Your first 90 days
Your first 90 days on Kesimpta for relapsing MS
What happens before the first fill, the days that matter, the label's rules and who to call, from the label, the drugmaker's own program and one insurer's written rules.
Kesimpta is a monthly pen you use at home, but the start takes some planning. Blood tests, any needed vaccines and an insurance approval come before the first dose. Then 3 starter doses arrive a week apart, and monthly doses begin at week 4. This page lays out that stretch from the FDA label, Novartis's support program and one insurer's written rules.
What has to happen before the first bottle ships
Kesimpta has no REMS, so the first dose waits on blood tests, any needed vaccines, an insurance approval and a lesson on using the pen. These are the 7 things in the way, in order.
A hepatitis B blood test
The label requires hepatitis B screening before the first dose.
- Kesimpta is not given to anyone with active hepatitis B. If a past infection or carrier status shows up, the label asks your neurologist to involve a liver specialist.FDA label
An antibody level test
The label requires a blood test of your immunoglobulin levels before the first dose.
- If your levels are low, it asks your neurologist to consult an immunology expert before starting.FDA label
Liver blood tests
Since August 2025, the label asks for liver enzyme and bilirubin tests before the first dose.
- Tell your neurologist if you have ever had liver problems.FDA label
Vaccines on time
The label asks for live vaccines at least 4 weeks before the first dose, and non-live vaccines at least 2 weeks before whenever possible.
- Live vaccines are not recommended during treatment or until your B cells recover.FDA label
Your other medicines
Tell your neurologist about every medicine that affects your immune system, including steroids and any earlier MS treatment.
- The label says the timing of a switch matters because the effects can add up.FDA label
Enrollment and the insurance check
You can enroll in Novartis Patient Support online, by phone, or through your doctor's office.
- A team member works with your doctor's office on insurance forms and coverage.Novartis Patient Support
A lesson on the pen
The label says the first injection should be done with guidance from a healthcare professional.
- Novartis says someone from your health care team will show you how to use the pen.FDA label
The days that matter
Counted from the first injection, with tests and vaccines before it. Starter doses fall on days 1, 8 and 15, and monthly doses begin on day 29. Type your first-dose date and the tiles become real dates you can add to your calendar.
The tiles below count days from a first dose. Enter the date of yours, or the date you expect, and each tile becomes a real date on your calendar.
The date stays on your device. It is not sent to Trial Friend or anyone else. The calendar file works with Apple, Google and Outlook calendars.Enrollment and the insurance check
You or the office enroll in Novartis Patient Support, and a team member helps with insurance forms.
- No source sets how long this takes, because each insurer works on its own timeline.
Hepatitis B, antibody and liver tests
All 3 are required before the first dose.
- Results that need a liver or immune specialist can add time before you start.
Last day for live vaccines
The label asks for any needed live or live-attenuated vaccines at least 4 weeks before the first dose.
- Ask your neurologist which vaccines you still need.
Last day for non-live vaccines, when possible
The label asks for non-live vaccines at least 2 weeks before the first dose whenever possible.
- Kesimpta may make non-live vaccines work less well.
Approval, then the pen arrives
Novartis says the pen is delivered to your door.
- If a private plan denies coverage over a prior authorization requirement, its Bridge Program may send up to 15 free doses.
First starter dose, 20mg (week 0)
The label says this first injection should be done with guidance from a trained healthcare professional.
- Let the pen sit out of the refrigerator for 15 to 30 minutes first.
Injection reactions are most common after the first dose
Fever, headache, muscle aches, chills and tiredness happened in 14.4% after the first injection in the trials.
- That fell to 4.4% after the second and under 3% after the third.
Second starter dose, 20mg (week 1)
The same 20mg pen, one week after the first.
- If you miss a starter dose, the Medication Guide says to talk to your healthcare provider.
Third starter dose, 20mg (week 2)
In the trials, about 95% of patients had B cell counts below normal 2 weeks after starting.
- That is why infections need attention.
No injection this week
The Medication Guide says there is no injection at week 3.
- The monthly doses start the following week.
First monthly dose, 20mg (week 4)
From here, one 20mg injection comes once a month.
- Novartis suggests using the same date each month to keep track.
Monthly dose and the next pen
Each carton holds one pen, so every dose is its own fill.
- Ask the pharmacy to time each delivery so a pen is in your refrigerator before dose day.
