommended. 5.3 reduction in immunoglobulins as expected with any b-cell depleting therapy, decreased immunoglobulin levels were observed. decrease in immunoglobulin m (igm) was reported in 7.7% of patients treated with kesimpta compared to 3.1% of patients treated with teriflunomide in rms clinical trials [see adverse reactions (6.1)] . treatment was discontinued because of decreased immunoglobulins in 3.4% of patients treated with kesimpta and in 0.8% of patients treated with teriflunomide. no decline in immunoglobulin g (igg) was observed at the end of the study. 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. 5.4 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 [see use in specific populations (8.1)] .

e warnings and precautions (5.3)] . for patients with low serum immunoglobulins, consult immunology experts before initiating treatment with kesimpta. vaccinations because vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation until b-cell repletion, administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of kesimpta for live or live-attenuated vaccines, and whenever possible, at least 2 weeks prior to initiation of kesimpta for inactivated vaccines [see warnings and precautions (5.1)] . 2.2 recommended dosage the recommended dosage of kesimpta is: initial dosing of 20 mg by subcutaneous injection at weeks 0, 1, and 2, followed by subsequent dosing of 20 mg by subcutaneous injection once monthly starting at week 4. missed doses if an injection of kesimpta is missed, it should be administered as soon as possible without waiting until the next scheduled dose. subsequent doses should be administered at the recommended intervals. 2.3 administration instructions administer by subcutaneous injection only. kesimpta is intended for patient self-administration by subcutaneous injection. administer kesimpta in the abdomen, thigh, or outer upper arm subcutaneously. do not give injection into moles, scars, stretch marks, or areas where the skin is tender, bruised, red, scaly, or hard. the first injection of kesimpta should be performed under the guidance of a healthcare professional [see warnings and precautions (5.2)] . kesimpta sensoready ® pens and syringes are for one-time use only and should be discarded after use. see instructions for use for complete administration instructions. 2.4 preparation of kesimpta the kesimpta “instructions for use” for each presentation contains more detailed instructions on the preparation of kesimpta. before administration, remove kesimpta sensoready pen or kesimpta prefilled syringe from the refrigerator and allow kesimpta to reach room temperature for about 15 to 30 minutes. do not remove the needle cover while allowing the prefilled syringe to reach room temperature. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. do not use if the liquid contains visible particles or is cloudy.

impta in clinical studies. in study 1 and study 2, 1882 patients with rms were randomized, 946 of whom were treated with kesimpta for a median duration of 85 weeks; 33% of patients receiving kesimpta were treated for up to 120 weeks [see clinical studies (14.1)] . the most common adverse reactions occurring in greater than 10% of patients treated with kesimpta and more frequently than in patients treated with teriflunomide were upper respiratory tract infections, injection-related reactions (systemic), headache, and injection-site reactions (local). the most common cause of discontinuation in patients treated with kesimpta was low immunoglobulin m (3.3%), defined in trial protocols as igm at 10% below the lower limit of normal (lln). table 1 summarizes the adverse drug reactions that occurred in study 1 and study 2. table 1: adverse reactions in patients with rms with an incidence of at least 5% with kesimpta and a greater incidence than teriflunomide (pooled study 1 and study 2) a 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. adverse reactions kesimpta 20 mg n = 946 % teriflunomide 14 mg n = 936 % upper respiratory tract infections a 39 38 injection-related reactions (systemic) 21 15 headache 13 12 injection-site reactions (local) 11 6 urinary tract infection 10 8 back pain 8 6 blood immunoglobulin m decreased 6 2 injection-related reactions and injection-site reactions the incidence of injection-related reactions (systemic) was highest with the first injection (14.4%), decreasing with subsequent injections (4.4% with second, less than 3% with third injection). injection-related reactions were mostly (99.8%) mild to moderate in severity. two (0.2%) patients treated with kesimpta reported serious injection-related reactions. there were no life-threatening injection-related reactions. most frequently reported symptoms (2% or greater) included fever, headache, myalgia, chills, and fatigue. in addition to systemic injection-related reactions, local reactions at the administration site were very common. local injection-site reactions were all mild to moderate in severity. the most frequently reported symptoms (2% or greater) included erythema, pain, itching, and swelling [see warnings and precautions (5.2)] . laboratory abnormalities immunoglobulins in study 1 and study 2, a decrease in the mean level of igm was observed in kesimpta-treated patients but was not associated with an increased risk of infections [see warnings and precautions (5.3)] . in 14.3% of patients in study 1 and study 2, treatment with kesimpta resulted in a decrease in a serum igm that reached a value below 0.34 g/l. kesimpta was associated with a decrease of 4.3% in mean igg levels after 48 weeks of treatment and an increase of 2.2% after 96 weeks. 6.2 immunogenicity as with all therapeutic proteins, there is potential for immunogenicity. the detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medication, and the underlying disease. for these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other ofatumumab products may be misleading. treatment-induced anti-drug antibodies (adas) were detected in 2 of 914 (0.2%) kesimpta-treated patients; no patients with treatment-enhancing or neutralizing adas were identified. there was no impact of positive ada titers on pk, safety profile or b-cell kinetics in any patient; however, these data are not adequate to assess the impact of adas on the safety and efficacy of kesimpta.

