Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

IMCIVREE 10 mg/ml injection solution

setmelanotide

This medicine is subject to additional monitoring, which will allow quicker detection of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is provided at the end of section 4.

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

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

What IMCIVREE is and what it is used for
What you need to know before using IMCIVREE
How to use IMCIVREE
Possible side effects
How to store IMCIVREE
Contents of the pack and other information

1. What IMCIVREE is and what it is used for

IMCIVREE contains the active substance setmelanotide. It is used in adults and children from the age of 2 years to treat obesity caused by certain genetic diseases that affect how the brain controls the sensation of hunger.

The genetic diseases for which this medicine is used as a treatment are:

Bardet-Biedl syndrome (BBS)
POMC (proopiomelanocortin) deficiency obesity
PCSK1 (proprotein convertase subtilisin/kexin type 1) deficiency obesity
LEPR (leptin receptor) deficiency obesity

People with these diseases lack certain natural substances involved in appetite control, or these substances do not function properly. This leads to increased levels of hunger and results in obesity. This medicine helps restore appetite control and reduces disease symptoms.

2. What you need to know before using IMCIVREE

Do not use IMCIVREE

if you are allergic to setmelanotide or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use IMCIVREE.

Before starting treatment with this medicine, and during treatment, your doctor should examine your skin for moles or dark spots. While using this medicine, you may develop additional moles or dark spots on your skin. An examination before starting treatment will help identify any new spots that may appear after you begin using this medicine.

Spontaneous penile erections are very common (may affect more than 1 in 10 people) in male patients using this medicine. If an erection lasts longer than 4 hours, seek medical attention immediately. Prolonged erections (priapism) may reduce your ability to have erections in the future if not treated.

Children

Do not give this medicine to children under 2 years of age, as there is no information available on its use in children younger than this.

Other medicines and IMCIVREE

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Use of IMCIVREE is not recommended in women who are pregnant or trying to become pregnant, as it has not been studied in pregnant women. Weight loss during pregnancy may harm the baby.

Talk to your doctor before starting this medicine if you are breastfeeding. Your doctor will explain the benefits and risks of taking IMCIVREE during this period.

Driving and using machines

This medicine is not expected to affect your ability to drive or use machines.

IMCIVREE contains benzyl alcohol

This medicine contains 10 mg of benzyl alcohol per 1 ml, equivalent to 1 mg per mg of your dose.

Benzyl alcohol has been associated with a risk of serious adverse effects in young children (under 3 years of age). There is an increased risk of benzyl alcohol accumulating in the body (called "metabolic acidosis") and causing "gasping syndrome." Children aged 2 years should be monitored by their doctor for signs of accumulation (such as rapid heartbeat, fast breathing, or confusion).

Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because accumulation may occur and lead to adverse effects (metabolic acidosis).

IMCIVREE contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; therefore, it is essentially

"sodium-free".

3. How to use IMCIVREE

Follow exactly the instructions for administering this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

IMCIVREE is administered as a subcutaneous injection once daily at the beginning of the day. This medicine is intended for long-term use.

Your doctor will advise you on the appropriate dose to inject.

Obesity due to proopiomelanocortin deficiency, obesity due to proprotein convertase subtilisin/kexin type 1 deficiency, and obesity due to leptin receptor deficiency.

In adults and children 12 years of age and older, the recommended doses are as follows:

Week of treatment	Daily dose in mg	Volume to be injected
Weeks 1 – 2	1 mg once daily	0.1 ml once daily
Week 3 onwards	2 mg once daily	0.2 ml once daily
If the dose is not sufficient and adverse effects are acceptable	2.5 mg once daily	0.25 ml once daily
If the dose is not sufficient and adverse effects are acceptable	3 mg once daily	0.3 ml once daily

In children aged 6 to < 12 years, the recommended doses are as follows:

Week of treatment	Daily dose in mg	Volume to be injected
Weeks 1 – 2	0.5 mg once daily	0.05 ml once daily
Week 3 – 4	1 mg once daily	0.1 ml once daily
Week 5 onwards	2 mg once daily	0.2 ml once daily
If the dose is not sufficient and adverse effects are acceptable	2.5 mg once daily	0.25 ml once daily

In children from 2 to <6 years of age, the recommended doses are as follows:

