For adults with obesity (BMI of ≥30 kg/m2), or with overweight (BMI of 27 kg/m2) with at least 1 weight-related comorbidity as an adjunct to a reduced-calorie diet and increased physical activity.1
Zepbound is not for cosmetic weight loss
Here's what to do:
*For eligible and commercially insured patients on Zepbound.
Governmental beneficiaries excluded,
apply.
Access additional resources
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Prescribe Zepbound 2.5 mg for appropriate patients1
What's needed to begin prescribing Zepbound?
Initiate with the 2.5-mg dose1
After 4 weeks, increase to the 5-mg dose1
Multiple doses to help individualize treatment with Zepbound1
Recommended maintenance dosages are 5 mg, 10 mg, or 15 mg1:
You can continue to increase the dose by 2.5-mg increments after at least 4 weeks on the current dose.
The maximum dose is 15 mg.1
Consider treatment response and tolerability when selecting maintenance dosage. If not tolerated,
consider a lower maintenance dosage
Image depicting the dose escalation of Zepbound. Starting dose is 2.5 mg once weekly for 4 weeks. Continue
to 5-mg maintenance dose once weekly for at least 4 weeks. The dose can be increased to 7.5 mg once weekly
for at least 4 weeks, followed by 10-mg maintenance dose once weekly for at least 4 weeks, then 12.5 mg
once
weekly for at least 4 weeks, and finally 15-mg maintenance dose once weekly as the maximum dose.
For adults with obesity (BMI of ≥30 kg/m2) or with overweight (BMI of ≥27 kg/m2) with at least 1 weight-related comorbidity as an adjunct to a reduced-calorie diet and increased physical activity.1
The 2.5-mg dosage is for treatment initiation and is not intended for chronic weight
management.1
Prior authorizations are common for the incretin class.
If patients' health insurance providers require prior authorizations, here's the clinical information you
may
need.
Requirements vary by plan. Information listed below includes common information that may be requested.
Get tips for prior authorization submission process
By enrolling in the Zepbound Savings Card Program (“Program”) and using the Zepbound Savings Card (“Card”),
you attest that you meet the eligibility criteria, and you agree to comply with the terms and conditions
described below: Card Eligibility: (1.) You have been prescribed Zepbound consistent with FDA approved product labeling
(2.) You are enrolled in a commercial drug insurance plan
(3.) You are not enrolled in any state, federal, or government funded healthcare program, including,
without limitation, Medicaid, Medicare, Medicare Part D, Medicare Advantage, Medigap, DoD, VA,
TRICARE®/CHAMPUS, or any state prescription drug assistance program. (4.) You are a resident of the United States or Puerto Rico
(5.) You are 18 years of age or older
Card Terms and Conditions For patients with commercial drug insurance coverage for Zepbound: You must have commercial drug
insurance that covers Zepbound®(tirzepatide) and a prescription consistent with FDA-approved
product
labeling to pay as little as $25 for a 1-month, 2-month, or 3-month prescription fill of Zepbound. Month is
defined as 28-days and up to 4 pens. Card savings are subject to a maximum monthly savings of up to $150 per
1-month prescription, $300 per 2-month prescription, or $450 per 3-month prescription fill and separate
maximum annual savings of up to $1,800 per calendar year. Card may be used for a maximum of up to 13
prescription fills per calendar year. Participation in the Program requires a valid patient HIPAA
authorization. Subject to Lilly USA, LLC’s (“Lilly”) right to terminate, rescind, revoke, or amend Card
eligibility criteria and/or Card terms and conditions which may occur at Lilly’s sole discretion, without
notice, and for any reason, Card expires and savings end on 12/31/2024.
For patients with commercial drug insurance who do not have coverage for Zepbound:
You must have commercial drug insurance that does not cover Zepbound and a prescription consistent with
FDA-approved product labeling to obtain savings of up to $563 off your 1-month prescription fill of
Zepbound. Month is defined as 28-days and up to 4 pens. Card savings are subject to a maximum monthly
savings of up to $563 and a separate maximum annual savings of up to $7,319 per calendar year. Card may be
used for a maximum of up to 13 prescription fills per calendar year. Participation in the Program requires a
valid patient HIPAA authorization. Subject to Lilly’s right to terminate, rescind, revoke, or amend Card
eligibility criteria and/or Card terms and conditions which may occur at Lilly’s sole discretion, without
notice, and for any reason, Card expires and savings end on 12/31/2024.
Additional Terms and Conditions
If you have an insurance plan that is participating in an alternate funding program (“AFP”) (examples
include, but are not limited to, ImpaxRX, Payer Matrix, SHARx, Script Sourcing, and Paydhealth) that
requires you to apply to the Zepbound Savings Card Program or otherwise pursue specialty drug prescription
coverage through an alternate funding vendor as a condition of, requirement for, or prerequisite to coverage
of Zepbound, you are not eligible for and are prohibited from using the Zepbound Savings Card Program. AFPs
include programs where coverage, reimbursement, or patient out of pocket costs for a product in some way
vary based on the availability of a manufacturer co-pay program. AFPs may modify, delay, deny, restrict, or
withhold insurance benefits or coverage from patients, or exclude Lilly products from coverage contingent
upon a member’s use of Zepbound Savings Card Program. You agree to inform the Zepbound Savings Card Program
if you are or become a member of such an alternative funding program. You are responsible for any applicable
taxes, fees, and any amount that exceeds the monthly or annual maximum Card savings. Monthly and annual
maximum savings are set at Lilly’s sole and absolute discretion and may be changed with or without notice at
any time for any reason. At its sole discretion and with or without notice, Lilly may reduce, eliminate, or
otherwise modify the Card savings for any reason, including but not limited to if your commercial drug
insurance plan imposes additional requirements which limits or prevents you from receiving coverage for
Zepbound, only allows partial coverage for Zepbound, removes coverage for Zepbound and requires you to
utilize the Card, does not provide a material level of financial assistance for the cost of Zepbound, or
does not apply Card payments to satisfy your co-payment, deductible, or coinsurance for Zepbound. Card
savings are not valid for: Massachusetts residents if an AB-rated generic equivalent is available;
California residents if an FDA-approved therapeutic equivalent is available. You must meet the Card
eligibility criteria, terms and conditions every time you use the Card. Card activation is required. No
party may seek reimbursement from your health insurance, any third party, or any health savings, flexible
spending, or other healthcare reimbursement accounts, for any amount of the savings received through the
Card. By utilizing the Card, you agree that if you are required to do so under the terms of your insurance
coverage for this prescription or are otherwise required to do so by law, you will notify your Insurance
Carrier of your redemption of the Card. Card savings cannot be combined or utilized with any other program,
discount, discount card, cash discount card, coupon, incentive, or similar offer involving Zepbound. You
agree that this Card savings is intended solely for the benefit of you, the patient, and that the Card
benefits are nontransferable. It is prohibited for any person to sell, purchase, or trade; or to offer to
sell, purchase, or trade, or to counterfeit the Card. The Card is not insurance. Lilly has the sole right to
interpret and apply Card eligibility criteria, and terms and conditions. Card eligibility, and terms and
conditions may be terminated, rescinded, revoked, or amended by Lilly at any time without notice and for any
reason. Eligibility criteria, and terms and conditions for the Zepbound Savings Card Program may change from
time to time; the most current version can be found at https://zepbound.lilly.com/coverage-savings. You may
be required to obtain a new Card, including if any Card terms and conditions have been terminated,
rescinded, revoked, or amended by Lilly. Card void where prohibited by law. Subject to Lilly’s right to
terminate, rescind, revoke or amend Card eligibility criteria and/or Card terms and conditions which may
occur at Lilly’s sole discretion, without notice, and for any reason, the Card expires and savings end on
12/31/2024.
Provide start information
REMIND Patients that Zepbound is administered using a single-dose pen. There is no need
to
see or handle the needle2*
ADVISE Patients to read the Instructions for Use3
ALLOW Patients to practice the injection using the demonstration device
CONSIDER having patients administer the first dose in the office
DISCUSS SAFETY profile and that Zepbound may cause some side effects†
For example, patients may experience nausea, diarrhea, or vomiting.1
In order to mitigate these gastrointestinal side effects, they may find it helpful to4-6:
Eat smaller meals—suggest that they split 3 daily meals into 4 or more smaller meals
Stop eating when they feel full
Avoid fatty foods
Try eating bland foods
Select Important Safety Information
Severe Gastrointestinal Disease: Use of Zepbound has been associated with gastrointestinal adverse reactions, sometimes severe. In clinical trials, severe gastrointestinal adverse reactions were reported more frequently among patients receiving Zepbound (5 mg 1.7%, 10 mg 2.5%, 15 mg 3.1%) than placebo (1.0%). Zepbound has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients.
Encourage patients to continue to drink plenty of water and eat healthy meals to ensure they meet their
needs
for protein, micronutrients, fiber, and fluids
RECOMMEND that patients who are using oral hormonal contraceptives switch to a non-oral
contraceptive method, or add a barrier method of contraception, for 4 weeks after initiation with
Zepbound
and
for 4 weeks after each dose escalation. Zepbound delays gastric emptying, so it may make oral
contraceptives
less effective.1
For adult patients with obesity (BMI ≥30 kg/m2) or overweight (BMI ≥27 kg/m2) with at least 1 weight-related comorbidity as an adjunct to a reduced-calorie diet and increased physical activity.1
*If a dose is missed, instruct patients to administer Zepbound as soon as possible within 4 days
after the missed dose. If more than 4 days have passed, skip the missed dose and administer the next dose on
the regularly scheduled day.
†Side effects may vary and should be evaluated by the healthcare provider for
appropriate management.
Watch how to use the Zepbound pen
Share this patient injection video with your patient to help them get familiar with self-injecting Zepbound.
00:00-00:05
[Animated intro sequence appears]
CAPTION: Before Janeth’s story, please see the safety information.
