Prescribing guide
Kesimpta (ofatumumab)Pre-treatment screening, vaccine timing, loading doses and prior authorization criteria for relapsing MSFor prescribers and their offices treating relapsing multiple sclerosis (MS): what the pharmacy needs before it ships, what the prior authorization wants documented, the titration and the monitoring the label requires.
Multiple sclerosis is not a rare disease. It is included because its newer treatments reach patients the same way rare disease drugs do, through screening labs, vaccine timing, a specialty pharmacy and a drugmaker program, and because Kesimpta is one of the most looked-up drug pages on Trial Friend.
Dispensing gate
No REMS. HBV, quantitative immunoglobulin and liver tests before dose 1, live vaccines at least 4 weeks and inactivated at least 2 weeks before when possible, prior authorization, a supervised first injection, and no active infection on each dose day.
Example PA threshold
FEP example: age 18 or older, relapsing MS (CIS, RRMS or active SPMS), HBV ruled out or treated, no active infection, no other MS DMT or immunosuppressant, no concurrent live vaccines.
Monitoring
Immunoglobulins at baseline, during treatment and after stopping until B-cell repletion; liver tests at baseline and as clinically indicated; infection check before each dose; HBV monitoring for at-risk patients; withhold at the first sign of PML.
Support line
Novartis Patient Support, 855-KESIMPTA (1-855-537-4678), Monday to Friday from 8:30 AM ET, until 8:30 PM per kesimpta.com or 8 PM per start.kesimpta.com; Co-Pay Plus as little as $0 on private plans up to $18,000 a year; Bridge Program up to 15 doses after a PA denial.
Give your patient their plan
A one-page handout for starting Kesimpta, in plain language: what the first fill waits on, the first dates, who will call and the symptoms to report, with blank lines for the start date and your office's number. The link opens the patient's full first 90 days page, where their dates become calendar entries.
trialfriend.com/p/kesimptaBefore the first fill: REMS, labs and enrollment
The steps that the pharmacy, the REMS or the drugmaker's program will wait on, in the order they usually need to happen. A first fill of a specialty drug most often stalls on one of these rather than on the plan.
| Step | What it requires | Source |
|---|---|---|
| Complete pre-dose screening | HBsAg and HBcAb at minimum, quantitative serum immunoglobulins, and ALT, AST, alkaline phosphatase and bilirubin. Consult liver disease experts for HBsAg-negative HBcAb-positive patients or HBV carriers, and immunology for low immunoglobulins. | FDA label |
| Vaccines | Live or live-attenuated vaccines at least 4 weeks before initiation; inactivated vaccines at least 2 weeks before whenever possible. Live vaccines not recommended during treatment or until B-cell repletion. | FDA label |
| Prior therapy washout | Consider the duration and mechanism of the previous immune therapy because of possible additive immunosuppression. Kesimpta has not been studied in combination with other MS therapies. | FDA label |
| Enroll in Novartis Patient Support | Patient enrolls at start.kesimpta.com or by calling 855-537-4678, or the office helps. Only the patient, legal guardian or caregiver may enroll in the co-pay program; plans, specialty pharmacies and PBMs may not. | Enrollment and terms |
| Insurance support | The Novartis team works with the office to manage insurance forms and helps if the patient's health plan changes. Option 2 on the support line is financial and insurance support. | Novartis Patient Support |
| Plan the first injection | Under the guidance of an appropriately trained healthcare professional. Train the patient or caregiver on technique, sharps disposal and full-dose delivery per the Instructions for Use. | FDA label |
| Product and storage | Carton of one 20mg/0.4mL Sensoready Pen (NDC 0078-1007-68) or one prefilled syringe (NDC 0078-1007-69). Refrigerate 2°C to 8°C; up to 7 days at room temperature not above 30°C. One carton per dose, so each dose is a fill. | FDA label |
| Co-Pay Plus | Private insurance only; as little as $0, combined annual limit up to $18,000, resets yearly. Novartis may cap help at $9,000 if the patient is in a co-pay maximizer. Excludes Medicare, Medicaid, TRICARE, VA, DoD and other federal or state programs. | Enrollment and terms |
| Denial path | Bridge Program: commercial insurance, valid prescription and a coverage denial based on a PA requirement; up to 15 doses or until approval. Uninsured: Novartis Patient Assistance Foundation, 1-800-277-2254. | Enrollment and terms |
Prior authorization criteria and what to document
One public policy as the example: Blue Cross Blue Shield Federal Employee Program, July 1, 2026. Approval two years at first. Renewals are 2 years at a time, with the same rules except the hepatitis B check. This policy was approved on June 11, 2026 and cites the April 2026 label, the current one. FEP removed its earlier rule to try 2 other MS treatments first in September 2024. It is here as an example of what a plan asks for, not as a rule.
