Important Safety Information

What is the most important information I should know about H.P. Acthar Gel?

Acthar can cause serious side effects, including:

  • Increased risk of infections. Acthar may affect your immune system. Therefore, patients may be more likely to get new infections, or inactive infections may become active. Tell your doctor right away if you have any signs of infection, such as fever, cough, vomiting, diarrhea; or sign of illness or flu; or any open cuts or sores.
  • Adrenal gland changes. 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. Tell your doctor right away if you experience weight loss, feel weak or tired, have stomach pain or develop a fever. Do not stop administering Acthar without talking to your doctor first.
  • Blood pressure changes. Acthar may cause an increase in blood pressure. Blood pressure should be checked during treatment.
  • Increased amount of water in the body, increased body salts, and low potassium in the blood. Acthar may cause your body to have increased amount of body salts and water that stays in the body, and may lower the amount of potassium in the blood. Your doctor may instruct you to make some dietary changes.
  • Vaccine eligibility. Patients should not receive certain vaccines during Acthar treatment. Talk to your doctor about which vaccines are safe for you.
  • Undetectable conditions. Acthar may hide (or mask) symptoms of other conditions or diseases, making it more difficult for your doctor to diagnose other conditions or diseases in you during treatment.
  • Stomach bleeding or ulcers. You may have an increased risk for bleeding from the stomach or having a stomach ulcer. Report any pain in the stomach area, vomiting or bloody vomit, bloody or black stools, excessive tiredness, increased thirst, difficulty breathing or increased heart rate.
  • Changes in mood or behavior. Irritability, depression, or trouble sleeping may occur.

What should I tell my doctor before using H.P. Acthar Gel?

Tell your doctor about all of your health conditions, including if you have:

  • A skin condition called scleroderma
  • Bone density loss (osteoporosis)
  • Infection throughout your body
  • An eye infection called ocular herpes simplex
  • Recently undergone surgery
  • History of or a current stomach ulcer
  • Heart problems
  • High blood pressure
  • Allergies to pig‐derived proteins
  • Diabetes
  • Kidney problems
  • Thyroid problems
  • Liver problems
  • Neuromuscular problems
  • Convulsions or seizures
  • Had exposure to someone with tuberculosis (TB)
  • Recently been vaccinated

Tell your doctor if you are pregnant or plan on becoming pregnant.

Tell your doctor about these and any other health conditions you may have or medicines you are taking, including prescription and non‐prescription medicines, vitamins, and herbal supplements.

How is H.P. Acthar Gel given?

Acthar should never be given intravenously (into a vein). Acthar is given as an injection into the muscle or under skin. Do not inject it into a vein, or give it by mouth. Inject Acthar exactly as your doctor tells you. Your doctor will tell you where to give the injection, how much to give, how often and when to give yourself the injection.

Refer to the full Prescribing Information for additional information on how Acthar is given.

What are the possible side effects of H.P. Acthar Gel?

See "What is the most important information I should know about H.P. Acthar Gel?"

Acthar can cause side effects similar to those that can happen with steroid treatments. Tell your doctor right away if you have any of the symptoms listed below while taking Acthar. Not all of the following side effects have occurred with Acthar, but they might be expected. Before beginning any treatment, you should discuss with your doctor the potential benefits and risks associated with Acthar.

Acthar can cause serious side effects.
Acthar may make certain other medical conditions worse such as diabetes (may increase blood sugar).

Acthar may cause:

  • eye problems such as cataracts, increased pressure in the eye (glaucoma), and possible damage to the optic nerve
  • 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.

Tell your doctor if you have any of the side effects listed above.

What are the most common side effects of H.P. Acthar Gel?

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
  • 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
  • lack of energy

Report side effects to your doctor. The side effects listed here are not all of the side effects possible with Acthar. Ask your doctor for more information. Tell your doctor if there is any side effect that bothers you or that does not go away.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1‐800‐FDA‐1088.

Please see full Prescribing Information for additional important safety information.

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

What is Acthar?

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

  • Treatment during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus.
  • 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 selected cases of systemic dermatomyositis (polymyositis).
  • The treatment of respiratory manifestations of symptomatic sarcoidosis.
  • The following: rheumatic disorders; collagen diseases; dermatologic diseases; allergic states; ophthalmic diseases; and respiratory diseases.

Important Safety Information

What is the most important information I should know about H.P. Acthar Gel?

Acthar can cause serious side effects, including:

What should I tell my doctor before using H.P. Acthar Gel?

Tell your doctor about all of your health conditions, including if you have:

Tell your doctor if you are pregnant or plan on becoming pregnant.

Tell your doctor about these and any other health conditions you may have or medicines you are taking, including prescription and non‐prescription medicines, vitamins, and herbal supplements.

How is H.P. Acthar Gel given?

Acthar should never be given intravenously (into a vein). Acthar is given as an injection into the muscle or under skin. Do not inject it into a vein, or give it by mouth. Inject Acthar exactly as your doctor tells you. Your doctor will tell you where to give the injection, how much to give, how often and when to give yourself the injection.

Refer to the full Prescribing Information for additional information on how Acthar is given.

What are the possible side effects of H.P. Acthar Gel?

See "What is the most important information I should know about H.P. Acthar Gel?"

Acthar can cause side effects similar to those that can happen with steroid treatments. Tell your doctor right away if you have any of the symptoms listed below while taking Acthar. Not all of the following side effects have occurred with Acthar, but they might be expected. Before beginning any treatment, you should discuss with your doctor the potential benefits and risks associated with Acthar.

Acthar can cause serious side effects.
Acthar may make certain other medical conditions worse such as diabetes (may increase blood sugar).

Acthar may cause:

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.

Tell your doctor if you have any of the side effects listed above.

What are the most common side effects of H.P. Acthar Gel?

The most common side effects of Acthar in infants include:

Other adverse reactions reported in adults and children over 2 years of age included:

Report side effects to your doctor. The side effects listed here are not all of the side effects possible with Acthar. Ask your doctor for more information. Tell your doctor if there is any side effect that bothers you or that does not go away.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1‐800‐FDA‐1088.

Please see full Prescribing Information for additional important safety information.

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

What is Acthar?

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