Patient weight/treatment week	Daily dose	Volume to be injected
<20 kg
Week 1 onwards	0.5 mg once daily	0.05 ml once daily
20–<30 kg
Weeks 1–2	0.5 mg once daily	0.05 ml once daily
Week 3 onwards (if dose is insufficient and adverse effects are acceptable)	1 mg once daily	0.1 ml once daily
30–<40 kg
Weeks 1–2	0.5 mg once daily	0.05 ml once daily
Weeks 3–4 (if dose is insufficient and adverse effects are acceptable)	1 mg once daily	0.1 ml once daily
Week 5 onwards (if dose is insufficient and adverse effects are acceptable)	1.5 mg once daily	0.15 ml once daily
≥40 kg
Weeks 1–2	0.5 mg once daily	0.05 ml once daily
Weeks 3–4 (if dose is insufficient and adverse effects are acceptable)	1 mg once daily	0.1 ml once daily
Weeks 5–6 (if dose is insufficient and adverse effects are acceptable)	1.5 mg once daily	0.15 ml once daily
Weeks 7–8 (if dose is insufficient and adverse effects are acceptable)	2 mg once daily	0.2 ml once daily
Week 9 onwards (if dose is insufficient and adverse effects are acceptable)	2.5 mg once daily	0.25 ml once daily

After the initial dose, if the adverse effects of a subsequent dose are not acceptable, the dose will be reduced to the level of the previous dose. If the adverse effects of the reduced dose are acceptable, dose escalation will continue.

In patients with mild or moderate renal impairment, no change in the dosing regimen is required.

For adults and children aged 12 to 17 years with severe renal impairment, the recommended doses are as follows:

Week of treatment	Daily dose in mg	Volume to be injected
Weeks 1 – 2	0.5 mg once daily	0.05 ml once daily
Week 3 onwards (if adverse effects are acceptable)	1 mg once daily	0.1 ml once daily
If the dose is not sufficient and adverse effects are acceptable	2 mg once daily	0.2 ml once daily
If the dose is not sufficient and adverse effects are acceptable	2.5 mg once daily	0.25 ml once daily
If the dose is not sufficient and adverse effects are acceptable	3 mg once daily	0.3 ml once daily

If the adverse effects of the initial dose of 0.5 mg are not acceptable, it will be reduced to 0.25 mg (0.025 ml). If the adverse effects of the 0.25 mg once-daily dose are acceptable, dose escalation will continue.

After the initial dose, if the adverse effects of a subsequent dose are not acceptable, the dose will be reduced to the previous dose level. If the adverse effects of the reduced dose are acceptable, dose escalation will continue.

If the adverse effects of the 3 mg dose are not acceptable, the dose will be reduced to 2.5 mg, and this dose will be maintained.

In children aged 6 to less than 12 years with severe renal impairment, the recommended doses are as follows:

Week of treatment	Daily dose in mg	Volume to be injected
Weeks 1 – 2	0.25 mg once daily	0.025 ml once daily
Week 3 – 4 (if adverse effects are acceptable)	0.5 mg once daily	0.05 ml once daily
Week 5 onwards (if adverse effects are acceptable)	1 mg once daily	0.1 ml once daily
If the dose is not sufficient and adverse effects are acceptable	2 mg once daily	0.2 ml once daily

If the adverse effects of the initial dose of 0.25 mg are not acceptable, treatment should be discontinued.

After the initial dose, if the adverse effects of a subsequent dose are not acceptable, the dose will be reduced to the previous dose level. If the adverse effects at the reduced dose are acceptable, dose escalation may continue.

If the adverse effects of the 2 mg dose are not acceptable, the dose will be reduced to 1 mg and this dose will be maintained.

In children from 2 to less than 6 years of age with severe renal impairment, the recommended doses are as follows:

Patient weight/treatment week	Daily dose	Volume to be injected
<20kg
Week 1 onwards	0.25 mg once daily	0.025 ml once daily
20–<30kg
Weeks 1–2	0.25 mg once daily	0.025 ml once daily
Week 3 onwards (if dose is insufficient and adverse effects are acceptable)	0.5 mg once daily	0.05 ml once daily
30–<40kg
Weeks 1–2	0.25 mg once daily	0.025 ml once daily
Weeks 3–4 (if dose is insufficient and adverse effects are acceptable)	0.5 mg once daily	0.05 ml once daily
Week 5 onwards (if dose is insufficient and adverse effects are acceptable)	1 mg once daily	0.1 ml once daily
≥40kg
Weeks 1–2	0.25 mg once daily	0.025 ml once daily
Weeks 3–4 (if dose is insufficient and adverse effects are acceptable)	0.5 mg once daily	0.05 ml once daily
Weeks 5–6 (if dose is insufficient and adverse effects are acceptable)	1 mg once daily	0.1 ml once daily
Week 7 onwards (if dose is insufficient and adverse effects are acceptable)	1.5 mg once daily	0.15 ml once daily

If the adverse effects of the initial dose of 0.25 mg are not acceptable, treatment should be discontinued.