| Element | What the policy asks | In the chart | Source |
|---|---|---|---|
| Age and diagnosis | 18 or older, relapsing MS including CIS, relapsing-remitting disease or active secondary progressive disease | Diagnosis and MS subtype in the note | FEP Blue policy |
| Hepatitis B | Not at risk, or HBV ruled out, or HBV treatment initiated | HBsAg and HBcAb results with dates | FEP Blue policy |
| Infection | Absence of active infection | Exam note at the time of the request | FEP Blue policy |
| Immunoglobulins | Prescriber agrees to monitor at the beginning, during and after discontinuation | Baseline quantitative immunoglobulins and the monitoring plan | FEP Blue policy |
| No combination | Not with another MS disease-modifying agent, or with immune-modulating or immunosuppressive therapy including immunosuppressant doses of corticosteroids | Medication list with the stop date of the prior DMT | FEP Blue policy |
| Vaccines | Not given concurrently with live or live-attenuated vaccines | Vaccine history and plan | FEP Blue policy |
| Approval and renewal | 2 years initial; renewal 2 years with the same criteria except HBV. No step therapy since the September 2024 revision | Renewal date on the chart | FEP Blue policy |
Kesimpta dosing and titration
| When | Label | Source |
|---|---|---|
| Week 0 (day 1) | 20mg SC, first injection under the guidance of a trained healthcare professional. | FDA label |
| Week 1 | 20mg SC. | FDA label |
| Week 2 | 20mg SC. No dose at week 3. | FDA label |
| Week 4, then monthly | 20mg SC once monthly. Trials dosed every 4 weeks after week 4. | FDA label |
| Missed dose | Label 2.2, any missed injection: give as soon as possible without waiting for the next scheduled dose, then resume at recommended intervals. The Medication Guide tells patients who miss the week 0, 1 or 2 dose to talk to their provider. | FDA label |
| Sites and preparation | Abdomen, thigh or outer upper arm. Warm 15 to 30 minutes at room temperature; do not use if cloudy or with particles. Single use. | FDA label |
| Pediatric and geriatric | Safety and effectiveness not established under 18. Too few patients 65 and older to assess differences. | FDA label |
Monitoring the Kesimpta label requires
| When | What | What the label says to do with it | Source |
|---|---|---|---|
| Before dose 1 | HBV, quantitative serum immunoglobulins, ALT, AST, alkaline phosphatase, bilirubin | Contraindicated with active HBV; hepatology consult for HBcAb-positive or HBsAg-positive; immunology consult if immunoglobulins are low | FDA label |
| First injection and after | Systemic injection-related reactions: fever, headache, myalgia, chills, fatigue; hypersensitivity including anaphylaxis and angioedema postmarketing | 14.4% first, 4.4% second, under 3% third; 99.8% mild to moderate. Permanently discontinue for hypersensitivity or a life-threatening reaction; rechallenge after a severe reaction under clinical observation | FDA label |
| Before each dose | Active infection | Delay until resolved. Infections 51.6% vs 52.7% teriflunomide, serious 2.5% vs 1.8%; URTI 39%, UTI 10% | FDA label |
| During treatment and after stopping | Quantitative serum immunoglobulins | IgM decrease 7.7% vs 3.1%; discontinuation for low immunoglobulins 3.4% vs 0.8%. Consider discontinuing with serious opportunistic or recurrent infections, or hypogammaglobulinemia needing IVIG | FDA label |
