Description
Setmelanotide injection is used to help lose weight and keep the weight off in patients with acquired hypothalamic obesity (HO) and obesity caused by proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), leptin receptor (LEPR) deficiency, or Bardet-Biedl syndrome (BBS). Your doctor will perform a test to check for POMC, PCSK1, or LEPR deficiency, or BBS before you use this medicine.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of setmelanotide injection in children younger than 2 years of age with obesity caused by POMC, PCSK1, LEPR deficiency, or BBS and in children younger than 4 years of age with acquired HO. Safety and efficacy have not been established.
Geriatric
Appropriate studies have not been performed on the relationship of age to the effects of setmelanotide injection in the geriatric population. Safety and efficacy have not been established.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Venlafaxine
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Adrenal gland problems or
- Depression, or history of or
- Diabetes insipidus—Use with caution. May make these conditions worse.
- General obesity or
- Kidney disease, end-stage or
- Obesity caused by other genetic conditions—Use is not recommended in patients with these conditions.
- Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
A nurse or other trained health professional will give you this medicine. It is given as a shot under your skin, usually in the stomach, thighs, or upper arms.
This medicine comes with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Setmelanotide may sometimes be given at home to patients who do not need to be in a hospital or clinic. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use the medicine.
If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that are red, swollen, or irritated, have scars or moles, or into the belly button, hip bones, or ribs.
You should receive this medicine 1 time each day when you first wake up.
Check the liquid in the vial. It should be clear to almost clear and colorless to slightly yellow. Do not use the medicine if the liquid is cloudy, discolored, or has particles in it. Do not use if the plastic cap is broken or missing. Do not shake.
Allow the medicine vial to warm to room temperature for 15 minutes before using it. Do not warm using any heat sources (eg, hot water, microwave). You may also warm the vial by rolling it gently between the palms of your hands for 60 seconds.
To use:
- Wash your hands with soap and water before and after using this medicine.
- Remove the plastic cap if you are using a new vial. Clean the top of the vial rubber stopper with 1 alcohol wipe.
- Fill the syringe with air by pulling back on the plunger to the prescribed dose. Remove the needle cap.
- With the vial on a flat surface and in an upright position, insert the needle straight down into the center of the vial rubber stopper. Push the air from the syringe into the vial.
- Turn the vial and syringe upside down. Slowly pull back on the plunger to fill with the prescribed dose. Check for air bubbles. If you see large air bubbles, gently tap the side of the syringe.
- Return the vial to an upright position and place it on a flat surface. While holding the vial with one hand and the barrel of the syringe between the fingertips of your other hand, pull the needle straight out of the vial. Do not recap the needle.
- Pinch the skin with your other hand. Insert the needle at a 90 degree angle into the pinched skin. Push the needle all the way into the skin. Keep the needle in your skin and count to 5 to make sure you receive the full dose.
Use a new needle and syringe each time you inject your medicine.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For injection dosage form (solution):
- For weight management in patients with acquired HO:
- Adults and children 6 years of age and older—At first, 0.5 milligrams (mg) injected under the skin once a day on Weeks 1 to 2, followed by 1 mg once a day on Weeks 3 to 4, then 2 mg once a day on Weeks 5 to 6, and 3 mg once a day on Week 7 and onward. Your doctor may adjust the dose as needed and tolerated.
- Children 4 to younger than 6 years of age—Dose is based on body weight and must be determined by your doctor.
- Weighing 40 kilograms (kg) or more—At first, 0.5 mg injected under the skin once a day on Weeks 1 to 2, followed by 1 mg once a day on Weeks 3 to 4, then 1.5 mg once a day on Weeks 5 to 6, and 2 mg once a day on Week 7 and onward. Your doctor may adjust the dose as needed and tolerated.
- Weighing 30 kg to less than 40 kg—At first, 0.5 mg injected under the skin once a day on Weeks 1 to 2, followed by 1 mg once a day on Weeks 3 to 4, and 1.5 mg once a day on Week 5 and onward. Your doctor may adjust the dose as needed and tolerated.
- Weighing 20 kg to less than 30 kg—At first, 0.5 mg injected under the skin once a day on Weeks 1 to 2 and 1 mg once a day on Week 3 and onward. Your doctor may adjust the dose as needed and tolerated.
- Weighing 15 kg to less than 20 kg—At first, 0.5 mg injected under the skin once a day on Week 1 and onward. Your doctor may adjust the dose as needed and tolerated.
- Children younger than 4 years of age—Use and dose must be determined by your doctor.
