KESIMPTA ofatumumab 20 mg/.4mL Injection, Solution, 1 syringe
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the CD20-directed Cytolytic Antibody class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Ofatumumab injection is used to treat certain types of chronic lymphocytic leukemia (CLL; a type of cancer of the white blood cells). Ofatumumab injection is in a class of medications called monoclonal antibodies. It works by killing cancer cells. Ofatumumab is also available as an injection (Kesimpta®) that is used to treat multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control). This monograph only gives information about ofatumumab injectio...
Read the full MedlinePlus article ↗- Ofatumumab — sold as Kesimpta — is used to treat relapsing forms of multiple sclerosis in adults. That includes relapsing-remitting MS, clinically isolated syndrome (a first MS-lik...
- What exactly is this medication used for?
- It's a subcutaneous injection — a small shot you give yourself under the skin, much like an insulin pen. You start with three injections in the first two weeks (at weeks 0, 1, and...
- How do I actually take it — is it a pill or a shot?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Ofatumumab — tap one for details:
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Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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4.000 mg / 0.4 mL
UNII 94ZLA3W45F
Arginine is an amino acid used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level and stability of liquid formulations.
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0.007 mg / 0.4 mL
UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
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5.5 mg / 0.4 mL
UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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0.080 mg / 0.4 mL
UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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2.722 mg / 0.4 mL
UNII 4550K0SC9B
Sodium acetate is a salt derived from acetic acid. It acts as a buffer to help maintain the medicine's pH stability and may serve as a preservative or solubilizer in liquid formulations.
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1.192 mg / 0.4 mL
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
7 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $24,380.200 | $9,752.08 / 0.4 ml |
| Medicaid paysCMS SDUD · 12 mo | $22,549.33 | $9,019.73 / 0.4 ml |
| Medicare drug plans payPart D · Q2 2026 | $24,424.64 | $9,769.86 / 0.4 ml |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Kesimpta 20 mg/.4mLthis 00078-1007-68 | Novartis | 1 syringe | $24,380.200 | — | Availability likely | — |
Where does this data come from?
⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 00078-1007-68 You're viewing this | 1 SYRINGE, GLASS in 1 CARTON (0078-1007-68) / .4 mL in 1 SYRINGE, GLASS | $24,380.20 / mL | $9,752.08 | 2020-08-20 | Active |
| 00078-1007-98 | 1 SYRINGE, GLASS in 1 CARTON (0078-1007-98) / .4 mL in 1 SYRINGE, GLASS | — | — | 2020-08-20 | Active |
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 00078-1007-68?
What is the difference between NDC 00078-1007-68 and NDC 00078-1007-98?
What NDC number is used to bill for this package of KESIMPTA ofatumumab 20 mg/.4mL Injection, Solution?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE 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. KESIMPTA is a CD20-directed cytolytic antibody 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. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Before initiating KESIMPTA, screen for Hepatitis B virus (HBV) and obtain serum quantitative immunoglobulins, aminotransferases, alkaline phosphatase, and bilirubin. ( 2.1 ) Administer KESIMPTA by subcutaneous injection only. ( 2.2 , 2.3 ) Initial Dosing: 20 mg administered at Weeks 0, 1, and 2. ( 2.2 ) Subsequent Dosing: 20 mg administered monthly starting at Week 4. ( 2.2 )
2.1Assessments Prior to First Dose of KESIMPTA Hepatitis B Virus Screening Prior to initiating KESIMPTA, perform Hepatitis B virus (HBV) screening. KESIMPTA is contraindicated in patients with active HBV confirmed by positive results for Hepatitis B surface antigen [HBsAg] and anti-HBV tests. For patients who are negative for HBsAg and positive for Hepatitis B core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult liver disease experts before starting and during treatment with KESIMPTA [see Warnings and Precautions (5.1)] .
Serum Immunoglobulins Prior to initiating KESIMPTA, perform testing for quantitative serum immunoglobulins [see 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)] .
Liver Function Tests Prior to initiating KESIMPTA, obtain serum aminotransferases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]), alkaline phosphatase, and bilirubin levels [see Warnings and Precautions (5.4)] .
2.2Recommended 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.
2.3Administration 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.
