Why is this medication prescribed?

Imcivree (setmelanotide) is a prescription medication that is used to treat certain rare genetic disorders associated with obesity and extreme hunger. It is specifically indicated for the treatment of:

• Pro-opiomelanocortin (POMC) deficiency: POMC deficiency is a rare genetic disorder characterized by disruptions in the production of various hormones, including melanocortins. This condition can lead to severe early-onset obesity, insatiable hunger, and adrenal insufficiency. Imcivree is prescribed to help regulate appetite and reduce excessive hunger in individuals with POMC deficiency.
• Proprotein convertase subtilisin/kexin type 1 (PCSK1) deficiency: PCSK1 deficiency is another rare genetic disorder that affects the production of certain hormones involved in appetite regulation. This condition can cause severe obesity, extreme hunger, and impaired satiety. Imcivree is used to help control appetite and reduce hunger in individuals with PCSK1 deficiency.

How should this medicine be used?

Imcivree (setmelanotide) is available as a subcutaneous injection and should be administered under the guidance of a healthcare professional. Here are the general guidelines for the use of Imcivree:

• Dosage: The dosage of Imcivree is determined by the healthcare provider based on the individual’s weight and specific genetic disorder. The medication is usually started at a low dose and gradually increased as needed.
• Administration: Imcivree is self-administered as a subcutaneous injection. The healthcare provider will provide detailed instructions on how to prepare and administer the medication. It is important to follow the instructions carefully.
• Injection Sites: Imcivree injections are typically administered in the abdomen (stomach area) or thigh. The injection site should be rotated to avoid injecting into the same spot repeatedly. This helps to reduce the risk of injection site reactions.
• Injection Frequency: The frequency of Imcivree injections will be determined by the healthcare provider. In general, it is administered once daily. It is important to adhere to the prescribed dosing schedule and not miss any doses.
• Monitoring and Adjustments: Regular monitoring of weight, appetite, and potential side effects is essential while using Imcivree. The healthcare provider will evaluate the individual’s response to the medication and may adjust the dosage if needed.
• Additional Recommendations: It is important to store Imcivree as per the instructions provided by the manufacturer. If any questions or concerns arise regarding the administration or usage of Imcivree, it is best to consult with the prescribing healthcare professional.

Please note that these are general guidelines, and specific instructions may vary depending on the individual’s condition. It is important to closely follow the instructions provided by the healthcare provider and seek clarification if any doubts arise.

Other uses for this medicine

Ilaris (canakinumab) is primarily approved for the treatment of cryopyrin-associated periodic syndromes (CAPS), systemic juvenile idiopathic arthritis (SJIA), and tumor necrosis factor receptor-associated periodic syndrome (TRAPS). However, there may be off-label or investigational uses of Ilaris that are not officially approved but are prescribed by healthcare providers based on their clinical judgment and available evidence.

What special precautions should I follow?

Regarding special precautions for Imcivree, it’s essential to follow the guidance provided by the prescribing healthcare professional and carefully read the medication’s prescribing information. Some general precautions associated with Imcivree include:

• Age and Weight Requirements: Imcivree is approved for use in patients aged 6 years and older who have specific genetic mutations associated with obesity. The appropriate dosage and usage should be determined by a healthcare professional based on the individual patient’s needs.
• Monitoring and Regular Follow-up: Regular monitoring of body weight, appetite, and height is typically recommended while using Imcivree. Healthcare professionals may also conduct laboratory tests to assess any potential side effects or monitor specific parameters related to the underlying genetic disorder being treated.
• Hypothalamic Dysfunction: Imcivree works by targeting the melanocortin-4 receptor pathway in the hypothalamus. Therefore, it is crucial to use Imcivree cautiously in patients with significant hypothalamic dysfunction or a history of severe headaches, seizures, or other symptoms related to the central nervous system.
• Hypersensitivity Reactions: Some individuals may experience hypersensitivity reactions to Imcivree. If any signs of allergic reactions, such as rash, itching, or swelling, occur, it is important to seek immediate medical attention.
• Pregnancy and Breastfeeding: The safety and effectiveness of Imcivree during pregnancy and breastfeeding have not been established. It is essential to discuss the potential risks and benefits with a healthcare professional if you are pregnant, planning to become pregnant, or breastfeeding.

These precautions are not exhaustive, and it’s crucial to consult with a healthcare professional or refer to the medication’s prescribing information for comprehensive and up-to-date guidance specific to your situation.

What special dietary instructions should I follow?

Regarding dietary instructions, Imcivree is usually prescribed along with a comprehensive weight management program that includes dietary modifications. The specific dietary instructions may vary depending on the individual and the underlying condition being treated. Your healthcare provider or a registered dietitian will provide detailed guidance on the appropriate diet and nutritional considerations while taking Imcivree.

What should I do if I forget a dose?

Regarding missed doses of Imcivree, it is generally recommended to take the missed dose as soon as you remember. However, if it is close to the time for your next scheduled dose, it’s best to skip the missed dose and continue with your regular dosing schedule. It’s important not to take a double dose to make up for a missed one.

What side effects can this medication cause?

Imcivree (setmelanotide) is a medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of certain rare genetic disorders associated with obesity. Like any medication, Imcivree can cause side effects. The following are some potential side effects that have been reported in clinical trials or post-marketing surveillance:

• Injection site reactions: Imcivree is administered via subcutaneous injection, and injection site reactions such as redness, swelling, pain, or itching may occur.
• Skin darkening or hyperpigmentation: Imcivree can cause changes in skin pigmentation, resulting in areas of increased darkness or hyperpigmentation.
• Nausea: Nausea is a common side effect of Imcivree treatment. This may include feelings of discomfort or the urge to vomit.
• Vomiting: Some individuals may experience episodes of vomiting as a side effect of Imcivree treatment.
• Diarrhea: Imcivree can cause diarrhea, which may be mild to moderate in severity.
• Upper respiratory tract infection: In clinical trials, upper respiratory tract infections, such as the common cold, were reported as side effects.
• Headache: Headaches, including migraines, have been reported in individuals taking Imcivree.
• Decreased appetite: Imcivree works by targeting pathways involved in appetite regulation. As a result, some individuals may experience a decrease in appetite as a side effect.

It’s important to note that not everyone will experience these side effects, and the severity and frequency of side effects may vary from person to person. If you are considering Imcivree treatment or have been prescribed the medication, it is crucial to consult your healthcare provider for more specific information and guidance tailored to your individual situation.

What should I know about storage and disposal of this medication?

Storage:

• Keep Imcivree refrigerated between 2°C to 8°C (36°F to 46°F).
• Protect the medication from light by storing it in the original packaging.
• Do not freeze Imcivree.
• If traveling, you may store Imcivree at room temperature (up to 25°C or 77°F) for a single period of up to 30 days. After that, discard any unused medication.
• Keep Imcivree out of reach of children and pets.

Disposal:

• Dispose of unused or expired Imcivree properly.
• Follow local regulations or guidelines for medication disposal in your area.
• Do not dispose of Imcivree in household trash or flush it down the toilet unless specifically instructed to do so.

In case of emergency/overdose

If you believe you or someone else has taken too much Imcivree or is experiencing severe side effects, it’s important to take the following steps:

• Contact emergency medical services or go to the nearest emergency room immediately.
• Inform the healthcare professionals about the medication taken, including the name (Imcivree) and dosage.
• If possible, bring the medication packaging or any remaining Imcivree with you to the healthcare facility.

What other information should I know?

• Before starting Imcivree, inform your healthcare provider about any medical conditions you have, including allergies, as well as any other medications or supplements you are taking.
• Attend all scheduled appointments with your healthcare provider to monitor your progress and discuss any concerns or side effects.
• It’s essential to follow the dosing instructions provided by your healthcare provider and not to exceed the prescribed dose.
• If you miss a dose, contact your healthcare provider for guidance on how to proceed.
• Inform any other healthcare professionals involved in your care that you are taking Imcivree.

Remember, the information provided here is a general guideline, and it’s important to consult your healthcare provider or pharmacist for specific instructions and advice regarding storage, disposal, and emergency procedures related to Imcivree.