`` Infantile Spasms | Acthar® Gel (repository corticotropin injection)

Relief for infantile spasms

Acthar Gel is FDA approved to treat infantile spasms in children and infants under 2 years of age.

Jillian, caregiver for Cassidy, who was treated with Acthar Gel.
Individual results may vary. Compensated by Keenova.

Links On this page What is Acthar Gel

What is Acthar Gel?

Acthar Gel is a prescription medicine used for the treatment of infantile spasms in infants and children under 2 years of age. Acthar is injected into the muscle. Do not inject it into a vein, under your child’s skin, or give it to your child by mouth.

What are infantile spasms?

Infantile spasms (IS) are a rare but serious seizure disorder that affects babies, usually within their first year of life. In the United States, about 2,000 to 2,500 babies are diagnosed each year.

The spasms may look brief or small and can last from a few seconds up to 10 seconds. They often occur after waking up from sleep and can happen in clusters of 2 to 100 at a time.

Even though they may appear subtle, infantile spasms are a medical emergency. Early treatment may help make the difference. Learn more about recognizing and treating IS.

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If your child has been diagnosed, treatment may help

Clinical studies showed that Acthar Gel may help stop infantile spasms in children and infants who received treatment.

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Could your baby be suffering from infantile spasms?

The first people to notice the motions and behaviors that give infantile spasms their name are usually parents and caregivers. At first, you might think your baby has colic or another routine health problem. However, many parents of babies with IS say that "something just doesn't feel right" about the way their baby is acting.
Spasms are uncontrolled movements. These include:
Repetitive bending of the neck, trunk, and limbs lasting 1-2 seconds Repetitive bending of the neck, trunk, and limbs lasting 1-2 seconds
Extension of arms, legs, or both Extension of arms, legs, or both
A brief head drop A brief head drop
Multiple spasms Multiple spasms are more common than a single event, and often occur on awakening in the morning or after a nap
Other seizure types Other seizure types
Flares
If your baby is having sudden, uncontrolled movements, it could be infantile spasms. It's crucial to act quickly. Take a video of their symptoms and share it with your pediatrician.

IS is a serious condition that requires immediate attention. If you think your child might have IS, speak with your pediatrician and a specialist called a pediatric neurologist as soon as possible. The potential consequences of IS can be difficult to face, but early diagnosis and intervention may lead to fewer long-term effects.

Treating infantile spasms with Acthar Gel

Acthar Gel is a prescription medicine for the treatment of infantile spasms in infants and children under 2 years of age. Acthar is injected into the muscle. Do not inject it into a vein, under your child’s skin, or give it to your child by mouth.

Learn how to safely administer Acthar Gel to your child

Watch this video to help guide you through giving an Acthar Gel injection to your child. This resource is available to help you feel more confident caring for your child.

Tips for injecting:

  • Follow your doctor’s instructions for injecting Acthar Gel
  • Always inject Acthar Gel into a muscle
  • Never inject Acthar Gel directly into a vein or under your child’s skin
  • Never give it to your child by mouth
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Get the IS injection guide

Download the guide to help you feel prepared for injections.

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Get the IS injection tracker calendar

Keep a record of when and where your loved one receives their injections to stay on schedule.

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Curious about how Acthar Gel has helped children with IS? See the clinical results
What is Acthar Gel?
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Acthar Gel is a prescription medicine used for:

  • Treatment for flares or on a regular basis (maintenance) in people with dermatomyositis or polymyositis (DM-PM)
  • Treatment for flares or on a regular basis (maintenance) in people with systemic lupus erythematosus (lupus)
  • Add-on therapy for short-term administration (to tide patients over an acute episode or exacerbation) in: psoriatic arthritis (PsA); rheumatoid arthritis (RA), including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); ankylosing spondylitis
  • Treatment for people with symptomatic sarcoidosis
  • Treatment of severe acute and chronic allergic and inflammatory conditions affecting different parts of the eye. This can include the front part of the eye such as the cornea and iris, or the back part of the eye such as the optic nerve and retina
  • Reduction of proteinuria in people with nephrotic syndrome of the idiopathic type (unknown origin) without uremia (accumulation of urea in the blood due to malfunctioning kidneys) or that due to lupus erythematosus (lupus)
  • Treatment for adults with acute relapses or flares of multiple sclerosis (MS). Studies have shown Acthar to be effective in speeding recovery from an MS relapse. However, there is no evidence that it affects the ultimate outcome or natural history of the disease
  • Treatment of infantile spasms in infants and children under 2 years of age

Acthar is injected beneath the skin or into the muscle.

IMPORTANT SAFETY INFORMATION
Toggle ISI tray

DO NOT take Acthar until you have talked to your doctor if you have any of the following conditions:

  • Have been given or are about to receive a live or live attenuated vaccine
  • A skin condition called scleroderma
  • Bone density loss or osteoporosis
  • Any infections, including fungal, bacterial, or viral
  • Eye infections, such as ocular herpes simplex
  • Had recent surgery
  • Stomach ulcers or a history of stomach ulcers
  • Heart failure
  • Uncontrolled high blood pressure
  • Addison's disease or Cushing's syndrome
  • Allergies to pig-derived proteins
  • Suspected infections at birth (in infants under 2 years of age)

Tell your doctor about any other health problems that you have. Give your doctor a complete list of medicines you are taking, including all prescription and nonprescription medicines, vitamins, and herbal supplements.