depletion of b-cell populations, and impaired immune function were observed in the offspring, in the absence of maternal toxicity, at plasma levels substantially higher than that in humans ( see data ). in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data intravenous administration of ofatumumab (weekly doses of 0, 20, or 100 mg/kg) to pregnant monkeys during the period of organogenesis (gestations days 20 to 50) resulted in no adverse effects on embryofetal development; however, b-cell depletion was observed in fetuses at both doses when assessed on gestation day 100. plasma exposure (c ave ) at the no-effect dose (100 mg/kg) for adverse effects on embryofetal development was greater than 5000 times that in humans at the recommended human maintenance dose of 20 mg. a no-effect dose for effects on b-cells was not identified; plasma exposure (c ave ) at the low-effect dose (20 mg/kg) was approximately 780 times that in humans at the recommended human maintenance dose (rhmd) of 20 mg/month. intravenous administration of ofatumumab (5 weekly doses of 0, 10, and 100 mg/kg, followed by biweekly doses of 0, 3, and 20 mg/kg) to pregnant monkeys throughout pregnancy resulted in no adverse effects on the development of the offspring. however, postnatal death, b-cell depletion, and impaired immune function were observed in the offspring at the high dose. the deaths at the high dose were considered secondary to b-cell depletion. plasma exposure (c ave ) in dams at the no-effect dose (100/20 mg/kg) for adverse developmental effects was approximately 500 times that in humans at rhmd. a no-effect level for mortality and immune effects in offspring was not established because of the limited number of evaluable offspring at the low dose. 8.2 lactation risk summary there are no data on the presence of ofatumumab in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. human igg is excreted in human milk, and the potential for absorption of ofatumumab to lead to b-cell depletion in the infant is unknown. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for kesimpta and any potential adverse effects on the breastfed infant from kesimpta or from the underlying maternal condition. 8.3 females and males of reproductive potential contraception females of childbearing potential should use effective contraception while receiving kesimpta and for 6 months after the last treatment of kesimpta [see warnings and precautions (5.4) and clinical pharmacology (12.3)] . 8.4 pediatric use safety and effectiveness in pediatric patients have not been established. 8.5 geriatric use clinical studies of kesimpta did not include sufficient numbers of geriatric patients to determine whether they respond differently from younger subjects.

s, and impaired immune function were observed in the offspring, in the absence of maternal toxicity, at plasma levels substantially higher than that in humans ( see data ). in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data intravenous administration of ofatumumab (weekly doses of 0, 20, or 100 mg/kg) to pregnant monkeys during the period of organogenesis (gestations days 20 to 50) resulted in no adverse effects on embryofetal development; however, b-cell depletion was observed in fetuses at both doses when assessed on gestation day 100. plasma exposure (c ave ) at the no-effect dose (100 mg/kg) for adverse effects on embryofetal development was greater than 5000 times that in humans at the recommended human maintenance dose of 20 mg. a no-effect dose for effects on b-cells was not identified; plasma exposure (c ave ) at the low-effect dose (20 mg/kg) was approximately 780 times that in humans at the recommended human maintenance dose (rhmd) of 20 mg/month. intravenous administration of ofatumumab (5 weekly doses of 0, 10, and 100 mg/kg, followed by biweekly doses of 0, 3, and 20 mg/kg) to pregnant monkeys throughout pregnancy resulted in no adverse effects on the development of the offspring. however, postnatal death, b-cell depletion, and impaired immune function were observed in the offspring at the high dose. the deaths at the high dose were considered secondary to b-cell depletion. plasma exposure (c ave ) in dams at the no-effect dose (100/20 mg/kg) for adverse developmental effects was approximately 500 times that in humans at rhmd. a no-effect level for mortality and immune effects in offspring was not established because of the limited number of evaluable offspring at the low dose.

