What Is Acthar?H.P. Acthar® Gel (repository corticotropin injection) is a prescription medicine for flares or on a regular basis (maintenance) in people with systemic lupus erythematosus (lupus).
Please see Important SafetyInformation on pages 14-17. Please see accompanying full Prescribing Information.
NEVER GIVING UPTHE FIGHT
Exploring your options for treating LUPUS
LIVING WITH LUPUS MEANS
WHY DO I NEED TREATMENT OPTIONS?At least 1.5 million Americans have lupus. Most are living with the type of lupus called systemic lupus erythematosus, or SLE. Despite being on treatment, many still experience active disease, and may need additional medicines to manage their symptoms.
Whether you’re new to treatment or already taking medicines for your lupus, it’s important to understand what treatment options are available.
This brochure is specifically about SLE, and will help you and your doctor explore those options, including H.P. Acthar® Gel (repository corticotropin injection), so you can keep up your fight against lupus.
WHAT ISLUPUS?Lupus is an autoimmune disease. There are different types of lupus—the most common type is systemic lupus erythematosus, often called “SLE” or “lupus” for short. It can affect your skin, your joints and the organs inside your body, including your kidneys. The disease can be mild or more severe.
There is no cure for lupus. However, with good medical care, most people living with lupus can manage their disease.
HOW DOES LUPUS AFFECT MY IMMUNE SYSTEM?Normally your immune system makes proteins called antibodies. They are the body’s natural defense system against germs and bacteria.
With lupus, your immune system can’t tell the difference between healthy cells and harmful germs. So by mistake it makes autoantibodies (“auto” means “self”) that attack and destroy healthy tissues. These antibodies cause inflammation, pain and damage to your body.
Please see Important Safety Information on pages 14-17. Please see accompanying full Prescribing Information. 3
DID YOU KNOW?
You can’t “catch” lupus from anyone. It’s a disease of your own immune (defense) system.
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LUPUS SYMPTOMS CAN VARYThe physical symptoms of lupus can come and go. You may experience periods of more active disease, referred to as flares (when symptoms worsen and you feel sick), and periods of remission (when symptoms improve and you feel better).
Symptoms of lupus can vary among patients. They can be mild or more serious, and can affect many parts of the body. The parts of the body that can be affected by lupus are shown in the diagram.
DID YOU KNOW?
• Lupus affects 10 times as many women as men. Children and teenagers can also develop lupus
• People of all races and ethnic groups can develop lupus, although women of color are 2 to 3 times more likely to develop lupus than Caucasians
BRAIN AND NERVOUS SYSTEM
• Extreme tiredness• Headaches• Fever
NOSE AND MOUTH
• Nose and mouth sores• Dry mouth
SKIN
• Butterfly-shaped rash across cheeks and nose
• Sensitivity to sun or light• Hair loss• Fingers turning white or blue
when cold
BLOOD
• Low red blood cell counts• Low white blood cell counts• Blood clotting• Other abnormal blood tests
KIDNEYS
• Kidney disease• Fluid retention and swelling in
feet, legs, hands or around eyes
JOINTS AND MUSCLES
• Painful or swollen joints• Muscle pain
HEART AND LUNGS
• Heart disease• Pain in chest with deep
breathing
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WHAT ARE MY TREATMENT OPTIONS?There are many medicines that can help manage lupus and lupus symptoms. Because everyone’s lupus is unique, your doctor— a rheumatologist, dermatologist, neurologist or other specialist— may create a treatment plan for you. It may include some of the more commonly-used medicines for lupus.
Acthar is FDA approved to treat lupus flares and for use on a regular basis (maintenance). Although Acthar has not been formally studied with other medicines, your doctor may prescribe it as part of a treatment regimen.
HOW ACTHAR IS THOUGHT TO WORKActhar is believed to work differently than other lupus medicines.
Acthar is not a steroid. It contains a naturally occurring, highly purified hormone called ACTH, which stands for adrenocorticotropic (a-DRE-no-cor-ti-co-TRO-pic) hormone.
One way Acthar is thought to work is by helping your body produce its own natural steroid hormones, such as cortisol. These hormones may assist your immune system by helping your body defend itself against inflammation.
Although the exact way Acthar works in the body is not completely understood, more research is being conducted. This information is based on nonclinical data where the relationship to clinical benefit is not known.
WHAT YOU NEED TO KNOW ABOUT ACTHARActhar should never be injected into a vein.
While taking Acthar 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. Signs of infection are fever, cough, vomiting or diarrhea. Other signs may be flu or any open cuts or sores.
Nonsteroidal anti-inflammatories,such as ibuprofen and naproxen
Medicine
Antimalarials, such as hydroxychloroquine
Tablet
Tablet
IV infusion
Tablet
Tablet
Injection
How it’s usually taken
Biologic treatments, such as belimumab
Corticosteroids,such as prednisone
Immunosuppressants,such as azathioprine
Actharrepository corticotropin
COMMON TREATMENT OPTIONS
Please see Important Safety Information on pages 14-17. Please see accompanying full Prescribing Information.