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

  • Never inject Acthar directly into a vein
  • Acthar is injected beneath the skin or into the muscle. Always inject Acthar with SelfJect beneath the skin
  • Follow your doctor's instructions for injecting Acthar
  • Never stop treatment suddenly unless your doctor tells you to do so
  • Try not to miss any scheduled doctor's appointments. It is important for the doctor to monitor you while taking Acthar
  • You may be more likely to get new infections. Also, old infections may become active. Tell your doctor if you see any signs of an infection. Contact your doctor at the first sign of an infection or fever.
    Signs of infection are: fever, cough, vomiting, or diarrhea. Other signs may be flu or any open cuts or sores
  • When taking Acthar long-term, your adrenal gland may produce too much of a hormone called cortisol. This can result in symptoms of Cushing's syndrome. This may cause increased upper body fat, a rounded “moon” face, bruising easily, or muscle weakness
  • Sometimes when you stop taking Acthar long-term, your body may not produce enough natural cortisol. This is called "adrenal insufficiency." Your doctor may prescribe a steroid medicine to protect you until the adrenal gland recovers
  • You might develop high blood pressure, retain too much salt and water, or have low blood potassium levels. As a result of this, your doctor may recommend some changes to your diet, such as eating less salt or taking certain supplements
  • Vaccines may not work well when you are on Acthar. Talk to your doctor about which vaccines are safe to use while you are taking Acthar
  • Acthar may hide symptoms of other diseases. This can make it more difficult for your doctor to make a diagnosis of something else is going on
  • Stomach or intestinal problems. Acthar may increase the risk of bleeding and stomach ulcers. Tell your doctor if you have stomach pains, bloody vomit, bloody or black stools, excessive tiredness, increased thirst, difficulty breathing, or increased heart rate
  • Taking Acthar can make you feel irritable or depressed. You may also have mood swings or trouble sleeping. These effects are reversible once Acthar therapy is stopped
  • If you have other conditions, such as diabetes or muscle weakness, you may find they get worse
  • You might develop certain eye conditions, such as cataracts, glaucoma, or optic nerve damage
  • Your body may develop allergies to Acthar; these allergies may be severe. Signs of allergic reaction include:
    • Skin rash and itching
    • Swelling of the face, tongue, lips, or throat
    • Trouble breathing
  • The effects of Acthar may be intensified if you have an underactive thyroid or cirrhosis of the liver
  • Long-term Acthar use can affect growth and physical development in children. This can be reversed when Acthar is no longer needed
  • Acthar may cause osteoporosis (weak bones)
  • Acthar might harm an unborn baby. Therefore, tell your doctor if you are pregnant or plan to become pregnant

What are the most common side effects of Acthar?

Commonly reported side effects of Acthar include:

  • Injection site reaction
  • Fatigue, physical weakness, and lack of energy
  • Fluid retention
  • Insomnia (difficulty sleeping)
  • Headache
  • High blood sugar

The most common side effects for the treatment of infantile spasms (IS) are:

  • Increased risk of infections
  • Convulsions
  • High blood pressure
  • Irritability
  • Fever

The above side effects may also be seen in adults and children over 2 years of age. Some children with IS progress to other forms of seizures. IS sometimes makes these seizures, which may become visible after treatment for IS has been completed.

These are not all of the possible side effects of Acthar.

Tell your doctor about any side effect that bothers you, or that does not go away. Call your doctor or pharmacist for medical advice about side effects. You may report side effects to the FDA. Call 1-800-FDA-1088 or visit www.fda.gov/medwatch . You may also report side effects by calling 1-800-844-2830.

Please see the full Prescribing Information. If you've been prescribed SelfJect, please see the 40-unit or 80-unit Instructions for Use and the 40-unit or 80-unit Quick Reference Guide.

For parents and caregivers of children with infantile spasms, please also see Medication Guide.

Toggle ISI tray

What is Acthar Gel?

Acthar Gel is a prescription medicine used for:

  • Treatment for flares or on a regular basis (maintenance) in people with dermatomyositis or polymyositis (DM-PM)
  • Treatment for flares or on a regular basis (maintenance) in people with systemic lupus erythematosus (lupus)
  • Add-on therapy for short-term administration (to tide patients over an acute episode or exacerbation) in: psoriatic arthritis (PsA); rheumatoid arthritis (RA), including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); ankylosing spondylitis
  • Treatment for people with symptomatic sarcoidosis
  • Treatment of severe acute and chronic allergic and inflammatory conditions affecting different parts of the eye. This can include the front part of the eye such as the cornea and iris, or the back part of the eye such as the optic nerve and retina
  • Reduction of proteinuria in people with nephrotic syndrome of the idiopathic type (unknown origin) without uremia (accumulation of urea in the blood due to malfunctioning kidneys) or that due to lupus erythematosus (lupus)
  • Treatment for adults with acute relapses or flares of multiple sclerosis (MS). Studies have shown Acthar to be effective in speeding recovery from an MS relapse. However, there is no evidence that it affects the ultimate outcome or natural history of the disease
  • Treatment of infantile spasms in infants and children under 2 years of age

Acthar is injected beneath the skin or into the muscle.

