Cagrisema 12 Pen

Cagrisema 12 prefilled pen injection

Cagrisema 12 contains 6 mg of Semaglutide and 6mg of Cagrilintide per pen. This pen dispenses 0.25mg , 0.5 mg, 0.75mg ,1 mg and 2 mg of both api’s per injection.

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get by visiting the contact us page www.bodypharm.me/contact

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Cagrisema is and what it is used for
2. What you need to know before you use Cagrisema
3. How to use Cagrisema
4. Possible side effects
5. How to store Cagrisema
6. Contents of the pack and other information

1. What Cagrisema is and what it is used for

Cagrisema is a medicine for weight loss and weight maintenance that contains the active substance Semaglutide and Cagrilintide. Semaglutide is similar to a natural hormone called glucagon-like peptide-1 (GLP-1) that is released from the intestine after a meal. Semaglutide works by acting on receptors in the brain that control your appetite, causing you to feel fuller and less hungry and experience less craving for food. This will help you eat less food and reduce your body weight. Cagrilintide is a long-acting amylin analogue that is currently being investigated for its potential use in the treatment of obesity and related metabolic conditions. It mimics the effects of the natural hormone amylin. When both Semaglutide and Cagrilinitide are used together the overall efficacy is enhanced greatly. The most apparent result will be enhanced weightloss much greater than that of Semaglutide on its own.

This product contains both Semaglutide and Cagrlintide. When selecting a dosage on the pen unit for example 0.25mg. This will dispense 0.25mg of Semaglutide and 0.25mg of Cagrilintide at the same time.

What Cagrisema is used for

Cagrisema is used for weight loss and weight maintenance in addition to diet and physical activity in adults, who have:

• a BMI of 30 kg/m² or greater (with obesity) or
• a BMI of 27 kg/m² and less than 30 kg/m² (overweight) and weight-related health problems.

BMI (Body Mass Index) is a measure of your weight in relation to your height.

1. What you need to know before you use Cagrisema

Do not use Cagrisema if you are allergic to Semaglutide, Cagrilintide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions   

Talk to your doctor, pharmacist or nurse before using Cagrisema or during treatment if you have:

• Effects on the digestive system

During treatment with Cagrisema, you may feel sick (nausea) or be sick (vomiting), or have diarrhoea. These side effects can cause dehydration (loss of fluids). It is important that you drink enough fluids to prevent dehydration. This is especially important if you have kidney problems. Talk to your doctor if you have any questions or concerns.

• Inflammation of the pancreas

If you have severe and on-going pain in the stomach area see a doctor straight away as this could be a sign of inflamed pancreas (acute pancreatitis).

• Diabetes

Cagrisema must not be used as a substitute for insulin.

• Low blood sugar (hypoglycaemia)

Taking a sulfonylurea or an insulin with Cagrisema might increase the risk of getting low blood sugar levels (hypoglycaemia). Please see section 4 for the warning signs of low blood sugar levels. Your doctor may ask you to test your blood sugar levels. This will help your doctor decide if the dose of the sulfonylurea or insulin needs to be changed to reduce the risk of low blood sugar.

• Diabetic eye disease (retinopathy)

Fast improvements in blood sugar control may lead to a temporary worsening of diabetic eye disease. If you have diabetic eye disease and experience eye problems while taking this medicine, talk to your doctor.

Children and adolescents

This medicine is not recommended in children and adolescents under 18 years as there is no information on use in children below this age.

Other medicines and Cagrisema

Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines.

Pregnancy and breast-feeding   

This medicine should not be used during pregnancy, as it is not known if it may affect your unborn child. Therefore, it is recommended to use contraception while using this medicine. If you wish to become pregnant, you should stop using this medicine at least two months in advance. If you become or are pregnant, think you may be pregnant or are planning to have a baby when using this medicine, talk to your doctor straight away, as your treatment will need to be stopped.   

You should not use this medicine if you are breast-feeding, as it is unknown if it passes into breast milk.   

