Patient leaflet - Imcivree 10 mg / ml solution for injection
1. What IMCIVREE is and what it is used for
IMCIVREE contains the active substance setmelanotide. It is used to treat obesity and control hunger in adults and children of 4 years and above with acquired hypothalamic obesity (aHO) which results from injury or impairment of an area of the brain called the hypothalamus.
IMCIVREE is also used in adults and children of 2 years and above, to treat obesity caused by certain genetic diseases that affect how your brain controls feelings of hunger.
The genetic diseases this medicine is used to treat are:
- POMC (pro-opiomelanocortin) deficiency
- PCSK1 (proprotein convertase subtilisin/kexin type 1) deficiency • LEPR (leptin receptor) deficiency
- Bardet-Biedl syndrome (BBS).
People with these diseases lack certain natural substances involved in controlling appetite or these substances do not work properly. This increases hunger levels and leads to obesity. The medicine helps to restore control of appetite and reduces symptoms of the disease.
2. What you need to know before you use IMCIVREE
Do not use IMCIVREE
- if you are allergic to setmelanotide 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 this medicine.
Before you start and during treatment with this medicine your doctor should examine your skin for any markings or dark areas. Whilst you are using this medicine you may get more marks or dark patches on your skin. A check before you start treatment will help you identify any new marks that appear once you have used this medicine.
It is very common (may affect more than 1 in 10 people) for male patients to get spontaneous erections of the penis when using this medicine. If an erection lasts more than 4 hours, please see a doctor urgently. Prolonged erections (priapism) can reduce your ability to get erections in the future if not treated.
Children
Do not give this medicine to children under the age of 4 years if they have aHO. Do not give this medicine to children under the age of 2 years if they have POMC, PCSK1, or LEPR deficiency or BBS.
There is no information on use in children below these ages.
Other medicines and IMCIVREE
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
It is not recommended to use this medicine when pregnant or while trying to get pregnant, as it has not been studied in pregnant women. Weight loss during pregnancy can harm the baby.
Talk to your doctor before using this medicine if you are breast-feeding. Your doctor will discuss with you the benefits and risks of using this medicine during this time.
Driving and using machines
This medicine has no or only a minor effect on your ability to drive or use machines, due to drowsiness.
IMCIVREE contains benzyl alcohol
This medicine contains 10 mg benzyl alcohol in each 1 ml which is equivalent to 1 mg for each mg of your dose.
Benzyl alcohol has been linked with the risk of severe side effects in young children (less than 3 years old). There is an increased possibility that benzyl alcohol could build-up in their body (called “metabolic acidosis”) leading to “gasping syndrome”. Children aged 2 years old should be monitored by their doctor for signs of this build-up (including rapid heartbeat, rapid breathing, or confusion).
Benzyl alcohol may cause allergic reactions.
Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding or if you have a liver or kidney disease. This is because benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).
IMCIVREE contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.
3. How to use IMCIVREE
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
This medicine is given as an injection under the skin, once a day, at the start of the day. The medicine is for long-term use.
Your doctor will advise you on the correct dose to inject.
The daily recommended dose based on your age, weight and the treatment week are provided in the tables below. There are different dosage tables depending on the disease that you are taking this medicine to treat. Make sure to check the correct table for your recommended dose.
Your doctor will regularly monitor you whilst you are taking this medicine to see if your dose needs to change. Following your starting dose your doctor will advise if you should increase your dose to the next level based on how well the treatment is working and any side effects you may be experiencing. In some circumstances your doctor may advise to lower your dose. Check with your doctor if you are not sure about your current dosage.
Detailed instructions on how to inject your dose of IMCIVREE are provided after the dosage tables.
