FOR MS RELAPSES Stepping toward a different treatment option LEARN WHAT ACTHAR CAN DO FOR YOU
As a person with multiple sclerosis (MS), you know firsthand the profound impact MS relapses can have on your life. Each relapse is different for every person, yet as unpredictable as MS relapses can be, treatment options do exist. Learning more about MS relapses and how Acthar may help you treat yours is the first step toward getting back to your life, the way you want to live it. What is an MS relapse? Multiple sclerosis is caused by damage to the protective covering that surrounds your nerve cells. This covering is called the myelin sheath. MS nerve damage is caused by inflammation. This inflammation occurs when the body s own immune cells attack the nervous system. This can occur in any area of the brain, optic nerve, or spinal cord. When the nerves are damaged in this way, nerve signals in these areas slow down or stop. Over the course of your journey with MS, you may find that new symptoms appear or existing symptoms worsen. When this happens, it is known as an MS relapse an acute attack, or exacerbation, of your MS symptoms. It is important to recognize MS relapses and take action quickly so you can treat them effectively. 2
How can I be sure I m having an MS relapse? For an attack to be considered an MS relapse, it must meet the following criteria: Old symptoms of MS become worse or new symptoms appear This can happen suddenly or gradually New or worsening symptoms must last at least 24 hours Unlike a pseudo-relapse, in which symptoms last less than 24 hours, true MS relapse symptoms last days, weeks, or even months Symptoms must occur at least 30 days after the last relapse Previous symptoms must remain stable for about 1 month prior to new or worsening symptoms There must be no other explanation for the symptoms In an MS relapse, symptoms aren t connected to any other cause and do not resolve when that cause is identified and treated It s important to treat your MS relapses right away. When new or worsening symptoms appear, talk with your healthcare provider immediately so he or she can assess them Please see pages 10 and 11 for Important Safety Information. 3
What are some symptoms of an MS relapse? Because each MS relapse can be different, symptoms can vary, too. Because nerves in any part of the brain or spinal cord may be damaged, people suffering from MS can have symptoms in many parts of the body. Common symptoms that can appear or worsen include: Vision loss Issues with chewing or swallowing Hand/arm weakness Bowel problems Fatigue Difficulty walking Speech changes Numbness/tingling Leg/foot weakness Sexual problems Muscle tightness or stiffness Coordination problems: tripping, dropping things Dizziness/poor balance Pain, burning, itching Bladder problems Memory problems Thinking problems Other symptoms 4
What should I know about Acthar as an option for treating my MS relapses? The first step in treating an MS relapse is to rule out other causes of the symptoms, including infections and overexertion. Once a relapse is identified, you have an FDA-approved treatment option: Acthar. H.P. Acthar Gel, commonly known as Acthar, has been used for over 30 years, and it was one of the first of only 2 medications approved by the FDA for MS relapses. Acthar contains the hormone ACTH, which stands for adrenocorticotropic ( a-dre-no-cor-ti-co-tro-pic ) hormone. It is a self-injectable treatment designed to speed recovery from MS relapses, and it has a well-established safety profile. Acthar may be prescribed for people who need an alternative MS relapse treatment. Common side effects of Acthar are similar to those seen with steroid medicines and may include fluid retention, change in glucose tolerance, increased blood pressure, behavior or mood changes, increased appetite, or weight gain. Visit www.acthar.com to learn more about Acthar Please see pages 10 and 11 for Important Safety Information. 5
How is Acthar different? Acthar is not a steroid. Acthar works in 2 ways: directly with your immune system and central nervous system and with your body to help it produce its own natural steroid hormones, such as cortisol, corticosterone, and aldosterone. These natural steroid hormones help reduce the inflammation causing your relapse. Also, Acthar is believed to affect T cells and B cells. This action is believed to impact the inflammatory processes. Acthar is an injectable treatment given subcutaneously (under the skin) or intramuscularly (into the muscle). Acthar injections can be self-administered or injected by a friend, family member, or healthcare provider. Acthar is believed to help your body reduce inflammation in multiple ways 6
Could Acthar be right for me? Have you ever been dissatisfied with your past MS relapse treatment and wished there was another effective treatment option available? Or are you interested in a treatment that can be self-injected at home or wherever is best for you? If so, Acthar might be right for you. Don t wait until your next relapse strikes. Let your healthcare provider know right away that you re interested in exploring this alternative treatment. In this kit, you ll find tools to help educate yourself and begin a conversation about Acthar with your healthcare provider: A webkey device that plugs into your computer s USB port and takes you directly to an Acthar website This site features more information on MS relapses and treatment with Acthar An Acthar request card entitled Could Acthar be right for me? Fill out the card and take it with you to your next appointment so you can review your current symptoms and treatments and discuss Acthar with your healthcare provider Ask your healthcare provider if Acthar might be right for you Please see pages 10 and 11 for Important Safety Information. 7
How can I get Acthar? If you and your healthcare provider decide that Acthar is right for you, Questcor, the maker of Acthar, wants to make sure you have all the resources you need to get your prescription. When your healthcare provider prescribes Acthar, you will automatically have access to the Acthar Support & Access Program (A.S.A.P.). Through this free service, members of our professional team will guide you every step of the way. They will: Handle the healthcare provider insurance relationship so you don t have to A.S.A.P. contacts your insurance company to secure the best insurance coverage with the lowest possible copay Speed delivery of the medication to your door by helping to coordinate delivery times and fulfillment expectations with the Specialty Pharmacy Coordinate injection training, if you need it, with Home Injection Training Services To learn more about A.S.A.P., visit www.acthar.com or call A.S.A.P. at 1-888-435-2284. 8
Nearly all insurance providers cover Acthar if you: Have trouble tolerating IV steroids Have not experienced symptom relief with IV steroids Have trouble receiving medication through your veins Remember: when it comes to MS relapses, you re not alone. Turn to Acthar and its support services to help you 9
Important Safety Information H.P. Acthar Gel (repository corticotropin injection) is indicated for the treatment of acute exacerbations of multiple sclerosis in adults. Controlled clinical trials have shown H.P. Acthar Gel to be effective in speeding the resolution of acute exacerbations of multiple sclerosis. However, there is no evidence that it affects the ultimate outcome or natural history of the disease. 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) 10
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, go to www.acthar.com, 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. 11
Visit www.acthar.com to learn more about Acthar H.P. Acthar Gel and Questcor are registered trademarks of Questcor Pharmaceuticals, Inc. 2013 Questcor Pharmaceuticals, Inc. PM-837-00 01/13 Printed in USA. 12