- For weight management in patients with BBS, POMC, PCSK1, or LEPR deficiency, :
- Adults and children 12 years of age and older—At first, 2 milligrams (mg) injected under the skin once a day for 2 weeks. Your doctor may adjust the dose as needed and tolerated. Maintenance dose is 3 mg injected under the skin once a day.
- Children 6 to younger than 12 years of age—At first, 1 mg injected under the skin once a day for 2 weeks. Your doctor may adjust the dose as needed and tolerated. Maintenance dose is 3 mg injected under the skin once a day.
- Children 2 to younger than 6 years of age—At first, 0.5 mg injected under the skin once a day for 2 weeks. Your doctor may adjust the dose as needed and tolerated. Maintenance dose is based on body weight and must be determined by your doctor.
- Weighing 40 kilograms (kg) or more—At first, 0.5 mg injected under the skin once a day on Weeks 1 to 2, followed by 1 mg once a day on Weeks 3 to 4, then 1.5 mg once a day on Weeks 5 to 6, and 2 mg once a day on Week 7 and onward.
- Weighing 30 kg to less than 40 kg—At first, 0.5 mg injected under the skin once a day on Weeks 1 to 2, followed by 1 mg once a day on Weeks 3 to 4, and 1.5 mg once a day on Week 5 and onward.
- Weighing 20 kg to less than 30 kg—At first, 0.5 mg injected under the skin once a day on Weeks 1 to 2 and 1 mg once a day on Week 3 and onward.
- Weighing 15 kg to less than 20 kg—0.5 mg injected under the skin once a day on Week 1 and onward.
- Children younger than 2 years of age—Use and dose must be determined by your doctor.
- For weight management in patients with acquired HO:
Missed Dose
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store in the refrigerator. Do not freeze.
Store the unopened vial in the refrigerator until the expiration date. You may remove the medicine from the refrigerator and store at room temperature for up to 30 days. You may also return it in the refrigerator. Throw away this medicine after 30 days of removing it from the refrigerator.
Store opened vial in the refrigerator. You may remove the medicine from the refrigerator and store at room temperature. You may also return it in the refrigerator. Throw away any unused medicine after 30 days, even if it still has medicine in it.
Throw away used needles in a hard, closed container where the needles cannot poke through. Keep this container away from children and pets.
Precautions
It is very important that your doctor checks your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.
If you have not lost weight after 12 to 16 weeks of treatment, check with your doctor.
This medicine may cause sexual function problems in men and women. Check with your doctor right away if you have an erection of the penis lasting longer than 4 hours.
This medicine may cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, or unusual tiredness or weakness.
This medicine may cause skin problems (eg, hyperpigmentation). Check with your doctor right away if you have darkening of the skin or skin lesions (moles or nevi) you already have, or development of new skin lesions.
Check with your doctor right away if you have confusion, dizziness, fever, lack of energy, change in mental status, nervousness, or sudden weakness. These may be symptoms of a serious adrenal gland problem (eg, acute adrenal insufficiency).
This medicine may cause hyponatremia (low sodium levels in the blood). Check with your doctor right away if you have coma, confusion, decreased urine output, dizziness, fast or irregular heartbeat, headache, increased thirst, muscle pain or cramps, nausea or vomiting, seizures, swelling of the face, ankles, or hands, trouble breathing, or unusual tiredness or weakness.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Aggressive, angry
- coma
- confusion
- darkening of the skin or skin lesions
- decreased urine output
- discouragement
- dizziness
- fast or irregular heartbeat
- feeling sad or empty
- headache
- increased thirst
- irritability
- lack of appetite
- loss of interest or pleasure
- muscle pain or cramps
- nausea or vomiting
- nervousness
- prolonged erection of the penis
- reddish purple lines on the arms, face, legs, trunk, or groin
- seizures
- swelling of the face, ankles, or hands
- thoughts of killing oneself changes in behavior
- tiredness
- trouble breathing
- trouble concentrating
- trouble sleeping
- unusual tiredness or weakness
Incidence not known
- Chest tightness
- cough
- difficulty swallowing
- fast heartbeat
- hives, itching, skin rash
- puffiness or swelling of the eyelids or around the face, lips, or tongue
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Back pain
- bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- body aches or pain
- change in hearing
- chills
- constipation
- diarrhea
- difficulty in moving
- dry mouth
- earache
- ear congestion
- ear drainage
- fever
- hair loss, thinning of hair
- headache
- joint pain
- lack or loss of strength
- loss of voice
- muscle stiffness or spasm
- pain in the arms or legs
- rash
- runny or stuffy nose
- sneezing
- sore throat
- stomach pain
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20506354
