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You may be wondering

About Acthar Gel

What is Acthar Gel?

Acthar Gel is a treatment for people living with certain chronic inflammatory or autoimmune conditions. It is administered as an injection. It can be given subcutaneously (under the skin) or intramuscularly (into the muscle). It's a mixture of proteins and natural hormones similar to ones that already exist in your body.

For certain conditions, if you're still experiencing symptoms on your current treatment, ask your doctor if Acthar Gel may be the right treatment for you.

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How is Acthar Gel thought to work?

Acthar Gel is not a steroid

Acthar Gel is thought to work differently from steroids. Acthar Gel interacts with melanocortin receptors and may affect cell activity relating to your condition.

Remember that Acthar Gel can have similar side effects to what you may experience with steroids.

Acthar Gel is believed to work with your immune system

Acthar Gel is thought to work with the body’s immune system to help reduce inflammation associated with certain chronic inflammatory or autoimmune conditions.

The way Acthar Gel works is not fully understood. Further studies are being done. The information above is based on lab and clinical data, and how it relates to patient benefits is unknown.

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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.