Acquired hypothalamic obesity (aHO)
The recommended doses are as follows:
| Adults and children aged 6 years or more | ||
| Treatment week | Daily dose | Volume to be injected |
| Week 1 | 0.5 mg | 0.05 ml |
| Week 2 | 1 mg | 0.1 ml |
| Week 3 | 2 mg | 0.2 ml |
| Week 4 and onward | 3 mg | 0.3 ml |
| Children aged 4 to less than 6 years | ||
| Treatment week | Daily dose | Volume to be injected |
| Patient weight is less than 20 kg | ||
| Week 1 | 0.5 mg | 0.05 ml |
| Week 2 | 1 mg | 0.1 ml |
| Week 3 and onward | 1.5 mg | 0.15 ml |
| Patient weight is 20 to less than 25 kg | ||
| Week 1 | 0.5 mg | 0.05 ml |
| Week 2 | 1 mg | 0.1 ml |
| Week 3 | 1.5 mg | 0.15 ml |
| Week 4 and onward | 2 mg | 0.2 ml |
| Patient weight is 25 to less than 30 kg | ||
| Week 1 | 0.5 mg | 0.05 ml |
| Week 2 | 1 mg | 0.1 ml |
| Week 3 | 1.5 mg | 0.15 ml |
| Week 4 | 2 mg | 0.2 ml |
| Week 5 and onward | 2.5 mg | 0.25 ml |
| Patient weight is 30 kg or more | ||
| Week 1 | 0.5 mg | 0.05 ml |
| Week 2 | 1 mg | 0.1 ml |
| Week 3 | 2 mg | 0.2 ml |
| Week 4 and onward | 3 mg | 0.3 ml |
Pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 deficiency (PCSK1) and leptin receptor (LEPR) deficiency
The recommended doses are as follows:
| Adults and children aged 12 years or more | ||
| Treatment week | Daily dose | Volume to be injected |
| Weeks 1-2 | 1 mg | 0.1 ml |
| Week 3 and onward | 2 mg | 0.2 ml |
| Additional possible doses as guided by your doctor | 2.5 mg | 0.25 ml |
| 3 mg | 0.3 ml | |
| Children aged 6 to less than 12 years | ||
| Treatment week | Daily dose | Volume to be injected |
| Weeks 1-2 | 0.5 mg | 0.05 ml |
| Weeks 3-4 | 1 mg | 0.1 ml |
| Week 5 and onward | 2 mg | 0.2 ml |
| Additional possible dose as guided by your doctor | 2.5 mg | 0.25 ml |
| Children aged 2 to less than 6 years | ||
Treatment week Daily dose Volume to be injected Patient weight is less than 20 kg | ||
| Week 1 and onward | 0.5 mg | 0.05 ml |
| Patient weight is 20 to less than 30 kg | ||
| Weeks 1-2 | 0.5 mg | 0.05 ml |
| Week 3 and onward | 1 mg | 0.1 ml |
| Patient weight is 30 to less than 40 kg | ||
| Weeks 1-2 | 0.5 mg | 0.05 ml |
| Weeks 3-4 | 1 mg | 0.1 ml |
| Week 5 and onward | 1.5 mg | 0.15 ml |
| Patient weight is 40 kg or more | ||
| Weeks 1-2 | 0.5 mg | 0.05 ml |
| Weeks 3-4 | 1 mg | 0.1 ml |
| Weeks 5-6 | 1.5 mg | 0.15 ml |
| Weeks 7-8 | 2 mg | 0.2 ml |
| Week 9 and onward | 2.5 mg | 0.25 ml |
Bardet-Biedl syndrome (BBS)
The recommended doses are as follows:
| Adults and children aged 16 years or more | ||
| Treatment week | Daily dose | Volume to be injected |
| Weeks 1-2 | 2 mg | 0.2 ml |
| Week 3 and onward | 3 mg | 0.3 ml |
| Children aged 6 to less than 16 years | ||
| Treatment week | Daily dose | Volume to be injected |
| Week 1 | 1 mg | 0.1 ml |
| Week 2 | 2 mg | 0.2 ml |
| Week 3 and onward | 3 mg | 0.3 ml |
| Children aged 2 to less than 6 years | ||
| Treatment week | Daily dose | Volume to be injected |
| Patient weight is less than 20 kg | ||
| Week 1 and onward | 0.5 mg | 0.05 ml |
| Patient weight is 20 to less than 30 kg | ||
| Weeks 1-2 | 0.5 mg | 0.05 ml |
| Week 3 and onward | 1 mg | 0.1 ml |
| Patient weight is 30 to less than 40 kg | ||
| Weeks 1-2 | 0.5 mg | 0.05 ml |
| Weeks 3-4 | 1 mg | 0.1 ml |
| Week 5 and onward | 1.5 mg | 0.15 ml |
| Patient weight is 40 kg or more | ||
| Weeks 1-2 | 0.5 mg | 0.05 ml |
| Weeks 3-4 | 1 mg | 0.1 ml |
| Weeks 5-6 | 1.5 mg | 0.15 ml |
| Weeks 7-8 | 2 mg | 0.2 ml |
| Week 9 and onward | 2.5 mg | 0.25 ml |
Patients with kidney disease
In patients with POMC, PCSK1 or LEPR deficiency or BBS and mild or moderate kidney disease, there are no changes required to the recommended dose.
