Zepbound

Zepbound (tirzepatide) is a prescription medicine used for weight loss and weight management in adults with obesity or who are overweight and have weight-related medical conditions. It is also used to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity.

Zepbound is a once-weekly injection used together with a reduced-calorie diet and increased physical activity.

Zepbound works by reducing your appetite and making you feel full sooner and for longer, helping you eat less, lose weight, and maintain weight loss.

Zepbound activates both GIP and GLP-1 receptors, meaning it has a dual mechanism of action, compared to semaglutide and orforglipron, which only activate GLP-1 receptors. Zepbound is a GIP and GLP-1 receptor agonist.

The clinical trial SURMOUNT-5 (NCT05822830) of adults with obesity who did not have type 2 diabetes demonstrated that Zepbound patients had an average weight loss of 50.3 lbs (22.8 kg), which was 20.2% of their body weight, and a 7.2-inch (18.4 cm) reduction in waist circumference, at 72 weeks.

Zepbound is FDA-approved to:

• Reduce excess body weight and maintain weight reduction long term in adults with obesity or who are overweight with weight-related medical problems
• Treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity.

Zepbound and Mounjaro contain the same active ingredient (tirzepatide), are both given as weekly injections, and both are made by Eli Lilly and Company. However, they have different FDA-approved uses and insurance coverage. Mounjaro is approved for type 2 diabetes management in adults and children 10 years and older, and Zepbound is FDA-approved for chronic weight management and obstructive sleep apnea (OSA) in certain adults.

The cost for prescription drugs varies depending on your insurance plan and which pharmacy you use. Refer to the Zepbound Prices, Coupons, Copay Cards & Patient Assistance for more information about the cost of this medicine.

Learn more: Zepbound cost with or without insurance.

Zepbound is usually given once a week and can be given with or without meals at any time of the day.

Zepbound is injected under the skin (subcutaneously) using a pre-filled single-dose pen, a multi-dose Kwikpen (for single patient use), and a single-dose vial with a syringe. Caregivers or patients should be trained on proper injection techniques and should read the instructions for use.

Inject Zepbound under the skin of your stomach (abdomen), thigh, or have another person inject it in the back of your upper arm. Do not inject into a muscle or vein. Change (rotate) your injection site with each weekly injection.

• Your doctor will usually start you on a low dose, which will gradually increase, but not more than once every 4 weeks.
• You may change the day of the week you use this medicine as long as there are at least three days between doses.
• Caregivers or patients should be trained on proper injection techniques. When using single-dose vials, a 1 mL syringe capable of measuring a 0.5 mL dose must be used for dose administration.
• Patients using multi-dose vials should always use a new syringe and needle for each injection.

You should follow the directions on your prescription label carefully and ask your pharmacist or doctor to explain any part you do not understand. It is important to use this medicine exactly as directed. Do not use more or less of this medicine or more often than your doctor prescribes.

Zepbound KwikPen

The KwikPen contains 4 fixed doses, and one dose is injected weekly (subcutaneously).

• For your weekly dose, you need to turn the dose knob all the way until it stops AND the iconis in the dose window.
• After 4 doses, throw away (discard) the Pen, including the unused medicine. The Pen will prevent you from dialing a full dose after you have given yourself 4 weekly doses. Do not inject the leftovermedicine. Do not transfer the leftover medicine from your Pen into a syringe.
• Do not share your tirzepatide Pen with other people, even if the pen needle has been changed. You may give other people a serious infection or get a serious infection from them.
• People who are blind or have vision problems should not use the Pen without help from a person who has been trained to use the pen.

Risk of Thyroid C-Cell Tumors

Zepbound has a boxed warning for the risk of thyroid C-cell tumors. A boxed warning is the strongest safety-related warning issued by the FDA.

In studies with rats, the active ingredient tirzepatide and medicines that work like tirzepatide have 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 use Zepbound if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Call your doctor immediately if you have thyroid tumor symptoms, such as a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath.

Other Warnings

Using this medicine with other tirzepatide-containing products or any GLP-1 receptor agonist is not recommended.

The safety and efficacy of using this medicine with other products for weight management have not been established.

Tirzepatide has not been studied in patients with a history of pancreatitis.

Never share a Zepbound KwikPen between patients, even if the pen needle is changed.

You should not use Zepbound if you have:

• Allergies to the tirzepatide or any ingredients contained in this medicine; see ingredients at the bottom of this page.
• A personal or family history of medullary thyroid carcinoma (a type of thyroid cancer); or multiple endocrine neoplasia type 2 (tumors in your glands).

