FAQs
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About KESIMPTA®
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Howdoes KESIMPTA work?
Here's what goes on withrelapsing MS:
The immune system uses certain cells, likeB-cells, to help fight infections. These cells can becomeactivated in the lymph nodes—the communication hub forthe immune system.
But there's a miscommunication that happensin relapsing MS. Instead of protecting the immune system, thesecells mistakenly attack the body's myelin—the fatty,protective covering of the nerves in the brain and spinal cord.
Here's what KESIMPTA does:
Although it's not known exactly how KESIMPTA works in relapsingMS, it's thought to travel specifically to the lymph nodesbased on the way it's taken. From there, it's believed to reduce the number of B-cells thatare thought to play a role in relapsing MS.
See how KESIMPTA works here.
This targeted approach to the lymphnodes is thought to limit the impact on other B-cells your bodyneeds to maintain immune function.
Howcan KESIMPTA help with relapsing MS?
KESIMPTA is a once monthly* treatment with at-home flexibilityand proven results for reducing relapses and active lesions andslowing disability progression.† It has a similar overallsafety profile to AUBAGIO® (teriflunomide).‡
See the results here.
Talk to your doctor to find out if KESIMPTAmay be right for you.
*Once monthly after 3 weeklystarter doses.
†Reduced annual rate of relapses by 51%and 58%, reduced average number of Gd+ T1 lesions per MRI by98% and 94%, reduced disability progression by 34% at 3 monthsand 32% at 6 months in 2 studies vs AUBAGIO.
‡ AUBAGIO isa registered trademark of Genzyme, a Sanofi company.
Whoshould not take KESIMPTA?
Don't take KESIMPTA if you:
have an active Hepatitis B Virus (HBV) infection.
have had an allergic reaction to ofatumumab, or a life-threatening injection-related reaction to KESIMPTA.
Whatis the most important information I should know about KESIMPTA?
KESIMPTA could increase the risk of serious, including life-threatening or fatal, infections:
Hepatitis B virus (HBV)reactivation: Before starting KESIMPTA, you'll get a bloodtest for HBV. If you've ever had HBV infection, it may becomeactive again during or after 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, and can result in death or severe disability. While no cases of PML were reported in RMS clinical trials with KESIMPTA, it could happen.
Weakened immune system:Taking KESIMPTA before or after other medicines that weakenyour immune system could increase your risk of gettinginfections
Other serious side effects are:
Local injection-site reactions: Symptoms include redness, swelling, itching, and pain.
Injection-related reactions (systemic): Symptoms include fever, headache, pain in the muscles, chills, tiredness, rash, hives, trouble breathing, swelling of the face, eyelids, lips, mouth, tongue and throat, and feeling faint, or chest tightness.
Low immunoglobulins: KESIMPTA may decrease some types of antibodies. Your doctor will do blood tests to check your immunoglobulin levels.
See full Important Safety Information here.
Whatare the most common side effects?
Upper respiratory tract infections: Symptoms include sore throat, runny nose, and headache.
Headache
See more details here.
Everyone reacts to medications differently. Talk withyour doctor about any possible side effects and if KESIMPTA isright for you.
Can Itake KESIMPTA while breastfeeding?
It is not known if KESIMPTA passes intobreast milk. Talk to your doctor about the best way to feedyour baby if you take KESIMPTA.
Can Itake KESIMPTA while pregnant?
It is not known if KESIMPTA will harm your unborn baby. Tellyour doctor if you're pregnant, think you might be pregnant, orplan to become pregnant before starting KESIMPTA. To help usbetter understand the effects of the treatment, there is aregistry for women who become pregnant during treatment withKESIMPTA. For more information or to register, visit MotherToBaby, call 1-877-311-8972 or send an email to MotherToBaby@health.ucsd.edu.
Can Itry to get pregnant while taking KESIMPTA?
