BROCHURE ACTHAR: ANOTHER WAY TO TREAT MS RELAPSES IN ADULTS LEARN WHAT ACTHAR MAY DO FOR YOU Please see the Important Safety Information on pages 12 15 and the accompanying full Prescribing Information.
As a person living with multiple sclerosis (MS), you know how challenging MS relapses can be. Learning more about MS relapses can be a good first step to managing them and getting back to the life you want to lead. This brochure shares some information on MS relapses and resources that you can review and discuss with your healthcare provider. WHAT IS AN MS RELAPSE? MS 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 THAT WHAT I M EXPERIENCING IS AN MS RELAPSE? For an attack to be considered an MS relapse, it must meet the following 4 criteria: 1. Old symptoms of MS become worse or new symptoms appear This can happen suddenly or gradually 2. 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 3. 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 4. There must be no other explanation for the symptoms In an MS relapse, symptoms aren t connected to any other cause, like the flu, and do not resolve It s important to treat your MS relapses when that cause is identified and treated right away. When new or worsening symptoms appear, talk with your healthcare provider immediately so he or she can assess them. Please see the Important Safety Information on pages 12 15 and the accompanying full Prescribing 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 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 your healthcare provider has determined you are having a relapse, ask if Acthar may be right for you. H.P. Acthar Gel, commonly known as Acthar, is 1 of only 2 medications approved by the FDA for MS relapses in adults. 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 the relief of MS relapses in adults. Acthar may be prescribed for people who need another MS relapse treatment option. Visit ActharMSrelapse.com/info_kit to learn more about Acthar. Please see the Important Safety Information on pages 12 15 and the accompanying full Prescribing Information. 5
WHAT SIDE EFFECTS COULD I EXPERIENCE WITH ACTHAR? Acthar can cause side effects similar to those with steroid treatments. Side effects include: Increased risk of infections. You may be more likely to get new infections. Also, old infections may become active. Signs of infection are fever, cough, vomiting, or diarrhea. Other signs may be flu or any open cuts or sores Adrenal gland changes. Taking Acthar long term may cause symptoms of Cushing s syndrome, such as upper body fat, rounded moon face, bruising easily, or muscle weakness Increased blood pressure, body salt, and fluid. Your doctor may recommend changes to your diet Unpredictable response to vaccines. Talk to your doctor about which vaccines are safe to use when taking Acthar Masking other conditions. Tell your doctor if you have any infections, changes in weight, excessive tiredness, increased thirst, fast heart rate, or difficulty breathing 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 any pain in the stomach area, vomiting, or bloody or black stools Changes in mood or behavior. You may be irritable, have mood swings, be depressed, or have trouble sleeping 6
Worsening of other medical conditions, including diabetes Eye problems, such as cataracts, glaucoma, or optic nerve damage Allergic reactions. Tell your doctor if you have a skin rash, swelling, or trouble breathing 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 Acthar is believed to help your body reduce inflammation in multiple ways. WHAT IS ACTHAR? Acthar is not a steroid. Acthar is an MS relapse treatment that contains ACTH, a melanocortin peptide. Acthar is thought to work directly with your immune system.* Also, 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. * While the exact way that Acthar works in the body is unknown, further studies are being conducted. This information is based on laboratory data, and how it relates to patient benefits is unknown. Please see the Important Safety Information on pages 12 15 and the accompanying full Prescribing Information. 7
COULD ACTHAR BE RIGHT FOR ME? You may be among people with MS who sit by hoping that an MS relapse will pass on its own. Or someone who is not aware that there are treatment options available specifically for MS relapse. You do not have to suffer through a relapse untreated. Acthar may be an option to treat your MS relapse. 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, such as: A list of website resources to explore, including ActharMSrelapse.com/info_kit, which has more information on MS relapses and treatment with Acthar An Acthar discussion guide Complete the checklist 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 the Important Safety Information on pages 12 15 and the accompanying full Prescribing Information. 8