Bardet-Biedl Syndrome

In adults and children from the age of 16 years, the recommended doses are as follows:

Treatment week	Daily dose in mg	Volume to be injected
Weeks 1 – 2	2 mg once daily	0.2 ml once daily
Week 3 onwards (if adverse effects are acceptable)	3 mg once daily	0.3 ml once daily

If the adverse effects of the initial 2 mg dose are not acceptable, it will be reduced to 1 mg (0.1 ml). If the adverse effects of the 1 mg once-daily dose are acceptable, dose escalation will continue.

If the adverse effects of the 3 mg dose are not acceptable, it will be reduced to 2 mg, and this dose will be continued.

In children aged 6 to less than 16 years, the recommended doses are as follows:

Treatment week	Daily dose in mg	Volume to be injected
Week 1	1 mg once daily	0.1 ml once daily
Week 2 (if adverse effects are acceptable)	2 mg once daily	0.2 ml once daily
Week 3 onwards (if adverse effects are acceptable)	3 mg once daily	0.3 ml once daily

If the adverse effects of the initial dose of 1 mg are not acceptable, it will be reduced to 0.5 mg (0.05 ml). If the adverse effects of the 0.5 mg dose are acceptable, dose escalation will continue.

After the initial dose, if the adverse effects of a subsequent dose are not acceptable, the dose will be reduced to the previous dose level.

If the adverse effects of the reduced dose are acceptable, dose escalation will continue.

If the adverse effects of the 3 mg dose are not acceptable, it will be reduced to 2 mg, and this dose will be maintained.

In children aged 2 to <6 years, the recommended doses are as follows:

Patient weight/treatment week	Daily dose	Volume to be injected
<20 kg
Week 1 onwards	0.5 mg once daily	0.05 ml once daily
20–<30 kg
Weeks 1–2	0.5 mg once daily	0.05 ml once daily
Week 3 onwards (if dose is not sufficient and adverse effects are acceptable)	1 mg once daily	0.1 ml once daily
30–<40 kg
Weeks 1–2	0.5 mg once daily	0.05 ml once daily
Weeks 3–4 (if dose is not sufficient and adverse effects are acceptable)	1 mg once daily	0.1 ml once daily
Week 5 onwards (if dose is not sufficient and adverse effects are acceptable)	1.5 mg once daily	0.15 ml once daily
≥40 kg
Weeks 1–2	0.5 mg once daily	0.05 ml once daily
Weeks 3–4 (if dose is not sufficient and adverse effects are acceptable)	1 mg once daily	0.1 ml once daily
Weeks 5–6 (if dose is not sufficient and adverse effects are acceptable)	1.5 mg once daily	0.15 ml once daily
Weeks 7–8 (if dose is not sufficient and adverse effects are acceptable)	2 mg once daily	0.2 ml once daily
Week 9 onwards (if dose is not sufficient and adverse effects are acceptable)	2.5 mg once daily	0.25 ml once daily

In patients with mild or moderate renal impairment, no adjustment of the dosing regimen is required.

For adults and children aged 16 to 17 years with severe renal impairment, the recommended doses are as follows:

Treatment week	Daily dose in mg	Volume to be injected
Weeks 1 – 2	0.5 mg once daily	0.05 ml once daily
Week 3 onwards (if adverse effects are acceptable)	1 mg once daily	0.1 ml once daily
If the dose is not sufficient and adverse effects are acceptable	2 mg once daily	0.2 ml once daily
If the dose is not sufficient and adverse effects are acceptable	2.5 mg once daily	0.25 ml once daily
If the dose is not sufficient and adverse effects are acceptable	3 mg once daily	0.3 ml once daily

If the adverse effects of the initial 0.5 mg dose are not acceptable, the dose will be reduced to 0.25 mg (0.025 ml). If the adverse effects of the 0.25 mg once-daily dose are acceptable, dose escalation will continue.

