Prospect: Patient Information

IMCIVREE 10 mg/ml injectable solution

setmelanotida

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

IMCIVREE contains the active ingredient setmelanotida. It is used in adults and in children aged 2 years and older to treat obesity caused by certain genetic diseases that affect the way the brain controls hunger sensation.

This medication is used to treat the following genetic diseases:

• Bardet-Biedl syndrome (SBB)
• Obesity due to proopiomelanocortin (POMC) deficiency
• Obesity due to PCSK1 (proprotein convertase subtilisin/kexin type 1) deficiency
• Obesity due to LEPR (leptin receptor) deficiency

People with these diseases lack certain natural substances that are involved in appetite control or these substances do not function correctly. This increases hunger levels and produces obesity. This medication helps to restore appetite control and reduces disease symptoms.

Do not use IMCIVREE

• If you are allergic to setmelanotida or any of the other components of this medication (listed in section 6).

Warnings and precautions

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

Before starting treatment with this medication, and while the treatment is ongoing, your doctor must examine your skin to detect marks or dark areas. While using this medication, it is possible that you may develop more marks or dark spots on your skin. A review before starting treatment will help you identify new marks that may appear once you have used this medication.

It is very common (may affect more than 1 in 10 people) for male patients to experience spontaneous erections of the penis when using this medication. If an erection lasts more than 4 hours, consult a doctor urgently. Prolonged erections (priapism) can reduce your ability to have erections in the future if not treated.

Children

Do not administer this medication to children under 2 years of age, as there is no information available on its use in children under that age.

Other medications and IMCIVREE

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Pregnancy and breastfeeding

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

This medication is not recommended for use in pregnant women or those attempting to become pregnant, as it has not been studied in pregnant women. Weight loss during pregnancy can harm the baby.

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

Driving and operating machinery

This medication should not affect your ability to drive or operate machinery.

IMCIVREE contains benzyl alcohol

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

Benzyl alcohol has been associated with the risk of severe adverse effects in young children (under 3 years of age). There is a higher probability of benzyl alcohol accumulating in your body (known as "metabolic acidosis") and causing "breathing syndrome." Children aged 2 years should be monitored by your doctor to detect this accumulation (manifesting with rapid heartbeats, rapid breathing, or confusion).

Benzyl alcohol can cause allergic reactions.

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

IMCIVREE contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose; that is, it is essentially "sodium-free."

Follow the exact administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Your doctor will advise you on the appropriate dose to be injected.

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

Inadults and children aged 12 years and older, the recommended doses are as follows:

Inchildren aged 6 to <12, the recommended doses are as follows:

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

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, the dose will be continued to be increased.

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

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

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 dose of 0.25 mg once a day are acceptable, the dose will be continued to be increased.

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, the dose will be continued to be increased.

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

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

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 of the reduced dose are acceptable, the dose will be continued to be increased.

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

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

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 of the reduced dose are acceptable, the dose will be continued to be increased.

If the adverse effects of the dose of 1.5 mg are not acceptable, it will be reduced to 1 mg and this dose will be continued to be administered.

Syndrome of Bardet-Biedl

Inadults and children aged 16 years and older, the recommended doses are as follows:

If the adverse effects of the initial dose of 2 mg are not acceptable, it will be reduced to 1 mg (0.1 ml). If the adverse effects of the dose of 1 mg once a day are acceptable, the dose will be continued to be increased.

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, the dose will be continued to be increased.

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

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

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 dose of 0.5 mg are acceptable, the dose will be continued to be increased.

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, the dose will be continued to be increased.

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

Inchildren aged 2 to less than 6 years, the recommended doses are as follows:

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, the dose will be continued to be increased.

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

Foradults 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 a day	0.05 ml once a day
Week 3 and beyond (if the adverse effects are acceptable)	1 mg once a day	0.1 ml once a day
If the dose is not sufficient and the adverse effects are acceptable	2 mg once a day	0.2 ml once a day
If the dose is not sufficient and the adverse effects are acceptable	2.5 mg once a day	0.25 ml once a day
If the dose is not sufficient and 4. Possible Adverse Effects Like all medicines, this medicine may cause side effects, although not everyone will experience them. Very common(may affect more than 1 in 10 people) Dark spots or patches on the skin Pain, bruises, or inflammation (redness or swelling) at the injection site Nausea or vomiting Headache Spontaneous erections Feeling thirsty or drinking more water Common(may affect up to 1 in 10 people) Dryness, redness, or itching of the skin Pain Increased sweating Decolorized areas or patches on the skin Skin lesions Hair loss Fatigue Feeling weak Dry mouth Indigestion Diarrhea Feeling constipated Stomach pain Feeling dizzy Increased erections Difficulty sleeping Feeling depressed Alteration of sexual excitement Increased libido Skin neoplasia Back pain Muscle cramps Pain in arms or legs Hot flashes Dizziness Uncommon(may affect up to 1 in 100 people) Brown spots or freckles on the skin Redness of the skin Rash Lines or spots on the skin Changes in hair color Swelling on the skin Skin inflammation Alterations in nail color or ungual crests Chest pain Sensitivity to heat or cold Itching around the injection site Chills Feeling cold Feeling hot Alteration of gum color Abdominal swelling Increased salivation Flatulence Acid reflux Drowsiness Increased sensitivity of vision, hearing, touch, and smell Migraine Loss or change in sense of smell Disturbances of taste Anxiety Change in mood Sexual dysfunction Inability for women to achieve or maintain sexual excitement Genital discomfort or sensitivity Decreased libido Female genital disorder Depressed mood Sleep disorder Ocular neoplasia Nightmares Flat, colored spots on the skin Joint pain Yawning Coughing Coughing up mucus Pain in chest muscles or bones Decoloration of the white part of the eyes Yellow discoloration of the eyes Reporting of side effects If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a side effect that does not appear in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine. 5. Conservation of IMCIVREE Keep this medication out of the sight and reach of children. Do not use this medication after the expiration date that appears on the box and in the vial. The expiration date is the last day of the month indicated. IMCIVREE must be stored in a refrigerator (between 2 °C and 8 °C) until the expiration date indicated on the box. Alternatively, IMCIVREE can be stored at room temperature, provided it is not higher than 30 °C, for a maximum of 30 days or until the expiration date, whichever occurs first. Store all vials (including those that have been opened) in the original box to protect them from light. After using a vial for the first time, discard it after 28 days. Do not freeze this medication. If IMCIVREE has been exposed to temperatures above 30 °C, do not use it and discard it according to local guidelines. Do not use this medication if you observe floating particles or if it is cloudy. Always use a new syringe for each injection. Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment. 6. Contents of the container and additional information Composition of IMCIVREE The active ingredient is setmelanotida. Each multi-dose vial contains 10 mg of setmelanotida in 1 ml of solution. The other components are: Benzyl alcohol (see section 2, "What you need to know before starting to use IMCIVREE") Sodium N-(carboxymethoxypolyethylene glycol 2000)-1,2-distearoyl-glycerol-3-phosphoethanolamine (mPEG-2000-DSPE) Sodium caramelize (see section 2, "What you need to know before starting to use IMCIVREE") Manitol Phenol Disodium edetate (see section 2, "What you need to know before starting to use IMCIVREE") Water for injection Hydrochloric acid (to adjust the pH) Sodium hydroxide (to adjust the pH) Appearance of the product and contents of the container IMCIVREE is a transparent to slightly colored solution. This medicine is presented in transparent glass vials with a stopper and a cap containing 1 ml of injectable solution. IMCIVREE is available in containers that contain 1 or 10 multi-dose vials. Only some container sizes may be marketed. Marketing authorization holder Rhythm Pharmaceuticals Netherlands B.V. Radarweg 29, 1043NX Amsterdam, Netherlands Responsible for manufacturing Recipharm Monts S.A.S. 18 Rue De Montbazon Monts 37260 FRANCE Last review date of this leaflet: Other sources of information The detailed information on this medicine is available on the European Medicines Agency website:http://www.ema.europa.eu. Страна регистрации Spain Активное вещество Setmelanotida Требуется рецепт Да Производитель Rhythm Pharmaceuticals Netherlands B.V. Состав Manitol (e-421) (11 mg mg), Carmelosa sodica (8 mg mg), Alcohol bencilico (10 mg mg), Edetato de disodio (1 mg mg), Hidroxido de sodio (e 524) (q.s. mg mg) Информация носит справочный характер и не является медицинской рекомендацией. Перед приёмом любых препаратов проконсультируйтесь с врачом. Oladoctor не несёт ответственности за медицинские решения, принятые на основе этого контента. Общайтесь с врачом онлайн Есть вопросы по этому лекарству или вашим симптомам? Свяжитесь с лицензированным врачом для получения помощи и персонализированного ухода. 5.01 отзыв Anna Moret Dermatology18 лет опыта Dr. Anna Moret is a board-certified dermatologist and dermatovenereologist. She specialises in adult and pediatric dermatology, venereology, aesthetic skin care, and general medicine. Her consultations are evidence-based and tailored to each patient’s dermatological needs. Dr. Moret provides expert evaluation and treatment for: • Skin conditions such as eczema, acne, rosacea, dermatitis, and psoriasis • Hair and scalp issues including hair loss, dandruff, and seborrheic dermatitis • Pediatric skin problems — from newborns to adolescents • Sexually transmitted infections (STIs) and dermatovenereology • Aesthetic concerns: skin ageing, non-invasive cosmetic treatments • Skin allergies and hypersensitivity reactions • Mole checks, lesion evaluation, and skin cancer screening • Skincare advice and personalised cosmeceutical routines Combining dermatology with general medical knowledge, Dr. Moret offers comprehensive care that addresses both skin health and underlying conditions. She also holds certification from the Canadian Board of Aesthetic Medicine, ensuring an internationally aligned approach to aesthetic dermatology. 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