00:05-00:09
[Animated intro sequence with Zepbound Logo appears]
CAPTION: once weekly Zepbound® (tirzepatide) injection 0.5 mL 2.5 mg |
5 mg
| 7.5 mg | 10 mg | 12.5 mg | 15 mg A Lilly Medicine visit www.zepbound.lilly.com or call 1-800-LillyRX
for
pricing information
00:09-00:52
[Opening indication appears and remains on-screen until the narrator concludes]
NARRATOR: Zepbound is an injectable prescription medicine that may help adults with obesity,
or
with
excess weight (overweight) who also have weight-related medical problems, lose weight and keep it off.
Zepbound should be used with a reduced-calorie diet and increased physical activity.
Zepbound contains tirzepatide and should not be used with other tirzepatide-containing products or any
GLP-1
receptor agonist medicines. It is not known if Zepbound is safe and effective when taken with other
prescription, over-the-counter, or herbal weight loss products. It is not known if Zepbound can be used
in
people who have had pancreatitis. It is not known if Zepbound is safe and effective for use in children
under
18 years of age.
00:53-01:37
NARRATOR: Select Safety Information. Warning. Tell your healthcare provider if you get a lump
or
swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of
thyroid cancer. In studies with rats, Zepbound and medicines that work like Zepbound caused thyroid
tumors,
including thyroid cancer. It is not known if Zepbound will cause thyroid tumors, or a type of thyroid
cancer
called medullary thyroid carcinoma (MTC) in people. Do not take Zepbound if you or any of your family
have
ever had MTC or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome
type 2
(MEN 2).
CAPTION: See Indication and Safety Summary with Warnings at the end of this video.
01:37-01:57
[Ambient music, ocean waves, and seagull sounds play in the background; Janeth walking along the
beach] CAPTION: Janeth was a clinical trial patient and was compensated for her time. JANETH: I tried so many things to lose weight, and I couldn't. I felt stuck in my
situation.
01:57-02:17
[Ambient music continues while photos of Janeth and her family are shown] JANETH: All my thought was food. Morning, afternoon, at night. Maybe I ate lunch, and half an hour
to
one hour and a half, I was hungry again. When everybody sleeping,
02:17-02:22
[Janeth speaking to the camera]
JANETH: I got hungry at one or two o'clock in the morning. I had to get up, go to the
fridge
02:22-02:26
[Janeth walking along the beach]
JANETH: and get something. And when I finish from work,
02:26-02:36
[Janeth speaking to the camera]
JANETH: I pass by restaurants or fast food, and I get something for me before then I go home.
When I
go home, I cook, and I eat again.
02:36-02:42
[Janeth walking along the beach]
JANETH: My struggle with the weight started after having my second kid. Before I have a
kid,
02:42-02:48
[Photos of Janeth and her family are shown]
JANETH: I will say I was on average size, probably six or eight. Then one day I found out
myself
as
size 18.
02:48-02:54
[Janeth is on-screen speaking, looking at a photo of her and her sister]
JANETH: When I see this picture is, it's me and my sister on my birthday.
02:54-02:58
[Close-up of the photo of her and her sister]
It's sad to see that picture, really.
02:58-03:03
[Janeth is on-screen speaking, looking at a photo of her and her sister]
I would, I would love to erase it, but only because my sister there. I don’t like, I don't
want
to
erase it,
03:03-03:07
[Close-up of the photo of her and her sister]
JANETH: but it's me. It was me.
03:07-03:21
[Janeth is on screen speaking to the camera; emotional]
JANETH: It's so sad. Sorry. So sad to be 30 years in your life for your weight. You’re hiding.
You
don't do anything. You miss so much time on your family.
03:21-03:27
[Ambient music fades out; Janeth walking into her bedroom]
JANETH: So, years passed by, and now that I'm my age,
03:27-03:29
[Janeth walks into the bedroom and opens the curtains]
JANETH: I feel like, I want to do something.
03:29-03:37
[Inspirational music plays in the background; Janeth walks into the kitchen with a grocery bag]
CAPTION: Individual results may vary. Talk to your doctor to see if
Zepbound® is right for you.
JANETH: When I did the trial, it take away the desire of food.
03:37-03:44
[Janeth is putting the groceries away in her kitchen]
CAPTION: Throughout a 17-month clinical trial, people who dieted,
exercised*,
and took Zepbound sustained weight loss—whether taking the 5-mg, 10-mg, or 15-mg dose.† *Reduced-calorie diet and increased physical activity.
JANETH: I was eating healthy and exercise. During 72 weeks, I was able to lose significant
weight
and maintain weight loss.
03:44-03:48
[Janeth on screen talking to the camera]
CAPTION: Throughout a 17-month clinical trial, people who dieted,
exercised*,
and took Zepbound sustained weight loss—whether taking the 5-mg, 10-mg, or 15-mg dose.† *Reduced-calorie diet and increased physical activity.
JANETH: My size, it was, it was going low. Like size 16,
03:48-03:51
[Janeth sorts through clothes on a clothing rack]
CAPTION:†Individual results may vary. In a 72-week study of adults
without
diabetes, average weight loss was 15.0% (34 lbs) for 5 mg, 19.5% (44 lbs) for 10 mg, 20.9% (48 lbs) for 15
mg,
and 3.1% (7 lbs) for placebo. In a 72-week study of adults with diabetes, average weight loss was 12.8%
(28
lbs)
for 10 mg, 14.7% (33 lbs) for 15 mg, and 3.2% (7 lbs) for placebo. Average starting weight was 231 lbs in
adults
without diabetes and 222 lbs in adults with diabetes.
