Launching a new MS drug responsibly, during Covid-19

 As
a company, Novartis had to ask themselves what launching a drug responsibly, in this environment would look like. Novartis recognized that their mission to bring
effective therapies to people who need them is only part of the bigger picture. 

 With health care delivery changing against the backdrop of COVID-19, Novartis needed to
ensure their accounting for the full impact on the MS community. Novartis
remains committed to supporting the shifting needs of people with Multiple Sclerosis in
response to the changes we are all experiencing.

 Through
their discussions with patient advocacy organizations, as well as with health care providers, Novartis came
to the decision that it is in the best interest of patients to ensure Kesimpta®
(ofatumumab) 20 mg injection is readily accessible upon its approval to
patients with relapsing forms of MS. 

 Novartis is also offering Alongside
Kesimpta® that provides people with relapsing MS with the education and
resources they need while using Kesimpta®. In addition to financial and
reimbursement support, the program also provides supplemental injection training
and ongoing support for people who have been prescribed Kesimpta®.

 Novartis
is committed to helping people afford Kesimpta® and is offering a $0 copay for
patients with commercial insurance and will provide free product while working
through benefit verification for eligible commercially-insured people[1]. 

Patients can learn more by calling
1-855-KESIMPTA (1-855-537-4678) or by visiting www.startkesimpta.com.

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Important
Safety Information

Who
should not take KESIMPTA?  Do
NOT take KESIMPTA if you have active hepatitis B virus (HBV) infection.

What
is the most important information I should know about KESIMPTA?

KESIMPTA
can cause serious side effects such as:

• Infections. Serious infections can happen
  during treatment with KESIMPTA. If you have an active infection, your
  health care provider (HCP) should delay your treatment with KESIMPTA until
  your infection is gone. KESIMPTA taken before or after other medicines that
  weaken the immune system may increase your risk of getting infections.
  Tell your HCP right away if you have any infections or get any symptoms
  including painful and frequent urination, nasal congestion, runny nose,
  sore throat, fever, chills, cough, or body aches.
• HBV reactivation. If you have ever had HBV
  infection, it may become active again during or after treatment with
  KESIMPTA (reactivation). If this happens, it may cause serious liver
  problems including liver failure or death. Before starting KESIMPTA, your
  HCP will do a blood test to check for HBV. They will also continue to
  monitor you during and after treatment with KESIMPTA for HBV. Tell your
  HCP right away if you get worsening tiredness or yellowing of your skin or
  the white part of your eyes.
• 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. PML can result in
  death or severe disability. Tell your HCP right away if you have any new
  or worsening neurologic signs or symptoms. These may include weakness on one side of your body, loss of
  coordination in arms and legs, vision problems, changes in thinking and
  memory, which may lead to confusion and personality changes. 
• Weakened immune system. KESIMPTA taken before or after
  other medicines that weaken the immune system could increase your risk of
  getting infections.

Before
you take KESIMPTA, tell your HCP about all your medical conditions, including
if you:

• Have or think you have an infection
  including HBV or PML.
• Have ever taken, currently take, or
  plan to take medicines that affect your immune system. These medicines
  could increase your risk of getting an
  infection.
• Have had a recent vaccination or
  are scheduled to receive any vaccinations.
• You
  should receive any required ‘live’ or ‘live-attenuated’ vaccines at least
  4 weeks before you start treatment with KESIMPTA. You should not receive
  ‘live’ or ‘live-attenuated’ vaccines while you are being treated with KESIMPTA and until your HCP tells you that your immune system is no longer weakened.
• Whenever
  possible, you should receive any ‘non-live’ vaccines at least 2 weeks
  before you start treatment with KESIMPTA.
• Talk
  to your HCP about vaccinations for your baby if you used KESIMPTA during
  your pregnancy.
• Are
  pregnant, think that you might be pregnant, or plan to become pregnant. It
  is not known if KESIMPTA will harm your unborn baby. Females who can
  become pregnant should use birth control (contraception) during treatment
  with KESIMPTA and for 6 months after your last treatment. Talk with your
  HCP about what birth control method is right for you during this time.
• Are breastfeeding or plan to
  breastfeed. It is not known if KESIMPTA passes into your breast milk. Talk
  to your HCP about the best way to feed your baby if you take KESIMPTA.

Tell
your HCP about all the medicines you take, including prescription and
over-the-counter medicines, vitamins, and herbal supplements.

How
should I use KESIMPTA?

See
the detailed Instructions for Use that comes with KESIMPTA for information
about how to prepare and inject a dose of KESIMPTA and how to properly throw
away (dispose of) used KESIMPTA Sensoready pens or prefilled syringes.

• Use
  KESIMPTA exactly as your HCP tells you to use it.
• Your HCP will show you how to
  prepare and inject KESIMPTA the right way before you use it for the first
  time.
• Do not inject into areas where the skin
  is tender, bruised, red, scaly or hard. Avoid areas with moles, scars, or
  stretch marks.

KESIMPTA
may cause serious side effects including:

• Injection-related
  reactions. Injection-related reactions
  are a common side effect of KESIMPTA. Injecting KESIMPTA can cause
  injection-related reactions that can happen within 24 hours (1 day)
  following the first injections and with later injections. Talk with your
  HCP if you have any of these signs and symptoms:
• at or near the injection site: redness of the skin, swelling, itching, and pain or
• that
  may happen when certain substances are released in your body: fever, headache, pain in the
  muscles, chills, and tiredness.
• Low
  immunoglobulins. KESIMPTA may cause a decrease
  in some types of antibodies. Your HCP will do blood tests to check your
  blood immunoglobulin levels.

The
most common side effects of KESIMPTA include:

• Upper respiratory tract infection,
  with symptoms such as sore throat and runny nose, and headache.
• Headache.

You
are encouraged to report negative side effects of prescription drugs to the
FDA.  Visit www.fda.gov/medwatch,
or call 1-800-FDA-1088.

Indication

What is KESIMPTA (ofatumumab) injection?
KESIMPTA is a prescription medicine used to treat adults with relapsing forms of multiple sclerosis (MS) including clinically isolated syndrome (CIS), relapsing-remitting disease, and active secondary progressive disease.

It is not known if KESIMPTA is safe or effective in children.

Please see full Prescribing Information, including Medication Guide.