l counts below lln. the cd19+ b-cell counts remained below lln for approximately 97% of patients in study 1 and 92% of patients in study 2 from 12 weeks through 120 weeks while on kesimpta treatment. in a study of bioequivalence using the same dosing regimen as in study 1 and study 2, before initiation of the maintenance phase, total cd19+ b-cell levels below the defined threshold of 10 cells/µl were achieved in 94% of patients starting at week 4 and 98% of patients at week 12. b-cell repletion data from studies 1 and 2 indicate a median time to b-cell recovery to either lln or baseline value of 24.6 weeks post-treatment discontinuation. pk and pd modeling and simulation for b-cell repletion corroborate these data, predicting median time to b-cell recovery to lln of 23 weeks post-treatment discontinuation. 12.3 pharmacokinetics absorption a subcutaneous dose of 20 mg every 4 weeks leads to a mean auc tau of 483 mcg h/ml and a mean c max of 1.43 mcg/ml at steady state. after subcutaneous administration, ofatumumab is believed to be predominantly absorbed via the lymphatic system similarly to other therapeutic monoclonal antibodies. distribution the volume of distribution at steady-state was estimated to be 5.42 l following subcutaneous administration of repeated kesimpta 20 mg dose. elimination ofatumumab is eliminated by both linear catabolic pathways and a non-linear b-cell mediated pathway, resulting in non-constant elimination half-life. initially, a higher baseline b-cell count results in greater b-cell-mediated elimination and shorter ofatumumab half-life. as the b-cells are depleted, the catabolic pathway predominates, resulting in a relatively longer ofatumumab half-life compared to earlier in therapy when both elimination pathways were available. following b-cell depletion, clearance was estimated to be 0.34 l/day following repeated subcutaneous administration of kesimpta 20 mg injections. the half-life at steady state was estimated to be approximately 16 days following subcutaneous administration of repeated kesimpta 20 mg dosage. metabolism ofatumumab is a protein for which the expected metabolic pathway is degradation to small peptides and amino acids by ubiquitous proteolytic enzymes. excretion ofatumumab, a monoclonal antibody, is not likely to undergo renal excretion. specific populations the following population characteristics do not have a clinically meaningful effect on the pharmacokinetics of ofatumumab: body weight, sex, age, race, or baseline b-cell count. patients with renal/hepatic impairment pharmacokinetics of ofatumumab in patients with renal or hepatic impairment have not been studied. drug interaction studies ofatumumab does not share a common clearance pathway with chemical drugs that are metabolized by the cytochrome p450 system or other drug metabolizing enzymes. additionally, there is no evidence that cd20 monoclonal antibodies are involved in the regulation of the expression of drug metabolizing enzymes. interactions between kesimpta and other medicinal products have not been investigated in formal studies.

ance was estimated to be 0.34 l/day following repeated subcutaneous administration of kesimpta 20 mg injections. the half-life at steady state was estimated to be approximately 16 days following subcutaneous administration of repeated kesimpta 20 mg dosage. metabolism ofatumumab is a protein for which the expected metabolic pathway is degradation to small peptides and amino acids by ubiquitous proteolytic enzymes. excretion ofatumumab, a monoclonal antibody, is not likely to undergo renal excretion. specific populations the following population characteristics do not have a clinically meaningful effect on the pharmacokinetics of ofatumumab: body weight, sex, age, race, or baseline b-cell count. patients with renal/hepatic impairment pharmacokinetics of ofatumumab in patients with renal or hepatic impairment have not been studied. drug interaction studies ofatumumab does not share a common clearance pathway with chemical drugs that are metabolized by the cytochrome p450 system or other drug metabolizing enzymes. additionally, there is no evidence that cd20 monoclonal antibodies are involved in the regulation of the expression of drug metabolizing enzymes. interactions between kesimpta and other medicinal products have not been investigated in formal studies.

