Zepbound

• Used to treat obesity
• Self-injection medication
• Once per week
• Not suitable for use in children

Zepbound contains tirzepatide. This medicine should be used with a reduced-calorie diet and increased physical activity in people who are overweight or obese. Zepbound works by slowing the movement of food from the stomach into the small intestine, which may make you feel full more quickly and for a longer period of time. This reduces the feeling of hunger, which makes it easier to stick to a weight loss plan.

Zepbound is prescribed to aid weight loss in obese people who have a body mass index (BMI) of 30 kg/m2 or higher. People who are overweight are considered a candidate for this medicine if they have a BMI between 27 and 30 and at least one weight-related health problem (such as high blood pressure, type 2 diabetes, high cholesterol or cardiovascular disease).

Zepbound is a once-weekly injection given under the skin (subcutaneous) using a pre-filled single-dose pen. Zepbound may be injected into the thigh or abdomen. You should rotate the injection site with each dose to avoid skin irritation.

Zepbound is used once a week. You can give yourself the injection at any time of the day. It is best to inject yourself at the same time each day to avoid missing any doses. You may change the day of the week you use this medicine as long as there is at least three days (72 hours) between doses.

Before you use the pen for the first time, your doctor will show you how to use it. Zepbound also comes with instructions for use. You should follow the directions carefully.

Store in the refrigerator between 2⁰C to 8⁰C, do not freeze. Do NOT use Zepbound if frozen. Store Zepbound in the original carton until use to protect it from light. If needed, each single-dose pen can be stored at room temperature up to 30⁰C for up to 21 days. Discard if not used within 21 days after removing from the refrigerator. Do not use this medicine if the pen has been damaged or if the medicine is cloudy, discoloured or has particles in it.

Dosage

Dosage should be determined by a doctor. The general recommended dose for weight loss in overweight/obese patients is:

• Adults: 2.5 mg under the skin (subcutaneously) once a week for four weeks. After four weeks, the dosage should be increased to 5 mg subcutaneously once a week by your doctor. Further dose increases: after at least four weeks on the current dose the weekly dose may be increased in 2.5 mg increments (7,5 mg, 10 mg, 12,5 mg or 15 mg) if necessary. Your doctor will usually start you on a low dose, which will gradually increase, but not more than once every four weeks.

Alcohol/driving

This medicine does not interact with alcohol.

Zepbound may cause hypoglycaemia (low blood sugar). It is unsafe to operate a car if your blood sugar is low. Do not drive if you experience low blood sugar symptoms (e.g., blurred vision, dizziness, feeling jittery). Taking Zepbound with other medicines to treat diabetes may increase your risk of hypoglycaemia. Talk to a doctor if you have any questions regarding this subject.

If you use more than you should/forget to use Zepbound

If you take more Zepbound than you were told to, contact your doctor immediately.

If you miss a dose of Zepbound, take the missed dose as soon as possible within four days (96 hours) after the missed dose. If more than four days have passed, skip the missed dose and take your next dose on the regularly scheduled day. Do not take 2 doses of Zepbound within three days (72 hours) of each other.

Do not use Zepbound if:

• You or any of your family have ever had a type of thyroid cancer called MTC.
• You have an endocrine system condition called MEN 2.
• You have had a serious allergic reaction to tirzepatide or any of the ingredients in Zepbound (see section 'What Zepbound contains').

When should this medicine be used with caution?

Before using Zepbound, tell your doctor about all of your medical conditions, including if you:

• Have or have had problems with your pancreas or kidneys.
• Have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.
• Have a history of diabetic retinopathy.
• Are pregnant or plan to become pregnant (see section 'Pregnancy and breastfeeding').
• Are breastfeeding or plan to breastfeed (see section 'Pregnancy and breastfeeding').

Pregnancy and breastfeeding

Pregnancy

Zepbound may harm your unborn baby. Tell your doctor if you become pregnant while using Zepbound.

Note: Birth control pills by mouth may not work as well while using Zepbound. If you take birth control pills by mouth, your doctor may recommend another type of birth control for four weeks after you start Zepbound and for four weeks after each increase in your dose of Zepbound. Talk to your doctor about birth control methods that may be right for you while using Zepbound.

Breastfeeding

It is not known if Zepbound passes into your breast milk. Talk to your doctor about the best way to feed your baby while using Zepbound.

Other medicines and Zepbound

Please tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription, herbal medicines or other natural products.

Zepbound may affect the way some medicines work, and some medicines may affect how Zepbound works.

Before using Zepbound, tell your doctor if you are taking medicines to treat diabetes including insulin or sulfonylureas. These medicines could increase your risk of low blood sugar. Talk to your doctor about low blood sugar levels and how to manage them.

Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine.

Like all medicines, this medicine can cause side effects, although some people may not experience any.

Zepbound can cause side effects, including:

• Possible thyroid tumours, including cancer.
• Serious stomach problems.
• Kidney problems.
• Gallbladder problems.
• Inflamed pancreas (acute pancreatitis).
• Severe allergic reactions.
• Low blood sugar levels.
• Change in vision in patients with type 2 diabetes.
• Depression or suicidal thoughts.

For more information about these serious side effects and a list of symptoms, see the package leaflet. Get emergency medical help if you experience serious side effects.

Other side effects of Zepbound include:

• Nausea, vomiting. Make sure you drink sufficient fluids to prevent dehydration.
• Stomach pain, heartburn, indigestion.
• Diarrhoea or constipation.
• Skin irritation at the injection site.
• Hypersensitivity reactions.
• Hair loss.
• Fatigue.

For a list of possible side effects, see the package leaflet. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Active ingredient: tirzepatide.

Inactive ingredients: sodium chloride, sodium phosphate dibasic heptahydrate, and water for injection. Hydrochloric acid solution and/or sodium hydroxide solution may have been added to adjust the pH.

Read the package leaflet before use.