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Who should not take Acthar?

You should not take Acthar if you have:

• A skin condition called scleroderma
• Bone density loss or osteoporosis
• Any infections, including fungal, bacterial, or viral
• Eye problems, such as ocular herpes simplex
• Had recent surgery
• Stomach ulcers or a history of ulcers
• Heart problems
• High blood pressure
• Allergies to pig-derived proteins
• Been recently given a vaccine or are about to take one
• Suspected congenital infections (in children under 2 years of age)
• A condition where your adrenal glands produce either too much of certain hormones (as with Cushing's syndrome), or not enough (adrenal insufficiency)

Tell your doctor if you have any of these conditions or any other health problems. Also, share with your doctor what medicines you are taking. Don't forget to mention nonprescription medicines, vitamins, and herbal supplements.

What is the most important information
I should know about Acthar?

• Never inject Acthar directly into a vein, and always take Acthar as prescribed by your doctor
• Never stop treatment suddenly unless your doctor tells you to
• Try not to miss any scheduled doctor's appointments, as it is important for the doctor to monitor you while taking Acthar

Acthar can cause side effects similar to those with steroid treatments. While taking Acthar, tell your doctor right away if you have any of the symptoms listed here:

• Increased risk of infections. You may be more likely to get new infections. Also, old infections may become active. Before and during treatment, 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
• Adrenal gland changes. When taking Acthar long term, your adrenal gland may produce too much of a hormone called cortisol, which may cause symptoms of Cushing's syndrome, such as upper body fat, rounded "moon" face, bruising easily, or muscle weakness
• Sometimes when you stop taking Acthar long term, your body may not produce enough cortisol on its own. This is called "adrenal insufficiency." Your doctor may prescribe a steroid medicine to protect you until the adrenal gland recovers
• Increased blood pressure, body salt, and fluid levels. Your doctor may check your blood pressure while you are being treated with Acthar. He or she may recommend some changes to your diet, such as eating less salt and taking certain supplements
• Unpredictable response to vaccines. Talk to your doctor about which vaccines are safe to use when you are taking Acthar
• Masking other conditions. 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 put you at increased risk for bleeding from the stomach or getting 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
• Changes in mood or behavior. Taking Acthar can make you feel irritable or depressed. You may also have mood swings or trouble sleeping
• Worsening of other medical conditions. If you have other conditions, such as diabetes or muscle weakness, you may find they get worse
• Eye problems. It's possible that you may develop certain eye conditions, such as cataracts, glaucoma, or optic nerve damage
• Allergic reactions. Your body may develop antibodies or become sensitive when Acthar is used long term. Signs of allergic reaction in children are:
  • Skin rash
  • Swelling of the face, tongue, lips, or throat
  • Trouble breathing
• Problems with growth and physical development. Using Acthar long term can affect growth and physical development in children. This can be reversed when Acthar is no longer needed
• Bone density loss. Acthar may cause osteoporosis at any age
• Potential harm to unborn baby. Tell your doctor if you are pregnant or plan on becoming pregnant

What are the most common side effects of Acthar?

The most common side effects of Acthar are similar to those of steroids. They include:

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 or visit www.fda.gov/medwatch. You may also report side effects by calling 1-800-778-7898.

Please see full Prescribing Information.

H.P. Acthar^® Gel [H P AK-thar jel]
(repository corticotropin injection)

What is H.P. Acthar Gel?

Acthar is a prescription medicine for the 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).

Acthar is injected beneath the skin or into the muscle.