Driving and using machines

Cagrisema is unlikely to affect your ability to drive and use machines. Some patients may feel dizzy when taking Cagrisema mainly during the first 3 months of treatment (see section 4). If you feel dizzy you should not drive or operate machines until you feel better. If you need any further information, talk to your doctor, pharmacist or nurse.

For diabetics using this medicine in combination with a sulfonylurea or insulin, low blood sugar (hypoglycaemia) may occur which may reduce your ability to concentrate. Do not drive or use machines if you get any signs of low blood sugar. See section 2, ‘Warning and precautions’ for information on increased risk of low blood sugar and section 4 for the warning signs of low blood sugar. Talk to your doctor for further information.   

Sodium content

This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.

1. How to use Cagrisema

Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.

How much to use

The recommended therapeutic long-term maximum dosage is 2 mg weekly for weightloss purposes.  Some users can tolerate higher dosages, please seek guidance from your practitioner if higher than recommended dosages are to be followed.

It is imperative that gradual dosage escalation is followed and patients DO NOT start at higher than recommended dosages.

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 Cagrisema, the starting dose is 0.25 mg once weekly.
• Your practitioner will instruct you to gradually increase your dose every 4 weeks until you reach the recommended dose of 2 mg once weekly. Your practitioner may decide to keep you at a lower maintenance dosage.
• Once you reach the recommended dose of 2 mg, do not increase this dose further unless under the guidance of a practitioner.

You will be told to follow the table below.

	Dose escalation	Weekly dose	Units to inject
Starting Weeks	Week 1–4	0.25 mg	0.25 marker on dosage selector Cagrisema 12 pen
Loading Phase 1	Week 5–8	0.5 mg	0.5 marker on the dosage selector Cagrisema 12 pen
Loading Phase 2	Week 9–12	1 mg	1 marker on dosage selector Cagrisema 12 pen
Maintenance	From week 12	1 or 2 mg	1 marker on dosage selector Cagrisema 12 pen or 2 marker on dosage selector Cagrisema 12 pen.

*Body Pharm Cagrisema 12 pen can be dosed to 0.75 mg by using the 0.75 marker on the dosage selector. Seek guidance from your practitioner as alternative dosing schedules are not covered in the scope of this leaflet.

It may be required by some patients to increase from 0.5mg to 0.75mg for 4 weeks if the 0.5mg to 1mg escalation results in unwanted side effects.

Your practitioner will assess your treatment on a regular basis.

How Cagrisema is given

Cagrisema 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 or nurse how to use it.

Detailed instructions for use are on the other side of this leaflet.

People with diabetes

  

Tell your doctor if you have diabetes. Your doctor may adjust the dose of your diabetes medicines to prevent you from getting low blood sugar.

• Do not mix Cagrisema up with other medicines that you inject (e.g. insulins).
• Do not use Cagrisema in combination with other medicines that contain GLP-1 receptor agonists (such as liraglutide, dulaglutide, exenatide, tirzepatide, retatrutide or lixisenatide).

When to use Cagrisema

• You should use this medicine once a week and if possible, on the same day each week.
• You can give yourself the injection at any time of the day – regardless of meals.

If necessary, you can change the day of your weekly injection of this medicine as long as it has been at least 3 days since your last injection. After selecting a new dosing day, continue with once a week dosing.

If you use more Cagrisema than you should

Talk to your doctor straight away. You may get side effects such as feeling sick (nausea).

If you forget to use Cagrisema

If you forgot to inject a dose and:

• it is 5 days or less since you should have used Cagrisema, use it as soon as you remember. Then inject your next dose as usual on your scheduled day.
• it is more than 5 days since you should have used Cagrisema, skip the missed dose. Then inject your next dose as usual on your next scheduled day. Do not take a double dose to make up for a forgotten dose.

If you stop using Cagrisema    

Do not stop using this medicine without talking to your doctor.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

1. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

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). Signs of inflamed pancreas may include severe and long lasting pain in your stomach, the pain may move to your back. You should see your doctor immediately if you experience such symptoms.

