INDIANAPOLIS, Jan. 14, 2020 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) today announced plans to add two more
cost-saving options to its suite of solutions for people who use
Lilly insulin by introducing lower-priced versions of
Humalog® Mix75/25™ KwikPen®
(insulin lispro protamine and insulin lispro injectable suspension
100 units/mL) and Humalog® Junior KwikPen®
(insulin lispro injection 100 units/mL). Both insulins will have 50
percent lower list prices compared to the branded versions and will
be available by mid-April.
Lilly's first lower-priced insulin, Insulin Lispro Injection
(100 units/mL), was made available in May
2019 at a 50 percent lower list price than
Humalog® (insulin lispro injection 100 units/mL). In
November 2019, more than 67,000
people filled prescriptions for Insulin Lispro Injection, and
approximately 10 percent of people using Humalog have transitioned
to the lower-priced option. Insulin Lispro Injection is now
distributed by all major U.S. wholesalers and can be ordered by any
pharmacy. Lilly will begin negotiations immediately with
wholesalers and payers to make these additional lower-priced
insulins available.
"Lilly is committed to offering the broadest suite of solutions
for people who need help affording their insulin, and our
lower-priced insulins are important options," said Mike Mason, president, Lilly Diabetes. "But real
change to our reimbursement system is needed. Insurance coverage
should ensure no one with diabetes is forced to ration or skip
doses for financial reasons."
Combined, Humalog U-100, Humalog Mix75/25, and Humalog Junior
KwikPen make up more than 90 percent of prescriptions written for a
Lilly mealtime insulin. With a lower-priced version of each
available, the vast majority of people using a Humalog formulation
will have an option that may reduce their out-of-pocket costs.
Humalog Mix75/25 is one of Lilly's most prescribed insulins, with
nearly 600,000 prescriptions filled in the last 12 months.
These insulins are identical molecules to the branded versions
and may be substituted at the pharmacy counter. Because most
insurance plans provide affordable copays for chronic medicines
that are much lower than the list price, people should ask their
pharmacist whether these options reduce their out-of-pocket
cost.
"The cost of insulin at the pharmacy varies dramatically
depending on a person's insurance coverage," said Mason. "These
lower-priced insulins may reduce out-of-pocket costs, especially
for people in the coverage gap of Medicare Part D, the uninsured or
those with high-deductible insurance plans."
The lower-priced version of Humalog Mix75/25 will be known as
Insulin Lispro Protamine and Insulin Lispro Injectable Suspension
Mix75/25™ KwikPen® (100 units/mL). The
lower-priced version of Humalog Junior KwikPen will be known as
Insulin Lispro Injection Junior KwikPen® (100 units/mL).
Both will have a list price of $265.20 for a package of five KwikPens.
More than 95 percent of people using Humalog pay less than
$100 for their monthly prescription
at retail pharmacies because of their insurance coverage or one of
Lilly's affordability solutions. Anyone who uses a Lilly insulin
can call the Lilly Diabetes Solution Center at (833) 808-1234
(9 am to 8 pm EST Monday through
Friday) to see whether there is an option that reduces their
out-of-pocket costs. Staffed by health care professionals, the
Solution Center may provide significant savings on Lilly insulins
in multiple ways, including out-of-pocket caps on what people with
commercial plans pay at the pharmacy and information about how to
access donated Lilly insulin at more than 150 free clinics across
the country. In 2019, Lilly's solutions helped up to 20,000 people
with diabetes each month reduce their out-of-pocket costs for
insulin.
PURPOSE and SAFETY SUMMARY
Important Facts About Humalog® (HU-ma-log) and
Insulin Lispro Injection
- Humalog is also known as insulin lispro injection.
- Humalog and Insulin Lispro Injection are fast-acting insulins.
They are used to control high blood sugar in adults and children
with diabetes. They are available only with a prescription.
- Humalog comes in two strengths: U-100 (100 units per
milliliter) and U-200 (200 units per milliliter). The Humalog U-200
prefilled pen contains 2 times as much insulin per 1
milliliter as standard (U-100) insulin. The dose window on the pen
shows your insulin dose.