It is not known if KESIMPTA will harm your unborn baby. Femaleswho can become pregnant should use birth control duringtreatment with KESIMPTA and for 6 months after your lasttreatment. Talk to your doctor about what birth control methodis right for you during this time. To help us better understandthe effects of the treatment, there is a registry for women whobecome pregnant during treatment with KESIMPTA. For moreinformation or to register, visit MotherToBaby,call 1-877-311-8972 or send an email to MotherToBaby@health.ucsd.edu.
Arethe effects of KESIMPTA being studied in pregnant women?
Yes, to help us better understand the effects of KESIMPTA thereis a registry for women who become pregnant during treatmentwith KESIMPTA. For more information or to register, visit MotherToBaby,call 1-877-311-8972 or send an email to MotherToBaby@health.ucsd.edu.
Can Ireceive vaccines while on KESIMPTA?
You shouldn't receive any live vaccineswhile taking KESIMPTA and until your doctor tells you that yourimmune system is no longer weakened. Any required live vaccinesshould be received at least 4 weeks before you start KESIMPTA.If possible, any "non-live" vaccines should be received atleast 2 weeks before you start treatment with KESIMPTA.
Howcan I become a KESIMPTA Crew member?
You can become a KESIMPTA Crew Member bycalling 1-877-879-0245 or emailing us atinfo@voices-of-inspiration.com.
Can Itravel with KESIMPTA?
Yes! You can take KESIMPTA at home or wherever you go with acooler or refrigerator. It's important to keep the KESIMPTASensoready® Pen between 2 °C to 8 °C (36°F to 46 °F). Keep the pen in the original carton toprotect from light until the time of use. Do not freeze. Toavoid foaming, do not shake. Also, don't forget to pack yoursharps container, alcohol swabs, and cotton balls. If needed,KESIMPTA may be stored for up to 7 days at room temperature, upto 86 °F (30 °C). If stored below 86 °F (30 °C),unused KESIMPTA may be returned to the refrigerator and must beused within the next 7 days. If not used within those 7 days,discard the medicine.
Howdo I store KESIMPTA?
You can store the KESIMPTA Sensoready® pens in acooler or refrigerator. It's important to keep the KESIMPTASensoready Pen between 2 °C to 8 °C (36 °F to 46 °F). Keep the product in the original carton to protectfrom light until the time of use. Do not freeze. To avoidfoaming, do not shake. If needed, KESIMPTA may be stored for upto 7 days at room temperature, up to 86 °F (30 °C). Ifstored below 86 °F (30 °C), unused KESIMPTA may bereturned to the refrigerator and must be used within the next 7days. If not used within those 7 days, discard the medicine.
Taking KESIMPTA
Whattests will my doctor need to do before I start on KESIMPTA?
Before starting KESIMPTA, you'll get ablood test for hepatitis B virus (HBV). If you've ever had HBVinfection, it may become active again during or after treatmentwith KESIMPTA. Your doctor will also have you get blood teststo check your immunoglobulin levels because KESIMPTA maydecrease some types of antibodies.
Whydo I need to be tested for Hepatitis B Virus (HBV) beforestarting KESIMPTA?
You'll be screened for HBV before startingKESIMPTA because if you've had HBV in the past, there's achance KESIMPTA can reactivate it. You'll get a simple bloodtest to be sure.
Howoften do I take KESIMPTA?
You'll give yourself 1 doseper week for the first 3 weeks, and then you'll skip a week. After that, you canmove on to 1 dose per month.
Howdo I take KESIMPTA?
Someone from your health care team willgive you guidance on how to take KESIMPTA for the first time.
If you need a refresher on how to take KESIMPTA, you can watchan additional demo video or download some quick tips here.
You can also ask your Alongside™ KESIMPTACoordinator to set up an additional online demo.
Call 1-855-KESIMPTA (1-855-537-4678), 8:30 AM–8:00 PMET, Monday–Friday.
Call 1-855-KESIMPTA (1-855-537-4678),8:30 AM–8:00 PM ET, Monday–Friday.
Do Ineed to take KESIMPTA at a hospital or doctor's office?
