Wegovy

• Medicine for weight loss
• Reduces appetite
• Solution for injection in pre-filled pen
• Do not use while pregnant or breastfeeding

Each FlexTouch pen contains four doses. Each pack of Wegovy, regardless of dosage strength, contains one pre-filled pen and four disposable NovoFine Plus needles (1 pen = 4 doses).

Wegovy is a medicine for weight loss and weight maintenance that contains the active substance semaglutide. This medicine works by acting on receptors in the brain that control your appetite, causing you to feel fuller and less hungry. The solution is injected underneath the skin surface using a pre-filled pen. Wegovy should be used with a reduced calorie meal plan and increased physical activity.

This medicine is used in adults, who have:

• A BMI of 30 kg/m² or greater (obesity).
• A BMI of 27 kg/m² and less than 30 kg/m² (overweight) and weightrelated health problems (such as diabetes, high blood pressure (hypertension), abnormal levels of fats in the blood, obstructive sleep apnoea, or a history of heart attack, stroke or vascular problems).
  

Wegovy is used together with diet and physical activity for weight management in adolescents ages 12 years and above, who have:

• Obesity, and
• 60 kg.

As an adolescent patient, you should only continue using Wegovy if you have lost at least 5% of your BMI after 12 weeks on the 2.4-mg dose or maximum tolerated dose.

Wegovy is given as an injection under the skin (subcutaneous injection). Do not inject it into a vein or muscle. The best places to give the injection are the upper arms, stomach or upper legs. Before you use the pen for the first time, ask your doctor, pharmacist or nurse how to use it.

Detailed instructions for use can be found in the package leaflet. Follow these instructions closely.

Dosage

Your dose should be determined by a doctor. The general guidelines for use are as follows:

Adults The recommended dose is 2.4 mg once weekly, taken on the same day. Your treatment will start at a low dose which will be gradually increased over 16 weeks of treatment as follows:

• When you first start using Wegovy, the starting dose is 0.25 mg once weekly.
• Your doctor will instruct you to gradually increase your dose every four weeks until you reach the recommended dose of 2.4 mg once weekly.
• Once you reach the recommended dose of 2.4 mg, do not increase this dose further.
• During treatment with Wegovy, you may experience nausea or vomiting. Ask your doctor to delay increasing your dose or to lower your dose to the previous level until your body adjusts and the symptoms improve.

You will most likely be told to follow the table below:

• Week 1–4: 0.25 mg once weekly
• Week 5–8: 0.5 mg once weekly
• Week 9–12: 1 mg once weekly
• Week 13–16: 1.7 mg once weekly
• From week 17: 2.4 mg once weekly

For adolescents, the same dose escalation schedule as for adults should be applied (see above). The dose should be increased until 2.4 mg (maintenance dose) or maximum tolerated dose has been reached. Weekly doses higher than 2.4 mg are not recommended.

Alcohol/driving

This medicine does not interact with alcohol.

Wegovy is not likely to affect your reaction time. For diabetics using this medicine in combination with a diabetes medicine, low blood sugar (hypoglycaemia) may occur which may reduce your ability to concentrate. Do not drive or use machines if you feel dizzy or get any signs of low blood sugar.

If you use too much/forget to use/stop using Wegovy

If you use more Wegovy than you should, talk to your doctor straight away. You may feel sick (nausea) or be sick (vomiting), or have diarrhoea. These side effects can cause dehydration (loss of fluids).

If you forgot to inject a dose and:

• it is five days or less since you should have used Wegovy, use it as soon as you remember. Then inject your next dose as usual on your scheduled day.
• it is more than five days since you should have used Wegovy, skip the missed dose. Then inject your next dose as usual on your scheduled day.

Do not inject a double dose to make up for a forgotten dose.

Do not stop using Wegovy without talking to a doctor first.

Wegovy is not suitable for everyone. Do not use Wegovy if you are allergic to any of the ingredients in this medicine (see section 'What Wegovy contains').

When should this medicine be used with caution?

Wegovy is not recommended if:

• You are using other weight loss products.
• You have type 1 diabetes.
• Your kidney function is severely impaired.
• Your liver function is severely impaired.
• You suffer from severe heart failure.
• You have diabetic eye disease (retinopathy).

There is little experience with this medicine in patients:

• Aged 75 and older.
• With liver problems.
• With a serious stomach or intestinal problem causing delayed gastric emptying, or with an inflammatory bowel disease.

See the package leaflet for more warnings associated with the use of Wegovy. Tell your doctor if any of the above applies to.

Pregnancy and breastfeeding

Wegovy should not be used during pregnancy and while breastfeeding.

Before starting treatment with Wegovy, a pregnancy test can be taken to rule out the chance of pregnancy.

To prevent pregnancy, you must use at least one reliable method of contraception.

If you wish to become pregnant, you should stop using this medicine at least two months in advance of the planned pregnancy. If you become pregnant while using Wegovy, talk to your doctor straight away as your treatment will need to be stopped.

Other medicines and Wegovy

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, herbal medicines or other natural products. Be sure to tell your doctor if you are taking anticoagulants (blood-thinning agents that reduce blood clotting). For more information, see the package leaflet.

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

The side effects that are known to be associated with Wegovy include:

Common (may affect up to 1 in 10 people): Complications of diabetic eye disease (diabetic retinopathy). If you have diabetes you should inform your doctor if you experience eye problems, such as changes in vision, during treatment with this medicine.

Uncommon (may affect up to 1 in 100 people):
Inflamed pancreas (acute pancreatitis). You should see your doctor immediately if you experience symptoms (see the package leaflet for a list of symptoms).

Rare (may affect up to 1 in 1,000 people):
Severe allergic reactions (anaphylactic reactions, angioedema). If you notice any signs of an allergic reaction, get emergency medical help immediately.

Other side effects of Wegovy include:

Very common (may affect more than 1 in 10 people):

• Headache.
• Nausea.
• Vomiting.
• Diarrhoea.
• Constipation.
• Abdominal pain.
• Feeling weak or tired.
  These symptoms usually occur when a dose is increased and usually go away over time.

Common (may affect up to 1 in 10 people):

• Dizziness.
• Upset stomach or indigestion.
• Gallstones.
• Hair loss.
• Injection site reactions.
• Low blood sugar (hypoglycaemia) in patients with diabetes.

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

The active substance is semaglutide.

• Wegovy 0.25 mg solution for injection: one prefilled pen contains 0.25 mg semaglutide in 0.5 ml solution (0.5 mg/ml).
• Wegovy 0.5 mg solution for injection: one prefilled pen contains 0.5 mg semaglutide in 0.5 ml solution (1 mg/ml).
• Wegovy 1 mg solution for injection: one prefilled pen contains 1 mg semaglutide in 0.5 ml solution (2 mg/ml).
• Wegovy 1.7 mg solution for injection: one prefilled pen contains 1.7 mg semaglutide in 0.75 ml solution (2.27 mg/ml).
• Wegovy 2.4 mg solution for injection: one prefilled pen contains 2.4 mg semaglutide in 0.75 ml solution (3.2 mg/ml).

The other ingredients are disodium phosphate dihydrate, propylene glycol, phenol, sodium hydroxide/hydrochloric acid (for pH adjustment), water for injection.

Read the package leaflet before use.