| As clinically indicated | Liver injury: fatigue, anorexia, nausea, vomiting, right upper abdominal discomfort, dark urine, jaundice | Measure liver tests promptly if symptoms; ALT or AST above 3x ULN with bilirubin above 2x ULN signals risk of severe DILI. Discontinue if no alternative etiology | FDA label |
| Ongoing | PML symptoms or MRI findings | Withhold at the first sign and evaluate; discontinue if confirmed. No RMS trial cases; fatal PML with IV ofatumumab for CLL at higher doses | FDA label |
| At-risk patients | HBV reactivation | None reported in MS; fulminant hepatitis, hepatic failure and death with IV ofatumumab in CLL and other anti-CD20 antibodies | FDA label |
Kesimpta drug interactions and contraindications
| Label category | Agents and what the label says | Source |
|---|---|---|
| Immunosuppressants, including systemic corticosteroids | May increase infection risk; consider additive immune effects. When switching, account for the duration and mechanism of the prior therapy | FDA label |
| Vaccines | Live or live-attenuated at least 4 weeks before, inactivated at least 2 weeks before when possible; live not recommended until B-cell repletion. May reduce inactivated vaccine response | FDA label |
| Infants exposed in utero | No live or live-attenuated vaccines until infant B-cell count is confirmed normal; inactivated vaccines may be given, consider specialist assessment of response | FDA label |
| Pregnancy | Fetal B-cell depletion in monkeys; effective contraception during treatment and for 6 months after the last dose. MotherToBaby Pregnancy Study in MS 1-877-311-8972 | FDA label |
| Lactation | No human data; human IgG is excreted in milk, effect on infant B cells unknown | FDA label |
| Contraindicated | Active HBV; history of hypersensitivity to ofatumumab or a life-threatening injection-related reaction to Kesimpta | FDA label |
Why a first fill stalls, and the fix
- Prior authorization pending or deniedThe FEP policy below asks for age 18 or older and a relapsing form of MS. It also asks for hepatitis B ruled out or treated, no active infection and no other MS disease-modifying drug at the same time. The neurologist's records usually answer what the plan is asking for.
- Test results are missingHepatitis B, antibody level and liver test results are required before the first dose. Ask the office to send them with the prior authorization so the plan does not ask twice.
- The plan denied coverage over the prior authorizationWith private insurance, the Novartis Bridge Program may send up to 15 doses free, or until coverage is approved. It requires a valid prescription and a denial based on a prior authorization requirement.
- A copay you cannot payPrivate insurance: the Co-Pay Plus offer, as little as $0, with a combined yearly limit of up to $18,000. Novartis may cap help at $9,000 if your plan uses a copay maximizer program.
- Medicare, Medicaid or other government coverageCo-Pay Plus and the Bridge Program do not apply to Medicare, Medicaid, TRICARE, VA, DoD or other federal or state plans. Novartis links to a Medicare Extra Help guide on its support page.
- No insuranceThe Novartis Patient Assistance Foundation, an independent nonprofit, may provide the medicine at no cost if you meet its income and insurance rules. Call 1-800-277-2254 or visit PAP.Novartis.com.
- Another MS medicine is still on the listThe FEP policy does not approve Kesimpta with another MS disease-modifying drug or with immune-suppressing medicines, including immunosuppressant doses of steroids. The office can document the stop date of the old treatment.