In patients with aHO and mild kidney disease, there are no changes required to the recommended dose. Patients with aHO and moderate kidney disease should follow the doses recommended for patients with severe kidney disease. For patients with severe kidney disease the recommended doses are as follows:
Adults and children aged 12 years or more (POMC, PCSK1 or LEPR deficiency or aHO) or 16 years or more (BBS)
| Treatment week | Daily dose | Volume to be injected |
| Weeks 1-2 | 0.5 mg | 0.05 ml |
| Week 3 and onward | 1 mg | 0.1 ml |
| Additional possible doses as guided by your doctor | 2 mg | 0.2 ml |
| 2.5 mg | 0.25 ml | |
| 3 mg | 0.3 ml | |
| Children aged 6 to less than 12 years (POMC, PCSK1 or LEPR deficiency or aHO) or 6 to less than 16 years (BBS) | ||
| Treatment week | Daily dose | Volume to be injected |
| Weeks 1-2 | 0.25 mg | 0.025 ml |
| Weeks 3-4 | 0.5 mg | 0.05 ml |
| Week 5 and onward | 1 mg | 0.1 ml |
| Additional possible dose as guided by your doctor | 2 mg | 0.2 ml |
| Children aged less than 6 years | ||
| Treatment week | Daily dose | Volume to be injected |
| Patient weight is less than 20 kg | ||
| Week 1 and onward | 0.25 mg | 0.025 ml |
| Patient weight is 20 to less than 30 kg | ||
| Weeks 1-2 | 0.25 mg | 0.025 ml |
| Week 3 and onward | 0.5 mg | 0.05 ml |
| Patient weight is 30 to less than 40 kg | ||
| Weeks 1-2 | 0.25 mg | 0.025 ml |
| Weeks 3-4 | 0.5 mg | 0.05 ml |
| Week 5 and onward | 1 mg | 0.1 ml |
| Patient weight is 40 kg or more | ||
| Weeks 1-2 | 0.25 mg | 0.025 ml |
| Weeks 3-4 | 0.5 mg | 0.05 ml |
| Weeks 5-6 | 1 mg | 0.1 ml |
| Weeks 7 and onward | 1.5 mg | 0.15 ml |
IMCIVREE 10 mg/ml solution for injection
setmelanotide M120256AF
VV-LAB-000854 V1.0 How to inject IMCIVREE
This medicine is injected under the skin, in the area around the belly button. Your doctor, pharmacist or nurse will show you how to do this. Once you are comfortable injecting yourself or your child, you will be able to do this at home.
This medicine should be injected at the start of your day. This medicine can be taken without regard to the timing of your meals.
Before injecting this medicine, please read the following instructions carefully.
Step 1. Prepare for the injection
- Get the items you will need and place on a clean, flat surface. You will need the following items that are supplied separately:
- Wash your hands with soap and warm water.
- Open the 2 alcohol wipes and the gauze pad.
Step 2 Examine the vial
- Check the expiry date on the vial label, this is shown after ‘EXP’: MM/YYYY.
- The liquid should look clear to slightly yellow.
Do not use if:
- the expiry date has passed
- the liquid is cloudy
- there are particles floating in the vial
- the plastic cap on a new vial is broken or missing - the vial has been stored at temperatures greater than 30 °C. Step 3. Prepare the vial
Before use, let the vial reach room temperature. Remove the vial from the refrigerator 15 minutes before injection or roll the vial gently between the palms of your hands for 60 seconds. - Do not use warm water, a microwave or other appliance to heat the vial
- Do not shake the vial
- If using a new vial, remove the plastic cap and throw it away in your household waste.