HOW CAN I GET ACTHAR? If you and your healthcare provider decide that Acthar is right for you, Mallinckrodt ARD, Inc., the distributor 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.). This is a no-cost service in place to support you every step of the way. Members of our professional team can Most insurance providers cover Acthar if you: help you receive Acthar, as well as injection Have trouble tolerating IV steroids training, so you or your Have not experienced symptom relief with IV steroids caregiver can learn how Have trouble receiving medication through your veins to inject the medication Remember: When it comes to at home. MS relapses, you re not alone. If you and your doctor thinks Acthar is right for you, A.S.A.P. is here to support you. Visit ActharMSrelapse.com/support or call A.S.A.P. at 1-888-435-2284. 9
WHAT RESOURCES ARE AVAILABLE? When you re living with MS relapses, you know how important it is to have access to answers and support. The most important resource you can turn to for help is your healthcare provider. There are also many other places you can go for information about MS relapses, how to manage them, how to prepare for relapses, and more. This guide includes some of those resources. Christine Acthar Ambassador Please see the Important Safety Information on pages 12 15 and the accompanying full Prescribing Information. 10
WEBSITES WITH INFORMATION ABOUT MS RELAPSES HELP......IS HERE Acthar ActharMSrelapse.com/info_kit American Academy of Neurology (AAN) aan.com/patients Can Do Multiple Sclerosis mscando.org Multiple Sclerosis Association of America (MSAA) mymsaa.org Multiple Sclerosis Foundation (MSF) msfocus.org National Institute of Neurological Disorders and Stroke (NINDS) ninds.nih.gov/disorders/ multiple_sclerosis National Multiple Sclerosis Society (NMSS) nationalmssociety.org These websites may identify third-party organizations and provide links to third-party websites or other third-party information ( Third-Party Content ). The Third-Party Content is meant for informational purposes only, is not endorsed by or under the control of Mallinckrodt, and is not meant to replace a physician s medical advice. Mallinckrodt has no responsibility or liability for and makes no representations whatsoever about any Third-Party Content. 11
WHAT IS ACTHAR? H.P. Acthar Gel (repository corticotropin injection) is a prescription medication used for the treatment of acute exacerbations of multiple sclerosis in adults. Controlled clinical trials have shown Acthar to be effective in speeding the resolution of acute relapses of multiple sclerosis. However, there is no evidence that it affects the ultimate outcome or natural history of the disease. IMPORTANT SAFETY INFORMATION Acthar is injected beneath the skin or into the muscle. Who should NOT take Acthar? You should not take Acthar if you have: A skin condition called scleroderma Allergies to pig-derived proteins Bone density loss or osteoporosis Been recently given a vaccine or are about to take one Any infections, including fungal, bacterial, or viral Suspected congenital infections (in children under Eye problems, such as ocular herpes simplex 2 years of age) Had recent surgery A condition where your adrenal glands produce Stomach ulcers or a history of ulcers either too much of certain hormones (as with Heart problems Cushing s syndrome), or not enough (adrenal High blood pressure 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. 12
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 13
IMPORTANT SAFETY INFORMATION (CONTINUED) 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 14
What are the most common side effects of Acthar? The most common side effects of Acthar are similar to those of steroids. They include: Fluid retention Behavior and mood changes Changes in blood sugar Changes in appetite and weight Increased blood pressure Specific side effects in children under 2 years of age include: Increased risk of infections Symptoms of Cushing s syndrome Increased blood pressure Cardiac hypertrophy (thickening of the heart muscle) Irritability Weight gain The above side effects may also be seen in adults and children over 2 years of age. 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 accompanying full Prescribing Information. 15
Visit ActharMSrelapse.com/info_kit to learn more about Acthar Mallinckrodt, the M brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. 2015 Mallinckrodt. PM-01-01-0605(1)b 08/15 Printed in USA. BROCHURE Katrina (front cover and above), Christine, and Paul (at left) Acthar Ambassadors