JANETH: it went down to 14, and after that,
03:51-03:53
[Janeth picks out a coral top and holds it up against herself while looking in the mirror]
CAPTION:†Individual results may vary. In a 72-week study of adults
without
diabetes, average weight loss was 15.0% (34 lbs) for 5 mg, 19.5% (44 lbs) for 10 mg, 20.9% (48 lbs) for 15
mg,
and 3.1% (7 lbs) for placebo. In a 72-week study of adults with diabetes, average weight loss was 12.8%
(28
lbs)
for 10 mg, 14.7% (33 lbs) for 15 mg, and 3.2% (7 lbs) for placebo. Average starting weight was 231 lbs in
adults
without diabetes and 222 lbs in adults with diabetes.
JANETH: I went down to 12, and I now it's size eight.
03:53-04:02
[Janeth washes vegetables. Janeth on screen talking to the camera]
CAPTION: †Individual results may vary. In a 72-week study of adults without diabetes,
average
weight loss was 15.0% (34 lbs) for 5 mg, 19.5% (44 lbs) for 10 mg, 20.9% (48 lbs) for 15 mg, and 3.1% (7
lbs)
for placebo. In a 72-week study of adults with diabetes, average weight loss was 12.8% (28 lbs) for 10 mg,
14.7%
(33 lbs) for 15 mg, and 3.2% (7 lbs) for placebo. Average starting weight was 231 lbs in adults without
diabetes
and 222 lbs in adults with diabetes.
JANETH: Before I, when I was overweight, my mind all the times think about food.
Always.
04:02-04:03
[Janeth cutting vegetables]
CAPTION:†Individual results may vary. In a 72-week study of adults
without
diabetes, average weight loss was 15.0% (34 lbs) for 5 mg, 19.5% (44 lbs) for 10 mg, 20.9% (48 lbs) for 15
mg,
and 3.1% (7 lbs) for placebo. In a 72-week study of adults with diabetes, average weight loss was 12.8%
(28
lbs)
for 10 mg, 14.7% (33 lbs) for 15 mg, and 3.2% (7 lbs) for placebo. Average starting weight was 231 lbs in
adults
without diabetes and 222 lbs in adults with diabetes.
JANETH: I look for excuse to and tell my kids,
04:04-04:08
[Janeth on screen talking to the camera]
CAPTION:†Individual results may vary. In a 72-week study of adults
without
diabetes, average weight loss was 15.0% (34 lbs) for 5 mg, 19.5% (44 lbs) for 10 mg, 20.9% (48 lbs) for 15
mg,
and 3.1% (7 lbs) for placebo. In a 72-week study of adults with diabetes, average weight loss was 12.8%
(28
lbs)
for 10 mg, 14.7% (33 lbs) for 15 mg, and 3.2% (7 lbs) for placebo. Average starting weight was 231 lbs in
adults
without diabetes and 222 lbs in adults with diabetes.
JANETH: "You want something? You want something? Okay, I cook something for you." When I cook
something for them,
04:08-04:09
[Janeth cutting vegetables]
CAPTION: †Individual results may vary. In a 72-week study of adults without diabetes,
average weight loss was 15.0% (34 lbs) for 5 mg, 19.5% (44 lbs) for 10 mg, 20.9% (48 lbs) for 15 mg, and
3.1% (7
lbs) for placebo. In a 72-week study of adults with diabetes, average weight loss was 12.8% (28 lbs) for
10
mg,
14.7% (33 lbs) for 15 mg, and 3.2% (7 lbs) for placebo. Average starting weight was 231 lbs in adults
without
diabetes and 222 lbs in adults with diabetes. JANETH: and for me.
04:09-04:16
[Janeth on screen talking to the camera]
JANETH: Now, really, I can cook and do everything, and it doesn't feel like I want to eat. I
have
the control.
04:16-04:18
[Janeth puts chopped vegetables in a bowl]
04:18-04:21
[Janeth mixes something in a saucepan]
JANETH: Since
04:23-04:24
[Janeth smiles and pours olive oil in a bowl]
JANETH: I'm more active now.
04:24-04:27
[Janeth adds seasoning to the bowl]
JANETH: Like I go to the pool, go to the park, go to the movie.
04:27-04:30
[Janeth places food on the grill]
Somebody invite me for party, like my family, I go,
04:30-04:31
[Janeth brings a plate of food over to a table]
JANETH: I go to them.
04:31-04:433
[Janeth smiling at an outdoor table during a meal]
04:33-04:34
[Janeth’s husband smiling at a table during a meal]
04:34-04:36
[Janeth and her sister take a selfie at the table]
04:36-04:38
[Janeth smiling into the camera]
JANETH: I feel happy when I see myself in the mirror.
