DOSING & ADMINISTRATION

A B-cell treatment designed with your patients in mind1

What makes KESIMPTA® (ofatumumab) different?

It's the Only SC delivered B-cell RMS treatment3

The Kesimpta (ofatumumab) Sensoready Pen.

Your patients treat themselves at home in just
1 MINUTE A MONTH* when they're ready to administer

*As per stability technical specification data, when the patient is ready to inject, it typically takes less than 1 minute a month to administer. Once-monthly dosing begins after the initial dosing period, which consists of 20 mg subcutaneous doses at weeks 0, 1, and 2. Please see Instructions for Use for more detailed instructions on preparation and administration of KESIMPTA.2,4

'The Sensoready® pen is painless and really easy. You never see the needle.' - Ananda: mom, wife, registered nurse, Kesimpta patient.

The Sensoready® Pen is easy for me
and I never see the needle.

Ananda: wife, mom, registered nurse, KESIMPTA patient

Please see Instructions for Use for more detailed instructions on preparation and administration of KESIMPTA.

Actual KESIMPTA patient who was compensated for their time. Individual results may vary.

What does the SC delivery difference mean for your RMS patients?

The Sensoready Pen can be administered at home or anywhere2‡

A preloaded device, ranked as easy-to-grip with audible and visual cues to help the
patient complete administration.2,5§

prefer the Sensoready Pen
attributes based on a survey

prefer the Sensoready Pen
attributes based on a survey

Meet the KESIMPTA
Sensoready Pen

See how patients learn to administer KESIMPTA with the Sensoready Pen

Take a different approach to RMS.
Make KESIMPTA your 1st choice treatment today!

KESIMPTA Sensoready pens must be refrigerated at 2°C to 8°C (36°F to 46°F). Keep product in the original carton to protect from light until the time of use. Do not freeze. To avoid foaming, do not shake.

§Based on a survey of multiple sclerosis (MS) nurses (N=50) and patients (N=80) in the US, Germany, France, and Italy. Participants were asked to compare attributes of the KESIMPTA Sensoready autoinjector pen with those of other DMT autoinjectors, some of which are not available in the US. The Sensoready Pen was not injected during the survey nor were all devices compared against each other by participants. A total of 17 attributes were assessed, with "easy to perform self-injection with the pen," "ease of preparation and set-up," and "ease of training patient in use" among those most preferred.5

'Kesimpta works with my busy schedule. I don't have to rearrange my routine for my treatment.' - Kristin: mother, real estate agent, Kesimpta patient.

KESIMPTA works with my busy schedule. I don't
have to rearrange my routine for my treatment.

Kristin: mom, real estate agent, KESIMPTA patient

Actual KESIMPTA patient who was compensated for their time. Individual results may vary.

KESIMPTA dosing schedule

How to discuss dosing with your patients2

To help patients understand dosing with KESIMPTA, share the instructions below:

Pick a day and start with 1 dose a week for the first 3 weeks. Skip the 4th week.

Pick a day and start with 1 dose a week for the first 3 weeks. Skip the 4th week.

Take your first monthly maintenance dose on the 5th week.

Take your first monthly maintenance dose on the
5th week.

Continue taking KESIMPTA once a month.

Continue taking KESIMPTA once a month.

Dosing regimen

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. After initial dosing, KESIMPTA is administered once monthly.2

Tracking tip

To keep it simple, tell patients to try to take KESIMPTA on the same date every month.
Example: If your first monthly dose is on April 15, take your next dose on May 15.

There's also a Quick Tips brochure available for you to download and share with your patients.

There's also a Quick Tips brochure available for you to download and share with your patients.

DOWNLOAD BROCHURE

Additional dosing information2

First Dose

The first injection should be performed under the guidance of a health care professional.

Missed Doses

Administer as soon as possible without waiting until the next scheduled dose; subsequent doses should be administered at the recommended intervals.