2.4Preparation 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.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS KESIMPTA is a clear to slightly opalescent, and colorless to slightly brownish-yellow solution available as follows: Injection: 20 mg/0.4 mL in a single-dose prefilled Sensoready Pen Injection: 20 mg/0.4 mL in a single-dose prefilled syringe Injection: 20 mg/0.4 mL solution in a single-dose prefilled Sensoready ® Pen ( 3 ) Injection: 20 mg/0.4 mL solution in a single-dose prefilled syringe ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS KESIMPTA is contraindicated in patients with: Active HBV infection [see Warnings and Precautions (5.1)] . History of hypersensitivity to ofatumumab or life-threatening injection-related reaction to KESIMPTA. Hypersensitivity reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.2)] .
Active HBV infection. ( 4 ) History of hypersensitivity to ofatumumab or life-threatening injection-related reaction to KESIMPTA. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Infections: Serious, including life-threatening and fatal infections, have occurred in patients treated with anti-CD20 therapies. 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.
( 5.1 ) Injection-Related Reactions and Hypersensitivity Reactions: Management for injection-related reactions and hypersensitivity reactions depends on the type and severity of the reaction. ( 4 , 5.2 ) 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.
( 5.3 ) Liver Injury: Clinically significant liver injury has occurred. Obtain serum aminotransferases, alkaline phosphatase, and bilirubin levels before initiating KESIMPTA, and during treatment as clinically indicated. Discontinue KESIMPTA in patients with evidence of liver injury in the absence of an alternative etiology.
( 5.4 ) 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 6 months after stopping KESIMPTA. ( 5.5 , 8.1 )
5.1Infections 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. In KESIMPTA 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 tre…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail elsewhere in the labeling: Infections [see Warnings and Precautions (5.1)] Injection-Related Reactions and Hypersensitivity Reactions [see Warnings and Precautions (5.2)] Reduction in Immunoglobulins [see Warnings and Precautions (5.3)] Liver Injury [see Warnings and Precautions (5.4)] Most common adverse reactions (incidence greater than 10%) are upper respiratory tract infection, headache, injection-related reactions, and local injection site reactions.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Approximately 1500 patients with RMS received KESIMPTA 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 decreas…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS
7.1Immunosuppressive or Immune-Modulating Therapies Concomitant usage of KESIMPTA with immunosuppressant drugs, including systemic corticosteroids, may increase the risk of infection. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with KESIMPTA. When switching from therapies with immune effects, the duration and mechanism of action of these therapies should be taken into account because of potential additive immunosuppressive effects when initiating KESIMPTA.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to KESIMPTA during pregnancy. Healthcare providers are encouraged to enroll pregnant patients, or pregnant women may register themselves in the MotherToBaby Pregnancy Study in Multiple Sclerosis by calling 1-877-311-8972, by sending an email to [email protected], or by going to www.mothertobaby.org/join-study. Risk Summary There are no adequate data on the developmental risk associated with the use of KESIMPTA in pregnant women.
Ofatumumab may cross the placenta and cause fetal B-cell depletion based on findings from animal studies. No teratogenicity was observed after intravenous administration of ofatumumab to pregnant monkeys during organogenesis. However, increased mortality, depletion of B-cell populations, and impaired immune function were observed in the offspring, in the absence of maternal toxicity, at plasma levels higher than that in humans ( see Data ).
Although there are no data on ofatumumab, monoclonal antibodies can be actively transported across the placenta, and ofatumumab may cause immunosuppression in the in utero -exposed infant (see Clinical Considerations ). 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.
Clinical Considerations Fetal/Neonatal adverse reactions Transport of endogenous IgG antibodies across the placenta is low in the first trimester and increases as pregnancy progresses and peaks during the third trimester. Transient peripheral B-cell depletion and lymphocytopenia have been observed in infants born to mothers exposed to other anti-CD20 antibodies during pregnancy. B-cell levels in infants following maternal exposure to KESIMPTA have not been adequately studied in clinical trials.