- Clean the top of the grey vial stopper with an alcohol wipe. Throw away the used alcohol wipe in your household waste. - Do not remove the vial stopper
Step 4. Prepare the syringe
- For doses of 0.25 mg (0.025 ml or 2.5 units), use a 0.3 ml syringe with 0.5 (half) unit increments and a 29 to 31 gauge needle with a 6 to 13 mm needle length, suitable for injection under the skin.
- For doses of 0.5 mg to 3 mg (0.05 ml to 0.3 ml), use a 1 ml syringe with 0.01 ml dosing increments and a 28 to 29 gauge needle with a 6 to 13 mm needle length, suitable for injection under the skin.
- Keep the protective needle cap on and pull back the plunger to fill the syringe with air equal to the amount of the medicine to be used.
- Remove the needle cap from the syringe. Pull the cap straight off and away from your body.
- Place the vial upright on a flat surface. Hold the syringe and place it directly over the vial. Insert the needle straight down into the centre of the grey vial stopper.
- Push the plunger down to inject the air from the syringe into the vial.
Without removing the needle, gently turn the vial upside down.
- Make sure the tip of the needle is fully in the medicine liquid and not in the air above the liquid.
Slowly pull back the plunger to fill the syringe with the amount of medicine needed for your dose. When measuring your dose, be sure to read the units starting from the end closest to the black rubber stopper.
- Keep the needle in the vial and check for any large air bubbles in the syringe.
If you see air bubbles these will need to be removed from the
syringe. To remove:
Gently tap the side of the syringe with your finger to move
the air bubble to the top of the syringe.
- Empty the syringe back into the vial.
- Follow the above steps to fill your syringe again. Pull the plunger more slowly this time and make sure the tip of the needle is always fully in the liquid in the vial to reduce the chance of air bubbles.
- Once there are no large air bubbles in the syringe, place the vial upright on a hard surface.
Hold the vial with one hand and the barrel of the syringe
between the fingertips of your other hand. Pull the needle
straight up and out of the vial.
Place the syringe on the hard surface, make sure the needle
does not touch the surface. Do not recap the needle.
Step 5. Prepare the injection site
Choose the area around your belly button for the injection.
- Change your injection site each day.
Make sure the injection site is at least 5 cm away from the
belly button.
- Do not inject an area that is red, swollen, or irritated.
- Clean your chosen injection site with your second alcohol wipe using a circular motion. - Allow the skin to dry for about 10 seconds.
- Do not touch, fan, or blow on the cleaned area.
Step 6. Injecting IMCIVREE
- Place the syringe between your thumb and index finger of the hand you write with.
With your other hand, gently pinch about 5 cm of skin
between your thumb and index finger. Make sure you hold the skin fold until the injection is complete.
Hold the middle of the syringe at a 90º angle to your skin and
push the needle straight into the injection site, making sure
the needle goes in all the way.
- Do not hold or push on the plunger while inserting the needle.
Holding the barrel of the syringe between your thumb and
middle finger, use your index finger to slowly push the plunger to inject the medicine.
Count to 5 after injecting this medicine to make sure all the
medicine has left the syringe.
- Let go of the pinched skin and pull the needle out.
Use a gauze pad to gently apply pressure to the injection site,
then throw the gauze pad into your household waste.
- Place your used syringe in the sharps bin. Do not throw away in your household waste.
- If you still have medicine left in your vial, place the vial back in the carton and store either in your refrigerator or in a safe place at a temperature of less than 30 °C until it is time for your next dose.
If you use more IMCIVREE than you should
If you or your child use more of this medicine than you should, contact your doctor.
If you forget to use IMCIVREE
If you forget to inject the medicine, skip the dose and inject your next dose at the usual time. Do not use a double dose to make up for a forgotten dose.