  • The use of premedication is not required

  • Prior to initiating KESIMPTA, perform hepatitis B virus (HBV) screening, test for quantitative serum immunoglobulins, and vaccinate (at least 4 weeks prior for live or live-attenuated vaccines and at least 2 weeks prior for inactivated vaccines)

'The box has an indicator to help keep it at the right temperature during shipping.' - Maggie: wife, mom, returning college student, Kesimpta patient.

The box has an indicator to help keep it at the right
temperature during shipping.

Maggie: wife, mom, returning college student,
KESIMPTA patient

Please see full KESIMPTA package insert for complete instructions for storage and handling.

Actual KESIMPTA patient who was compensated for their time. Individual results may vary.

Start your patients right away

Life with RMS is complicated enough, starting treatment shouldn't be

SCREEN

Screen your patient for HBV
and
test their Ig levels2

SHOW

Demonstrate KESIMPTA
administration using the
Sensoready Demo Pen

START

Start today with samples and
submit 1-page Start Form

Sample program is only available to patients who are determined to be appropriate candidates for treatment with KESIMPTA.

Administration details for your patients and your office

How KESIMPTA is administered

Your patients can administer KESIMPTA with the Sensoready Pen at home or anywhere with these steps. These are not the complete instructions for using KESIMPTA. Please see full Instructions For Use.2

Patients should take Sensoready Pen out of the fridge 15 to 30 minutes before injection.

Patients should take the Sensoready Pen out of the fridge 15-30 minutes before injection.

After a thorough hand wash, they clean their preferred injection site with an alcohol wipe.

After a thorough hand wash, they clean their preferred injection site with an alcohol wipe.

Patients then apple the pen to the site at a 90 degree angle and press down. A click lets them know it's working. When they hear the second click, it's done. They can also check the green indicator to confirm a full dose.

Patients then apply the pen to the site at a 90º angle and press down. A click lets them know it's working. When they hear the second click, administration is almost complete. They can also check the green indicator to confirm a full dose.

For more information, download the Quick Tips for Use brochure for patients

For more information, download the Quick Tips for Use brochure for patients

DOWNLOAD BROCHURE

How does KESIMPTA administration differ from another B-cell therapy?

B-cell therapy administration times4,7

This shows Kesimpta B-cell therapy administration times compared to Ocrevus® (ocrelizumab) B-cell administration times.

KESIMPTA is administered once a month subcutaneously. Ocrevus is dosed twice yearly via infusion.

*As per stability technical specification data, when the patient is ready to inject, it typically takes less than 1 minute a month to administer. Once-monthly dosing begins after the initial dosing period, which consists of 20 mg subcutaneous doses at weeks 0, 1, and 2. Please see Instructions for Use for more detailed instructions on preparation and administration of KESIMPTA.2,4

See Ocrevus Prescribing Information for complete dosing and administration instructions.

Read more about Kristin's experience with KESIMPTA

Download her 1 minute KESIMPTA story

Read more about Kristin's experience with KESIMPTA

Download her 1 minute KESIMPTA story

DOWNLOAD BROCHURE

Start patients on KESIMPTA today

DOWNLOAD START FORM

Submit a Start Form by fax or online at CoverMyMeds®

VISIT COVERMYMEDS®

MOA=mechanism of action; RMS=relapsing multiple sclerosis; SC=subcutaneous.

#Sample program is only available to patients who are determined to be appropriate candidates for treatment with KESIMPTA.

