Acthar Gel for infantile spasms: baby smiling Acthar Gel for infantile spasms: baby smiling

Getting a diagnosis of infantile spasms is the first step toward treatment

Acthar Gel for infantile spasms

Could my baby have infantile spasms?

Infantile spasms (IS) is a seizure disorder in babies. It’s extremely rare, with only about 2000 to 2500 cases in the United States each year.

Acthar Gel for infantile spasms: baby resting on mom’s chest

Parents and caregivers are usually the first people to notice the motions and behaviors that give infantile spasms its name. Initially, you might think your baby has colic or another routine health problem. However, parents of children with IS often say that “something just doesn’t feel right” about the way their baby is acting.

What you may see

Spasms usually begin within a baby’s first year. They occur most often in the morning or after a nap. They may last from less than a few seconds to up to 10 seconds, and they can happen in clusters of 2 to 100 at a time.

Spasms, which are a type of seizure, involve sudden, uncontrolled movements. These include:

Repetitive bending of the neck, trunk, and limbs lasting 1–2 seconds
Extension of arms, legs, or both
A brief head drop
Multiple spasms are more common than a single event, and often occur on awakening in the morning or after a nap
Other seizure types may arise

If your baby is having sudden, uncontrolled movements, it could be infantile spasms. Take a video of their symptoms and share it with your pediatrician.

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

Infantile spasms stopped for a majority of children who took Acthar Gel

A study of medical records examined children with infantile spasms at 2 weeks and 3 months after treatment with Acthar Gel. Ninety-seven of the 230 children in the study were treated with Acthar Gel.

Of those 97 children in the study,

68%

had no spasms or hypsarrhythmia
after 2 weeks of treatment.

Hypsarrhythmia is a chaotic pattern of brain waves that happens in children with infantile spasms. It can only be detected with an electroencephalogram (EEG).


After 3 months of treatment,

55% of those 97 children taking Acthar Gel still
had no spasms or hypsarrhythmia.

Remember that Acthar Gel can have similar side effects to what your child may experience with steroids. Common side effects of Acthar Gel include infections, increased blood pressure, irritability and changes in behavior, changes in appetite and weight, diarrhea, and vomiting. These are not all the possible side effects of Acthar Gel. You should talk to your pediatrician if your baby has any side effect that bothers them or does not go away.

There were certain limits in this study. Acthar Gel is not a cure. Though Acthar Gel has been shown to help some children, not all children may experience the same results. Additionally, the study did not take into account the effectiveness of Acthar Gel as it relates to the cause of IS.

Infantile spasms stopped for most children after 2 weeks of treatment with Acthar Gel

A single-blinded clinical trial of 29* children with infantile spasms compared the effectiveness of Acthar Gel to prednisone after 2 weeks of treatment. In this study:

87%

of 29 children treated with Acthar Gel had no spasms or
hypsarrhythmia after 2 weeks of treatment compared
with 29% of children who were treated with prednisone.

*Not every child in the study was treated with Acthar Gel. The study included 29 children, and 15 children were treated with Acthar Gel.

The most frequent side effects were irritability and excessive appetite after treatment with Acthar Gel. High blood pressure and high blood sugar levels were monitored. No child needed to stop or change treatment because of these side effects.

There were certain limits in this study. Acthar Gel is not a cure. Though Acthar Gel has been shown to help some children, not all children may experience the same results. Most of the children who did not respond to prednisone did respond to Acthar Gel treatment. And 1 of the 2 children who didn’t respond to Acthar Gel did respond to prednisone.

Acthar Gel patient using laptop: resources for treatment journey

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Resources to support you as you provide care for your child with IS

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Talk to your doctor about Acthar Gel.

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GET THE IS MEDICATION Guide
Get more information on infantile spasms and Acthar Gel.
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What is 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.

IMPORTANT SAFETY
INFORMATION

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

  • Suspected infections at birth (in infants under 2 years of age)
  • Has been given or is 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

Tell your doctor about any other health problems that your child has. Give your doctor a complete list of medicines your child is 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, under your child’s skin, or give it to your child by mouth
  • Always inject Acthar into the muscle of your child
  • 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 your child while taking Acthar
  • Your child 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, people’s adrenal glands 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 people stop taking Acthar long-term, their bodies may not produce enough natural cortisol. This is called “adrenal insufficiency.” Your doctor may prescribe a steroid medicine to protect your child until the adrenal gland recovers
  • Your child 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 child’s diet, such as eating less salt or taking certain supplements
  • Vaccines may not work well when people are on Acthar. Talk to your doctor about which vaccines are safe to use when your child is taking Acthar
  • Acthar may hide symptoms of other diseases. This can make it more difficult for your doctor to make a diagnosis if something else is going on
  • Stomach or intestinal problems. Acthar may increase the risk of bleeding and stomach ulcers. Tell your doctor if your child has stomach pains, bloody vomit, bloody or black stools, excessive tiredness, increased thirst, difficulty breathing, or increased heart rate
  • Taking Acthar can make people feel irritable or depressed. They may also have mood swings or trouble sleeping. These effects are reversible once Acthar therapy is stopped
  • If your child has other conditions, such as diabetes or muscle weakness, you may find they get worse
  • Your child might develop certain eye conditions, such as cataracts, glaucoma, or optic nerve damage
  • Your child’s 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 your child has 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. People should tell their doctor if they 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 masks 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 your child, 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-10881-800-FDA-1088 or visit www.fda.gov/medwatch. You may also report side effects by calling 1-800-844-2830 1-800-844-2830.

