Finding an Effective Infantile Spasms Treatment for Your Child

A rare yet devastating condition, infantile spasms (IS) is a seizure disorder that typically occurs during the first 4-11 months of childhood. Children with IS have specific types of seizures called spasms. They also have chaotic brain-wave patterns called hypsarrhythmia.

Acthar is a prescription medication containing natural, highly purified adrenocorticotropin (a-DRE-no-cor-tico-tro-pin) hormone, or ACTH. Acthar was approved by the FDA as a treatment for IS and is one clinically proven therapy that has been shown to stop spasms and hypsarrhythmia (Learn more). In one clinical study reviewed by the FDA, 87% of children had no spasms and no hypsarrhythmia by week 2 after injections of 75 U/m2 twice a day. It’s important to know that every child will respond to treatment differently.

The most common side effects of Acthar in infants include infections, increased blood pressure, irritability and changes in behavior, changes in appetite and weight, diarrhea, and vomiting.

These are not all of the possible side effects of Acthar. For more information, ask your doctor, nurse, or pharmacist, or call 1-800-465-9217. You may report side effects to the FDA at 1-800-FDA-1088.

For a full list of indications, contraindications, warnings, precautions, and adverse events related to Acthar, please refer to the full Prescribing Information and Medication Guide.

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

Getting Acthar for
Your
Child

Getting Acthar for
Your
Child

Learn how we can help find ways to make Acthar affordable for you and your child.

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Meet Real Families Affected by IS

Meet Real Families Affected by IS

The Child Neurology Foundation’s Parent Mentor Network connects you with parents and caregivers who have faced IS.

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Important Safety Information

Patients, parents, and caregivers should be aware of the important information about H.P. Acthar® Gel.

Acthar should never be given intravenously (into a vein). Acthar should not be used in patients with a skin condition called scleroderma, bone density loss (osteoporosis), infection throughout the body, eye infection called ocular herpes simplex, recent surgery, history of or a current stomach ulcer, heart problems, high blood pressure, or allergy to pig-derived proteins. Tell your doctor about any health problems or medicines.

Acthar may cause side effects similar to side effects that happen due to treatment with steroid medicines. Not all of these side effects have occurred with Acthar, but they may occur. Acthar is a medicine that affects a patient’s immune system, and therefore patients may be more likely to get new infections, or inactive infections may become active. Acthar has effects on the adrenal gland. When a patient is taking Acthar, their adrenal gland may produce too much of a hormone called cortisol. This can cause symptoms of Cushing’s syndrome (upper body fat, rounded face, thin skin), which is more common in patients who take this medicine for a long time. When a patient stops taking Acthar after a long time, the body may not produce enough cortisol on its own (adrenal insufficiency). The doctor may prescribe a steroid medicine to protect the body until the adrenal gland recovers. Do not stop administering Acthar without talking to your doctor first. Your doctor may check your blood pressure during treatment and may instruct you to make some dietary changes. Patients should not receive certain vaccines during treatment with Acthar. Talk to your doctor about which vaccines are safe for use. Acthar may hide (or mask) symptoms of other conditions or diseases, and it may be more difficult for your doctor to diagnose other conditions or diseases in you or your child during treatment. The person receiving Acthar has an increased risk for bleeding from the stomach or having a stomach ulcer. Inform your doctor about any pain in the stomach area, bloody vomit, or bloody or black stools. While on Acthar, changes in mood and behavior such as irritability, depression, or trouble sleeping may occur.

Other side effects are possible. Acthar may make certain other medical conditions worse such as diabetes (may increase blood sugar); cause eye problems such as cataracts, increased pressure in the eye (glaucoma), and possible damage to the optic nerve; and cause allergic reactions to Acthar (seen as skin rash, swelling of the face, tongue, lips, or throat, and trouble breathing). Acthar may affect growth and physical development after long-term use. Long-term use of Acthar may cause an increase in the size of the heart, but this condition usually goes away after Acthar is stopped.

The most common side effects of Acthar in infants include infections, increased blood pressure, irritability and changes in behavior, changes in appetite and weight, diarrhea, and vomiting. Other adverse reactions reported in adults and children over 2 years of age included abdominal bloating, anxiety, asthma, chest discomfort, congestive heart failure, dizziness, shortness of breath, redness of the face, fluid retention, flushing, headache, injection site pain, tiredness, muscle weakness, nervousness, rapid heart rate, and lack of energy. Tell your doctor if there is any side effect that bothers you or your child or that does not go away.

These are not all of the possible side effects of Acthar. For more information, ask your doctor, nurse, or pharmacist, go to www.acthar.com, or call 1-800-465-9217. You may report side effects to the FDA at 1-800-FDA-1088.