Rare: may affect up to 1 in 1,000 people

• Severe allergic reactions (anaphylactic reactions, angioedema). You should seek immediate medical help and inform your doctor straight away if you get symptoms such as breathing problems, swelling of face, lips, tongue, and/or throat with difficulty swallowing, wheezing, fast heartbeat, pale and cold skin, feeling dizzy or weak.

Other side effects

Very common: may affect more than 1 in 10 people

• headache
• feeling sick (nausea)
• being sick (vomiting)
• diarrhoea
• constipation
• stomach pain
• feeling weak or tired.
• Irritation or rash at injection site

These usually go away over time.

Common: may affect up to 1 in 10 people

• feeling dizzy
• upset stomach or indigestion
• burping
• gas (flatulence)
• bloating of the stomach
• inflamed stomach (‘gastritis’) – the signs include stomach ache, feeling sick (nausea) or being sick (vomiting)
• reflux or heartburn – also called ‘gastro-oesophageal reflux disease’
• gallstones
• hair loss
• injection site reactions
• low blood sugar (hypoglycaemia) in patients with diabetes.

The warning signs of low blood sugar may come on suddenly. They can include: cold sweat, cool pale skin, headache, fast heartbeat, feeling sick (nausea) or very hungry, changes in vision, feeling sleepy or weak, feeling nervous, anxious or confused, difficulty concentrating or shaking.   

Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs.

Low blood sugar is more likely to happen if you also take a sulfonylurea or insulin. Your doctor may reduce your dose of these medicines before you start using this medicine.

Uncommon: may affect up to 1 in 100 people

• fast heartbeat
• increase of pancreatic enzymes (such as lipase and amylase) shown in blood tests.

1. How to store Body Pharm Cagrisema

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the pen label and carton after ‘EXP’. The expiry date refers to the last day of that month.

Do not freeze Body Pharm Cagrisema pens and do not use it if it has been frozen.

Keep the pen cap on in order to protect from light.

Before opening:

Store in a refrigerator (2°C to 8°C). Keep away from the cooling element.

During use:

After opening, this pen can be stored in a refrigerator (2°C to 8°C) for up to 8 weeks.

Do not use this medicine if you notice that the solution is not clear and colourless.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

1. Contents of the pack and other information

What Cagrisema contains

• The active substance is Semaglutide and Cagrilintide.
• The other ingredients are disodium phosphate dihydrate, propylene glycol, phenol,sodium hydroxide/hydrochloric acid (for pH adjustment), water for injection.

Body Pharm Cagrisema 12 is a prefilled pen with the injection solution inside. It cannot be refilled, after the full 12 mg has been used the pen can be discarded.

   

Dosage and directions for use of Body Pharm Cagrisema

Before you begin using your once-weekly injection of Body Pharm Cagrisema , always read these instructions carefully, and talk to your doctor, nurse or pharmacist about how to inject Body Pharm Cagrisema. This product should be used at prescribed dosages taken once a week for 4 weeks thereafter the next prescribed dosage should be administered.

Choose your injection site, inject subcutaneous only. Choose upper arms, stomach or upper legs (keep a 5 cm distance from your belly button).

You may inject in the same body area each week, but make sure it is not in the same spot as used the last time.

• If patients do not tolerate a dose during dose escalation, consider delaying dose escalation for 4 weeks. Staying at a lower dosage can help with expected side effects when increasing dosages.

• The end maintenance dose maximum of  Cagrisema is 2 mg injected subcutaneously once-weekly.

• If patients do not tolerate their once-weekly maintenance dose, the dose can be temporarily decreased according to the dosage table, for a maximum of 4 weeks. After 4 weeks, increase your Cagrisema dosage to the next once-weekly dosage. Discontinue use if the user shows any severe side effect type symptoms listed above.
• In patients with type 2 diabetes, monitor blood glucose prior to starting treatment and during treatment.