6 mins read

Overview: Imcivree is an injection given under your skin used to promote and maintain weight loss in people with obesity caused by certain conditions. It helps people lose weight by decreasing the amount of food eaten and increasing the amount of energy used by the body. Common side effects include skin darkening and pain, itching, or redness where this medicine is given. Contact your health care provider right away if you have new or worsening depression or thoughts of suicide. Get emergency help if you get an erection that lasts longer than four hours, trouble breathing, or swelling of your face, lips, tongue, or throat.

Uses

What is Imcivree used for?

Imcivree (setmelanotide) is commonly used to help lose weight and maintain weight loss in certain people with obesity caused by the following conditions.

  • Bardet-Biedl syndrome (BBS)
  • Low levels of pro-opiomelanocortin (POMC) , proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR)

Imcivree may also be used for other conditions as determined by your health care provider.

How does Imcivree work (mechanism of action)?

Imcivree activates a specific receptor in the body called the melanocortin 4 (MC4) receptor, which is thought to decrease hunger and promote weight loss by decreasing the amount of calories eaten and increasing the amount of energy used by the body. This medicine is only for certain people with conditions where the MC4 receptor is not activated enough. You will likely have a genetic test to confirm that you may benefit from this medicine.

How is Imcivree supplied (dosage forms)?

Brands and other names

  • Imcivree

Dosage forms and strengths

  • 10 mg/mL multiple-dose vial

How should I store Imcivree?

Unopened Imcivree should be stored in the original carton in the refrigerator, between 36 F and 46 F (2 C and 8 C). Unopened Imcivree may also be stored for up to 30 days at room temperature, between 36 F and 77 F (2 C and 25 C). It can be exposed to temperatures up to 86 F (30 C) for shorter periods of time, such as when transporting it. 

Throw away Imcivree 30 days after it is punctured, opened, or first removed from the refrigerator.

Side Effects

What are the most common side effects of Imcivree?

The most common side effects of Imcivree are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Skin changes (see below)
  • Pain, itching, swelling, or redness near the injection site
  • Stomach pain, nausea, or vomiting
  • Headache
  • Diarrhea
  • Depression
  • Changes in sexual arousal (see below)

There may be other side effects of Imcivree that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Imcivree?

While less common, the most serious side effects of Imcivree are described below, along with what to do if they happen.

Severe Allergic Reactions. Imcivree may cause allergic reactions, which can be serious. Stop using Imcivree and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Changes in Sexual Arousal. Imcivree can cause penile erections (priapism) that happen without any sexual activity in men and changes in sexual arousal that happen without any sexual activity in women. Permanent damage to the penis may occur if priapism is not treated quickly. Stop using Imcivree and get emergency help if you have any of the following symptoms of priapism. 

  • Erection lasting for more than four hours 
  • Erection that is unrelated to sexual stimulation
  • Painful or tender penis 

Depression and Suicidal Thoughts or Actions. Imcivree may cause depression, suicidal thoughts, or suicidal actions in a small number of people. If you are about to harm yourself, call 911 or call or text 988, the Suicide & Crisis Lifeline. Call your health care provider right away if you have any of the following symptoms.

  • New or increased thoughts of suicide or death
  • Suicide attempt
  • New or increased feelings of anxiety, depression, or other unusual changes in mood or behavior

Skin Changes. Imcivree can cause skin hyperpigmentation, darkening of moles you already have, or growth of new moles due to how the medicine works in the body. These skin changes will go away after you stop using the medicine. Your health care provider may perform a full body exam before and during your treatment with Imcivree to check for skin changes. Keep all appointments with your health care provider and report any skin changes right away.

Warnings & Precautions

Who should not use Imcivree?

Allergies to Ingredients. People who are allergic to any of the following should not use Imcivree.

  • Imcivree
  • Setmelanotide
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Imcivree.

What should I know about Imcivree before using it?

Do not use Imcivree unless it has been prescribed to you by a health care provider. Use it as prescribed. 

Do not share Imcivree with other people, even if they have the same condition as you. It may harm them.

Keep Imcivree out of the reach of children. If this medicine is kept in a refrigerator, take special precautions to keep it away from children who also use the refrigerator.

Imcivree is an injection given under the skin of the belly, upper arm, or thigh. Imcivree should not be injected into painful, damaged, or infected areas of skin. Make sure that you or a caregiver understands how to properly prepare and use Imcivree. Read the “Instructions for Use” that comes with your medicine. If you have any questions, talk to your health care provider.

What should I tell my health care provider before using Imcivree?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Imcivree is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Mental health problems, such as depression, suicidal thoughts, or suicidal behaviors
  • Areas of skin that are darkened or discolored
  • Kidney problems

Pregnancy. It is not known if or how Imcivree could affect pregnancy or harm an unborn baby. However, weight loss during pregnancy may harm an unborn baby. Tell your health care provider if you are pregnant, think you may be pregnant, or plan to become pregnant.

Breastfeeding. Do not breastfeed while using Imcivree. It is not known if Imcivree passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. 

How can I get more information about Imcivree?

For more information about Imcivree, you can visit the drugmaker’s website at www.imcivree.com or call them at 857-264-4280.

Interactions

Does Imcivree interact with foods or drinks?

There are no known interactions between Imcivree and foods or drinks.

There are no known interactions between Imcivree and alcohol.

Does Imcivree interact with other medicines (drug interactions)?

There are no known interactions between Imcivree and other medicines. Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Imcivree?

If you or someone else has used too much Imcivree, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Imcivree?

If you miss a dose of Imcivree, use your next dose at the regularly scheduled time the next day. Do not use double or extra doses.