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For adults with multiple sclerosis attacks

Relief is possible

What is multiple sclerosis?

Multiple sclerosis (MS) is a neuroinflammatory condition that affects your brain and spinal cord. It can affect how you walk, your speech, and even your thought process. The exact cause of MS is unknown. Research suggests that both family history and factors in your environment may contribute to multiple sclerosis.

MS is often characterized by relapses or exacerbations, also known as attacks. MS attacks can happen at any time, which can make the condition feel unpredictable.

People who have been living with MS attacks may still have symptoms, even while they take medicine. If you are an adult who has been living with MS attacks 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 multiple sclerosis attacks

As with many conditions, different people experience MS attacks in different ways. Each attack can be unlike the last.

You may experience symptoms such as:

Pain

Muscle
tightness or
stiffness

Poor balance

Fatigue

Vision loss

Numbness or
tingling

These are just some of the symptoms associated with an MS attack. Symptoms can vary from person to person, so be sure to talk to your doctor about any symptoms you may be having.

Some people with MS attacks experienced improvements after taking Acthar Gel

An unblinded registry study looked at the effects of Acthar Gel in adults with MS attacks. In this study, the physical and psychological impact of MS was rated in 125* people 2 months and 6 months after taking Acthar Gel. People used a questionnaire to report their physical and psychological well-being.

The study measured how much MS affects daily activities, including:

The ability to perform
physically demanding tasks

How bothersome are
balance problems, difficulty
moving, and stiffness

Limitations on regular activities

And psychological impacts such as:

Problems concentrating

Feeling mentally fatigued

*145 people were enrolled in the study of which 125 received at least 1 dose of Acthar Gel and contributed to the study data.

After 2 months of treatment, some people in the study self-reported

IMPROVEMENTS

in their physical and psychological subscale scores.

For these people, improvements were maintained 6 months after starting Acthar Gel.

Thirty-five people reported side effects. Common side effects included MS attack, urinary tract infection, common cold, and swelling in the arms or legs. Eleven people reported serious side effects (MS attack, urinary tract infection, and weakness).

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 all be due to Acthar Gel.

Acthar Gel patient: Kimberly shares her experience of taking Acthar Gel

MEET KIMBERLY

"I definitely do not let MS define
who I am."

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

Some people with MS attacks experienced improvement in MS-related vision problems after taking Acthar Gel

A separate unblinded study examined people with optic neuritis who took Acthar Gel. In the study, 24 adults took Acthar Gel for a total of 15 days.

Following treatment with Acthar Gel

IMPROVEMENTS

in visual impairment due to optic neuritis were observed.

Three people reported side effects. Common side effects included changes to the structures of the eye (unrelated to treatment), spots in vision, and possible change in hearing. Three people reported serious side effects (allergic reaction, a diagnosis of breast cancer [unrelated to treatment], and MS attack).

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 all be due to Acthar Gel.

Optic neuritis is a common MS-related eye condition that may lead to pain and temporary vision loss typically in 1 eye.

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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
  • Always inject Acthar beneath the skin or into the muscle
  • 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. Signs of allergic reaction are:
    • 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 for additional Important Safety Information.

For parents and caregivers of patients with Infantile Spasms, please click here for Important Safety Information.