Neurology
Relapsing multiple sclerosis (MS): the approved drugs compared for prescribers
Kesimpta side by side on what each first fill waits on, what the label requires you to monitor and what an insurer asks to see, with FDA decisions, label changes and open trials for relapsing multiple sclerosis (MS).
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.
The relapsing multiple sclerosis (MS) prescribing guide
One page per drug with the dispensing gate, prior authorization documentation, dosing, monitoring and interactions, each line sourced.
The drugs side by side
Each cell is a summary of that drug's prescribing guide, which carries the full detail and a source on every line. Insurer thresholds are one public policy shown as an example; plans differ.
| Kesimptaofatumumab | |
|---|---|
| Label dated | April 1, 2026 |
| Starting dose | 20mg SC, first injection under the guidance of a trained healthcare professional. |
| 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 |
| Required 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 |
| 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 |
| 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 |
- Label dated
- April 1, 2026
- Starting dose
- 20mg SC, first injection under the guidance of a trained healthcare professional.
- 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
- Required 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
- 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
- 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
FDA decisions for relapsing multiple sclerosis (MS)
From the Trial Friend FDA decision calendar, which records each date from the sponsor's or the FDA's own announcement.
- Date not disclosedFenebrutinib, NDA, Genentech (Roche)Pending
Recent label changes
What changed in each label revision, from the FDA's approval letters and the labels' own revision lists.
- April 2026Kesimpta. The FDA approved minor updates to the pregnancy section, and the fetal risk warning is listed as changed this month. The dose, tests and other warnings did not change. FDA letter
- August 2025Kesimpta. The FDA added a liver injury warning for anti-CD20 MS drugs, including Kesimpta. Liver blood tests are now required before the first dose. FDA letter
- April 2024Kesimpta. The label added more on allergic and injection-related reactions, and the pregnancy registry was added for patients. FDA letter
- January 2024Kesimpta. The FDA added safety language on serious, including life-threatening or fatal, infections with anti-CD20 drugs used for MS. FDA letter
- August 2020Kesimpta. The FDA approved Kesimpta as a monthly injection for adults with relapsing forms of MS, as a prefilled pen and a prefilled syringe. FDA letter
Open trials
Questions prescribers ask about Relapsing multiple sclerosis (MS)
Does Kesimpta require a REMS?
No. Kesimpta has no REMS. Its prescribing guide lists what does gate the first fill and its source.
What monitoring does Kesimpta require?
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.
What do insurers require before covering Kesimpta?
This is one public insurer policy, an example rather than every plan. 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.
Which support program starts Kesimpta patients on therapy?
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.
A reference for licensed professionals, checked on November 8, 2026. Labels and plan policies change; the label on DailyMed and the plan's current policy govern. Not medical advice. For patients: the Relapsing multiple sclerosis (MS) page and the first 90 days pages for Kesimpta.