References

Baram TZ, Mitchell WG, Tournay A, Snead OC III, Hanson RA, Horton EJ. High-dose corticotropin (ACTH) versus prednisone for infantile spasms: a prospective, randomized, blinded study. Pediatrics. 1996;97:375-379.
Brunson KL, Khan N, Eghbal-Ahmadi M, Baram TZ. Corticotropin (ACTH) acts directly on amydgala neurons to down-regulate corticotropin-releasing hormone gene expression. Ann Neurol. 2001;49:304-312.
Catania A, Gatti S, Colombo G, Lipton JM. Targeting melanocortin receptors as a novel strategy to control inflammation. Pharmacol Rev. 2004;56:1-29.
Data on file: RD-001-00. Questcor Pharmaceuticals, Inc.
Data on file: RD-002-00. Questcor Pharmaceuticals, Inc.
Data on file: RD-003-00. Questcor Pharmaceuticals, Inc.
Data on file: RD-004-00. Questcor Pharmaceuticals, Inc.
Glaze DG, Hrachovy RA, Frost JD Jr, Kellaway P, Zion TE. Prospective study of outcome of infants with infantile spasms treated during controlled studies of ACTH and prednisone. J Pediatr. 1988;112:389-396.
H.P. Acthar® Gel (repository corticotropin injection) prescribing information, Questcor Pharmaceuticals, Inc; October 2010.
Hrachovy RA, Frost JD Jr. Severe encephalopathic epilepsy in infants: infantile spasms (West syndrome). In: Pellock JM, Bourgeois BFD, Dodson WE, eds. Pediatric Epilepsy: Diagnosis and Therapy. 3rd ed. New York, NY: Demos Medical Publishing, LLC; 2008:249-268.
Kivity S, Lerman P, Ariel R, Danziger Y, Mimouni M, Shinnar S. Long-term cognitive outcomes of a cohort of children with cryptogenic infantile spasms treated with high-dose adrenocorticotropic hormone. Epilepsia. 2004;45:255-262.
Koo B, Hwang PA, Logan WJ. Infantile spasms: outcome and prognostic factors of cryptogenic and symptomatic groups. Neurology. 1993;43:2322-2327.
Lombroso CT. A prospective study of infantile spasms: clinical and therapeutic correlations. Epilepsia. 1983;24:135-158.
Mackay MT, Weiss SK, Adams-Webber T, et al. Practice parameter: medical treatment of infantile spasms: report of the American Academy of Neurology and the Child Neurology Society. Neurology. 2004;62:1668-1681.
Pellock JM, Hrachovy R, Shinnar S, et al. Infantile spasms: a U.S. consensus report. Epilepsia. 2010;51:2175-2189.
Sher PK, Sheikh MR. Therapeutic efficacy of ACTH in symptomatic infantile spasms with hypsarrhythmia. Pediatr Neurol.1993;9:451-456.
Shields WD. Infantile spasms: little seizures, big consequences. Epilepsy Curr. 2006;6:63-69.
Singer WD, Haller JS, Sullivan LR, Wolpert S, Mills C, Rabe EF. The value of neuroradiology in infantile spasms. J Pediatr. 1982;100:47-50.
Singer WD, Rabe EF, Haller JS. The effect of ACTH therapy upon infantile spasms. J Pediatr. 1980;96:485-489.
Sorel L, Dusaucy-Bauloye A. [Findings in 21 cases of Gibbs’ hypsarrhythmia; spectacular effectiveness of ACTH.] Acta Neurol Psychiatr Belg. 1958;58:130-41.

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

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