The potential duration of B-cell depletion in infants exposed to ofatumumab in utero , and the impact of B-cell depletion on the safety and effectiveness of vaccines, are unknown. Avoid administering live vaccines to neonates and infants exposed to KESIMPTA in utero before confirming B-cell count is within normal range [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.2)] . Data Animal Data In the embryo-fetal development (EFD) study, intravenous administration of ofatumumab (weekly doses of 0, 20, or 100 mg/kg) to pregnant monkeys during the period of organogenesis (gestation 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 avg ) 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 avg ) 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. In the enhanced pre- and post-natal development (ePPND) study, 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 from gestation day 20 until birth 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 of 100/20 mg/kg. The deaths were considered secondary to B-cell depletion. Plasma exposure (C avg ) 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 establi…
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to KESIMPTA during pregnancy. Healthcare providers are encouraged to enroll pregnant patients, or pregnant women may register themselves in the MotherToBaby Pregnancy Study in Multiple Sclerosis by calling 1-877-311-8972, by sending an email to [email protected], or by going to www.mothertobaby.org/join-study. Risk Summary There are no adequate data on the developmental risk associated with the use of KESIMPTA in pregnant women.
Ofatumumab may cross the placenta and cause fetal B-cell depletion based on findings from animal studies. No teratogenicity was observed after intravenous administration of ofatumumab to pregnant monkeys during organogenesis. However, increased mortality, depletion of B-cell populations, and impaired immune function were observed in the offspring, in the absence of maternal toxicity, at plasma levels higher than that in humans ( see Data ).
Although there are no data on ofatumumab, monoclonal antibodies can be actively transported across the placenta, and ofatumumab may cause immunosuppression in the in utero -exposed infant (see Clinical Considerations ). 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.
Clinical Considerations Fetal/Neonatal adverse reactions Transport of endogenous IgG antibodies across the placenta is low in the first trimester and increases as pregnancy progresses and peaks during the third trimester. Transient peripheral B-cell depletion and lymphocytopenia have been observed in infants born to mothers exposed to other anti-CD20 antibodies during pregnancy. B-cell levels in infants following maternal exposure to KESIMPTA have not been adequately studied in clinical trials.
The potential duration of B-cell depletion in infants exposed to ofatumumab in utero , and the impact of B-cell depletion on the safety and effectiveness of vaccines, are unknown. Avoid administering live vaccines to neonates and infants exposed to KESIMPTA in utero before confirming B-cell count is within normal range [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.2)] . Data Animal Data In the embryo-fetal development (EFD) study, intravenous administration of ofatumumab (weekly doses of 0, 20, or 100 mg/kg) to pregnant monkeys during the period of organogenesis (gestation 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 avg ) 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 avg ) 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. In the enhanced pre- and post-natal development (ePPND) study, 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 from gestation day 20 until birth 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 of 100/20 mg/kg. The deaths were considered secondary to B-cell depletion. Plasma exposure (C avg ) 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 nu…
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of KESIMPTA did not include sufficient numbers of geriatric patients to determine whether they respond differently from younger subjects.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The precise mechanism by which ofatumumab exerts its therapeutic effects in multiple sclerosis is unknown, but is presumed to involve binding to CD20, a cell surface antigen present on pre-B and mature B lymphocytes. Following cell surface binding to B lymphocytes, ofatumumab results in antibody-dependent cellular cytolysis and complement-mediated lysis.
12.2Pharmacodynamics B-cell Depletion For B-cell counts, assays for CD19+ B-cells are used because the presence of ofatumumab interferes with the CD20 assay. In Study 1 and Study 2, KESIMPTA administered as recommended, resulted in a reduction of CD19+ B-cells to below the LLN in 77.0% and 78.8% of patients, respectively, one week after treatment initiation, and in 95.0% and 95.8% of patients, respectively, two weeks after treatment initiation [see Dosage and Administration (2.2) and Clinical Studies (14)] . In Study 1 and Study 2, at Week 12, 99.3% to 99.5% of patients had CD19+ B-cell 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.
Pharmacokinetics and pharmacodynamics 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.
12.3Pharmacokinetics 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
5.42L 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
0.34L/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-met…
🧬 Mechanism of Action ▾
12.1Mechanism of Action The precise mechanism by which ofatumumab exerts its therapeutic effects in multiple sclerosis is unknown, but is presumed to involve binding to CD20, a cell surface antigen present on pre-B and mature B lymphocytes. Following cell surface binding to B lymphocytes, ofatumumab results in antibody-dependent cellular cytolysis and complement-mediated lysis.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied KESIMPTA (ofatumumab) injection is a preservative-free, clear to slightly opalescent and colorless to slightly brownish-yellow solution for subcutaneous administration, which is supplied as follows: KESIMPTA Sensoready Pen: Carton of one 20 mg/0.4 mL single-dose prefilled Sensoready Pen NDC 0078-1007-68 KESIMPTA Prefilled Syringe: Carton of one 20 mg/0.4 mL single-dose prefilled syringe NDC 0078-1007-69
16.2Storage and Handling KESIMPTA Sensoready pens and prefilled syringes must be refrigerated at 2ºC to 8ºC (36ºF to 46ºF). Keep the product in the original carton to protect from light until the time of use. Do not freeze.