Please see full Prescribing Information for additional Important Safety Information.

For parents and caregivers of patients with IS, please also see Medication Guide.

What is 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.

What is 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.

IMPORTANT SAFETY INFORMATION

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

  • Suspected infections at birth (in infants under 2 years of age)
  • Has been given or is 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

Tell your doctor about any other health problems that your child has. Give your doctor a complete list of medicines your child is 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, under your child’s skin, or give it to your child by mouth
  • Always inject Acthar into the muscle of your child
  • 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 your child while taking Acthar
  • Your child 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, people’s adrenal glands 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 people stop taking Acthar long-term, their bodies may not produce enough natural cortisol. This is called “adrenal insufficiency.” Your doctor may prescribe a steroid medicine to protect your child until the adrenal gland recovers
  • Your child 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 child’s diet, such as eating less salt or taking certain supplements
  • Vaccines may not work well when people are on Acthar. Talk to your doctor about which vaccines are safe to use when your child is taking Acthar
  • Acthar may hide symptoms of other diseases. This can make it more difficult for your doctor to make a diagnosis if something else is going on
  • Stomach or intestinal problems. Acthar may increase the risk of bleeding and stomach ulcers. Tell your doctor if your child has stomach pains, bloody vomit, bloody or black stools, excessive tiredness, increased thirst, difficulty breathing, or increased heart rate
  • Taking Acthar can make people feel irritable or depressed. They may also have mood swings or trouble sleeping. These effects are reversible once Acthar therapy is stopped
  • If your child has other conditions, such as diabetes or muscle weakness, you may find they get worse
  • Your child might develop certain eye conditions, such as cataracts, glaucoma, or optic nerve damage
  • Your child’s 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 your child has 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. People should tell their doctor if they 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 masks 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 your child, 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-10881-800-FDA-1088 or visit www.fda.gov/medwatch. You may also report side effects by calling 1-800-844-2830 1-800-844-2830.

Please see full Prescribing Information for additional Important Safety Information.

For parents and caregivers of patients with IS, please also see Medication Guide.

What is 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.

IMPORTANT SAFETY INFORMATION

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

  • Suspected infections at birth (in infants under 2 years of age)
  • Has been given or is 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

Tell your doctor about any other health problems that your child has. Give your doctor a complete list of medicines your child is 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, under your child’s skin, or give it to your child by mouth
  • Always inject Acthar into the muscle of your child
  • 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 your child while taking Acthar
  • Your child 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, people’s adrenal glands 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 people stop taking Acthar long-term, their bodies may not produce enough natural cortisol. This is called “adrenal insufficiency.” Your doctor may prescribe a steroid medicine to protect your child until the adrenal gland recovers
  • Your child 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 child’s diet, such as eating less salt or taking certain supplements
  • Vaccines may not work well when people are on Acthar. Talk to your doctor about which vaccines are safe to use when your child is taking Acthar
  • Acthar may hide symptoms of other diseases. This can make it more difficult for your doctor to make a diagnosis if something else is going on
  • Stomach or intestinal problems. Acthar may increase the risk of bleeding and stomach ulcers. Tell your doctor if your child has stomach pains, bloody vomit, bloody or black stools, excessive tiredness, increased thirst, difficulty breathing, or increased heart rate
  • Taking Acthar can make people feel irritable or depressed. They may also have mood swings or trouble sleeping. These effects are reversible once Acthar therapy is stopped
  • If your child has other conditions, such as diabetes or muscle weakness, you may find they get worse
  • Your child might develop certain eye conditions, such as cataracts, glaucoma, or optic nerve damage
  • Your child’s 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 your child has 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. People should tell their doctor if they 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 masks 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 your child, 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-10881-800-FDA-1088 or visit www.fda.gov/medwatch. You may also report side effects by calling 1-800-844-2830 1-800-844-2830.

Please see full Prescribing Information for additional Important Safety Information.

For parents and caregivers of patients with IS, please also see Medication Guide.