If the adverse effects of the 3 mg dose are not acceptable, the dose will be reduced to 2.5 mg, and this dose will be maintained.

In children aged 6 to less than 16 years with severe renal impairment, the recommended doses are as follows:

Treatment week	Daily dose in mg	Volume to be injected
Weeks 1 – 2	0.25 mg once daily	0.025 ml once daily
Weeks 3 – 4 (if adverse effects are acceptable)	0.5 mg once daily	0.05 ml once daily
Week 5 onwards (if adverse effects are acceptable)	1 mg once daily	0.1 ml once daily
If the dose is not sufficient and adverse effects are acceptable	2 mg once daily	0.2 ml once daily

If the adverse effects of the initial dose of 0.25 mg are not acceptable, treatment should be discontinued.

After the initial dose, if the adverse effects of a subsequent dose are not acceptable, the dose should be reduced to the previous dose level.

If the adverse effects at the reduced dose are acceptable, dose escalation may continue.

If the adverse effects of the 2 mg dose are not acceptable, the dose should be reduced to 1 mg, and this dose should be continued.

In children aged 2 to less than 6 years with severe renal impairment, the recommended doses are as follows:

Patient weight/treatment week	Daily dose	Volume to be injected
<20kg
Week 1 onwards	0.25 mg once daily	0.025 ml once daily
20–<30kg
Weeks 1–2	0.25 mg once daily	0.025 ml once daily
Week 3 onwards (if dose is insufficient and adverse effects are acceptable)	0.5 mg once daily	0.05 ml once daily
30–<40kg
Weeks 1–2	0.25 mg once daily	0.025 ml once daily
Weeks 3–4 (if dose is insufficient and adverse effects are acceptable)	0.5 mg once daily	0.05 ml once daily
Week 5 onwards (if dose is insufficient and adverse effects are acceptable)	1 mg once daily	0.1 ml once daily
≥40kg
Weeks 1–2	0.25 mg once daily	0.025 ml once daily
Weeks 3–4 (if dose is insufficient and adverse effects are acceptable)	0.5 mg once daily	0.05 ml once daily
Weeks 5–6 (if dose is insufficient and adverse effects are acceptable)	1 mg once daily	0.1 ml once daily
Week 7 onwards (if dose is insufficient and adverse effects are acceptable)	1.5 mg once daily	0.15 ml once daily

If the adverse effects of the initial dose of 0.25 mg are not acceptable, treatment should be discontinued.

Your doctor should regularly check the effectiveness of the medicine; the doctor may adjust the dose if necessary. In children and adolescents during growth periods, the impact on weight loss and their growth and development should be monitored.

This medicine is intended for long-term use. Interrupting or irregular use may result in the recurrence or worsening of symptoms. Make sure to carefully follow the dosing schedule indicated by your doctor or pharmacist.

How to inject IMCIVREE

IMCIVREE is injected into the fatty layer under the skin of the stomach. Your doctor, pharmacist, or nurse will show you how to do this. Once you feel comfortable administering the injection yourself or giving it to your child, you may do so at home.

IMCIVREE should be injected at the beginning of the day to maximize hunger reduction while you are awake. IMCIVREE may be taken independently of meal times.

Before injecting IMCIVREE, carefully read the following instructions.

Step 1. Prepare for injection

Gather the items you need and place them on a clean, flat surface.

You will need the following items, which are supplied separately:

Clear glass vial with a gray rubber stopper and a small amount of clear liquid at the bottom

Black-and-white technical drawing of a syringe with graduated scale and plunger, positioned diagonally on a white background

Stylized drawing of two overlapping medical wipes with the text TOALLITA CON ALCOHOL in black uppercase letters

White medical gauze square with a fine grid pattern and the black text GASA centered on a white background

Biological waste container with lid and biohazard symbol on a

Wash your hands with soap and hot water.
Open the 2 alcohol wipes and the gauze.

Step 2. Inspect the vial

Check the expiration date on the vial label, shown after the marking «EXP»: MM/YYYY.

Technical drawing of a glass vial with liquid and an enlargement showing the

The liquid should be clear to slightly yellowish.
Do not use IMCIVREE if:
the expiration date has passed
the liquid is cloudy
there are floating particles in the vial
the plastic cap of a new vial is broken or missing
the vial has been stored at temperatures above 30 °C.

Step 3. Prepare the vial

Before use, allow the vial to reach room temperature. To do this, remove the vial from the refrigerator 15 minutes before injection, or gently roll the vial between the palms of your hands for 60 seconds.
Do not use hot water, a microwave, or any other device to warm the vial.
Do not shake the vial.

Two hands holding a small vial with a cap, with gray arrows indicating clockwise and counterclockwise rotation movements

If using a new vial, remove the plastic cap and dispose of it with household waste.

Two hands holding a small glass vial while one hand lifts the protective cap above to

Clean the top of the gray stopper of the vial with an alcohol wipe. Dispose of the used alcohol wipe with household waste.
Do not remove the stopper from the vial.

Technical drawing of a glass vial with liquid and a square ampoule being moved toward the stopper via a curved arrow

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 needle of size 29 to 31 gauge with a length of 6 to 13 mm, suitable for subcutaneous injection.

dose of 0.25 mg = 0.025 ml or 2.5 units

Technical drawing of a syringe with an enlargement of the barrel showing the graduated scale and the plunger positioned at number 5

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 increments and a needle of size 28 to 29 gauge with a length of 6 to 13 mm, suitable for subcutaneous injection.

Dose of 0.5 mg = 0.05 ml	Dose of 1 mg = 0.1 ml

Dose of 2 mg = 0.2 ml	Dose of 3 mg = 0.3 ml

Leave the protective needle cap in place and pull the plunger to fill the syringe with an amount of air equal to the amount of medication to be used.

Technical drawing of a syringe with graduated markings and two gray arrows indicating push and pull movements of the plunger

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 position it directly over the vial. Insert the needle straight down into the center of the gray rubber stopper of the vial.

A hand holding a syringe with needle pointing downward to draw liquid from a glass vial, with an arrow indicating the movement

Push the plunger to inject the air from the syringe into the vial.
Without removing the needle, carefully turn the vial downward.
Make sure the tip of the needle is fully immersed in the liquid medication and not in the air above the liquid.

Hands holding a vial and syringe to draw liquid, with an enlargement showing the

Slowly pull the plunger to fill the syringe with the amount of medication required for your dose. When measuring the dose, make sure to read the units starting from the end closest to the black rubber plunger.
Keep the needle in the vial and check whether large air bubbles have formed in the syringe.

Small air bubbles

Two vertical syringes with graduated scales from 1 to 4 showing liquid levels at

Large air bubbles

If you see air bubbles, you must remove them from the syringe. To remove them:
Gently tap the side of the syringe with your finger to allow the air bubbles to move to the top of the syringe.
Empty the syringe back into the vial.
Repeat the previous steps to fill the syringe again. This time, pull the plunger more slowly and ensure the needle tip remains fully submerged in the liquid in the vial to reduce the likelihood of air bubbles forming.
When 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 the other hand. Pull the needle straight up and out of the vial.

A hand holding a syringe and pushing it toward the

Place the syringe on the hard surface and ensure the needle does not touch the surface.

Do not recap the syringe.

Step 5. Prepare the injection site

Choose an area on the abdomen to administer the injection.
Change the injection site each day.
Ensure the injection site is at least 5 cm away from the navel.
Do not administer the injection into any area that is red, swollen, or irritated.

Medical diagram showing a cross with a central circle and a 5 cm measurement line indicating distance from the center

Clean the selected injection site with the 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. Inject IMCIVREE

Hold the syringe between the thumb and index finger of your writing hand.
With your other hand, gently pinch about 5 cm of skin between your thumb and index finger.

Make sure to keep holding the skin fold until the injection is complete.

Black line drawing showing a hand pressing with fingers on the skin of the abdominal or thigh area for

Hold the center of the syringe at a 90º angle to the skin and push the needle straight into the injection site, ensuring the needle is fully inserted.
Do not hold or push the plunger while inserting the needle.

A hand holding a syringe to inject its contents with the

Holding the barrel of the syringe between your thumb and middle finger, use your index finger to slowly push the plunger and inject the medication.

A hand holding a horizontal syringe injecting liquid into the fatty tissue of the upper thigh of a person

After injecting IMCIVREE, count to 5 to ensure all the medication has been delivered from the syringe.
Release the skin fold and remove the needle.
Use a gauze pad to gently press on the injection site, then discard it with household waste.
Dispose of the used syringe in a dedicated sharps container. Do not dispose of it with household waste.
If there is still medication remaining in the vial, return the vial to its carton and store it in the refrigerator or in a safe place at a temperature below 30 °C until the next dose.

