Find Out How Acthar Works

How Acthar Works for Excess Urinary Protein

Acthar is a prescription medication containing a natural, highly purified adrenocorticotropin hormone (ACTH), which has been used for over 30 years to effectively treat patients for a variety of conditions.

Acthar binds to specific receptors in the body (often called melanocortin “receptors” or “MCRs” by healthcare professionals). There are 5 different types of these receptors throughout the body, and Acthar binds to all 5 of them. Some of these MCR receptors are found in the adrenal cortex. This is the outer portion of the adrenal gland found on the top of each of your kidneys.

Acthar is believed to work in 2 ways

Acthar is believed to work in the adrenal cortex to release natural steroid hormones that help control key body functions. Acthar is not a steroid, but it does cause some actions in your body in a way that's similar to steroids.

Acthar also causes effects in your body beyond what steroids can do. Other MCRs are found in cells inside your kidneys. Acthar is believed to work here by producing effects that help lower protein levels in your urine to a more normal level.

The exact mechanism of action of Acthar is unknown, and further investigation is being conducted.

This information is based on nonclinical data and the relationship to clinical benefit is unknown.

Dosing for Your Acthar Treatment

The usual dose of Acthar is 40-80 units injected either beneath the skin (subcutaneously) or into the muscle (intramuscularly) every 24-72 hours. This treatment is a self-injection, so you have the option of giving it to yourself at home or any place that works best for you. In some cases, you can also have it injected by a healthcare professional or caregiver.

Your doctor will decide on the best dose for you. In a recent case series, the usual dose of Acthar for treating proteinuria was 80 units injected subcutaneously twice a week for 6 months. Dosage and frequency may vary. It's important for you to complete the full course of Acthar as instructed by your doctor.

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 call1-800-465-9217. 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.

PM-776-00

Uses

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

  • 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 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.

PM-776-00

Uses

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

  • 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 following: rheumatic disorders; collagen diseases; dermatologic diseases; allergic states; ophthalmic diseases; and respiratory diseases.