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

What is the most important information I should know about Acthar Gel?

Acthar Gel can cause serious side effects including:

1.
Increased risk of infections.
Acthar Gel is a medicine that can affect your child's immune system. When your child is taking Acthar Gel, it can lower the ability of your child's immune system to fight infections.
Acthar Gel may:
- make your child more likely to get new infections
- worsen an infection that your child already has
- cause an inactive infection to become active, such as tuberculosis (TB)
Before starting Acthar Gel, tell your doctor if your child has:
- an infection or signs of an infection, such as:
  - fever
  - cough
  - vomiting
  - diarrhea
  - other signs of flu or illness
- a family member with an infection or signs of an infection
While taking Acthar Gel, your child should:
- stay away from people who are sick or who have infections
- tell your doctor right away if your child has any sign of infection such as:
  - fever (but your child may not have a fever with an infection)
  - cough
  - vomiting
  - diarrhea or
  - other signs of illness or flu and
  - any open cuts or sores on his or her body
2.
Effects on the adrenal gland after stopping Acthar Gel.
When your child stops taking Acthar Gel, his or her body may not produce enough of a hormone called cortisol on its own (adrenal insufficiency). Your child may need to take steroid medicine to protect the body until the adrenal gland recovers and is working well again, especially to protect the body if they have surgery or trauma. Do not stop giving your child injections of Acthar Gel without talking to your doctor first.
Your doctor will tell you when and how to slowly stop giving the injections to avoid serious side effects.
While slowly stopping your child's injections of Acthar Gel or after you stop giving the injections, call your doctor right away if your child has any of the following:
- appears weak
- loses weight or has a decrease in appetite
- appears tired or lacking energy
- appears pale
- has stomach pain
- appears sick or is with a fever
3.
Effects on the adrenal gland while taking Acthar Gel.
When your child is taking Acthar Gel, his or her adrenal gland may produce too much cortisol. This can cause symptoms of Cushing's syndrome. Cushing's syndrome is more common in children who take Acthar Gel for a long time.
Symptoms of Cushing's syndrome include:
- increased upper body fat around the neck, but not the arms and legs
- weight gain
- rounded or "moon" face
- thin skin, easy bruising, and stretch marks on thighs, belly and trunk
- slowed growth rates in children
- weak bones (osteoporosis)
While receiving treatment with Acthar Gel other side effects can happen that are like side effects that happen due to treatment with steroid medicines. The risk of getting side effects may increase the longer your child is treated with Acthar Gel. Side effects may include:
- increased blood pressure. Your doctor may check your child's blood pressure during treatment. If your child's blood pressure increases, your doctor may talk with you about possible treatment choices.
- too much water in the body (water retention), increased amount of body salts, and low potassium in the blood. Acthar Gel may cause your child to have an increased amount of body salts and water that stays in the body, and may lower the amount of potassium in your child's blood. Follow your doctor's instructions about if you need to decrease your child's salt intake or if you need to feed your child foods high in potassium.
4.
Your child should not receive certain vaccines during treatment with Acthar Gel.
Your child may receive killed or inactivated vaccines while receiving Acthar Gel. Before your child receives any vaccines, talk to your doctor about which vaccines are safe for your child. Certain vaccines could cause your child to have serious side effects, or the vaccine may not be effective.
5.
Hiding (masking) symptoms of other conditions or diseases.
It may be more difficult for your doctor to diagnose other conditions or diseases in your child during treatment with Acthar Gel. During treatment and after treatment ends, tell your doctor if your child has:
- any signs or symptoms of infection. See number 1 of this section in the Medication Guide.
- changes in body weight
- bloody or black tarry stool
- vomiting
- stomach pain
- excessive tiredness
- increased thirst
- fast heart rate
- difficulty breathing
6.
Stomach and intestinal problems. Acthar Gel may cause bleeding of the stomach or intestine.
Your child has an increased risk for bleeding from the stomach or having a stomach ulcer. Tell your doctor if your child has any pain in the stomach area (abdominal pain), vomits blood, or has bloody or black stools.
7.
Changes in mood and behavior.
During treatment with Acthar Gel your child may be irritable, have rapid changes in his or her mood, be depressed, have other changes in his or her behavior, or have trouble sleeping.
Tell your doctor if your child has any of the side effects or symptoms listed above.

What is Acthar Gel?

Acthar Gel is a prescription medicine that is used to treat infantile spasms in infants and children under 2 years of age.

What should I tell my doctor before my child takes Acthar Gel?