Tell your doctor if you have ever had:

• Pancreas problems
• Kidney disease
• A severe stomach problem, such as problems with digesting food or slowed emptying of your stomach (gastroparesis)
• Are planning surgery or another procedure that uses anesthesia or deep sedation
• Diabetic retinopathy (a diabetes complication that affects the eyes)
• Gallbladder disease

Pregnancy and fertility

Tell your healthcare providers if you are pregnant or plan to become pregnant, as Zepbound may harm your unborn baby. Zepbound should be discontinued if pregnancy is recognized.

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 your health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979).

Zepbound can make birth control pills less effective. Ask your doctor about other birth control options such as an injection, implant, skin patch, vaginal ring, condom, diaphragm, cervical cap, or contraceptive sponge. If you take birth control pills, you may need to use additional birth control methods for 4 weeks after starting this medicine, and for 4 weeks each time the dose is raised.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed while using this medicine. Zepbound may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using this medicine.

Common Zepbound Side Effects

The most common Zepbound side effects include:

• Feeling sick, nausea 25%
• Diarrhea 19%
• Constipation 17%
• Indigestion, dyspepsia 9%
• Abdominal pain 9%
• Vomiting 8%
• Injection reactions 6%
• Tiredness, fatigue 5%
• Hypersensitivity reactions 5%
• Hair loss 5%

These common side effects occurred in 5% or more of patients taking Zepbound 5mg in Zepbound clinical trials SURMOUNT-1 (NCT04184622) and SURMOUNT-2 (NCT04657003), two randomized, double-blind, placebo-controlled trials.

Serious Side Effects

Zepbound may cause serious side effects. Call your doctor at once if you have:

• Serious allergic reactions. Zepbound may cause serious hypersensitivity reactions, including anaphylaxis and angioedema. Seek immediate medical attention if there are signs of an allergic reaction, including hives, difficulty breathing, feeling light-headed, swelling of your face, lips, tongue, or throat.
• Severe stomach problems. This medicine has been associated with gastrointestinal side effects, including intestinal obstruction and severe constipation. If you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting, or you may feel the pain from your abdomen to your back. Zepbound is not recommended in patients with severe gastroparesis (delayed gastric emptying).
• Dehydration leading to kidney problems. 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. Talk to your healthcare provider if you are urinating less than usual, if your urine is a dark yellow, or if you have nausea, vomiting, or diarrhea that does not go away.
• Gallbladder Problems. Acute gallbladder disease has occurred in people using Zepbound and other GLP-1 receptor agonists. Tell your healthcare provider right away if you have symptoms of pain in your upper stomach (abdomen), fever, yellowing of your skin or eyes (jaundice), or clay-colored stools.
• Pancreas problems (pancreatitis). Stop using this medicine 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 nausea or vomiting. You may feel the pain from your abdomen to your back.
• Low blood sugar (hypoglycemia). Symptoms may include headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery; or
• Vision changes. Vision changes or eye side effects (diabetic retinopathy) can occur in patients with type 2 diabetes, including blurry vision or blurred vision or any other vision changes.
• Thyroid tumor symptoms. This medicine has a risk of thyroid C-cell tumors. Call your doctor at once if you have symptoms including swelling or a lump in your neck, trouble swallowing, a hoarse voice, or if you feel short of breath.
• Depression or thoughts of suicide. You should pay attention to any changes in your mood, behaviors, feelings, or thoughts. Call your healthcare provider right away if you have any changes to your mental health that are new, worse, or worry you.
• Risk of pulmonary aspiration during general anesthesia or deep sedation. When using this medicine, there is an increased risk of food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sedation. Tell all your healthcare providers that you are taking Zepbound before you are scheduled to have surgery or other procedures.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Zepbound Dose for Weight Loss

Initial dose: 2.5 mg under the skin (subcutaneously) once a week. The 2.5 mg dosage is for treatment initiation and is not approved as a maintenance dosage.Dose increase after 4 weeks: The dosage should be increased to 5 mg subcutaneously once a week.Further dose increases: After at least 4 weeks on the current dose, the dosage may be increased in 2.5 mg increments.Recommended maintenance dose: 5 mg, 10 mg, or 15 mg injected subcutaneously once weekly.Maximum dose: 15 mg subcutaneously once a week.