- It is not known if Humalog or Insulin Lispro Injection are safe
and effective for children with type 2 diabetes or for children
younger than 3 years of age with type 1 diabetes. There were no
studies done with these insulins in these groups of children. If
your doctor decides to give your child one of these insulins, he or
she may give you special instructions.
Important Facts about Humalog®
Mix50/50™, Humalog® Mix75/25™, and
Insulin Lispro Protamine and Insulin Lispro Injectable Suspension
Mix75/25
- Humalog Mix50/50 and Humalog Mix75/25 are known as insulin
lispro protamine and insulin lispro injectable suspension.
- Humalog Mix50/50, Humalog Mix75/25, and Insulin Lispro
Protamine and Insulin Lispro Injectable Suspension Mix75/25 are
mixed insulins. This means they contain a mix of fast-acting and
intermediate-acting insulins. They are used to control high blood
sugar in people with diabetes. They are available only with a
prescription.
- It is not known if Humalog Mix50/50, Humalog Mix75/25, or
Insulin Lispro Protamine and Insulin Lispro Injectable Suspension
Mix75/25 are safe and effective for children younger than 18 years
of age. There were no studies done with these insulins in children
younger than 18. If your doctor decides to give your child one of
these insulins, he or she may give you special instructions.
All Humalog and Insulin Lispro Injection products contain
insulin lispro. Humalog Mix50/50, Humalog Mix75/25, and Insulin
Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25
contain insulin lispro protamine mixed with insulin lispro.
Warnings
Do not take Humalog, Insulin Lispro Injection, Humalog
Mix50/50, Humalog Mix75/25, or Insulin Lispro Protamine and Insulin
Lispro Injectable Suspension Mix75/25 if you have:
- symptoms of low blood sugar (hypoglycemia)
- an allergy to insulin lispro products or any of their
ingredients.
Do not reuse needles or share your insulin injection supplies
with other people. This includes your:
- prefilled pen for use by a single patient
- cartridges
- reusable pen that works with Lilly 3mL cartridges
- needles
- syringes
You or the other person can get
a serious infection. This can happen even if you change the
needle.
Do not change the type of insulin you take or your
dose, unless your doctor tells you to. This could cause low or high
blood sugar, which could be serious.
Do not use a syringe to remove Humalog from your
prefilled pen. This can cause you to take too much insulin. Taking
too much insulin can lead to severe low blood sugar. This may
result in seizures or death.
Humalog, Insulin Lispro Injection, Humalog Mix50/50, Humalog
Mix75/25, and Insulin Lispro Protamine and Insulin Lispro
Injectable Suspension Mix75/25 may cause serious side effects. Some
of these can lead to death. The possible serious side
effects are:
- Low blood sugar. This can cause:
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dizziness or light-headedness
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sweating
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confusion
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headache
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blurred vision
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slurred speech
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shakiness
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fast heartbeat
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anxiety
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irritability
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mood change
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hunger
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If you are at risk of having
severely low blood sugar, your doctor may prescribe a glucagon
emergency kit. These are used when your blood sugar becomes too low
and you are unable to take sugar by mouth. Glucagon helps your body
release sugar into your bloodstream.
- Severe allergic reaction.
Get emergency help right
away if you have:
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rash over your whole body
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trouble breathing
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fast heartbeat
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sweating
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faint feeling
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shortness of breath
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extreme drowsiness
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dizziness
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confusion
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swelling of your face, tongue,
or throat
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- Low potassium in your blood. This can lead to
severe breathing problems, irregular heartbeat, and death.
- Heart failure. Taking diabetes pills called
thiazolidinediones (thIE-uh-zOH-li-dEEn-dIE-OHns), or "TZDs," with
insulin lispro products may cause heart failure in some people.
This includes people who do not have any heart problems. If you
have heart failure, it may get worse if you take TZDs with these
insulin lispro products. Tell your doctor if you have any new
symptoms of heart failure, or if they get worse. Some symptoms of
heart failure include: shortness of breath, swelling of ankles and
feet, and sudden weight gain. Your doctor may need to change or
stop treatment with TZDs and your insulin lispro product.
- High blood sugar and ketoacidosis. You can have
these serious problems when your insulin pump or infusion set stops
working. They can also happen if your insulin is no longer
effective. For these reasons, always keep extra insulin injection
supplies with you.
Common side effects
The most common side effects of Humalog, Insulin Lispro
Injection, Humalog Mix50/50, Humalog Mix75/25, and Insulin Lispro
Protamine and Insulin Lispro Injectable Suspension Mix75/25
are:
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low blood sugar
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allergic reactions
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reactions where you have injected insulin
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changes in fat tissue where you have injected insulin
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swelling of your hands or feet
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weight gain
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itching
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rash
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These are not all of the possible side effects. Tell your
doctor if you have any side effects. You can report side effects at
1-800-FDA-1088 or www.fda.gov/medwatch.
Before using
Talk with your doctor about low blood sugar and how to manage
it. Also tell your doctor:
- about all of the medicines you take, including over-the-counter
medicines, vitamins, and herbal supplements.
- about any other prescription medicines you take, especially
ones called TZDs.
- about all of your medical conditions, including if you have
heart failure or other heart, liver, or kidney problems.
- if you are pregnant, breastfeeding, or plan to become pregnant
or breastfeed.
How to take
Read the Instructions for Use that come with your
Humalog, Insulin Lispro Injection, Humalog Mix50/50, Humalog
Mix75/25, or Insulin Lispro Protamine and Insulin Lispro Injectable
Suspension Mix75/25. Be sure to take your insulin lispro
product and check your blood sugar levels exactly as your
doctor tells you to. Your doctor may tell you to change your dose
because of illness, increased stress, or changes in your weight,
diet, or physical activity level. He or she may also tell you to
change the amount or time of your dose because of other medicines
or different types of insulin you take.
Before injecting your insulin lispro product
You can inject your insulin dose yourself, or you can have a
trained caregiver inject it for you. Make sure you or your
caregiver:
- Check the insulin label before each injection. This will help
you make sure that you are taking the correct insulin.
- Use a new needle for each injection. You can get a serious
infection or the wrong dose of insulin if you re-use needles.
- Change (rotate) where you inject your insulin with each dose.
This can reduce your chance of getting pits, lumps, or thickened
skin where you inject your insulin. Do not inject your
insulin into the exact same spot or where the skin has pits or
lumps. Avoid injecting into thickened, tender, bruised,
scaly, hard, scarred, or damaged skin.
When you are ready to inject
- If you are taking Humalog or Insulin Lispro Injection, inject
it under your skin within 15 minutes before or right after you eat
a meal.
- If you are taking Humalog Mix50/50, Humalog Mix75/25, or
Insulin Lispro Protamine and Insulin Lispro Injectable Suspension
Mix75/25, inject it under your skin within 15 minutes before you
eat a meal.
Staying safe while taking your insulin lispro product
To stay safe while taking your insulin, be sure to never
inject Humalog U-200, Humalog Mix50/50, Humalog Mix75/25, or
Insulin Lispro Protamine and Insulin Lispro Injectable Suspension
Mix75/25 in your vein, muscle, or with an insulin pump. Also
be sure not to:
- mix Humalog U-200, Humalog Mix50/50, Humalog Mix75/25, or
Insulin Lispro Protamine and Insulin Lispro Injectable Suspension
Mix75/25 with other insulins or liquids.
- drive or use heavy machinery until you know how your insulin
lispro product affects you.
- drink alcohol or use other medicines that contain alcohol when
taking your insulin lispro product.
Learn more
For more information, call 1-800-545-5979 or go to
www.humalog.com or www.lillyinsulinlispro.com.
For additional information talk to your doctor and please see
Humalog Full Prescribing Information, Insulin Lispro Injection Full
Prescribing Information, Humalog Mix75/25 Full Prescribing
Information, Insulin Lispro Protamine and Insulin Lispro Injectable
Suspension Mix75/25 Full Prescribing Information and Humalog
Mix50/50 Full Prescribing Information.
Please see Patient Information and Instructions for Use included
with the product.