Before your child takes Acthar Gel, read the section above "What is the most important information I should know about Acthar Gel?" and tell your doctor if your child has:

an infection
diabetes
heart problems
kidney problems
stomach or intestinal problems
thyroid problems
liver problems
neuromuscular problems
convulsions or seizures
had exposure to someone with Tuberculosis (TB)
a previous allergic reaction such as hives, itching or trouble breathing, to Acthar Gel or pork products
had recent surgery
had a recent vaccination or is scheduled to receive a vaccination
a family member who is receiving vaccinations

Tell your doctor about all the medicines your child takes, including prescription and non- prescription medicines, vitamins and herbal supplements. Do not start giving a new medicine to your child without first speaking to your doctor.

How should I give Acthar Gel to my child?

Acthar Gel is given as an injection into the muscle. Do not inject it under the skin, into a vein, or give it to your child by mouth.

Inject Acthar Gel exactly as your doctor tells you. Your doctor will tell you where to give the injection, how much to give, how often and when to give it to your child.
Do not use Acthar Gel until your doctor has taught you how to give the injection to your child.
To give Acthar Gel:
- Take the bottle from the refrigerator. Do not open the bottle or pry the cap (rubber stopper) off.
- Warm the contents by rolling the bottle between your hands for a few minutes.
- Wash your hands.
- Prepare the skin where you are going to give the injection by wiping it with a new sterile alcohol wipe. Before giving the injection, look at the site prepared for the injection and make sure that it no longer looks wet. A wet site can cause burning.
- Wipe the top of the vial rubber stopper with a new sterile alcohol wipe.
- Use a new sterile needle and syringe to draw up the amount of Acthar Gel the doctor has told you to use.
- Give the injection the way the doctor has instructed you.
- Return the bottle to the refrigerator as soon as possible.

Keep all of your child's follow-up appointments with your doctor

It is important for you to tell your doctor if your child's spasms continue or change in any way during treatment or after treatment has stopped so that they can monitor your child's progress.

Infantile Spasms sometimes hides (masks) other seizures your child or infant may have. Once treated with Acthar Gel, the Infantile Spasms symptoms may disappear. This may allow the other seizures to become visible for the first time. Tell your child's doctor right away if you see a change in your child's seizures/spasms.

What are the possible side effects of Acthar Gel?

Acthar Gel can cause serious side effects.

See "What is the most important information I should know about Acthar Gel."
Acthar Gel may make certain other medical conditions worse, such as diabetes (may increase blood sugar).
Eye problems. Your child can get cataracts, increased pressure in the eye (glaucoma), and possible damage to the optic nerve if treated with Acthar Gel for a long time.
Allergic reactions to Acthar Gel. Your child may have an allergic reaction to Acthar Gel. Allergic reactions may not happen until your child has received several injections of Acthar Gel. Tell your doctor right away if your child has any of the following signs of an allergic reaction:
- skin rash
- swelling of the face, tongue, lips, or throat
- trouble breathing
Changes in growth and physical development. Acthar Gel may affect your child's growth and physical development and may weaken his or her bones. This is more likely to happen with long term use of Acthar Gel.
Enlarged heart. Acthar Gel may cause an increase in the size of your child's heart. This is more likely to happen with long term use of Acthar Gel but usually goes away after Acthar Gel is stopped.

The most common side effects of Acthar Gel for patients with infantile spasms include:

Infections
muscle contractions that you cannot control (convulsions)
increased blood pressure
irritability and changes in behavior
fever

These are not all the possible side effects of Acthar Gel. Tell your doctor if your child has any side effect that bothers them or does not go away. For more information, ask your child's doctor or pharmacist.

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

How should I store Acthar Gel?

Store vials of Acthar Gel in the refrigerator between 36°F to 46°F (2°C to 8°C).

Throw away any vials after the expiration date printed on the label.

Keep Acthar Gel and all other medicines out of the reach of children

General information About Acthar Gel

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Acthar Gel for a condition for which it has not been prescribed. Do not give Acthar Gel to other people, even if they have the same symptoms. It may harm them.

This Medication Guide summarizes the most important information about Acthar Gel. If you would like more information, talk with your child's doctor. You can ask your child's doctor or pharmacist for information about Acthar Gel that is written for healthcare professionals. For more information, go to www.acthar.com or call 1-800-462-3636.

What are the ingredients in Acthar Gel?

Active ingredient: Corticotropin

Inactive ingredients: gelatin, phenol, cysteine, sodium hydroxide and/or acetic acid to adjust pH, and water for injection

Manufactured for:

Keenova ARD LLC

Bridgewater, NJ 08807

Rev 09/2026

This Medication Guide has been approved by the U.S. Food and Drug Administration.