Usual Adult Zepbound Dose for Obstructive Sleep Apnea

Initial dose: 2.5 mg under the skin (subcutaneously) once a week. The 2.5 mg dosage is for treatment initiation and is not approved as a maintenance dosage.Dose increase after 4 weeks: The dosage should be increased to 5 mg subcutaneously once a week.Further dose increases: After at least 4 weeks on the current dose, the dosage may be increased in 2.5 mg increments.Recommended maintenance dose: 10 mg to 15 mg injected subcutaneously once weekly.Maximum dose: 15 mg subcutaneously once a week.

Zepbound is available as single-dose pens and vials:

• 2.5 mg/0.5 mL
• 5 mg/0.5 mL
• 7.5 mg/0.5 mL
• 10 mg/0.5 mL
• 12.5 mg/0.5 mL
• 15 mg/0.5 mL

Zepbound KwikPen (single-patient-use) or multi-dose vial, each containing 4 doses, is approved by the FDA.

• 10 mg/2.4 mL (4.17 mg/mL) for four 2.5 mg/0.6 mL doses
• 20 mg/2.4 mL (8.33 mg/mL) for four 5 mg/0.6 mL doses
• 30 mg/2.4 mL (12.5 mg/mL) for four 7.5 mg/0.6 mL doses
• 40 mg/2.4 mL (16.7 mg/mL) for four 10 mg/0.6 mL doses
• 50 mg/2.4 mL (20.8 mg/mL) for four 12.5 mg/0.6 mL doses
• 60 mg/2.4 mL (25 mg/mL) for four 15 mg/0.6 mL doses

Take the missed dose as soon as you remember it within 4 days after the missed dose. However, if more than 4 days have passed, skip the missed dose and continue your regular dosing schedule. Do not inject two doses within 3 days of each other.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at Poison Help If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

Birth control pills may not work as well while receiving this medicine. Your doctor may suggest you use another form of birth control for 4 weeks after starting this medicine and for 4 weeks after each dose change. Talk to your healthcare provider about the best birth control methods that may be right for you while using this medicine.

Taking Zepbound with other medicines to treat diabetes, like insulin or sulfonylureas, may increase your risk of hypoglycemia. Talk to your doctor and pharmacist about low blood sugar and how to manage it.

Zepbound slows gastric emptying and so may change the absorption of other oral medicines that you take. Your doctor will monitor patients on oral medications that have a narrow therapeutic index (e.g., warfarin) or medicines that are dependent on threshold concentrations, while being treated with Zepbound.

This list is not complete. Many other drugs may interact with this medicine, including prescription and over-the-counter medicines, vitamins, and herbal products.

Single-dose pen and the single-dose vial

• Store in the refrigerator between 36⁰F to 46⁰F (2⁰C to 8⁰C).
• Do not freeze. Do not use if frozen.
• Store the single-dose pens in the original carton until use to protect them from light.
• If needed, each single-dose pen or single-dose vial can be stored at room temperature up to 86⁰F (30⁰C) for up to 21 days. Throw away the single-dose pen or single-dose vial after a total of 21 days at room temperature.

Multi-dose vial

• Store in the refrigerator between 36°F and 46°F (2°C and 8°C) or at room temperature [up to 86°F (30°C)].
• Throw away the multi-dose vial after a total of 30 days at room temperature, 30 days after first use, or after taking 4 weekly doses, even if it still has medicine in it.

Zepbound KwikPen Storage

Unused Pens:

• Store unused Pens in the refrigerator between 36°F and 46°F (2°C and 8°C).
• Unused Pens may be used until the expiration date (EXP) printed on the label if the Pen has been kept inthe refrigerator.
• Do not freeze your Pen. Throw away (discard) the Pen if it has been frozen.

Used Pens:

• You may store your used Pen at room temperature up to 86°F (30°C) after your injection.
• Keep away from heat and light.
• Keep your Pen and needles out of the sight and reach of children.
• Throw away the Pen 30 days after first use, even though the Pen has medicine left in it.
• Throw away the Pen after receiving 4 weekly doses. Attempting to inject any leftover medicine could resultin an incomplete dose, even though the Pen still has medicine left in it.

Active ingredient: tirzepatide

Inactive ingredients: sodium chloride, sodium phosphate dibasic heptahydrate, and water for injection.

Benzyl alcohol, glycerin, and phenol are also inactive ingredients in the multi-dose vial and single-patient-use KwikPen.

Hydrochloric acid solution and/or sodium hydroxide solution may have been added to adjust the pH.

Zepbound Eli Lilly and Company.

Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA.