FOR ADULTS WITH TYPE 2 DIABETES
Tirzepatide is proven to
help lower A1C*
*Along with diet and exercise
Tirzepatide is proven to lower A1C in adults with type 2 diabetes*
*Along with diet and exercise.
What is Tirzepatide?
Tirzepatide is a prescribed medication in injectable form that, when combined with a proper diet and regular exercise, helps to regulate blood sugar levels in adults diagnosed with type 2 diabetes mellitus.
The suitability of Tirzepatide for individuals with a history of pancreatitis has not been established. It is not intended for individuals with type 1 diabetes. Additionally, the safety and efficacy of Tirzepatide for children below the age of 18 remain undetermined.
*In studies with or without diabetes medications, 75% to 90% of people taking Tirzepatide reached an A1C of less than 7%, with an average starting A1C of 7.9% to 8.6% across the 5-mg, 10-mg, and 15-mg doses.
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Warning:
Inform your healthcare provider if you experience any neck lumps or swelling, voice changes, difficulty swallowing, or shortness of breath. These symptoms could indicate thyroid cancer. Research on rats has shown that Tirzepatide and similar medications may lead to thyroid tumors, including thyroid cancer. However, it is unclear whether Tirzepatide can cause thyroid tumors or a specific type of thyroid cancer known as medullary thyroid carcinoma (MTC) in humans. Tirzepatide should not be used by individuals who have a family history of MTC or who suffer from a condition known as Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Tirzepatide is not a weight loss drug.
‡Individual results may vary. In studies with or without other diabetes medications, weight loss in adults ranged from 12 lb (5 mg) to 25 lb (15 mg).
Tirzepatide is the first and only approved treatment in a different class of medication for type 2 diabetes.*
*It works differently than other type 2 diabetes medications by directly activating GIP and GLP-1 pathways to help regulate blood sugar.
GIP=glucose-dependent insulinotropic polypeptide; GLP-1=glucagon-like peptide-1.
What is Tirzepatide?
Tirzepatide is a prescribed medication in injectable form that, when combined with a proper diet and regular exercise, helps to regulate blood sugar levels in adults diagnosed with type 2 diabetes mellitus.
The suitability of Tirzepatide for individuals with a history of pancreatitis has not been established. It is not intended for individuals with type 1 diabetes. Additionally, the safety and efficacy of Tirzepatide for children below the age of 18 remain undetermined.
Tirzepatide for type 2 diabetes
†In studies with or without other diabetes medications, the percentage of people taking Tirzepatide who reached an A1C of less than 7% ranged from 75% (5 mg) to 90% (10 mg). People had an average starting A1C of 7.9% to 8.6% across the 5-mg, 10-mg, and 15-mg doses. A 40-week study was conducted to see if Tirzepatide 5-mg, 10-mg, and 15-mg plus a basal insulin worked better than basal insulin alone. 90% of people taking Tirzepatide 10-mg plus basal insulin achieved an A1C of under 7%.
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Tirzepatide may lead to significant adverse reactions, such as:
• Pancreatitis, which is the inflammation of the pancreas. If you experience persistent severe abdominal pain that doesn't subside, with or without nausea and vomiting, and the pain extends from your stomach to your back, it's crucial to discontinue Tirzepatide immediately and contact your healthcare provider without delay.
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Hypoglycemia Alert:
When using Tirzepatide in conjunction with other medications known to reduce blood sugar levels, like sulfonylureas or insulin, there may be an elevated risk of experiencing hypoglycemia. Be vigilant for its indicators, which can manifest as:
• Dizziness or a sensation of being lightheaded
• Sweating
• Confusion or sleepiness
• Headaches
• Blurred vision
• Slurred speech
• Tremors
• A rapid heartbeat
• Feelings of anxiety, irritability, or shifts in mood
• Hunger
• Muscle weakness
• A jittery feeling
It's important to recognize these symptoms promptly to manage and correct low blood sugar effectively.
Talk to your doctor about Tirzepatide at your next visit
How Tirzepatide works
Tirzepatide is a prescribed medication in injectable form that, when combined with a proper diet and regular exercise, helps to regulate blood sugar levels in adults diagnosed with type 2 diabetes mellitus.
The suitability of Tirzepatide for individuals with a history of pancreatitis has not been established. It is not intended for individuals with type 1 diabetes. Additionally, the safety and efficacy of Tirzepatide for children below the age of 18 remain undetermined.
Tirzepatide helps your body both regulate blood sugar and decrease how much food you eat
Tirzepatide is not a weight loss drug.
It may start working to lower blood sugar from the first dose
The 2.5 mg starting dose is not meant for blood sugar control.
Tirzepatide works in multiple ways. It helps:
THE BODY RELEASE INSULIN WHEN BLOOD SUGAR IS HIGH
THE BODY REMOVE EXCESS SUGAR FROM THE BLOOD
STOP THE LIVER FROM MAKING AND RELEASING TOO MUCH SUGAR
REDUCE HOW MUCH FOOD IS EATEN
SLOW DOWN HOW QUICKLY FOOD LEAVES THE STOMACH. THIS LESSENS OVER TIME
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Serious allergic reactions. Discontinue Tirzepatide immediately and seek urgent medical attention if you exhibit symptoms indicative of a severe allergic reaction. These symptoms can include:
Swelling of your face, lips, tongue, or throat, difficulty breathing or swallowing, intense rash or itching, fainting or feeling lightheaded, an unusually fast heartbeat
About Trizepatide
*In studies with or without other diabetes medications, 75% to 90% of people taking Tirzepatide reached an A1C of less than 7%, with an average starting A1C of 7.9% to 8.6% across the 5-mg, 10-mg, and 15-mg doses.
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Tirzepatide can cause serious side effects, including:
Kidney problems (kidney failure). For individuals with kidney issues, experiencing diarrhea, nausea, and vomiting can lead to dehydration due to fluid loss. This may exacerbate existing kidney conditions. It's crucial to stay hydrated by drinking adequate fluids to minimize the risk of dehydration.
Tirzepatide is not a weight loss drug.
‡Individual results may vary. In studies with or without other diabetes medications, weight loss in adults ranged from 12 lb (5 mg) to 25 lb (15 mg).
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Severe stomach problems. Tirzepatide has been associated with gastrointestinal issues, which can be serious. It's important to inform your healthcare provider if you encounter persistent or severe stomach problems.
See how Tirzepatide compares
In clinical studies, Tirzepatide was compared to some other medicines for type 2 diabetes.
Tirzepatide A1C results
In a 40-week study, the Tirzepatide 5-mg, 10-mg, and 15-mg doses were compared to Ozempic 1 mg in 1879 adults with type 2 diabetes who were also taking metformin and had a starting A1C of 8.3%.
Tirzepatide weight results
*Tirzepatide is not a weight loss drug.
Individual results may vary. In this study, the Tirzepatide 5-mg, 10-mg, and 15-mg doses were compared to Ozempic 1 mg. The average starting weight was between 204 to 209 pounds.
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Changes in vision. Tell your healthcare provider if you have changes in vision during treatment with Tirzepatide.
Once-weekly Tirzepatide is here to help you lower your A1C*
*Along with diet and exercise.
Talk to your doctor about Tirzepatide at your next visit
How to use Tirzepatide
In a study involving adults with type 2 diabetes, a medication utilizing the same type of single-dose pen as Tirzepatide was found to be user-friendly by 99% of participants, following proper instruction. However, it's important to note that the usage instructions for the Tirzepatide single-dose pen are not the same as those used in the study.
Follow these 4 steps to use your Tirzepatide pen:
Choose an appropriate site for your injection. Your healthcare provider will assist in determining the most suitable location for you. The medication can be self-administered or given by someone else into your abdomen, thighs, or the back of your upper arms. However, it is recommended that another individual administer the injection if it's to be placed in the back of your upper arm.
Pull off the base cap.
Place the base flat on your skin, then unlock.
Press and hold the button for up to 10 seconds. Listen for the first click. It means the injection has started. The second click means that the injection is complete.‡
‡These are not the complete instructions for using Tirzepatide. Before starting Tirzepatide, your health care provider should show you how to use the pen. Read the Instructions for Use included with your pen.
Select Safety Information
Gallbladder problems. Individuals on Tirzepatide have occasionally encountered gallbladder issues. Should you notice any gallbladder-related symptoms, it's crucial to inform your healthcare professional immediately. These symptoms can include:
Pain in the upper abdominal area, Fever, Jaundice, which is characterized by a yellow tint to the skin or eyes, Stools that are pale or clay-colored. Prompt attention to these signs is important for your health and well-being.
How to store your Tirzepatide pens
Keep Tirzepatide in the refrigerator
- Make sure the temperature is between 36°F to 46°F (2°C to 8°C)
- Store the pens in the original packaging to protect your pen from light
- Do not freeze the Tirzepatide pens
- The pen has glass parts. Handle it carefully. If you drop the pen on a hard surface, do not use it. Use a new pen for your injection
- Keep in mind, some refrigerators can be colder near the back than on the front/on the door
- Always check your pen to ensure it's not frozen before using it
Going on a trip?
Tirzepatide can last unrefrigerated for up to 21 days. Just make sure the temperature does not get any higher than 86°F (30°C). Keep your pen in its original carton to protect your pen from light.
What is Tirzepatide?
Tirzepatide is a prescribed medication in injectable form that, when combined with a proper diet and regular exercise, helps to regulate blood sugar levels in adults diagnosed with type 2 diabetes mellitus.
The suitability of Tirzepatide for individuals with a history of pancreatitis has not been established. It is not intended for individuals with type 1 diabetes. Additionally, the safety and efficacy of Tirzepatide for children below the age of 18 remain undetermined.
Once-weekly Tirzepatide has multiple dose options
Tirzepatide offers a range of dosing options to suit individual needs, which you can determine with your doctor's guidance. Initially, your prescription may begin at 2.5 mg taken once a week. Following a period of 4 weeks, the dosage typically increases to 5 mg.
Remember, Tirzepatide is intended for weekly use. For any inquiries or further information regarding your Tirzepatide regimen, it's best to consult your healthcare provider.
What happens next?
During your medical appointments, discuss your response to the 2.5-mg and 5-mg doses of Tirzepatide with your doctor. After you've been on the 5 mg dose, your doctor might decide to maintain this dosage for more than 4 weeks. Together, you can evaluate whether there's a need to adjust your dose higher than 5 mg.
Managing possible side effects
Talk to your doctor if you have any side effect that bothers you or does not go away.
While individual reactions may vary, the following are the most frequently reported side effects by those on Tirzepatide:
• Nausea
• Diarrhea
• Reduced appetite
• Vomiting
• Constipation
• Indigestion
• Stomach pain
During clinical trials, the majority of instances involving nausea, vomiting, and diarrhea were reported during periods of dosage escalation. However, these incidents tended to diminish over time.
Gastrointestinal (GI) side effects occurred more frequently in participants taking Tirzepatide compared to those on a placebo. Consequently, a higher number of individuals discontinued Tirzepatide due to these adverse effects.
Important Safety Information:
• Kidney complications (including kidney failure): For those with renal issues, symptoms like diarrhea, nausea, and vomiting can lead to dehydration, potentially worsening kidney conditions. It's imperative to maintain fluid intake to lower the risk of dehydration.
• Severe gastrointestinal issues: There have been reports of significant stomach-related problems associated with Tirzepatide. Should you experience severe or unrelenting stomach issues, inform your healthcare provider promptly.
If you experience nausea, talk to your doctor. In the meantime, some people find the following tips may help:
Eat smaller meals–try splitting your 3 daily meals into 4 or more smaller ones
Stop eating when you feel full
Avoid fat or fatty foods
Try eating bland foods like toast, crackers, or rice
One part of managing type 2 diabetes is managing A1C
Your body needs insulin to use sugar for energy
The hormone insulin helps your body use or store the blood sugar it gets from food. Read more about type 2 diabetes below or go to the American Diabetes Association (ADA) website for more information.
If you have type 2 diabetes:
-
Your body doesn't make enough insulin, doesn't use insulin well, or both.
-
Since the sugar is not being used for energy, it stays in your blood.
-
This leads to high blood sugar. Over time, this could hurt your eyes, kidneys, nerves, heart, and blood vessels.
What is the A1C test?
What the A1C test does
The A1C test's purpose is to gauge the mean glucose concentration in your blood over the previous 2 to 3 months. Elevated levels of blood glucose or A1C correlate with an increased likelihood of complications related to diabetes. Typically, individuals with type 2 diabetes undergo this test at a minimum of twice annually.
What the results mean
The A1C values are expressed as percentages. A higher percentage signifies elevated levels of blood sugar. The American Diabetes Association (ADA) suggests that for most adults with type 2 diabetes, the target is to maintain an A1C level below 7%.
Your healthcare provider will collaborate with you to determine a personalized A1C target.
What does weight have to do with type 2 diabetes?
Excess weight is a known risk factor for type 2 diabetes, as it can make it more challenging for your body to utilize the insulin it produces, due to impaired blood sugar utilization.
Even though your pancreas continues to produce insulin, your body's sensitivity to insulin diminishes.
Weight reduction can enhance your body's insulin sensitivity and contribute to lower blood sugar levels.