04:38-04:42
[Janeth replaces the photo of her and her sister with a new photo]
JANETH: I am excited about where I am today
04:42-04:46
[We see the new photo Janeth has placed is the selfie with her sister taken at dinner]
JANETH: and where I want to go. I would like to
04:46-04:56
[Janeth on screen speaking to the camera]
JANETH: go back to school, finish my degree. I would like to lose more weight. I would like to
have
more time with my kids, my grandkids.
04:56-04:59
[Janeth puts on headphones on the beach]
JANETH: I will tell you it's a hope to lose weight.
04:59-05:07
[Janeth is power walking on the beach]
JANETH: If I did it, you can do it. I am still on my journey, and I'm not finished.
05:07-05:14
[Janeth is walking toward the camera on the beach]
JANETH: I am hopeful about where I am going.
05:14-05:19
[Janeth smiling at the camera while on the beach]
JANETH: I am unstoppable.
05:20-05:25
[Animated Zepbound logo appears on screen]
CAPTION: once weekly Zepbound® (tirzepatide) injection 0.5 mL 2.5mg |
5mg
| 7.5mg | 10mg | 12.5 mg | 15mg
A Lilly Medicine visit www.zepbound.lilly.com or call 1-800-LillyRX for pricing information
05:20-05:31
[Animated Lilly Medicine logo appears on screen]
CAPTION: Lilly
A MEDICINE COMPANY
05:31-06:23
[Animated data and safety claims appear on screen]
CAPTION: INDICATION AND SAFETY SUMMARY WITH WARNINGS
once weekly Zepbound® (tirzepatide) injection 0.5 mL 2.5 mg | 5 mg | 7.5 mg | 10 mg | 12.5
mg|
15 mg
NARRATOR: Indication and Safety Summary with Warnings. Zepbound® is an injectable
prescription medicine that may help adults with obesity, or with excess weight (overweight) who also
have
weight-related medical problems, lose weight and keep it off. It should be used with a reduced-calorie
diet
and increased physical activity. Zepbound contains tirzepatide and should not be used with other
tirzepatide-containing products or any GLP-1 receptor agonist medicines. It is not known if Zepbound is
safe
and effective when taken with other prescription, over-the-counter, or herbal weight loss products. It
is
not
known if Zepbound can be used in people who have had pancreatitis. It is not known if Zepbound is safe
and
effective for use in children under 18 years of age.
06:23-7:40
CAPTION: INDICATION AND SAFETY SUMMARY WITH WARNINGS
once weekly zepbound® (tirzepatide) injection 0.5 mL 2.5mg | 5mg | 7.5mg | 10mg | 12.5 mg|
15mg
NARRATOR: Warnings. Zepbound may cause tumors in the thyroid, including thyroid cancer. Watch for
possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness
of
breath. If you have any of these symptoms, tell your healthcare provider. Do not use Zepbound if you or
any of
your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC). Do not use
Zepbound if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use Zepbound if you
have
had
a serious allergic reaction to tirzepatide or any of the ingredients in Zepbound. Zepbound may cause
serious
side effects, including, severe stomach problems. Stomach problems, sometimes severe, have been reported
in
people who use Zepbound. Tell your healthcare provider if you have stomach problems that are severe or
will
not go away. Kidney problems (kidney failure). Diarrhea, nausea, and vomiting may cause a loss of fluids
(dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce
your
chance of dehydration.
07:40-9:17
CAPTION: INDICATION AND SAFETY SUMMARY WITH WARNINGS
once weekly Zepbound® (tirzepatide) injection 0.5 mL 2.5 mg | 5 mg | 7.5 mg | 10 mg | 12.5
mg|
15 mg
NARRATOR: Gallbladder problems. Gallbladder problems have happened in some people who use
Zepbound.
Tell
your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain
in
your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.
Inflammation of the pancreas (pancreatitis). Stop using Zepbound and call your healthcare provider right
away
if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting.
You
may feel the pain from your abdomen to your back. Serious allergic reactions. Stop using Zepbound and
get
medical help right away if you have any symptoms of a serious allergic reaction, including swelling of
your
face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or
feeling
dizzy, or very rapid heartbeat. Low blood sugar (hypoglycemia). Your risk for getting low blood sugar
may
be
higher if you use Zepbound with medicines that can cause low blood sugar, such as a sulfonylurea or
insulin.
Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or
drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability,
mood
changes, hunger, weakness or feeling jittery.
09:17-10:11
CAPTION: INDICATION AND SAFETY SUMMARY WITH WARNINGS
once weekly Zepbound® (tirzepatide) injection 0.5 mL 2.5 mg | 5 mg | 7.5 mg | 10 mg | 12.5
mg|
15 mg
NARRATOR: Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you
have
changes in vision during treatment with Zepbound. Depression or thoughts of suicide. You should pay
attention
to changes in your mood, behaviors, feelings or thoughts. Call your healthcare provider right away if
you
have
any mental changes that are new, worse, or worry you. Common side effects. The most common side effects
of
Zepbound include nausea, diarrhea, vomiting, constipation, stomach (abdominal) pain, indigestion,
injection
site reactions, feeling tired, allergic reactions, belching, hair loss, and heartburn. These are not all
the
possible side effects of Zepbound. Talk to your healthcare provider about any side effect that bothers
you
or
doesn’t go away.