If you use more IMCIVREE than you should

If you or your child use more IMCIVREE than prescribed, contact your doctor.

If you forget to use IMCIVREE

If you forget to inject the medication, skip the missed dose and inject the next dose at the usual time. Do not take a double dose to make up for a missed dose.

If you stop using IMCIVREE

If you stop using this medicine, hunger may return and you may stop losing weight.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

Skin markings or darkened areas
Pain, bruising, or swelling (redness or inflammation) at the injection site
Fatigue
Nausea or vomiting
Headache
Spontaneous penile erections
Increased penile erections
Cutaneous neoplasia

Common (may affect up to 1 in 10 people)

Dry, red, or itchy skin
Rash
Skin lesions
Hair loss
Feeling of weakness
Pain
Dry mouth
Indigestion
Diarrhea
Feeling of constipation
Stomach pain
Heartburn
Dizziness
Female genital discomfort
Sleep problems
Feeling of depression
Disturbance in the sexual arousal process
Increased sexual desire
Eosinophilia, a type of white blood cell
Back pain
Muscle cramps
Cough

Uncommon (may affect up to 1 in 100 people)

Redness of the skin
Lines or spots on the skin
Increased sweating
Abnormal distribution of fat tissue
Itchy rash
Scaly skin
Sensitivity to heat or cold
Chills
Feeling of cold
Feeling of heat
Change in gum color
Abdominal swelling
Increased salivation
Flatulence
Blood tests showing elevated liver enzyme levels
Drowsiness
Migraine
Loss or change in sense of smell
Taste disturbances
Inability in females to achieve or maintain sexual arousal
Genital discomfort or sensitivity
Decreased sexual desire
Female genital disorder
Menstrual pain
Sleep disorder
Nightmares
Flat, pigmented skin mole
Joint pain
Yawning
Runny nose
Pain in muscles or bones
Pain in arms or legs
Blood tests showing elevated muscle enzyme levels
Discoloration of the white part of the eyes
Hot flushes
Dizziness
Appetite disorders
Feeling of thirst

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if these adverse effects are not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of IMCIVREE

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

Do not use this medicine after the expiry date stated on the carton and on the vial. The expiry date refers to the last day of the month indicated.

IMCIVREE should be stored in a refrigerator (between 2 °C and 8 °C) until the expiry date stated on the carton. Alternatively, IMCIVREE may be stored at room temperature not exceeding 30 °C for up to 30 days or until the expiry date, whichever comes first. Keep all vials (including those that have been opened) in the original carton to protect them from light. After first use of a vial, discard it after 28 days.

Do not freeze this medicine.

If IMCIVREE is exposed to temperatures above 30 °C, do not use it and dispose of it according to local guidelines. Do not use this medicine if you notice floating particles or if it appears cloudy.

Always use a new syringe for each injection.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging no longer required. This will help protect the environment.

6. Contents of the container and other information

Composition of IMCIVREE

The active substance is setmelanotide. Each multidose vial contains 10 mg of setmelanotide in 1 ml of solution.

The other components are:

benzyl alcohol (see section 2, "What you need to know before using IMCIVREE")
sodium N-(carbonyl-methoxypolyethylene glycol 2000)-1,2-distearoyl-glycero-3-phosphoethanolamine (mPEG-2000-DSPE)
sodium carmellose (see section 2, "What you need to know before using IMCIVREE")
mannitol
phenol
disodium edetate (see section 2, "What you need to know before using IMCIVREE")
water for injections
hydrochloric acid (to adjust pH)
sodium hydroxide (to adjust pH)

Appearance of the medicine and contents of the pack

IMCIVREE is a solution ranging from clear to slightly coloured.

This medicine is presented in clear glass vials with a stopper and a cap, containing 1 ml of injectable solution.

IMCIVREE is available in packs containing 1 or 10 multidose vials.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Rhythm Pharmaceuticals Netherlands B.V.

Radarweg 29,

1043NX Amsterdam,

The Netherlands

Date of the most recent revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

IMCivree 10 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

1. What IMCIVREE is and what it is used for

2. What you need to know before using IMCIVREE

3. How to use IMCIVREE

4. Possible adverse effects

5. Storage of IMCIVREE

6. Contents of the container and other information