To avoid foaming, do not shake. If necessary, KESIMPTA may be stored for up to 7 days at room temperature, not to exceed 30°C (86°F). Write the date removed from the refrigerator in the space provided on the carton labeling.
If stored below 30°C (86°F), unused KESIMPTA may be returned to the refrigerator and must be used within the next 7 days or discarded after 7 days.
16.1How Supplied KESIMPTA (ofatumumab) injection is a preservative-free, clear to slightly opalescent and colorless to slightly brownish-yellow solution for subcutaneous administration, which is supplied as follows: KESIMPTA Sensoready Pen: Carton of one 20 mg/0.4 mL single-dose prefilled Sensoready Pen NDC 0078-1007-68 KESIMPTA Prefilled Syringe: Carton of one 20 mg/0.4 mL single-dose prefilled syringe NDC 0078-1007-69
📦 Storage and Handling ▾
16.2Storage and Handling KESIMPTA Sensoready pens and prefilled syringes must be refrigerated at 2ºC to 8ºC (36ºF to 46ºF). Keep the product in the original carton to protect from light until the time of use. Do not freeze.
To avoid foaming, do not shake. If necessary, KESIMPTA may be stored for up to 7 days at room temperature, not to exceed 30°C (86°F). Write the date removed from the refrigerator in the space provided on the carton labeling.
If stored below 30°C (86°F), unused KESIMPTA may be returned to the refrigerator and must be used within the next 7 days or discarded after 7 days.
📋 Description ▾
11 DESCRIPTION Ofatumumab is a recombinant human monoclonal immunoglobulin G1 (IgG1) antibody that binds to human CD20 expressed on B-cells. Ofatumumab is produced in a murine NS0 cell line and consists of two IgG1 heavy chains and two kappa light chains with a molecular weight of approximately 146 kDa. KESIMPTA (ofatumumab) injection is a sterile, preservative-free solution for subcutaneous use.
Each 20 mg/0.4 mL KESIMPTA Sensoready Pen or prefilled syringe delivers 0.4 mL of solution. Each 0.4 mL contains 20 mg of ofatumumab, and arginine (4 mg), disodium edetate (0.007 mg), polysorbate 80 (0.08 mg), sodium acetate trihydrate (2.722 mg), sodium chloride (1.192 mg), and Water for Injection, USP with a pH of 5.5. Hydrochloric acid may have been added to adjust pH.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read FDA-approved patient labeling (Medication Guide and Instructions for Use). Infections Advise patients to contact their healthcare provider for any signs of infection during treatment or after the last dose. Signs include fever, chills, constant cough, or dysuria [see Warnings and Precautions (5.1)] .
Advise patients that KESIMPTA may cause reactivation of hepatitis B infection and that monitoring will be required if they are at risk [see Warnings and Precautions (5.1)] . Advise patients that PML has happened with an intravenous form of ofatumumab administered at a higher intravenous dosage in patients with CLL, as well as with drugs that are similar to KESIMPTA, and may happen with KESIMPTA. Inform the patient that PML is characterized by a progression of deficits and usually leads to death or severe disability over weeks or months.
Instruct the patient of the importance of contacting their healthcare provider if they develop 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 and Hypersensitivity Reactions Inform patients about the signs and symptoms of injection-related reactions and hypersensitivity reactions. Inform patients that injection-related reactions generally occur within 24 hours and predominantly following the first injection.
A hypersensitivity reaction may occur with any injection, and any new or worsening symptoms with subsequent KESIMPTA injections should prompt consideration of a hypersensitivity reaction. Advise patients to seek immediate medical attention if they experience signs or symptoms of a severe or life-threatening injection-related reaction or hypersensitivity reaction, and to contact their healthcare provider if they experience any signs or symptoms of an injection-related reaction or hypersensitivity reaction [see Warnings and Precautions (5.2)] .