10:11-11:15
CAPTION: INDICATION AND SAFETY SUMMARY WITH WARNINGS
once weekly Zepbound® (tirzepatide) injection 0.5 mL 2.5 mg | 5 mg | 7.5 mg | 10 mg | 12.5
mg|
15 mg
NARRATOR: Tell your healthcare provider if you have any side effects. You can report side effects
at
1-800-FDA-1088 or www.fda.gov/medwatch. Before using Zepbound. Your healthcare provider should show you
how to
use Zepbound before you use it for the first time. Tell your healthcare provider if you are taking
medicines
to treat diabetes including insulin or sulfonylureas which could increase your risk of low blood sugar.
Talk
to your healthcare provider about low blood sugar levels and how to manage them. If you take birth
control
pills by mouth, talk to your healthcare provider before you use Zepbound. Birth control pills may not
work
as
well while using Zepbound. Your healthcare provider may recommend another type of birth control for 4
weeks
after you start Zepbound and for 4 weeks after each increase in your dose of Zepbound.
11:15-12:08
CAPTION: INDICATION AND SAFETY SUMMARY WITH WARNINGS
once weekly Zepbound® (tirzepatide) injection 0.5 mL 2.5 mg | 5 mg | 7.5 mg | 10 mg | 12.5
mg|
15 mg
NARRATOR: Review these questions with your healthcare provider. Do you have other medical
conditions,
including problems with your pancreas or kidneys, or severe problems with your stomach, such as slowed
emptying of your stomach (gastroparesis) or problems digesting food? Do you take diabetes medicines,
such
as
insulin or sulfonylureas? Do you have a history of diabetic retinopathy? Do you take any other
prescription
medicines or over-the-counter drugs, vitamins, or herbal supplements? Are you pregnant, plan to become
pregnant, breastfeeding, or plan to breastfeed? Zepbound may harm your unborn baby. Tell your healthcare
provider if you become pregnant while using Zepbound. It is not known if Zepbound passes into your
breast
milk. You should talk with your healthcare provider about the best way to feed your baby while using
Zepbound.
12:09-13:23
CAPTION: INDICATION AND SAFETY SUMMARY WITH WARNINGS
once weekly Zepbound® (tirzepatide) injection 0.5 mL 2.5 mg | 5 mg | 7.5 mg | 10 mg | 12.5
mg|
15 mg
NARRATOR: Pregnancy Exposure Registry. There will be a pregnancy exposure registry for women who
have
taken Zepbound during pregnancy. The purpose of this registry is to collect information about the health
of
you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you
may
contact Lilly at 1-800-LillyRx (1-800-545-5979). How to take. Read the Instructions for Use that come
with
Zepbound. Use Zepbound exactly as your healthcare provider says. Zepbound is injected under the skin
(subcutaneously) of your stomach (abdomen), thigh, or upper arm. Use Zepbound 1 time each week, at any
time of
the day. Change (rotate) your injection site with each weekly injection. Do not use the same site for
each
injection. If you take too much Zepbound, call your healthcare provider, seek medical advice promptly,
or
contact a Poison Center expert right away at 1-800-222-1222.
13:24-14:09
CAPTION: INDICATION AND SAFETY SUMMARY WITH WARNINGS
once weekly Zepbound® (tirzepatide) injection 0.5 mL 2.5 mg | 5 mg | 7.5 mg | 10 mg | 12.5
mg|
15 mg
NARRATOR: Learn more. Zepbound is a prescription medicine. For more information, call
1-800-LillyRx
(1-800-545-5979) [or go to www.zepbound.lilly.com]. This summary provides basic information about
Zepbound
but
does not include all information known about this medicine. 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 healthcare provider. Be sure to talk to your healthcare provider about Zepbound and how to take it.
Your
healthcare provider is the best person to help you decide if Zepbound is right for you.
14:09 -14:17
CAPTION: INDICATION AND SAFETY SUMMARY WITH WARNINGS
once weekly Zepbound® (tirzepatide) injection 0.5 mL 2.5 mg | 5 mg | 7.5 mg | 10 mg | 12.5
mg|
15 mg
CAPTION: ZP CON CBS 08NOV2023. Zepbound® and its delivery device base are registered
trademarks
owned
or
licensed by Eli Lilly and Company, its subsidiaries, or affiliates.
14:18-14:20
[Animated Zepbound logo appears on screen]
CAPTION: once weekly Zepbound® (tirzepatide) injection 0.5 mL 2.5mg |
5mg
| 7.5mg | 10mg | 12.5 mg | 15mg
A Lilly Medicine
visit www.zepbound.lilly.com or call 1-800-LillyRX for pricing information
14:20-14:22
[Animated Lilly Medicine logo appears on screen]
CAPTION: Lilly
A MEDICINE COMPANY
References
Zepbound. Prescribing Information. Lilly USA, LLC.
Zepbound. Instructions for Use. Lilly USA, LLC.
Zepbound. Medication Guide. Lilly USA, LLC.