INSTRUCTIONS FOR USE

ACTHAR ^®GEL [AK-thar jel]

(repository corticotropin injection)

for subcutaneous use only

Single-Dose Pre-filled SelfJect™ Injector

Green Body Injector: 40 USP Units/0.5 mL of Acthar Gel

Step 1: Read These Instructions

Carefully read, understand, and follow this Instructions for Use before you use the Acthar Gel single-dose pre-filled SelfJect injector.
Contact your healthcare provider if you are unsure of how to give the injection.

Important Information

The Acthar Gel single-dose pre-filled SelfJect injector is for under the skin (subcutaneous) injection only.
The Acthar Gel single-dose pre-filled SelfJect injector must only be given by adults 18 years of age and older.
The Acthar Gel single-dose pre-filled SelfJect injector is a pre-filled injector for 1-time use only (single-dose).
The Acthar Gel single-dose pre-filled SelfJect injector with the green body should only be used to give a single dose of 40 units. Doses other than 40 units cannot be given with this Acthar Gel single-dose pre-filled SelfJect injector.
This injector is not an auto-injector. The Handle must be pushed down by hand (see "The parts of the Acthar Gel single-dose pre-filled SelfJect injector" figure below).
The injector has a Needle Guard to protect you and others from injury after it has been used.

The parts of the Acthar Gel single-dose pre-filled SelfJect injector are shown below:
Before Use	After the Injection is Complete

Storing Your Injector

Store the Acthar Gel single-dose pre-filled SelfJect injector in the refrigerator between 36°F and 46°F (2°C and 8°C).
Store the Acthar Gel single-dose pre-filled SelfJect injector in the original plastic tray to protect the injector from light.
When it is time to use the Acthar Gel single-dose pre-filled SelfJect injector, take 1 injector from the refrigerator and return any unused injectors to the refrigerator.
After removing the injector from the refrigerator, it can be stored at room temperature between 68°F and 77°F (20°C and 25°C) for up to 24 hours.
If the Acthar Gel single-dose pre-filled SelfJect injector has been left at room temperature for more than 24 hours, contact Keenova Therapeutics plc: 1-800-462-3636.
Do not heat the Acthar Gel single-dose pre-filled SelfJect injector.
Do not freeze the Acthar Gel single-dose pre-filled SelfJect injector.
Do not put the Acthar Gel single-dose pre-filled SelfJect injector into direct sunlight.
Keep the Acthar Gel single-dose pre-filled SelfJect injector and all medicines out of the reach of children.

Step 2: Prepare to Use the Acthar Gel single-dose pre-filled SelfJect injector

Choose a clean, well-lit room to give the injection.

Take the injector tray out of the refrigerator.
If the injector trays are in a multipack carton, take the injector tray out and return any unused injector trays to the refrigerator.
Do not inject Acthar Gel right after removing it from the refrigerator. The injector does not work as well when cold.

Check that you have the correct medicine and dose.
Check the expiration date (EXP) on the package.
Do not use if the expiration date has passed.

Remove the injector from the injector tray and let it sit on a clean, dry, flat surface at room temperature to warm for a minimum of 45 minutes and no more than 24 hours before use.
Do not heat the injector.

Before use, the injector should look like this. The Bottom Cap should remain on the injector until you give the injection.
Do not use the injector if the Bottom Cap is missing or not securely attached. If dropped, inspect the injector. Do not use if the injector is damaged or the Bottom Cap has come off.

Gather an alcohol swab and sharps disposal container.
You may also gather an adhesive bandage, gauze, or cotton ball to use after the injection to stop any bleeding.

Step 3: Choose and Clean the Injection Site

The Acthar Gel single-dose pre-filled SelfJect injector is for under the skin (subcutaneous) injection only.
Choose 1 of these sites for injection:
- Upper thigh
- Belly (abdomen), not within 1-inch of belly button (navel)
- Back of arm (only if someone else is giving the injection)

Choose a different site for each injection. Do not use the same injection site more than 1 time each week.
Do not inject through clothing.
Avoid injecting into:
- Irritated skin (red, swollen, or painful)
- Tattoos
- Warts
- Scars
- Birthmarks
- Within 1-inch of the knee
- Within 1-inch of the groin area
- Stretch marks

Wash your hands well with soap and water.

Clean the injection site with an alcohol swab.
Do not touch, fan, or blow on the injection site after you have cleaned it.

Step 4: Inspect and Uncap

Make sure the injector has warmed at room temperature for a minimum of 45 minutes before you continue.
Inspect the medicine in the Window.
If needed, wipe away any condensation (water collected) from the Window with a dry cloth.
Check the medicine in the Window. It should be a clear light yellow or orange solution.
Do not use if the medicine is cloudy or you see particles.
Note: It is normal to see air bubbles.