Someone from your health care team will give you guidance onhow to take KESIMPTA for the first time. After that, you cantake KESIMPTA at home or wherever you go with a cooler orrefrigeration. If you are taking KESIMPTA away from home,you'll need to bring your sharps container, alcohol swabs, andcotton balls. It's important to keep the KESIMPTA Sensoready®Pen between 36 °F and 46 °F and in its original cartonuntil you are ready to use it. Do not freeze. To avoid foaming,do not shake.
Whathappens if I miss a dose?
If you miss an injection of KESIMPTA atWeek 0, 1, or 2, talk to your doctor. If you miss a monthlyinjection, take it as soon as possible without waiting untilthe next scheduled dose. After that, take your KESIMPTAinjections a month apart.
Check out how to take KESIMPTA here.
How do I safely dispose of my KESIMPTA Sensoready®Pen?
The best way is to use an FDA-clearedsharps container.
Ask your Coordinator how to get one forfree. You'll get a pre-paid return label to send your fullsharps container back, and you'll be sent a new container.
You shouldn't throw away your Sensoready® Pen inyour household trash. If you don't have an FDA-cleared sharpscontainer, you can use a household container that is:
made of a heavy-duty plastic,
can be closed with a tight-fitting,puncture-resistant lid without sharps being able to comeout,
upright and stable during use,
leak-resistant, and
properly labeled to warn ofhazardous waste inside the container
Is there any latex in the KESIMPTA Sensoready®Pen?
No, the Sensoready® Pen does not contain anylatex.
DoesKESIMPTA have a patient assistance or support program?
Yes! It's called Alongside™ KESIMPTA, and every KESIMPTA prescription comes with a membership.Members receive personalized support from a dedicatedCoordinator who can determine if you're eligible to save onKESIMPTA, and help you learn how to take it.
See what Alongside KESIMPTA can do here and become a member if youhave a prescription but aren't enrolled yet.
Howwill I feel after the first dose?
Everyone reacts to KESIMPTA a little differently, but it's notuncommon to feel injection-related reactions within 24 hoursafter your first dose. These reactions may include fever,headache, muscle pain, chills, and fatigue, but generallydecrease with each KESIMPTA dose. Reactions at or near theinjection site include redness of the skin, swelling, itching,and pain. For more information on KESIMPTA reactions, pleasevisit our safety page here.
Savings &Support
What is Alongside™ KESIMPTA?
Alongside KESIMPTA is amembership that comes with every KESIMPTA prescription. Membersreceive personalized support from a dedicated Coordinator whocan determine if you're eligible to save on KESIMPTA, and helpyou learn how to take it.
See what Alongside KESIMPTA can do here and become a member if youhave a prescription but aren't enrolled yet.
Whathappens after I'm enrolled in Alongside KESIMPTA?
Here's what happens next:
We'll help you get startedby figuring out delivery and savings, including if you're eligible to pay as little as $0* co-pay once you are covered
We'll mail you a welcomepackage with some important details inside
You'll get a dedicatedCoordinator who will answer any questions throughout yourmembership
Get in touch at 1-855-KESIMPTA (1-855-537-4678),8:30 AM–8:00 PM ET, Monday–Friday.
*Access Card Program: Limitationsapply. People with commercial insurance may receive up to an$18,000 annual limit and/or up to 12 months of free productwhile coverage is pursued. Offer not valid under Medicare,Medicaid, or any other federal or state health insuranceprogram. See complete Terms & Conditions at start.kesimpta.com.
DoesAlongside KESIMPTA offer injection support?
Yes—injection demonstrations are available. Choose fromvirtual demos or thisdemo video.
Keep in mind these demos do not replace anyinstructions provided by your doctor. If you have anyquestions, please get in touch with your doctor.
To schedule a demo or to get a Sensoready®Training Pen, call 1-855-KESIMPTA (1-855-537-4678),8:30 AM–8:00 PM ET, Monday–Friday.