Maceira E, Lesar TS, Smith H. Medication related nausea and vomiting in palliative medicine. Ann
Palliat
Med. 2012;1(2):161-176.
Kruger DF, Bode B, Spollett GR. Understanding GLP-1 analogs and enhancing patients success. Diabetes
Educ. 2010;36(suppl 3):44S-72S.
Reid TS. Practical use of glucagon-like peptide-1 receptor agonist therapy in primary care. Clin
Diabetes. 2013;31(4):148-157.
IMPORTANT SAFETY INFORMATION
Warning:
WARNING: RISK OF THYROID C-CELL
TUMORS
In rats, tirzepatide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at
clinically relevant exposures. It is unknown whether Zepbound causes thyroid C-cell tumors, including
medullary
thyroid carcinoma (MTC), in humans as human relevance of tirzepatide-induced rodent thyroid C-cell tumors
has
not been determined.
Zepbound is contraindicated in patients with a personal or family history of MTC or in patients with
Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC
with
the use of Zepbound and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia,
dyspnea,
persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain
value
for early detection of MTC in patients treated with Zepbound.
Contraindications:
Zepbound is contraindicated in patients with a personal or family history of MTC or in
patients with MEN
2, and in patients with known serious hypersensitivity to tirzepatide or any of the excipients in Zepbound.
Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with
tirzepatide.
Risk of Thyroid C-cell Tumors: Counsel patients regarding the potential risk for MTC with the
use
of Zepbound and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea,
persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value
for early detection of MTC in patients treated with Zepbound. Such monitoring may increase the risk of
unnecessary
procedures, due to the low test specificity for serum calcitonin and a high background incidence of thyroid
disease. Significantly elevated serum calcitonin values may indicate MTC and patients with MTC usually have
calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be
further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be
further evaluated.
Severe Gastrointestinal Disease: Use of Zepbound has been associated with gastrointestinal
adverse
reactions, sometimes severe. In clinical trials, severe gastrointestinal adverse reactions were reported more
frequently among patients receiving Zepbound (5 mg 1.7%, 10 mg 2.5%, 15 mg 3.1%) than placebo (1.0%). Zepbound
has
not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is
therefore
not recommended in these patients.
Acute Kidney Injury: Use of Zepbound has been associated with acute kidney injury, which can
result
from dehydration due to gastrointestinal adverse reactions to Zepbound, including nausea, vomiting, and
diarrhea. In
patients treated with GLP-1 receptor agonists there have been postmarketing reports of acute kidney injury and
worsening of chronic renal failure, which may sometimes require hemodialysis. Some of these events have been
reported in patients without known underlying renal disease. A majority of the reported events occurred in
patients
who had experienced nausea, vomiting, diarrhea, or dehydration. Monitor renal function in patients reporting
adverse
reactions to Zepbound that could lead to volume depletion.
Acute Gallbladder Disease: Treatment with Zepbound and GLP-1 receptor agonists is associated
with
an increased occurrence of acute gallbladder disease. In clinical trials of Zepbound, cholelithiasis was
reported in
1.1% of Zepbound-treated patients and 1.0% of placebo-treated patients, cholecystitis was reported in 0.7% of
Zepbound-treated patients and 0.2% of placebo-treated patients, and cholecystectomy was reported in 0.2% of
Zepbound-treated patients and no placebo-treated patients. Acute gallbladder events were associated with weight
reduction. If cholecystitis is suspected, gallbladder diagnostic studies and appropriate clinical follow-up are
indicated.
Acute Pancreatitis: Acute pancreatitis, including fatal and non-fatal hemorrhagic or
necrotizing
pancreatitis, has been observed in patients treated with GLP-1 receptor agonists or tirzepatide. In clinical
trials
of tirzepatide for a different indication, 14 events of acute pancreatitis were confirmed by adjudication in 13
tirzepatide-treated patients (0.23 patients per 100 years of exposure) versus 3 events in 3 comparator-treated
patients (0.11 patients per 100 years of exposure). In Zepbound clinical trials, 0.2% of Zepbound-treated
patients
had acute pancreatitis confirmed by adjudication (0.14 patients per 100 years of exposure) versus 0.2% of
placebo-treated patients (0.15 patients per 100 years of exposure). Zepbound has not been studied in patients
with a
prior history of pancreatitis. It is unknown if patients with a history of pancreatitis are at higher risk for
development of pancreatitis on Zepbound. Observe patients for signs and symptoms of pancreatitis, including persistent severe
abdominal pain sometimes radiating to the back, which may or may not be accompanied by vomiting. If pancreatitis
is
suspected, discontinue Zepbound and initiate appropriate management. If the diagnosis of pancreatitis is
confirmed,
Zepbound should not be restarted.
Hypersensitivity Reactions: There have been postmarketing reports of serious hypersensitivity
reactions (e.g., anaphylaxis, angioedema) in patients treated with tirzepatide. In Zepbound clinical trials,
0.1% of
Zepbound-treated patients had severe hypersensitivity reactions compared to no placebo-treated patients. If
hypersensitivity reactions occur, advise patients to promptly seek medical attention and discontinue use of
Zepbound. Do not use in patients with a previous serious hypersensitivity reaction to tirzepatide or any of the
excipients in Zepbound. Use caution in patients with a history of angioedema or anaphylaxis with a GLP-1
receptor
agonist because it is unknown if such patients will be predisposed to these reactions with Zepbound.