Pull the Bottom Cap off to remove it and throw it away in your household trash.
Avoid touching the Gray Needle Guard. The injector is now ready for use.
After the injector has been warmed for a minimum of 45 minutes and you have prepared the injection site, use the injector right away.
Do not recap the injector as this may damage the needle.

When the Bottom Cap is removed, do not let the Gray Needle Guard touch any surface before injection.

Step 5: Inject

Place the injector straight on the cleaned skin at a 90-degree angle.
Do not pinch the skin.

Slowly push the Handle down to inject the medicine.
Do not lift the injector during the injection. If you do, the injector will lock out and you will not get the full dose of medicine.
You may hear a "click" when the injection begins.

The injection is complete when the Green Colored Body disappears and you may hear a "click".

Before you lift the injector up, check to make sure that no part of the Green Colored Body remains visible. If you see color, continue pushing down on the Handle until the Green Colored Body disappears completely.

Step 6: Lift

Lift the injector straight up at a 90-degree angle off the injection site.
If the Yellow Band is visible, it means that the Needle Guard is locked. You cannot use the injector again.

After the injection is complete, the injector should look like this:

After use, the injector should not look like this:

If you see the Green Colored Body and the Yellow Band at the same time, then you did not give the full dose.

Do not try to inject with this injector again.

Do not use another injector. Contact your healthcare provider.

If there is any bleeding at the injection site, cover the site with an adhesive bandage, a cotton ball, or a gauze. Apply gentle pressure until the bleeding stops.

Step 7: Throw Away (Dispose of) your Used Acthar Gel single-dose pre-filled SelfJect injector

Put your used Acthar Gel single-dose pre-filled SelfJect injector in an FDA-cleared sharps disposal container right away after use.
Do not throw away your injector 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 labelled 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 needles and syringes. 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.

Manufactured for:

Keenova ARD LLC

Bridgewater, NJ 08807

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: 09/2026

Quick Reference Guide

ACTHAR^®GEL [AK-thar jel]

(repository corticotropin injection)

for subcutaneous use only

40 USP Units/0.5 mL

Single-Dose Pre-filled SelfJect™ Injector

Before use	After the Injection is Complete

Important Information

The Acthar Gel single-dose pre-filled SelfJect injector is for under the skin (subcutaneous) injection only.

1. Read These Instructions

Contact your healthcare provider if you are unsure of how to give the injection.
This is not an auto-injector. The Handle must be pushed down by hand.
This is a single-dose injector (for 1-time use only).
The injector has a Needle Guard to protect you after use.

2. Prepare to Use the Acthar Gel single-dose pre-filled SelfJect Injector

Take the injector out of the refrigerator and remove it from its injector tray to warm at room temperature for a minimum of 45 minutes.
Do not use the injector right after removing from the refrigerator. The injector does not work as well when cold. Do not heat. Check the expiration date (EXP) on the package. Complete this injection in a clean, well-lit room. Gather alcohol swab, adhesive bandage, and a sharps disposal container.

3. Choose and Clean the Injection Site

For under the skin (subcutaneous) injection only. Choose 1 of these sites for injection: Upper thigh Belly (abdomen), not within 1-inch of belly button (navel) Back of arm (only if someone else is giving the injection) Choose a different site for each injection. Do not inject through clothing. Avoid injecting into: Irritated skin (red, swollen, or painful) Tattoos, warts, scars, or birthmarks Within 1-inch of knee or groin area Stretch marks		Wash your hands well with soap and water.
		Clean the injection site with an alcohol swab.

4. Inspect and Uncap

Inspect the medicine in the Window. The medicine should be a clear light yellow or orange solution.
Do not use if the medicine is cloudy or you see particles.
It is normal to see air bubbles.

Pull Bottom Cap off to remove it and throw it away.

Do not recap the injector as this may damage the needle.
Avoid touching the Gray Needle Guard.
Use the injector right away.

5. Inject

(a) Place the injector straight on the cleaned skin at a 90-degree angle.

Do not pinch the skin.

(b) Slowly push down the Handle to inject the medicine.

Do not lift the injector during the injection. You may hear a "click" when the injection begins.

6. Lift and Throw Away (Dispose of)

Lift the injector straight up at a 90-degree angle off the injection site.

The Needle Guard is locked when you see the yellow band.

Place the injector in an approved sharps disposal container according to local regulations.

Do not throw away (dispose of) in your household trash.

SPC-0131 Rev 9