IMPORTANT SAFETY INFORMATION

DO NOT take Acthar until you have talked to your doctor if you have any of the following conditions:

  • Have been given or are about to receive a live or live attenuated vaccine
  • A skin condition called scleroderma
  • Bone density loss or osteoporosis
  • Any infections, including fungal, bacterial, or viral
  • Eye infections, such as ocular herpes simplex
  • Had recent surgery
  • Stomach ulcers or a history of stomach ulcers
  • Heart failure
  • Uncontrolled high blood pressure
  • Addison's disease or Cushing's syndrome
  • Allergies to pig-derived proteins
  • Suspected infections at birth (in infants under 2 years of age)

Tell your doctor about any other health problems that you have. Give your doctor a complete list of medicines you are taking, including all prescription and nonprescription medicines, vitamins, and herbal supplements.

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

  • Never inject Acthar directly into a vein
  • Acthar is injected beneath the skin or into the muscle. Always inject Acthar with SelfJect beneath the skin
  • Follow your doctor's instructions for injecting Acthar
  • Never stop treatment suddenly unless your doctor tells you to do so
  • Try not to miss any scheduled doctor's appointments. It is important for the doctor to monitor you while taking Acthar
  • You may be more likely to get new infections. Also, old infections may become active. Tell your doctor if you see any signs of an infection. Contact your doctor at the first sign of an infection or fever.
    Signs of infection are: fever, cough, vomiting, or diarrhea. Other signs may be flu or any open cuts or sores
  • When taking Acthar long-term, your adrenal gland may produce too much of a hormone called cortisol. This can result in symptoms of Cushing's syndrome. This may cause increased upper body fat, a rounded “moon” face, bruising easily, or muscle weakness
  • Sometimes when you stop taking Acthar long-term, your body may not produce enough natural cortisol. This is called "adrenal insufficiency." Your doctor may prescribe a steroid medicine to protect you until the adrenal gland recovers
  • You might develop high blood pressure, retain too much salt and water, or have low blood potassium levels. As a result of this, your doctor may recommend some changes to your diet, such as eating less salt or taking certain supplements
  • Vaccines may not work well when you are on Acthar. Talk to your doctor about which vaccines are safe to use while you are taking Acthar
  • Acthar may hide symptoms of other diseases. This can make it more difficult for your doctor to make a diagnosis of something else is going on
  • Stomach or intestinal problems. Acthar may increase the risk of bleeding and stomach ulcers. Tell your doctor if you have stomach pains, bloody vomit, bloody or black stools, excessive tiredness, increased thirst, difficulty breathing, or increased heart rate
  • Taking Acthar can make you feel irritable or depressed. You may also have mood swings or trouble sleeping. These effects are reversible once Acthar therapy is stopped
  • If you have other conditions, such as diabetes or muscle weakness, you may find they get worse
  • You might develop certain eye conditions, such as cataracts, glaucoma, or optic nerve damage
  • Your body may develop allergies to Acthar; these allergies may be severe. Signs of allergic reaction include:
    • Skin rash and itching
    • Swelling of the face, tongue, lips, or throat
    • Trouble breathing
  • The effects of Acthar may be intensified if you have an underactive thyroid or cirrhosis of the liver
  • Long-term Acthar use can affect growth and physical development in children. This can be reversed when Acthar is no longer needed
  • Acthar may cause osteoporosis (weak bones)
  • Acthar might harm an unborn baby. Therefore, tell your doctor if you are pregnant or plan to become pregnant

What are the most common side effects of Acthar?

Commonly reported side effects of Acthar include:

  • Injection site reaction
  • Fatigue, physical weakness, and lack of energy
  • Fluid retention
  • Insomnia (difficulty sleeping)
  • Headache
  • High blood sugar

The most common side effects for the treatment of infantile spasms (IS) are:

  • Increased risk of infections
  • Convulsions
  • High blood pressure
  • Irritability
  • Fever

The above side effects may also be seen in adults and children over 2 years of age. Some children with IS progress to other forms of seizures. IS sometimes makes these seizures, which may become visible after treatment for IS has been completed.

These are not all of the possible side effects of Acthar.

Tell your doctor about any side effect that bothers you, or that does not go away. Call your doctor or pharmacist for medical advice about side effects. You may report side effects to the FDA. Call 1-800-FDA-1088 or visit www.fda.gov/medwatch. You may also report side effects by calling 1-800-844-2830.

Please see the full Prescribing Information. If you've been prescribed SelfJect, please see the 40-unit or 80-unit Instructions for Use and the 40-unit or 80-unit Quick Reference Guide.

For parents and caregivers of children with infantile spasms, please also see Medication Guide.

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