Hypoglycemia: Zepbound lowers blood glucose and can cause hypoglycemia. In a trial of patients
with
type 2 diabetes mellitus and BMI ≥27 kg/m2, hypoglycemia (plasma glucose <54 mg/dL) was reported
in
4.2% of Zepbound-treated patients versus 1.3% of placebo-treated patients. In this trial, patients taking
Zepbound
in combination with an insulin secretagogue (e.g., sulfonylurea) had increased risk of hypoglycemia (10.3%)
compared
to Zepbound-treated patients not taking a sulfonylurea (2.1%). Hypoglycemia has also been associated with
Zepbound
and GLP-1 receptor agonists in adults without type 2 diabetes mellitus. There is also increased risk of
hypoglycemia
in patients treated with tirzepatide in combination with insulin. Inform patients of the risk of hypoglycemia
and
educate them on the signs and symptoms of hypoglycemia. In patients with diabetes mellitus, monitor blood
glucose
prior to starting Zepbound and during Zepbound treatment. The risk of hypoglycemia may be lowered by a reduction
in
the dose of sulfonylurea (or other concomitantly administered insulin secretagogue) or insulin.
Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Mellitus: Rapid
improvement
in glucose control has been associated with a temporary worsening of diabetic retinopathy. Tirzepatide has not
been studied in patients with non-proliferative diabetic retinopathy requiring acute therapy, proliferative
diabetic retinopathy, or diabetic macular edema. Patients with a history of diabetic retinopathy should be
monitored for progression of diabetic retinopathy.
Suicidal Behavior and Ideation: Suicidal behavior and ideation have been reported in clinical
trials with other chronic weight management products. Monitor patients treated with Zepbound for the emergence
or
worsening of depression, suicidal thoughts or behaviors, and/or any unusual changes in mood or behavior.
Discontinue Zepbound in patients who experience suicidal thoughts or behaviors. Avoid Zepbound in patients with
a
history of suicidal attempts or active suicidal ideation.
Most common adverse reactions: The most common adverse reactions, reported in ≥5% of patients treated with Zepbound are: nausea, diarrhea, vomiting, constipation, abdominal pain, dyspepsia, injection site reactions, fatigue, hypersensitivity reactions, eructation, hair loss, and gastroesophageal reflux disease.
Drug Interactions: Zepbound lowers blood glucose. When initiating Zepbound, consider reducing
the
dose of concomitantly administered insulin secretagogues (e.g., sulfonylureas) or insulin to reduce the risk of
hypoglycemia. Zepbound delays gastric emptying and thereby has the potential to impact the absorption of
concomitantly administered oral medications. Caution should be exercised when oral medications are concomitantly
administered with Zepbound. Monitor patients on oral medications dependent on threshold concentrations for
efficacy
and those with a narrow therapeutic index (e.g., warfarin) when concomitantly administered with Zepbound.
Pregnancy: Advise pregnant patients that weight loss is not recommended during pregnancy and to
discontinue Zepbound when a pregnancy is recognized. Available data with tirzepatide in pregnant patients are
insufficient to evaluate for a drug-related risk of major birth defects, miscarriage, or other adverse maternal
or
fetal outcomes. Based on animal reproduction studies, there may be risks to the fetus from exposure to
tirzepatide
during pregnancy. There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed
to
Zepbound (tirzepatide) during pregnancy. Pregnant patients exposed to Zepbound and healthcare providers are
encouraged to contact Eli Lilly and Company at 1-800-LillyRx
(1-800-545-5979).
Lactation: There are no data on the presence of tirzepatide or its metabolites in animal or
human
milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health
benefits of breastfeeding should be considered along with the mother’s clinical need for Zepbound and any
potential adverse effects on the breastfed infant from Zepbound or from the underlying maternal condition.
Females and Males of Reproductive Potential: Use of Zepbound may reduce the efficacy of oral
hormonal contraceptives due to delayed gastric emptying. This delay is largest after the first dose and
diminishes
over time. Advise patients using oral hormonal contraceptives to switch to a non-oral contraceptive method or
add a
barrier method of contraception, for 4 weeks after initiation with Zepbound and for 4 weeks after each dose
escalation.
Pediatric Use: The safety and effectiveness of Zepbound have not been established in pediatric
patients less than 18 years of age.
Zepbound® is indicated as an adjunct to a reduced-calorie diet and increased physical activity
for chronic weight management in adults with an initial body mass index (BMI) of:
30 kg/m2 or greater (obesity) or
27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid
condition (e.g., hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea, or
cardiovascular disease).
Limitations of Use:
Zepbound contains tirzepatide. Coadministration with other tirzepatide-containing products or with any
glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended.
The safety and efficacy of Zepbound in combination with other products intended for weight management,
including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.
Zepbound has not been studied in patients with a history of pancreatitis.