WHY CONSIDER ACTHAR FOR MY LUPUS?ACTHAR IS...
• FDA-approved to treat lupus flares and for use on a regular basis (maintenance)
• A treatment that has been used in other inflammatory and autoimmune diseases, such as rheumatoid arthritis and psoriatic arthritis
Acthar is an injection. It can be self-injected or given to you by a friend, family member, caregiver, doctor or nurse.
You can inject at home or wherever is best for you. At no cost to you, a nurse will teach you how to self-inject in the comfort of your own home.
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WHAT YOU NEED TO KNOW ABOUT ACTHARYou should not take Acthar if you have a skin condition called scleroderma, bone density loss (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 or allergies to pig-derived proteins. Tell your doctor about any health problems you have or medicines you are taking.
Please see additional Important SafetyInformation on pages 14-17. Please seeaccompanying full Prescribing Information.
A FIGHT TO INSPIRE
Hear other people living with lupus talk about their experience with Acthar at actharlupus.com/resources.
Get your Doctor Discussion Guide at
actharlupus.com/resources
and find out if Acthar
is right for you.
ACTHAR IS AN OPTION TO HELP FIGHT LUPUS
IS ACTHAR RIGHT FOR ME?Only you and your doctor can decide if Acthar is right for you. Ask your doctor to review your current treatment plan the next time you visit. Mention that you’ve heard about Acthar and would like to find out if it could be an option for treating your lupus.
Because every patient is unique, Acthar dosing is individualized—your doctor will decide how much Acthar you should take and when to take it according to your lupus symptoms.
WHAT HAPPENS AFTER I AM PRESCRIBED ACTHAR?You’ll automatically be enrolled in our Acthar Support & Access Program (A.S.A.P.). Provided at no cost to you, an Acthar Care Counselor will ensure you get support and encouragement every step of the way.
1. Your Acthar Care Counselor will call you and work directly with your doctor and insurance company to help get the best coverage with the lowest possible co-pay.
2. You’ll receive our Keep Up the Fight Against Lupus welcome kit containing tools and resources to help you get started on Acthar.
3. Your Acthar will be shipped directly to you as fast as possible from a specialty pharmacy.
4. A nurse can train you on how to self-inject Acthar in the comfort of your own home.
5. You’ll receive ongoing support and coaching, including a toll-free 24/7 nurse hotline to answer any questions you may have while on Acthar.
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DOWNLOAD AND DISCUSS!
Download your Doctor Discussion Guide at actharlupus.com/resources to help you talk about Acthar with your doctor.
WITH YOU EVERY STEP OF THE FIGHT
Remember, your doctor is your primary source of information. Call your doctor if you have any questions. Learn more about Acthar support programs at actharlupus.com/support.
WHAT YOU NEED TO KNOW ABOUT ACTHARYou should not take Acthar if you have recently been given a vaccine or are about to take one, or you have a condition where your adrenal glands produce either too much of certain hormones (as with Cushing’s syndrome), or not enough (adrenal insufficiency).
Please see additional Important SafetyInformation on pages 14-17. Please seeaccompanying full Prescribing Information.
CONNECT WITH YOUR LUPUS COMMUNITYThe lupus community is very active in supporting patients and their families. These associations are dedicated to finding a cure for lupus. Their free programs and information can be helpful in making your life with lupus a little easier.
Lupus Foundation of America (LFA) Visit lupus.org
Alliance for Lupus Research (ALR) Visit lupusresearch.org
Lupus Research Institute (LRI) Visit lupusresearchinstitute.org
Molly’s Fund Visit mollysfund.org
GLOSSARYDEFINITION OF WORDS IN THIS BROCHURE
Antibody—Proteins produced by your immune system to fight germs, other invaders and foreign particles.
Autoantibodies—Antibodies that attack the body’s own healthy cells, rather than defending them.
Flare—A time when your symptoms worsen in one or more organ systems in your body. Your doctor may consider increasing or changing your treatment.
Immune system—Protects the body from harm by recognizing and destroying viruses, fungi, bacteria, toxins, chemicals and other foreign bodies.
Maintenance—Taking medicine on a regular basis in order to prevent relapses.
Specialty pharmacy—A type of pharmacy specializing in the shipment and handling of certain medications, including Acthar, that are not found in retail pharmacies.
To find out more about Acthar, please visit us at actharlupus.com
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WHAT YOU NEED TO KNOW ABOUT ACTHARThe most common side effects of Acthar are similar to those of steroids. They include fluid retention, changes in blood sugar, increased blood pressure, behavior and mood changes and changes in appetite and weight.
WE’RE IN THIS FIGHT TOGETHER
Don’t be shy—go online, make a call, go to a lupus event. Check out the lupus community section at actharlupus.com/community.
The third party websites on this page are meant for informational purposes only, are not endorsed by or under the control of Mallinckrodt Pharmaceuticals, and are not meant to replace a physician’s medical advice. Mallinckrodt Pharmaceuticals has no responsibility or liability for and makes no representations whatsoever about any third party website.
Please see additional Important SafetyInformation on pages 14-17. