Patient information: uses, side effects, how to take - Imcivree

What is IMCIVREE?

IMCIVREE is a prescription medicine used in adults and children:
- 4 years of age and older with acquired hypothalamic obesity (HO) to help them lose weight and keep the weight off.
- 2 years of age and older with obesity due to Bardet-Biedl syndrome (BBS) to help them lose weight and keep the weight off.
- 2 years of age and older with obesity due to the genetic conditions proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency, to help them lose weight and keep the weight off.
Your healthcare provider should order a genetic test to confirm POMC, PCSK1, or LEPR deficiency before you start using IMCIVREE.
IMCIVREE is not for use in people with the following conditions because it may not work:
- Obesity due to suspected POMC, PCSK1, or LEPR deficiency not confirmed by genetic testing or with benign or likely benign genetic testing results.
- Other types of obesity not related to acquired HO, BBS, or POMC, PCSK1, or LEPR deficiency, including obesity associated with other genetic conditions and general obesity.

It is not known if IMCIVREE is safe and effective in children under 2 years of age.

Do not use IMCIVREE if you have had a serious allergic reaction to setmelanotide or any of the ingredients in IMCIVREE. Serious allergic reactions, including a severe allergic reaction called anaphylaxis, can happen when you use IMCIVREE. See the end of this Patient Information leaflet for a complete list of ingredients in IMCIVREE.

Before using IMCIVREE, tell your healthcare provider about all your medical conditions, including if you:

have or have had areas of darkened skin, including skin discoloration (hyperpigmentation).
have or have had depression, or suicidal thoughts or behavior.
have had a prior allergic reaction to setmelanotide or any of the ingredients in IMCIVREE.
have kidney problems.
have adrenal insufficiency.
have diabetes insipidus.
are pregnant or planning to become pregnant. Losing weight while pregnant may harm your unborn baby. Your healthcare provider may stop your treatment with IMCIVREE if you become pregnant. Tell your healthcare provider if you become pregnant or think you might be pregnant during treatment with IMCIVREE.
are breastfeeding or plan to breastfeed. It is not known if IMCIVREE passes into your breastmilk. You should not breastfeed during treatment with IMCIVREE.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use IMCIVREE?

See the detailed Instructions for Use to learn how to prepare and inject IMCIVREE.
IMCIVREE is given as an injection under your skin (subcutaneous) by you or a caregiver.
A healthcare provider should show you or your caregiver how to prepare and inject your dose of IMCIVREE before injecting for the first time. Do not try to inject IMCIVREE unless you have been trained by a healthcare provider.
Use IMCIVREE exactly as prescribed by your healthcare provider.
IMCIVREE should be injected 1 time each day when you first wake up. IMCIVREE can be given with or without food.
If you miss a dose of IMCIVREE, inject your next dose at the regularly scheduled time the next day.

What are the possible side effects of IMCIVREE?

IMCIVREE may cause serious side effects, including:

Male and female sexual function problems. IMCIVREE can cause an erection that happens without any sexual activity in males (spontaneous penile erection) and unwanted sexual reactions (changes in sexual arousal that happen without any sexual activity) in females. If you have an erection lasting longer than 4 hours, get emergency medical help right away.
Depression and suicidal thoughts or actions. You or a caregiver should call your healthcare provider right away if you have any new or worsening symptoms of depression, suicidal thoughts or behaviors, or any unusual changes in mood or behavior.
Serious allergic reactions. Stop taking IMCIVREE and get medical help right away if you have any symptoms of a serious allergic reaction including:
- swelling of your face, lips, tongue or throat
- problems breathing or swallowing
- severe rash or itching
- fainting or feeling dizzy
- rapid heartbeat
Increased skin pigmentation, darkening of skin lesions (moles or nevi) you already have, and development of new skin lesions. These changes happen because of how IMCIVREE works in the body and will go away when you stop using IMCIVREE. You should have a full body skin exam before starting and during treatment with IMCIVREE to check for skin changes.
Adrenal insufficiency. If you have acquired HO and adrenal insufficiency, your healthcare provider should evaluate your adrenal function before starting IMCIVREE. You or your caregiver should call your healthcare provider if you have changes in feeling tired or exhausted (fatigue), lack of energy (lethargy), mental status, or dizziness, or fever, or signs of infection during treatment with IMCIVREE. Your healthcare provider should monitor and adjust any medicines that may be affected during treatment.
Low sodium levels in the blood. If you have acquired HO and diabetes insipidus, you or your caregiver should watch for signs of dehydration. You or your caregiver should contact your healthcare provider if you have changes in fluid intake or urine output, confusion, lethargy, or nausea and vomiting during treatment with IMCIVREE. Your healthcare provider should closely monitor sodium levels in your blood and adjust your other medicines if needed.