Liver Injury Inform patients that liver injury has been reported with anti-CD20 B-cell depleting therapies, including KESIMPTA. Instruct patients treated with KESIMPTA to promptly report any symptoms that may indicate liver injury, including fatigue, anorexia, nausea, vomiting, right upper abdominal discomfort, dark urine, or jaundice. A blood test should be obtained before patients start therapy, and during treatment as clinically indicated [see Warnings and Precautions (5.4)] .
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 (5.5) and Use in Specific Populations (8.3)] . Pregnancy Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.5) and Use in Specific Populations (8.1, 8.3)] . Pregnancy Exposure Registry Instruct patients that if they are pregnant or plan to become pregnant while taking KESIMPTA, they should inform their healthcare provider.
Encourage patients to enroll in the MotherToBaby Pregnancy Study in Multiple Sclerosis if they become pregnant while taking KESIMPTA [see Use in Specific Populations (8.1)] . Instruction on Injection Technique Patients or caregivers should be instructed by a healthcare professional on how to administer KESIMPTA [see Instructions for Use] .…
💬 Medication Guide ▾
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 4/2026 MEDICATION GUIDE KESIMPTA ® (KEY-simp-ta) (ofatumumab) injection, for subcutaneous use What is the most important information I should know about KESIMPTA?
KESIMPTA can cause serious side effects, including: Infections. Serious infections, which can be life-threatening or cause death, can happen during treatment with KESIMPTA. If you have an active infection, your healthcare provider should delay your treatment with KESIMPTA until your infection is gone.
KESIMPTA taken before or after other medicines that weaken the immune system may increase your risk of getting infections. Tell your healthcare provider right away if you have any infections or get any symptoms, including painful and frequent urination, nasal congestion, runny nose, sore throat, fever, chills, cough, or body aches. Hepatitis B virus (HBV) reactivation.
Before starting treatment with KESIMPTA, your healthcare provider will do blood tests to check for HBV. If you have ever had HBV infection, the HBV may become active again during or after treatment with KESIMPTA. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems, including liver failure or death.
You should not receive KESIMPTA if you have active hepatitis B liver disease. Your healthcare provider will monitor you for HBV infection during and after you stop using KESIMPTA. Tell your healthcare provider right away if you get worsening tiredness or yellowing of your skin or white part of your eyes during treatment with KESIMPTA.
Progressive Multifocal Leukoencephalopathy (PML). PML may happen with KESIMPTA. PML is a rare, serious brain infection caused by a virus that may get worse over days or weeks.
PML can result in death or severe disability. Tell your healthcare provider right away if you have any new or worsening neurologic signs or symptoms. These may include weakness on one side of your body, loss of coordination in arms and legs, vision problems, changes in thinking and memory which may lead to confusion and personality changes.
Weakened immune system. KESIMPTA taken before or after other medicines that weaken the immune system could increase your risk of getting infections. What is KESIMPTA?
KESIMPTA is a prescription medicine used to treat adults with relapsing forms of multiple sclerosis (MS), including: clinically isolated syndrome relapsing-remitting disease active secondary progressive disease It is not known if KESIMPTA is safe or effective in children. Do not use KESIMPTA if you: have an active hepatitis B virus infection. have had an allergic reaction to ofatumumab or life-threatening injection-related reaction to KESIMPTA. See the end of this Medication Guide for a complete list of ingredients in KESIMPTA.
Before using KESIMPTA, tell your healthcare provider about all of your medical conditions, including if you: have or think you have an infection, including HBV or PML. See “What is the most important information I should know about KESIMPTA?” have ever taken, currently take, or plan to take medicines that affect your immune system. These medicines could increase your risk of getting an infection. have a history of liver problems. have had a recent vaccination or are scheduled to receive any vaccinations.
You should receive any required ‘live’ or ‘live-attenuated’ vaccines at least 4 weeks before you start treatment with KESIMPTA . You should not receive ‘live’ or ‘live-attenuated’ vaccines while you are being treated with KESIMPTA and until your healthcare provider tells you that your immune system is no longer weakened. Whenever possible, you should receive any ‘non-live’ vaccines at least 2 weeks before you start treatment with KESIMPTA .
Talk to your healthcare provider about vaccinations for your baby if you used KESIMPTA during your pregnancy. are pregnant, think that you might be pregnant, or plan to become pregnant. It is not known if KESIMPTA wi…