The American Diabetes Association (ADA) notes that in some cases, a modest weight loss of 5%-7% of your total body weight can significantly enhance diabetes management. For an individual weighing 200 lb, this equates to shedding 10-15 lb.
SAFETY SUMMARY WITH WARNINGS
Warnings -
Tirzepatide has the potential to induce thyroid tumors, including thyroid cancer. Be vigilant for symptoms like neck lumps or swelling, voice hoarseness, difficulty swallowing, or breathing issues. Should these symptoms arise, promptly inform your healthcare provider.
Avoid using Tirzepatide if you or a family member has been diagnosed with medullary thyroid carcinoma (MTC), or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Additionally, do not use Tirzepatide if you have allergies to it or its components.
Significant adverse effects of Tirzepatide may include:
• Pancreatitis (inflammation of the pancreas): Cease Tirzepatide use and contact your healthcare provider immediately if you experience unrelenting severe abdominal pain, with or without vomiting, that radiates to your back.
• Hypoglycemia (low blood sugar): The risk of low blood sugar is heightened if Tirzepatide is used alongside other medications that can also lower blood sugar, such as sulfonylureas or insulin. Symptoms to watch for include dizziness, sweating, confusion, headaches, blurred vision, slurred speech, shakiness, rapid heartbeat, anxiety, irritability, mood swings, hunger, weakness, and jitteriness.
• Severe allergic reactions: Discontinue Tirzepatide and seek immediate medical assistance if you experience any signs of a serious allergic reaction, which can include facial swelling, breathing or swallowing difficulties, intense rashes or itching, fainting, dizziness, or an extremely fast heartbeat.
• Kidney issues (including kidney failure): For those with kidney problems, dehydration caused by diarrhea, nausea, and vomiting can worsen renal conditions. It's vital to consume fluids to lessen the risk of dehydration.
• Severe gastrointestinal problems: Some individuals on Tirzepatide have reported serious stomach issues. Notify your healthcare provider if you have persistent or severe stomach problems.
• Vision changes: If you notice any alterations in your vision while on Tirzepatide, inform your healthcare provider.
• Gallbladder issues: Some Tirzepatide users have experienced gallbladder problems. Contact your healthcare provider immediately if you exhibit symptoms such as upper abdominal pain, fever, jaundice, or clay-colored stools.
Common side effects of Tirzepatide include nausea, diarrhea, decreased appetite, vomiting, constipation, indigestion, and abdominal pain. This is not an exhaustive list of side effects. Discuss any side effects that concern you or do not subside with your healthcare provider.
You can report side effects to the FDA at 1-800-FDA-1088 or visit FDA MedWatch.
Before starting Tirzepatide:
• Ensure your healthcare provider demonstrates how to properly use Tirzepatide.
• Discuss with your healthcare provider how to manage low blood sugar.
• If you use oral contraceptives, consult your healthcare provider before starting Tirzepatide, as it may affect the pill's effectiveness. An alternative form of contraception may be recommended for 4 weeks after beginning Tirzepatide and after each dosage increase.
Consider discussing the following with your healthcare provider:
• Any other health conditions you have, especially those related to the pancreas, kidneys, or severe stomach issues like gastroparesis or difficulty digesting food.
• Any other diabetes medications you're taking, such as insulin or sulfonylureas.
• A history of diabetic retinopathy.
• If you are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed. The effects of Tirzepatide on unborn babies or breast milk are unknown.
• Any other prescription medications, over-the-counter drugs, vitamins, or herbal supplements you're taking.
How to use Tirzepatide:
• Follow the Instructions for Use provided with Tirzepatide.
• Administer Tirzepatide precisely as directed by your healthcare provider.
• Inject Tirzepatide subcutaneously into your abdomen, thigh, or upper arm.
• Apply Tirzepatide once a week, at any time that suits you.
• Do not combine Tirzepatide and insulin in the same injection.
• You may inject Tirzepatide and insulin in the same area of your body, but not adjacent to each other.
• Rotate your injection site with each weekly dose and avoid using the same spot consecutively.
• If you take too much Tirzepatide, contact your healthcare provider or seek medical advice immediately.
INDICATION
Tirzepatide is a medication administered by injection, prescribed for adults with type 2 diabetes to enhance blood sugar control in conjunction with dietary management and physical activity.
The appropriateness of Tirzepatide for individuals who have experienced pancreatic inflammation (pancreatitis) remains uncertain. This medication is not designed for those with type 1 diabetes. Furthermore, the safety and efficacy of Tirzepatide for minors under the age of 18 have not been established.