Howdo I get insurance coverage support for KESIMPTA?
Your Alongside KESIMPTA Coordinator willidentify the correct coverage assistance options to meet yourneeds. If you're commercially insured and have coverage forKESIMPTA, they can enroll you in a $0 Co-pay Program.*
If you are not covered for KESIMPTA,Coordinators will provide support to your doctor as your doctorpursues an appeal with your health care plan.
*Access Card Program:Limitations apply. People with commercial insurance may receiveup to an $18,000 annual limit and/or up to 12 months of freeproduct while coverage is pursued. Offer not valid underMedicare, Medicaid, or any other federal or state healthinsurance program. See complete Terms & Conditionsat start.kesimpta.com.
Howdo I reach the Alongside KESIMPTA Support Team?
You can reach the Alongside KESIMPTA Support Team by calling1-855-KESIMPTA (1-855-537-4678),8:30 AM–8:00 PM ET, Monday–Friday.
About Relapsing Forms of
MultipleSclerosis
Whatis relapsing multiple sclerosis (RMS)?
Relapsing multiple sclerosis is a diseasethat affects the central nervous system (CNS), which iscomposed of the brain and spinal cord. The myelin, whichprotects the nerves in the CNS, gets damaged, and results in avariety of symptoms. A relapse is when new symptoms occur orwhen existing symptoms worsen.
Whatis clinically isolated syndrome (CIS)?
CIS is the first occurrence of neurologicalsymptoms that lasts a minimum of 24 hours. It is caused byinflammation or loss of myelin, which protects the nerves inthe central nervous system (CNS).
Whatis relapsing-remitting multiple sclerosis (RRMS)?
RRMS describes the condition ofexperiencing cycles of relapses followed by periods ofremission. RRMS is the most common form of relapsing MS.
Whatis active secondary progressive multiple sclerosis (SPMS)?
Active SPMS is the early stage of SPMS inwhich people experience fewer relapses but don't bounce back aswell between relapses, and have increased disability. ActiveSPMS means a person may have had at least 1 relapse in the last2 years.
Whatare the symptoms of RMS? What does RMS look like? What does itfeel like?
The symptoms associated with RMS arevariable and unpredictable. Every individual with RMS mayexperience a different variety and pattern of symptoms overtime.
Whatare the early signs of RMS?
As the symptoms of RMS vary from person toperson, there are no specific early signs of RMS.
Whatcauses RMS? Is RMS hereditary?
The cause of RMS is unknown, and multiplefactors are still being studied.
Howis RMS treated?
Although there is no cure for RMS, thereare a variety of treatment options on the market that differ inefficacy, side effects, and dosing and administration. Thetreatments are administered through different methods such asinjections, infusions, or pills. Medications, calleddisease-modifying therapies, or DMTs, don't generally treatdaily symptoms. Studies show that DMTs may help reduce relapsesand slow disability progression.
Whatkind of doctor diagnoses RMS?
A neurologist typically diagnoses andtreats patients with RMS.
Howis RMS diagnosed?
There is no single way to diagnose RMS. Your doctor can performa variety of tests to rule out other conditions including aneurologic exam, an MRI, spinal fluid analysis, and bloodtests. For more information on diagnosis, click here.
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Pay as little as $0 co-pay* & enroll in the
Alongside™ KESIMPTA Support Program.
Learn More
Pay as little as $0 co-pay* &
enroll in the Alongside™
KESIMPTA Support Program.
Learn More
MRI, magnetic resonance imaging; MS, multiple sclerosis; RMS, relapsing multiple sclerosis.
*Limitations apply. Offer not valid under Medicare, Medicaid, or any other federal or state health insurance program. Patients with commercial insurance coverage for KESIMPTA may receive up to $18,000 in annual co-pay benefits. Patients with commercial insurance and an initial denial of coverage may receive up to 12 months of free product while coverage is pursued. Novartis reserves the right to rescind, revoke, or amend this program without notice. See complete Terms & Conditions at start.kesimpta.com.