This summary provides basic information about
Humalog, Insulin Lispro Injection, Humalog Mix50/50, Humalog
Mix75/25, and Insulin Lispro Protamine and Insulin Lispro
Injectable Suspension Mix75/25. It does not include all information
known about these medicines. Read the information that comes with
your prescription each time your prescription is filled. This
information does not take the place of talking with your doctor. Be
sure to talk to your doctor or other health care provider about
your insulin lispro product and how to take it. Your doctor is the
best person to help you decide if these medicines are right for
you.
Humalog®,
Humalog® Mix50/50TM, and
Humalog® Mix75/25TM are trademarks
or registered trademarks owned or licensed by Eli Lilly and
Company, its subsidiaries, or affiliates.
HI BOI SP CON BS 15NOV2019
About Diabetes
Approximately 30 million
Americans1 and an estimated 425 million adults worldwide
have diabetes.2 Type 2 diabetes is the most common type
internationally, accounting for an estimated 90 to 95 percent of
all diabetes cases in the United
States alone.1 Diabetes is a chronic disease that
occurs when the body does not properly produce or use the hormone
insulin.
About Lilly Diabetes
Lilly has been a global leader in
diabetes care since 1923, when we introduced the world's first
commercial insulin. Today we are building upon this heritage by
working to meet the diverse needs of people with diabetes and those
who care for them. Through research, collaboration and quality
manufacturing we strive to make life better for people affected by
diabetes. We offer a wide range of therapies and a continued
determination to provide real solutions—from medicines and
technologies to support programs and more. For the latest updates,
visit http://www.lillydiabetes.com/or follow us on Twitter:
@LillyDiabetes and Facebook: LillyDiabetesUS.
About Eli Lilly and Company
Lilly is a global
health care leader that unites caring with discovery to create
medicines that make life better for people around the world. We
were founded more than a century ago by a man committed to creating
high-quality medicines that meet real needs, and today we remain
true to that mission in all our work. Across the globe, Lilly
employees work to discover and bring life-changing medicines to
those who need them, improve the understanding and management of
disease, and give back to communities through philanthropy and
volunteerism. To learn more about Lilly, please visit us at
lilly.com and lilly.com/newsroom. P-LLY
This press release contains forward-looking statements (as that
term is defined in the Private Securities Litigation Reform Act of
1995) about Humalog® Mix75/25™ (insulin
lispro protamine and insulin lispro injectable suspension 100
units/mL) or Humalog® Junior KwikPen®
(insulin lispro injection 100 units/mL) as a treatment for patients
with diabetes and reflects Lilly's current belief. However,
as with any pharmaceutical product, there are substantial risks and
uncertainties in the process of development and commercialization.
Among other things, there can be no guarantee that
Humalog® Mix75/25™ (insulin lispro protamine
and insulin lispro injectable suspension 100 units/mL) or
Humalog® Junior KwikPen® (insulin lispro
injection 100 units/mL) will be commercially successful. For
further discussion of these and other risks and uncertainties, see
Lilly's most recent Form 10-K and Form 10-Q filings with the United
States Securities and Exchange Commission. Except as required by
law, Lilly undertakes no duty to update forward-looking statements
to reflect events after the date of this release.
_______________________________
1. Centers for Disease Control and Prevention. National
Diabetes Statistics Report, 2017. Atlanta, GA: Centers for Disease Control and
Prevention, U.S. Dept of Health and Human Services; 2017.
2. International Diabetes Federation. IDF Diabetes
Atlas, 8th edn. Brussels,
Belgium: International Diabetes Federation, 2017.
http://www.diabetesatlas.org.
PP-SP-US-0143 1/2020 ©Lilly USA, LLC 2020. All rights reserved.
Refer
to:
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Greg Kueterman;
kueterman_gregory_andrew@lilly.com; 317.277.4021
(Lilly Diabetes Communications)
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Dani Barnhizer;
dbarnhizer@lilly.com; 317.276.3598
(Lilly Diabetes Communications)
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Kevin Hern;
hern_kevin_r@lilly.com; 317.277.1838
(Investor Relations)
|
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