B cells are down
By week 12 in the trials, 99.3% to 99.5% of patients had B cell counts below normal.
- They mostly stayed there while treatment continued.
Monthly dose and the next pen, number 2
The label, revision by revision
The FDA lists which sections changed in each revision of a label. These are the revisions the current Kesimpta label records, dated by the FDA, with a plain note on what each one meant for a patient. Older references and handouts can lag these by months.
Current label dated April 1, 2026, read from the FDA's label database today. FDA label
- April 2026
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 2025
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 2024
The label added more on allergic and injection-related reactions, and the pregnancy registry was added for patients.FDA letter
- January 2024
The FDA added safety language on serious, including life-threatening or fatal, infections with anti-CD20 drugs used for MS.FDA letter
- August 2020
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
How the label says to take it
The parts of the prescribing information and the patient leaflet that come up in the first 3 months, in plain words.
- Three starter doses, then monthly
The label gives 20mg at weeks 0, 1 and 2, then 20mg once a month starting at week 4.
- The dose does not depend on your weight.FDA label
- If you miss a monthly dose
The label says to inject it as soon as possible without waiting for the next scheduled dose.
- After that, keep the injections a month apart.FDA label
- Where to inject
You inject into the front of the thigh or the stomach area.
- A caregiver may also use the outer upper arm.
- Avoid moles, scars, stretch marks and skin that is tender, bruised, red, scaly or hard.FDA label
- The first injection has help
The label says the first injection should be done with guidance from a trained healthcare professional.
- That way a reaction can be treated, and you learn the pen.FDA label
- Keep it cold
Store pens in the refrigerator at 36°F to 46°F (2°C to 8°C), in the carton, away from light.
- Do not freeze or shake them.FDA label
- Room temperature for up to 7 days
A pen may stay at room temperature up to 86°F (30°C) for 7 days.
- Write the date you took it out on the carton, and throw it away if unused after 7 days.FDA label
- One pen, one time
Each pen or prefilled syringe is used once and then thrown away in a puncture-resistant sharps container.FDA label
- Pregnancy and birth control
Kesimpta may harm an unborn baby, based on animal studies.
- The label advises effective birth control during treatment and for 6 months after the last dose.
- The MotherToBaby pregnancy study takes calls at 1-877-311-8972.FDA label
- If you used Kesimpta while pregnant
Tell your baby's healthcare provider.
- The label says the baby should not get live vaccines until tests show the baby's B cell count is normal.FDA label
- Breastfeeding
It is not known whether Kesimpta passes into breast milk.
- The Medication Guide asks you to talk with your healthcare provider about the best way to feed your baby.FDA label
What the label says to act on
The symptoms the label singles out, and what it tells patients and prescribers to do about each. If any of these happen, the label's instruction is the one to follow, with your care team.
Signs of an injection reaction or allergy
Fever, headache, muscle pain, chills, tiredness, rash, hives, trouble breathing, swelling of the face, lips, tongue or throat, feeling faint or chest tightness.
- The Medication Guide says to contact your healthcare provider right away.
- Get emergency help if a reaction is severe.FDA label
Signs of infection
Painful and frequent urination, a stuffy or runny nose, sore throat, fever, chills, cough or body aches.
- Tell your healthcare provider right away.
- The label says a dose waits until an active infection clears.FDA label
Signs of PML, a rare brain infection
Weakness on one side of the body, loss of coordination in arms or legs, vision problems, changes in thinking or memory, confusion or personality changes.
- Call your healthcare provider right away.
- No case was reported in the MS trials.FDA label
Signs of liver injury
Yellow skin or eyes, nausea, vomiting, dark urine, or feeling tired or weak.
- The label says liver injury has happened weeks to months after a dose.
- Tell your healthcare provider right away.FDA label
Hepatitis B coming back
If you have ever had hepatitis B, it may become active again during or after treatment and cause serious liver problems.
- The Medication Guide says your provider will monitor you for hepatitis B during and after treatment.FDA label
Common side effects
In the 2 main trials, upper respiratory infections occurred in 39% on Kesimpta against 38% on teriflunomide.
- Injection reactions occurred in 21% against 15%, and headache in 13% against 12%.FDA label
Why the pharmacy or the insurer says no, and what fixes it
Most first-fill delays are one of these. Knowing which one tells you who to call.