For a full list of indications, contraindications, warnings, precautions, and adverse events related to Acthar, please refer to the full Prescribing Information. For parents and caregivers of IS patients, please also see Medication Guide.

Uses

H.P. Acthar® Gel (repository corticotropin injection) is an adrenocorticotropic hormone (ACTH) analogue used for:

  • Monotherapy treatment of infantile spasms in infants and children under 2 years of age.
  • The treatment of acute exacerbations of multiple sclerosis in adults.
  • Inducing a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus.
  • The treatment of an exacerbation or as maintenance therapy in select cases of systemic dermatomyositis (polymyositis).
  • The following: rheumatic disorders; collagen diseases; dermatologic diseases; allergic states; ophthalmic diseases; and respiratory diseases.

Important Safety Information

Patients, parents, and caregivers should be aware of the important information about H.P. Acthar® Gel.

Acthar should never be given intravenously (into a vein). Acthar should not be used in patients with a skin condition called scleroderma, bone density loss (osteoporosis), infection throughout the body, eye infection called ocular herpes simplex, recent surgery, history of or a current stomach ulcer, heart problems, high blood pressure, or allergy to pig-derived proteins. Tell your doctor about any health problems or medicines.

Acthar may cause side effects similar to side effects that happen due to treatment with steroid medicines. Not all of these side effects have occurred with Acthar, but they may occur. Acthar is a medicine that affects a patient’s immune system, and therefore patients may be more likely to get new infections, or inactive infections may become active. Acthar has effects on the adrenal gland. When a patient is taking Acthar, their adrenal gland may produce too much of a hormone called cortisol. This can cause symptoms of Cushing’s syndrome (upper body fat, rounded face, thin skin), which is more common in patients who take this medicine for a long time. When a patient stops taking Acthar after a long time, the body may not produce enough cortisol on its own (adrenal insufficiency). The doctor may prescribe a steroid medicine to protect the body until the adrenal gland recovers. Do not stop administering Acthar without talking to your doctor first. Your doctor may check your blood pressure during treatment and may instruct you to make some dietary changes. Patients should not receive certain vaccines during treatment with Acthar. Talk to your doctor about which vaccines are safe for use. Acthar may hide (or mask) symptoms of other conditions or diseases, and it may be more difficult for your doctor to diagnose other conditions or diseases in you or your child during treatment. The person receiving Acthar has an increased risk for bleeding from the stomach or having a stomach ulcer. Inform your doctor about any pain in the stomach area, bloody vomit, or bloody or black stools. While on Acthar, changes in mood and behavior such as irritability, depression, or trouble sleeping may occur.

Other side effects are possible. Acthar may make certain other medical conditions worse such as diabetes (may increase blood sugar); cause eye problems such as cataracts, increased pressure in the eye (glaucoma), and possible damage to the optic nerve; and cause allergic reactions to Acthar (seen as skin rash, swelling of the face, tongue, lips, or throat, and trouble breathing). Acthar may affect growth and physical development after long-term use. Long-term use of Acthar may cause an increase in the size of the heart, but this condition usually goes away after Acthar is stopped.

The most common side effects of Acthar in infants include infections, increased blood pressure, irritability and changes in behavior, changes in appetite and weight, diarrhea, and vomiting. Other adverse reactions reported in adults and children over 2 years of age included abdominal bloating, anxiety, asthma, chest discomfort, congestive heart failure, dizziness, shortness of breath, redness of the face, fluid retention, flushing, headache, injection site pain, tiredness, muscle weakness, nervousness, rapid heart rate, and lack of energy. Tell your doctor if there is any side effect that bothers you or your child or that does not go away.

These are not all of the possible side effects of Acthar. For more information, ask your doctor, nurse, or pharmacist, go to www.acthar.com, or call 1-800-465-9217. You may report side effects to the FDA at 1-800-FDA-1088.

For a full list of indications, contraindications, warnings, precautions, and adverse events related to Acthar, please refer to the full Prescribing Information. For parents and caregivers of IS patients, please also see Medication Guide.

Uses

H.P. Acthar® Gel (repository corticotropin injection) is an adrenocorticotropic hormone (ACTH) analogue used for:

  • Monotherapy treatment of infantile spasms in infants and children under 2 years of age.
  • The treatment of acute exacerbations of multiple sclerosis in adults.
  • Inducing a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus.
  • The treatment of an exacerbation or as maintenance therapy in select cases of systemic dermatomyositis (polymyositis).
  • The following: rheumatic disorders; collagen diseases; dermatologic diseases; allergic states; ophthalmic diseases; and respiratory diseases.