-study criteria were met. the maximal duration of treatment for an individual patient was 120 weeks. neurologic evaluations were performed at baseline, every 3 months during blinded treatment, and at the time of a suspected relapse. brain mri scans were performed at baseline, 1 year and 2 years. the primary endpoint of both trials was the annualized relapse rate (arr) over the treatment period. additional outcome measures included: 1) the time to 3-month confirmed disability progression for the pooled populations, 2) the number of t1 gde lesions per scan at weeks 48 and 96, and 3) the annualized rate of new or enlarging t2 mri lesions. disability progression was defined as an increase in edss of at least 1.5, 1, or 0.5 points in patients with a baseline edss of 0, 1 to 5, or 5.5 or greater, respectively. in study 1, a total of 927 patients were randomized to receive kesimpta (n = 465) or teriflunomide (n = 462). of those randomized to kesimpta, 90% completed the study; of those randomized to teriflunomide, 81% completed the study. demographics and disease characteristics were balanced across treatment arms. the mean age was 38 years, 89% were white, and 69% were female. the mean time since ms diagnosis was 5.7 years and the median edss score at baseline was 3.0; 60% had been treated with a non-steroid therapy for ms. at baseline, the mean number of relapses in the previous year was 1 and the mean number of t1 gde lesions on mri scan was 1.5. in study 2, a total of 955 patients were randomized to receive kesimpta (n = 481) or teriflunomide (n = 474). of those randomized to kesimpta, 83% completed the study; of those randomized to teriflunomide, 82% completed the study. demographics and disease characteristics were balanced across treatment arms. the mean age was 38 years, 87% were white, and 67% were female. the mean time since ms diagnosis was 5.5 years and the median edss score at baseline was 2.5; 61% had been treated with a non-steroid therapy for ms. at baseline, the mean number of relapses in the previous year was 1.3, and the mean number of t1 gde lesions on mri scan was 1.6. in both studies, kesimpta significantly lowered the arr compared to teriflunomide. kesimpta significantly reduced the risk of 3-month confirmed disability progression compared to teriflunomide. kesimpta significantly reduced the number of t1 gde lesions and the rate of new or enlarging t2 lesions in both studies. key results for study 1 and study 2 are presented in table 2 and figure 1. table 2: key clinical and mri endpoints from study 1 and study 2 a disability progression was defined as an increase in edss of at least 1.5, 1, or 0.5 points in patients with a baseline edss of 0, 1 to 5, or 5.5 or greater, respectively. b prospective pooled analysis of studies 1 and 2. proportion of patients with 3-month confirmed disability progression refers to kaplan-meier estimates at month 24. study 1 study 2 endpoints kesimpta 20 mg (n = 465) teriflunomide 14 mg (n = 462) kesimpta 20 mg (n = 481) teriflunomide 14 mg (n = 474) clinical endpoints annualized relapse rate (primary endpoint) 0.11 0.22 0.10 0.25 relative reduction 51% ( p < 0.001) 58% ( p < 0.001) proportion of patients with 3-month confirmed disability progression a,b relative risk reduction 10.9% kesimpta vs 15.0% teriflunomide 34.3% ( p = 0.003) mri endpoints mean number of t1 gd-enhancing lesions per mri scan 0.01 0.46 0.03 0.52 relative reduction 98% ( p < 0.001) 94% ( p < 0.001) number of new or enlarging t2 lesions per year 0.72 4.00 0.64 4.16 relative reduction 82% ( p < 0.001) 85% ( p < 0.001) figure 1: time to first 3-month confirmed disability progression by treatment full analysis set a similar effect of kesimpta on the key efficacy results compared to teriflunomide was observed across the two studies in exploratory subgroups defined by sex, age, body weight, prior non-steroid ms therapy, and baseline disability and disease activity. figure 1: time to first 3-month confirmed disability progression by treatment full analysis set

the refrigerator and must be used within the next 7 days or discarded after 7 days.

any symptoms suggestive of pml. inform the patient that typical symptoms associated with pml are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes [see warnings and precautions (5.1)] . vaccinations advise patients to complete any required live or live-attenuated vaccinations at least 4 weeks and, whenever possible at least 2 weeks, prior to initiation of kesimpta for inactivated vaccines. administration of live-attenuated or live vaccines is not recommended during kesimpta treatment and until b-cell recovery [see warnings and precautions (5.1)] . injection-related reactions inform patients about the signs and symptoms of injection-related reactions, and that these reactions generally occur within 24 hours and predominantly following the first injection. advise patients to contact their healthcare provider if they experience signs or symptoms of injection-related reactions [see warnings and precautions (5.2)] . contraception advise females of childbearing potential to use effective contraception while receiving kesimpta and for 6 months after the last treatment of kesimpta [see warnings and precautions (5.4) and use in specific populations (8.3)] . instruction on injection technique patients or caregivers should be instructed by a healthcare professional on how to administer kesimpta [see instructions for use] . instruct patients or caregivers in the technique of proper syringe and needle disposal, and advise them not to reuse these items. instruct patients to inject the full amount of kesimpta according to the directions provided in the instructions for use. dispose of pens and syringes in a puncture-resistant container. manufactured by: novartis pharmaceuticals corporation east hanover, nj 07936 u.s. license no.: 1244 kesimpta and sensoready are [registered] trademarks of novartis ag. t2022-52