Acthar Gel patient: Brandi carrying backpack outdoors Acthar Gel patient: Brandi carrying backpack outdoors

For people with dermatomyositis and polymyositis

Relief is possible

What are dermatomyositis and polymyositis?

About dermatomyositis

Dermatomyositis is a chronic inflammatory condition that causes gradual changes in your skin and weakness in your muscles. Most people with dermatomyositis have symptoms in their shoulders, neck, arms, and legs.

About polymyositis

Polymyositis is a chronic inflammatory condition that causes gradual weakness in your muscles. Most people with polymyositis have symptoms in their shoulders, arms, hips, thighs, and belly/abdomen.

We don’t know what causes these conditions. Most likely, both family history and factors in your environment may contribute to them.

People who have been living with dermatomyositis or polymyositis for a while may have seen their condition spread to new areas of the body. If you’ve been living with dermatomyositis or polymyositis and are still experiencing symptoms, you’re not alone. There may be a treatment that can help.

How you may feel

Signs and symptoms of dermatomyositis and polymyositis

Your dermatomyositis or polymyositis may make you feel muscle weakness and stiff joints.

People with dermatomyositis often have symptoms on their skin, such as painful or itchy red or purple spots.

Doctors saw improvements in some people with DM-PM after treatment with Acthar Gel

A study based on a review of medical records looked at how Acthar Gel affected the symptoms of people with DM-PM. The study examined 8 people for 12 months before and for 12 months after treatment with Acthar Gel.

The most commonly reported symptoms in this study included:

Muscle weakness

Pain

Stiffness/pain in joints

Swelling

Of the 8 people in the study, 6 reported changes in their DM-PM symptoms. Doctors rated 67% of these 6 people as having symptoms that improved.*

*Of the 6 people who reported changes in their symptoms, doctors also rated 1 person as having symptoms that worsened and 1 person as having no change in symptoms. There were no results reported for 2 of the 8 people included in the study.

Two people reported side effects. Common side effects included bruising and red or bloodshot eyes. One person reported a serious side effect (shortness of breath).

There were certain limits in this study. Acthar Gel is not a cure. Though Acthar Gel has been shown to help some people, not all people may experience the same results. Keep in mind that people in these clinical settings were on several treatments in addition to Acthar Gel. The results seen in these people may not be due to Acthar Gel.

Some people with dermatomyositis and polymyositis experienced improvements after treatment with Acthar Gel

A separate 24-week, unblinded study examined the health of 10 people* with dermatomyositis and polymyositis after taking Acthar Gel.

70%

of the 10 people in the study saw improvements in their condition after taking Acthar Gel.

Some people had increased strength in their muscles and improved function in their joints. Some people who had moderate to severe rashes saw improvements in rashes after taking Acthar Gel.

*The study started with 11 people. One person stopped participating in the study because of a symptom not related to treatment with Acthar Gel.

100%

of the 10 people in the study reduced their steroid dose.

&
50%

of the 10 people in the study stopped using steroids completely.

Eight patients reported side effects. Common side effects included injection site bruising and rash, high blood sugar, and trouble sleeping. Three patients reported serious side effects (viral infections, bone loss, and chest pain).

There were certain limits in this study. Acthar Gel is not a cure. Though Acthar Gel has been shown to help some people, not all people may experience the same results. Keep in mind that people in these clinical settings were on several treatments in addition to Acthar Gel. The results seen in these people may not be due to Acthar Gel.

Acthar Gel patient: Cynthia shares her experience treating her dermatomyositis with Acthar Gel

MEET CYNTHIA

"After talking to my doctor, on the risks and the benefits, we decided to go with Acthar Gel."

Individual results may vary. Actual patient compensated for her time.

Acthar Gel patient: Tottie shares her experience treating her polymyositis with Acthar Gel

MEET TOTTIE

"Be an advocate for your own health."

Individual results may vary. Actual patient compensated for her time.

Acthar Gel patient using laptop: resources for treatment journey

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Resources for your treatment journey

Download tools to help you learn more about Acthar Gel.

Talk to your doctor about Acthar Gel.

GET RESOURCES
Get the facts on dermatomyositis and polymyositis.
DOWNLOAD THE FACT SHEET
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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 symptoms of 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 when you are 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 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 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 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 1-800-FDA-1088 or visit www.fda.gov/medwatch. You may also report side effects by calling 1-800-844-28301-800-844-2830.

Please see 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 see the Medication Guide.

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 symptoms of 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.

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 symptoms of 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 when you are 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 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 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 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 1-800-FDA-1088 or visit www.fda.gov/medwatch. You may also report side effects by calling 1-800-844-28301-800-844-2830.

Please see 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 see the Medication Guide.

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 symptoms of 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 when you are 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 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 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 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 1-800-FDA-1088 or visit www.fda.gov/medwatch. You may also report side effects by calling 1-800-844-28301-800-844-2830.

Please see 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 see the Medication Guide.