References: 1. Torres JB, Roodselaar J, Sealey M, et al. Distribution and efficacy of ofatumumab and ocrelizumab in humanized-CD20 mice following subcutaneous or intravenous administration. P2.2-052. Poster presented at: 71st American Academy of Neurology Annual Meeting; May 4-10, 2019; Philadelphia, PA. 2. Kesimpta [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2020. 3. National Multiple Sclerosis Society. Medications. Accessed February 10, 2022. https://www.nationalmssociety.org/Treating-MS/Medications 4. Data on file. Injection time. Novartis Pharmaceuticals Corp; East Hanover, NJ. June 2020. 5. Ross AP, Besser C, Stoneman S, Gaunt H, Barker N. Patient and nurse preferences for the Sensoready autoinjector pen versus other autoinjectors in multiple sclerosis: results from a multicenter survey. P210. Poster presented at: ACTRIMS Forum; February 25-27, 2021; Virtual. 6. Data on file. Market access. Novartis Pharmaceuticals Corp; East Hanover, NJ. September 2021. 7. Ocrevus [package insert]. San Francisco, CA: Genentech, Inc; 2021.

IMPORTANT SAFETY INFORMATION

Contraindication: KESIMPTA is contraindicated in patients with active hepatitis B virus infection.

WARNINGS AND PRECAUTIONS

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

INDICATION

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.

SEE IMPORTANT SAFETY INFORMATION

INDICATION

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.

IMPORTANT SAFETY INFORMATION

Contraindication: KESIMPTA is contraindicated in patients with active hepatitis B virus infection.

WARNINGS AND PRECAUTIONS

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 have been fatal in patients treated with other anti-CD20 antibodies. The overall rate of infections and serious infections in KESIMPTA-treated patients was similar to teriflunomide-treated patients (51.6% vs 52.7%, and 2.5% vs 1.8%, respectively). The most common infections reported by KESIMPTA-treated patients in 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 resolved.

Consider the potential increased immunosuppressive effects when initiating KESIMPTA after an immunosuppressive therapy or initiating an immunosuppressive therapy after KESIMPTA.

Hepatitis B Virus: Reactivation: No reports of hepatitis B virus (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 treated with ofatumumab at higher intravenous doses for chronic lymphocytic leukemia (CLL) than the recommended dose in MS 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 treated with ofatumumab at higher intravenous doses for CLL than the recommended dose in MS. Perform HBV screening in all patients before initiation of KESIMPTA. Patients who are negative for HBsAg and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], should consult liver disease experts before starting and during KESIMPTA treatment.

Progressive Multifocal Leukoencephalopathy: No cases of progressive multifocal leukoencephalopathy (PML) have been reported for KESIMPTA in RMS clinical studies; however, PML resulting in death has occurred in patients being treated with ofatumumab at higher intravenous doses for CLL than the recommended dose in MS. In addition, JC virus infection resulting in PML has also been observed in patients treated with other anti-CD20 antibodies and other MS therapies. If PML is suspected, withhold KESIMPTA and perform an appropriate diagnostic evaluation. If PML is confirmed, KESIMPTA should be discontinued.

Vaccinations: Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines at least 4 weeks and, whenever possible at least 2 weeks prior to starting KESIMPTA for 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.

Vaccination of Infants Born to Mothers Treated with KESIMPTA During Pregnancy. For infants whose mother was treated with KESIMPTA during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines. If the B-cell count has not recovered in the infant, do not administer the vaccine as having depleted B-cells may pose an increased risk in these infants.

Injection-Related Reactions: Injection-related reactions with systemic symptoms occurred most commonly within 24 hours of the first injection, but were also observed with later injections. There were no life-threatening injection reactions in RMS clinical studies.

The first injection of KESIMPTA should be performed under the guidance of an appropriately trained health care professional. If injection-related reactions occur, symptomatic treatment is recommended.

Reduction in Immunoglobulins: As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. 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.

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.

Most common adverse reactions (>10%) are upper respiratory tract infection, headache, injection-related reactions, and local injection-site reactions.

Please see full Prescribing Information, including Medication Guide.

KESIMPTA, the KESIMPTA logo, and SENSOREADY are registered trademarks of Novartis AG.

ALONGSIDE is a trademark of Novartis AG.

CoverMyMeds is a registered trademark of CoverMyMeds, LLC.

All registered trademarks are the property of their respective owners.