Novartis Patient Support
- A dedicated team that works with your doctor's office on insurance forms and helps if your health plan changes
- The Co-Pay Plus offer, as little as $0 for eligible patients with private insurance, with a combined yearly limit of up to $18,000 that resets each year
- The Bridge Program, up to 15 free doses while a private plan's prior authorization denial is worked out
- Co-pay and Bridge help are not open to Medicare, Medicaid, TRICARE, VA, DoD or other federal or state plans
- Home delivery of the pen and refresher resources for using it
- For people without insurance, the independent Novartis Patient Assistance Foundation at 1-800-277-2254
Questions prescribers' offices ask about Kesimpta
What is the Kesimpta loading dose schedule?
The April 2026 label gives 20mg subcutaneously at weeks 0, 1 and 2, then 20mg once monthly starting at week 4; there is no week 3 dose. In the pivotal trials, starter doses were days 1, 7 and 14 and maintenance was every 4 weeks. Section 2.2 says any missed injection is given as soon as possible, then resume the recommended intervals. The Medication Guide tells patients who miss the week 0, 1 or 2 dose to talk to their provider.
What labs are required before starting Kesimpta?
Three sets, per the April 2026 label: HBV screening (at minimum HBsAg and HBcAb), quantitative serum immunoglobulins, and ALT, AST, alkaline phosphatase and bilirubin. Active HBV is a contraindication; HBsAg-negative HBcAb-positive patients or HBV carriers need hepatology input, and low immunoglobulins need immunology input. The liver panel was added in August 2025.
How far before Kesimpta should vaccines be given?
At least 4 weeks before initiation for live or live-attenuated vaccines and, whenever possible, at least 2 weeks before for inactivated vaccines, per the April 2026 label. Live vaccines are not recommended during treatment or after discontinuation until B-cell repletion (median 24.6 weeks in the trials). Kesimpta may blunt response to inactivated vaccines.
Does the first Kesimpta injection need to be supervised?
Yes. The April 2026 label says the first injection should be performed under the guidance of an appropriately trained healthcare professional. Systemic injection-related reactions occurred in 14.4% with the first injection, 4.4% with the second and under 3% with the third; premedication showed only limited benefit in RMS trials.
What do insurers ask for to approve Kesimpta?
The FEP policy shown here took effect July 1, 2026 and cites the April 2026 label. It asks for age 18 or older, a relapsing form of MS, HBV ruled out or treated, no active infection and agreement to monitor immunoglobulins. It excludes combination with another MS DMT, immunosuppressants or live vaccines, and approves 2 years at a time with no step therapy.
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Sources
- DailyMed - KESIMPTA- ofatumumab injection, solution (prescribing information revised April 2026, SPL version 11, Medication Guide and Instructions for Use), Novartis Pharmaceuticals Corporation, via DailyMed, 2026-04-01.
- Novartis Patient Support™ | KESIMPTA® (ofatumumab), Novartis, 2026-11-08.
- Sign up for Novartis Patient Support, Novartis, 2026-11-08.
- Treat on Your Terms | KESIMPTA® (ofatumumab), Novartis, 2026-11-08.
- 5.60.047 Kesimpta (Prescription Drugs, Central Nervous System Drugs), Blue Cross Blue Shield Federal Employee Program, 2026-07-01.
- BLA 125326/S-084 supplement approval letter, updates to section 8.1 (Pregnancy), FDA, 2026-04-01.
- BLA 125326/S-083 supplement approval letter, safety labeling change on liver injury, FDA, 2025-08-18.
- BLA 125326/S-079 supplement approval letter, hypersensitivity and injection-related reactions and pregnancy registry, FDA, 2024-04-12.
- BLA 125326/S-080 supplement approval letter, safety labeling change on serious infections, FDA, 2024-01-19.
- BLA 125326/S-070 supplement approval letter, Kesimpta (ofatumumab) for relapsing forms of MS, FDA, 2020-08-20.
A reference drawn from the April 1, 2026 label, the drugmaker's published program and one public insurer policy shown as an example, checked on November 8, 2026. Labels and policies change; the label on DailyMed and the plan's current policy govern. Trial Friend is not a medical provider. It reports what these documents say and does not judge whether a drug is safe or right for any patient; that is the prescriber's decision. Not a substitute for the prescribing information.