In the treatment of Infantile Spasms, other types of seizures may occur because some patients with infantile spasms progress to other forms of seizures (for example, Lennox-Gastaut Syndrome). Additionally the spasms sometimes mask other seizures and once the spasms resolve after treatment with H.P. Acthar Gel, the other seizures may become visible. Parents and caregivers should inform their physician of any new onset of seizures so that appropriate management can then be instituted. [see Adverse Reactions (6.1.1)].

H.P. Acthar* Gel(repository corticotropin injection)

Manufactured for Questcor Pharmaceuticals, Inc.

Questcor Pharmaceuticals, Inc. 3260 Whipple Road Union City, CA 94587 USA

phone (800) 411-3065           (510) 400-0700 fax     (510) 400-0799

PL065/Rev. 02  No. 1350Issued: 10/2010

H.P. Acthar® Gel (H P AK-thar jel)(repository corticotropin Injection)

This Medication Guide provides information only about the use of H.P. Acthar Gel for the treatment of Infantile Spasms. If your doctor prescribes H.P. Acthar Gel for you or your child for any other reason, talk to your doctor for information about how this medicine is used to treat your medical condition.

Read this Medication Guide before your child receives H.P Acthar Gel and each time you refill your child’s prescription. There may be new information. This Medication Guide does not take the place of talking with your doctor about your child’s medical condition or treatment.

What is the most important information I should know about H.P. ACTHAR GEL?

H.P. Acthar Gel can cause serious side effects including:

1. Increased risk of infections. H.P Acthar Gel is a medicine that can affect your child’s immune system. When your child is taking H.P. Acthar Gel, it can lower the ability of your child’s immune system to fight infections. H.P. Acthar Gel may:

Before starting H.P. Acthar Gel, tell your doctor if your child has:

While taking H.P. Acthar Gel, your child should:

2. Effects on the adrenal gland after stopping H.P. Acthar Gel.

When your child stops taking H.P. Acthar Gel, his or her body may not produce enough of a hormone called cortisol on its own (adrenal insufficiency). Your child may need to take steroid medicine to protect the body until the adrenal gland recovers and is working well again, especially to protect the body if they have surgery or trauma. Do not stop giving your child injections of H.P. Acthar Gel without talking to your doctor first. Your doctor will tell you when and how to slowly stop giving the injections to avoid serious side effects.

While slowly stopping your child’s injections of H.P. Acthar Gel or after you stop giving the injections, call your doctor right away if your child has any of the following:

3. Effects on the adrenal gland while taking H.P. Acthar Gel

When your child is taking H.P. Acthar Gel, his or her adrenal gland may produce too much cortisol. This can cause symptoms of Cushing’s syndrome. Cushing’s syndrome is more common in children who take H.P. Acthar Gel for a long time.

Symptoms of Cushing’s syndrome include:

While receivin