- 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.FEP Blue policy
- 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.FDA label
- 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.Enrollment and terms
- 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.Enrollment and terms
- 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.Novartis Patient Support
- 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.Novartis Patient Support
- 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.FEP Blue policy
Blue Cross Blue Shield Federal Employee Program prior authorization policy, July 1, 2026
- Age 18 or older
- Relapsing MS, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease
- Not at risk for hepatitis B, or hepatitis B ruled out, or treatment for it started
- No active infection
- Your doctor agrees to monitor immunoglobulins at the start, during treatment and after stopping
- Not used with another MS disease-modifying drug, or with immune-suppressing therapy including immunosuppressant doses of steroids
- Not given at the same time as live or live-attenuated vaccines
Approval length. 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. FEP Blue policy
Who to call, and what they can do
The drugmaker's program handles most of the first-fill problems above. Charity funds and foundation help are on the help paying page.
- 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
Details as the drugmaker publishes them. Novartis Patient Support
Five questions for the pharmacist or the support line
- Are my hepatitis B, antibody level and liver test results already on file with my neurologist's office?
- Which vaccines do I still need, and is there time to get live ones 4 weeks before my first dose?
- Where will my first injection happen, and who will show me how to use the pen?
- When will my pens arrive, and will they come cold?
- Has my Co-Pay Plus offer been applied, and does my plan use a copay maximizer?
- Who schedules each monthly delivery, and when does my insurance approval need renewing?
Questions people ask in the first weeks
How long does it take to start Kesimpta after it is prescribed?
There is no fixed number of days. Blood tests, live vaccines 4 weeks ahead, enrollment and the prior authorization each take their own time. Novartis Patient Support can tell you where the insurance review stands.
How often do I inject Kesimpta?
Once a month after 3 starter doses. The label gives 20mg at weeks 0, 1 and 2, no dose at week 3, then 20mg once a month starting at week 4.
What tests do I need before my first Kesimpta dose?
The label requires hepatitis B screening, a blood test of immunoglobulin levels, and liver tests (ALT, AST, alkaline phosphatase and bilirubin). Kesimpta is not given with active hepatitis B.
Do I need vaccines before starting Kesimpta?
The label asks for live vaccines at least 4 weeks before the first dose, and non-live vaccines at least 2 weeks before whenever possible. Live vaccines are not recommended during treatment or until your B cells recover.
Do I have to do my first injection at the doctor's office?
The label says the first injection should be done with guidance from a trained healthcare professional. It does not name a place. Ask your neurologist how they set up that first dose.
What if I miss a dose?
For a missed monthly dose, the label says to inject it as soon as possible, then keep doses a month apart. For a missed starter dose, the Medication Guide says to talk to your healthcare provider.
Can I travel with Kesimpta?
The label allows a pen to stay at room temperature, up to 86°F (30°C), for up to 7 days. Write the date you took it out on the carton.
Is Kesimpta approved for children or primary progressive MS?
Neither is in the label. It covers adults with relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting MS and active secondary progressive MS. Safety and effectiveness in children have not been established.
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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, April 1, 2026.
- Novartis Patient Support™ | KESIMPTA® (ofatumumab), Novartis, November 8, 2026.
- Sign up for Novartis Patient Support, Novartis, November 8, 2026.
- Treat on Your Terms | KESIMPTA® (ofatumumab), Novartis, November 8, 2026.
- 5.60.047 Kesimpta (Prescription Drugs, Central Nervous System Drugs), Blue Cross Blue Shield Federal Employee Program, July 1, 2026.
- BLA 125326/S-084 supplement approval letter, updates to section 8.1 (Pregnancy), FDA, April 1, 2026.
- BLA 125326/S-083 supplement approval letter, safety labeling change on liver injury, FDA, August 18, 2025.
- BLA 125326/S-079 supplement approval letter, hypersensitivity and injection-related reactions and pregnancy registry, FDA, April 12, 2024.
- BLA 125326/S-080 supplement approval letter, safety labeling change on serious infections, FDA, January 19, 2024.
- BLA 125326/S-070 supplement approval letter, Kesimpta (ofatumumab) for relapsing forms of MS, FDA, August 20, 2020.
This page explains what the FDA label, the drugmaker's support program and an insurer policy say. It is not medical advice and does not tell anyone to start, stop or change a medicine. Dosing, test timing and restarts after a gap are decisions for the prescribing neurologist. Found an error? Use the report link in the footer and it will be checked against the source.