If you stop using IMCIVREE
This medicine is intended for long-term use. If you stop using this medicine your hunger may return and your weight loss may stop. Make sure to follow the dosing schedule as instructed by your doctor or pharmacist.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people)
- Mole on your skin
- Headache
- Feeling sick (nausea)
- Being sick (vomiting)
- Dark areas or patches on your skin
- Spontaneous penile erections
- Increased penile erections
- Pain, bruising or inflammation (redness and/or swelling) at the site of injection
Feeling tired
Common (may affect up to 1 in 10 people)
- An excess of eosinophils, a type of white blood cell
- Feeling depressed
- Trouble sleeping
- Disturbance in sexual arousal
- Increased sexual desire
- Feeling dizzy
- Diarrhoea
- Stomach pain
- Dry mouth
- Indigestion
- Feeling constipated
- Heartburn
- Flatulence
- Blood tests showing increased liver enzyme levels
- Dry, red or itchy skin
- Rash
- Lesions on your skin
- Hair loss
- Joint aches
- Back pain
- Muscle pain
- Female genital discomfort
- Feeling weak
- Pain
Uncommon (may affect up to 1 in 100 people)
- Irregular mole on your skin
- Appetite disorders
- Feeling thirsty
- Sleep disorder
- Nightmares
- Decreased sexual desire
- Drowsiness
- Migraine headache
- Loss or change in sense of smell
- Taste disorders
- Discolouration of the white part of the eyes
- Vertigo
- Hot flush
- Yawning
- Runny nose
- Cough
- Stomach bloating
- Stomach discomfort
- Increase in saliva
- Redness of the skin
- Lines or streaks on your skin
- Increased sweating
- Abnormal distribution of fat tissue
- Itchy rash
- Flaky skin
- Changes in hair colour
- Discoloured nails
- Patches of skin that are darker and thicker than usual
- Pain in the muscles or bones
- Muscle cramps
- Pain in arms or legs
- Blood tests showing increased muscle enzyme levels
- Female inability to achieve or maintain sexual arousal
- Genital pain, discomfort or sensitivity
- Female genital disorder
- Period pains
- Sensitivity to hot or cold (feeling hot or cold)
- Chills
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store IMCIVREE
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 carton and vial after ‘EXP’. The expiry date refers to the last day of that month.
This medicine should be stored in a refrigerator at 2 °C to 8 °C until the expiry date on the carton and vial. Alternatively, this medicine may be kept at room temperature, no warmer than 30 °C, for up to 30 days or until the expiry date, whichever is sooner. Store all vials (even those you have opened) in the original carton to protect them from light. After you first use a vial, discard after 28 days.
Do not freeze this medicine.
If this medicine is exposed to temperatures above 30 °C do not use and discard according to local guidelines. Do not use this medicine if you notice floating particles or cloudiness. Always use a new syringe for each injection.
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.
6. Contents of the pack and other information
What IMCIVREE contains
- The active substance is setmelanotide. Each multidose vial contains 10 mg setmelanotide in 1 ml of solution.
The other ingredients are:
- Benzyl alcohol (see section 2 ‘IMCIVREE contains benzyl alcohol’) - N-(carbonyl-methoxypolyethylene glycol 2000)-1,2-distearoyl- glycero-3-phosphoethanolamine sodium salt (mPEG-2000-DSPE) - Carmellose sodium (see section 2 ‘IMCIVREE contains sodium’) - Mannitol
- Phenol
- Disodium edetate (see section 2 ‘IMCIVREE contains sodium’) - Water for injections
- Hydrochloric acid (for pH-adjustment)
- Sodium hydroxide (for pH-adjustment)
What IMCIVREE looks like and contents of the pack
IMCIVREE is a clear colourless to slightly coloured solution. This medicine comes in clear glass vials with a stopper and cap, containing 1 ml of solution for injection.
Marketing Authorisation Holder and Manufacturer
Rhythm Pharmaceuticals Netherlands B.V.
Radarweg 29
1043NX Amsterdam
Netherlands
This leaflet was last revised in April 2026.
large
air
bubbles
small
air
bubbles
0.25 mg dose = 0.025 ml = 2.5 units
1 mg dose = 0.1 ml
2 mg dose = 0.2 ml 3 mg dose = 0.3 ml 0.5 mg dose = 0.05 ml
5 cm
90°
VV-LAB-000854 V1.0