What is Acthar?

H.P. Acthar® Gel, or Acthar, is a prescription medication containing the hormone adrenocorticotropin ("a-DRE-no-cor-ti-co-tro-pin"), also known as ACTH. Acthar is FDA-approved for the treatment of dermatomyositis (DM) and polymyositis (PM).

Learn More »

Who Could Benefit From Acthar?

Acthar is FDA-approved for use during an exacerbation or as maintenance therapy in selected cases of systemic dermatomyositis (polymyositis).

Understand Your Condition

Acthar and Dermatomyositis/ Polymyositis

Dermatomyositis (DM) and polymyositis (PM) are two types of myositis, a disorder caused by inflammation of muscle tissue. DM and PM are types of myositis included in a group of autoimmune muscle diseases that result in chronic muscle inflammation and muscle weakness. Another name used to describe the group of muscle diseases that includes DM and PM is idiopathic (that is, unknown) inflammatory myopathies. There is no cure for these conditions, but treating them is important to help keep the muscle weakness and other clinical signs of DM and PM from getting worse. Common symptoms of DM and PM include muscle weakness, muscle pain,and feeling tired. Muscle weakness may present as difficulty going up stairs, getting up from a chair, reaching your arms up over your head, or swallowing. There are other types of myositis, such as inclusion body myositis (IBM); Acthar is not approved for treatment of IBM.

In addition to worsening muscle weakness, both DM and PM may include symptoms of weight loss, symptoms of lung inflammation, such as shortness of breath or cough, and/or a low-grade fever. Patients with DM, but not PM, may have a patchy skin rash that most often occurs on the eyelids and on the skin over the muscles used to extend or straighten joints, such as knuckles, elbows, knees, and toes. DM symptoms and signs also may include a swollen area around the fingernails, hard bumps under the skin created by calcium deposits, and sensitivity to light.

When you experience worsening of disease symptoms, Acthar may be an option.

Only your healthcare provider can determine if Acthar may be right for you.

Learn More »

Questcor

Uses

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

Monotherapy treatment of infantile spasms (IS) in infants and children under 2 years of age.
The treatment of exacerbations of multiple sclerosis in adults.
For 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 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, 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.

H.P. Acthar^® Gel and Questcor^® are registered trademarks of Questcor Pharmaceuticals, Inc.

Prescribing Information

Acthar Referral/Prescription Form