The most common side effects of IMCIVREE include:

darkening of the skin
injection site reactions
nausea
headache
diarrhea
stomach pain
vomiting
depression
erection that happens without any sexual activity in males

These are not all the possible side effects of IMCIVREE.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Rhythm Pharmaceuticals at 1-833-789-6337.

General information about the safe and effective use of IMCIVREE.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaﬂet. Do not use IMCIVREE for a condition for which it was not prescribed. Do not give IMCIVREE to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about IMCIVREE that is written for health professionals.

What are the ingredients in IMCIVREE?

Active ingredient: setmelanotide

Inactive ingredients: benzyl alcohol, carboxymethylcellulose sodium, edetate disodium dihydrate, N-(carbonyl-methoxypolyethylene glycol 2000)-1, 2-distearoyl- glycero-3-phosphoethanolamine sodium salt, mannitol, phenol, hydrochloric acid, sodium hydroxide and water for injection.

INSTRUCTIONS FOR USE

IMCIVREE™ [im-SIV-ree]

(setmelanotide)

injection, for subcutaneous use

This Instructions for Use contains information on how to inject IMCIVREE. Read and follow these instructions before injecting IMCIVREE.

Important Information You Need to Know Before Injecting IMCIVREE

IMCIVREE is for injection under the skin only (subcutaneous injection). Do not inject IMCIVREE into a vein or muscle.
The IMCIVREE vial may be used to give more than 1 dose of medicine (multiple-dose vial) but is for single patient use only and should not be shared with other patients.
Inject IMCIVREE 1 time each day when you first wake up.
Take IMCIVREE with or without food.
IMCIVREE is given by you or a caregiver. A healthcare provider will show you or your caregiver how to inject your dose of IMCIVREE before you inject for the first time. Ask your healthcare provider or call IMCIVREE Guidance, Partnership, Support (GPS) at 1-844-YOUR-GPS (1-844-968-7477) if you have questions.

Important note:

Only use the syringes and needles provided to you for use with IMCIVREE.
Always use a new syringe and needle for each injection to prevent contamination.
Throw away used syringes and needles in a puncture-resistant, disposable sharps container as soon as you finish giving the injection. See “Disposing of IMCIVREE” at the end of these instructions.
Do not reuse or share your needles with other people.
Do not recap the needle. Recapping the needle can lead to a needle stick injury.

Understanding Your IMCIVREE Dose

Calculate the number of doses of IMCIVREE in each vial:

Each unopened IMCIVREE vial contains 10 milligrams (mg) of medicine in 1 milliliter (mL) of solution.
The vial will contain both medicine and air. Most of the vial will be filled with air.
Your healthcare provider will determine your dose of medicine in milligrams (mg).
The IMCIVREE vial may be used to give more than 1 dose of medicine (multiple-dose vial).
Use Figure A to see how many times you may use each vial based on your prescribed dose.
Do not use more doses from a single vial than listed in Figure A

Preparing to Inject IMCIVREE

Step 1 Gather your supplies.

Gather the supplies you will need for your injection ( Figure B ).
Place your supplies on a clean, flat work surface.

