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Imcivree
Used for Weight loss
Used for Weight loss
Imcivree (setmelanotide) is an injectable medication for adults and children with certain rare conditions. It's FDA approved for acquired hypothalamic obesity (HO). It's also approved to help with obesity caused by some genetic conditions. These are Bardet-Biedl syndrome (BBS) and POMC, PCSK1, or LEPR deficiency. The medication works as a melanocortin agonist. It lessens appetite and makes the body use more energy, leading to weight loss. It's injected under the skin once a day. Side effects include darkening of skin color and nausea. More serious risks include depression and suicidal thoughts.
What is Imcivree (setmelanotide)?
What is Imcivree (setmelanotide) used for?
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Weight loss and long-term weight management in people ages 4 years and older with obesity due to damage to the hypothalamus (acquired hypothalamic obesity, HO)
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Weight loss and long-term weight management in people ages 2 years and older with obesity due to certain genetic conditions:
How Imcivree (setmelanotide) works
Imcivree (setmelanotide) is a melanocortin agonist. It attaches to melanocortin-4 receptors in the brain that help regulate appetite. This lowers your appetite and also helps your body use up more energy.
By lowering appetite and helping your body use more energy, Imcivree (setmelanotide) can promote weight loss.
When does Imcivree (setmelanotide) start working?Time passed since treatment started:
Drug facts
| Common Brands | Imcivree |
|---|---|
| Drug Class | Melanocortin agonist |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Prescription only |
Side effects of Imcivree (setmelanotide)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Darkening or discoloration of the skin (58%)
- Nausea (55%)
- Vomiting (38%)
- Headache (37%)
- Moles (new, larger, or darker ones; 15%)
- Constipation (12%)
- Dizziness (12%)
- Mouth or throat pain (11%)
Less Common Side Effects
- Other stomach upset
- Unplanned erections or more frequent erections
- Adrenal insufficiency
- Ear infection
- Injection site reaction (e.g., redness, itchiness, swelling, pain, bruising)
Note: Side effects were from people 4 years and older with acquired HO. Side effects might differ for those with BBS, or POMC, PCSK1, or LEPR deficiency.
Imcivree (setmelanotide) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Depression: feeling sad or hopeless, feeling less interested than usual in activities that you typically enjoy, low energy
- Suicidal thoughts and behavior
- Problems with sexual function: unexpected erections, erections lasting longer than 4 hours, unwanted sexual arousal
- Serious allergic reaction: trouble breathing; trouble swallowing; fast heartbeat; swelling of your face, lips, tongue, or throat
When do Imcivree (setmelanotide) possible side effects begin and end?
Time passed since treatment started:
H
D
W
M
Injection site reactions
Nausea or vomiting
Darker skin
Risk of depression
Risk of suicidal thoughts
Seek immediate medical care if you experience this side effect.
If a line continues to the right, you'll likely keep experiencing this side effect once it starts.
The following Imcivree (setmelanotide) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- High sodium level—confusion, increased thirst, muscle weakness, unusual weakness or fatigue, twitching muscles
- Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
- Low sodium level—muscle weakness, fatigue, dizziness, headache, confusion
- Prolonged or painful erection
- Thoughts of suicide or self-harm, worsening mood, feelings of depression
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
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Pros and cons of Imcivree (setmelanotide)
Pros
- First treatment of its kind for obesity caused by rare genetic conditions (POMC, PCSK1, or LEPR deficiency, and BBS)
- First FDA-approved medication for obesity caused by problems with the hypothalamus
- Approved for young children of certain ages
Cons
- Must give as an injection under the skin
- Often causes nausea and vomiting
- Has a risk of depression or unusual changes in mood, behavior, and thoughts
Pharmacist tips for Imcivree (setmelanotide)
- The care team will train you or a caregiver on how to prepare and inject Imcivree (setmelanotide). They'll make sure you can do it on your own. Review the Instructions For Use to draw up your dose into a syringe and inject the medication. Ask your care team if you have questions about how to prepare and inject the medication.
- Inject Imcivree (setmelanotide) once a day in the morning when you first wake up, with or without food. You can use a journal to keep track of your injections and the injection sites you use.
- Use a 1-mL syringe with a 28-gauge or 29-gauge needle for your Imcivree (setmelanotide) injections. Your care team or pharmacy should provide you these supplies. Ask them if you're not sure about which syringes and needle size to use.
- How to store unopened vials of Imcivree (setmelanotide): Store unopened vials in the refrigerator in their original box. You can also keep them at room temperature (up to 77ºF) for up to 30 days or until they expire, whichever comes first. Throw away any vials kept at room temperature for more than 30 days or that are past their expiration date, even if they still have medication in them.
- How to store opened vials of Imcivree (setmelanotide): You can keep opened vials either in the refrigerator or at room temperature (up to 77ºF). Opened vials are only good for 30 days or until their expiration date, no matter where you keep them. Throw away any vials that have been open for more than 30 days or have expired, even if they have medication left in them.
- Before you use Imcivree (setmelanotide) for each injection: Take the vial out of the refrigerator 15 minutes before your injection so it can warm to room temperature. You can gently roll it between your hands for a minute. But don't use heat sources like a microwave or hot water. Check that the liquid is clear to slightly pearly and colorless to slightly yellow. Don't use if it's discolored or has particles in it.
- How to draw up your Imcivree (setmelanotide) dose and how to inject: Follow your care team's instructions for drawing up your dose with the right syringes and needles. This helps you prepare and inject the medication safely. Your prescriber will tell you how much to draw up and the steps to follow. Ask if you're not sure about anything.
- Where to inject Imcivree (setmelanotide): Inject the medication under the skin of the front of the middle of your thighs or your stomach (at least 2 inches from your belly button). You can also inject it into the back of your upper arm with someone's help. Use a different spot each day, at least 1 inch from the last injection. Avoid injecting into your belly button, ribs, hip bones, scars, or moles. Also don't inject into red, swollen, or irritated skin. This helps prevent skin irritation.
- After each Imcivree (setmelanotide) injection: Throw away used syringes and needles in an FDA-cleared sharps container right away. You can also use a heavy-duty plastic container with tight-fitting lid like an empty laundry detergent bottle. Label the container so people know there's hazardous waste inside. Don't throw away syringes or needles in your household trash. These tips help keep you and others safe from needle sticks.
Risks and warnings for Imcivree (setmelanotide)
Imcivree (setmelanotide) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Problems with sexual function
Some people taking Imcivree (setmelanotide) have had sexual problems. They've included unexpected erections in males and unwanted sexual arousal in females. If this happens and it bothers or worries you, talk to your prescriber.
Get medical help right away if you have an erection that lasts longer than 4 hours because this could cause permanent damage.
Depression and suicidal thoughts
- Risk factors: History of depression | History of having suicidal thoughts
Imcivree (setmelanotide) can cause depression or suicidal thoughts and behavior. Be sure you, your family, and your friends know to watch for any new or worsening signs of depression. Also watch for unusual mood changes or behavior. If this happens, let your prescriber know as soon as possible. If you start to think about hurting yourself, call 911 right away. You might need to stop taking Imcivree (setmelanotide).
Allergic reactions
Although rare, some people have had a serious allergic reaction to Imcivree (setmelanotide). This can include anaphylaxis. Reactions can happen within minutes to hours after an injection.
Get medical help right away if you have any signs of an allergic reaction after using Imcivree (setmelanotide). Watch for trouble breathing, throat tightness, or swelling of your face or tongue.
Darkening of your skin or moles and appearance of new moles
Imcivree (setmelanotide) can cause your skin or moles to darken. This usually goes away after you stop taking the medication. Other effects can include new moles that show up or moles that get bigger in size.
Your care team will do a skin examination of your whole body before you start Imcivree (setmelanotide). They'll also check your skin periodically during treatment. These examinations help look out for any new skin spots.
Adrenal insufficiency in people with acquired HO
In studies, some people with acquired HO had serious symptoms of adrenal insufficiency while taking Imcivree (setmelanotide). This means your adrenal glands can't make enough hormones. This includes cortisol, which is your body's stress hormone.
Watch for symptoms of adrenal insufficiency while taking this medication. Tell your care team if you feel very tired, weak, dizzy, or generally unwell.
Abnormal sodium levels in people with acquired HO and central diabetes insipidus
In studies, some people with acquired HO who took Imcivree (setmelanotide) had changes in their sodiumm levels. Some had low sodium, and others had high sodium. This happened in people who also had a condition that affect water balance called central diabetes insipidus (DI).
If you have this condition and acquired HO, your care team will check your sodium levels with blood tests. They'll check especially if your fluid intake changes or if you become dehydrated.
Tell your care team if you have symptoms of abnormal sodium levels while taking Imcivree (setmelanotide). This can include nausea, fatigue, dizziness, muscle weakness or cramps, headaches, or thirst.
Imcivree (setmelanotide) dosage
The average cost for 9 vials of 1ml of 10mg/ml of Imcivree (setmelanotide) is $32,719.81 with a free GoodRx coupon. This is 6.60% off the average retail price of $35,031.68. 
Vial
Vial| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 1ml of 10mg/ml | 9 vials | $32,719.81 | $3,635.53 |
Typical dosage for Imcivree (setmelanotide)
You'll typically start at a low dose for 2 weeks. Then, your prescriber will raise the dose to a maintenance dose. They'll adjust it based on how well it's working and if you have bothersome or serious side effects.
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Acquired hypothalamic obesity (HO)
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Adults and children 6 years and older
- Weeks 1 to 2: The typical dose is 0.5 mg (0.05 mL) injected under the skin once a day.
- Weeks 3 to 4: The typical dose is 1 mg (0.1 mL) injected under the skin once a day.
- Weeks 5 to 6: The typical dose is 2 mg (0.2 mL) injected under the skin once a day.
- Week 7 and beyond: The typical dose is 3 mg (0.3 mL) injected under the skin once a day.
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Children 4 to under 6 years old
- Weeks 1 to 2: The typical dose is 0.5 mg (0.05 mL) injected under the skin once a day.
- Week 3 and beyond: Depending on your child's body weight, the prescriber might raise the dose every 2 weeks to a maintenance dose. They'll tell you how much to give. The dose is injected under the skin once a day.
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BBS or POMC, PCSK1, or LEPR deficiency
- Adults and children 12 years and older
- Starting dose: The typical dose is 2 mg (0.2 mL) injected under the skin once a day for 2 weeks.
- Maintenance dose: The typical dose is 3 mg (0.3 mL) injected under the skin once a day.
- Children 6 to under 12 years old
- Starting dose: The typical dose is 1 mg (0.1 mL) injected under the skin once a day for 2 weeks.
- Maintenance dose: The typical dose is 3 mg (0.3 mL) injected under the skin once a day. - Children 2 to under 6 years old
- Starting dose: The typical dose is 0.5 mg (0.05 mL) injected under the skin once a day for 2 weeks.
- Maintenance dose: Depending on your child's body weight, the prescriber might raise the dose every 2 weeks to a maintenance dose. They'll tell you how much to give. The dose is injected under the skin once a day.
- Adults and children 12 years and older
Your dose might differ if you have kidney problems.
How much does Imcivree (setmelanotide) cost?
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Imcivree (brand)
$32,719.81
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