Step 2 Check your IMCIVREE vial.
	Check the expiration (Exp) date on the vial label ( Figure C ). Check the liquid. The liquid should look clear to almost clear and colorless to slightly yellow. The liquid should be free of particles. Do not use if: The expiration (Exp) date has passed. The liquid is cloudy. There are particles floating in the vial. The plastic cap on a new vial is broken or missing.
Step 3 Prepare your IMCIVREE vial.
	Allow the vial to reach room temperature. Remove the vial from the refrigerator 15 minutes before injection. You can also warm the vial by rolling it gently between the palms of your hands for 60 seconds ( Figure D ). Do not try to warm the vial by using a heat source such as hot water or a microwave. Do not shake the vial. Wash your hands with soap and warm water.
	If using a new vial, remove the plastic cap ( Figure E ) and throw away this plastic cap in the trash. Do not put the plastic cap back on the vial.
	Clean the top of the vial rubber stopper with 1 alcohol wipe ( Figure F ). Throw away the alcohol wipe in the trash. Do not remove the vial rubber stopper.
Step 4 Prepare the syringe. When measuring your dose, be sure to read the markings starting from the end closest to the black rubber stopper ( Figure G ).
	Fill the syringe with air. Keep the protective needle cap on the syringe. Pull back on the plunger until the end of the black rubber stopper stops at your dose. Fill the syringe with air equal to the amount of the medicine to be given ( Figure H ). Remove the protective needle cap from the syringe. Remove the protective needle cap by pulling it straight off and away from your body.
	Insert the needle. Place the vial on the clean, flat work surface. With the vial in the upright position, place the syringe directly over the vial and insert the needle straight down into the center of the vial rubber stopper ( Figure I ). Push the air from the syringe into the vial.
	Fill the syringe with IMCIVREE Keep the needle in the vial and slowly turn the vial upside down. Make sure to keep the tip of the needle in the medicine ( Figure J ). Slowly pull back on the plunger to fill the syringe with the amount of IMCIVREE needed for your prescribed dose. Be careful not to pull the plunger out of the syringe. Do not use more than 1 vial of IMCIVREE to give a single dose. Use a new vial that has enough medicine for your prescribed dose.
	Check for large air bubbles ( Figure K ). Keep the needle in the vial and check the syringe for large air bubbles.
What to do if you see large air bubbles: Large air bubbles can reduce the dose of medicine you receive. To remove large air bubbles: Gently tap the side of the syringe with your finger to move the air bubbles to the top of the syringe. Move the tip of the needle above the medicine and slowly push the plunger up to push the large air bubbles back into the vial. After the large air bubbles are removed, pull back on the plunger again (more slowly this time) to fill the syringe with your prescribed dose of medicine.
	Withdraw the needle Return the vial to an upright position and place it on the clean, flat work surface. While holding the vial with 1 hand and the barrel of the syringe between the fingertips of your other hand, pull the needle straight out of the vial ( Figure L ). Set the syringe down on the clean, flat work surface. Make sure the needle does not touch the surface. Do not recap the needle
Injecting IMCIVREE Step 5 Prepare your injection site.
	Choose the area where you will give the injection. Choose from the following recommended injection sites: belly (abdomen) ( Figure M ) front of the middle thighs ( Figure N ) back of the upper arm ( Figure O ) Be sure to choose an area on the belly (abdomen) at least 2 inches from the belly button. Do not inject into the belly button, ribs, and hip bones, as well as scars or moles. Do not inject in an area that is red, swollen, or irritated
Clean the injection site with the second alcohol wipe using a circular motion. Do not touch, fan, or blow on the cleaned area. Allow the skin to dry for about 10 seconds.
Rotate your injection site each day. You should use a different injection site each time you give an injection, at least 1 inch away from the area you used for your previous injection. You may want to use a calendar or diary to record your injection sites.
Step 6 Place your hands for the injection.
	With 1 hand, pinch about 2 inches of skin at the injection site between your thumb and index (pointer) finger ( Figure P ). Pinching the skin is important to help make sure that you inject the medicine under the skin (into fatty tissue) but not any deeper (into the muscle).
Step 7 Inject and release.
	With your other hand, place the syringe between the thumb and index (pointer) finger. Hold the middle of the syringe (where the markings are printed) at a 90-degree angle to your body and push the needle straight into the injection site ( Figure Q ). Make sure that you push the needle all the way into the skin. Do not hold or push on the plunger while inserting the needle.
	Slowly push the plunger down to inject the medicine ( Figure R ) Keep the needle in your skin and count to 5 to make sure that all the medicine is given. Let go of the pinched skin and remove the needle. Use the gauze pad to gently apply pressure to the injection site. Do not recap the needle.
Tips for giving injections to children When giving a child an injection, it can help to have the child do other things. Have the child: squeeze something soft like a ball or stuffed animal. slowly breathe in and out. sing a song, count, or name favorite colors or animals.
Storing IMCIVREE Store unopened and opened vials in the original carton to protect them from light. Store opened vials of IMCIVREE in the refrigerator between 36°F to 46°F (2°C to 8°C). If needed, opened vials may be removed from the refrigerator and stored at temperatures ranging from refrigerated to room temperature (36°F to 77°F (2°C to 25°C)). Vials may be returned to the refrigerator. Throw away all opened vials 30 days after first opening, even if some medicine is still left in the vial. Unopened vials of IMCIVREE may be stored in the refrigerator between 36°F to 46°F (2°C to 8°C) until the expiration date. If needed, unopened vials may also be removed from the refrigerator and stored at temperatures ranging from refrigerated to room temperature (36°F to 77°F (2°C to 25°C)) for up to 30 days. Vials may be returned to the refrigerator. Throw away IMCIVREE if it has been more than 30 days since the vial was first removed from the refrigerator. If necessary, vials may be stored at room temperature below 86°F (30°C) and may be returned to refrigerated conditions. Throw away IMCIVREE that has been stored above 86°F (30°C). Write the date on the carton when you first open the vial. Keep IMCIVREE, needles, syringes, and all medicines out of the reach of children.
Disposing of IMCIVREE
	Alcohol wipes, used gauze pads, and vials can be thrown away in the trash. Throw away (dispose of) used syringes and needles in a puncture-resistant container, such as an FDA-cleared sharps disposal container immediately after use ( Figure S ). Do not throw away (dispose of) syringes and needles in your household trash. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used syringes and needles. For more information about safe sharps disposal and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal. Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container. Note: Keep your sharps disposal container out of the reach of children and pets.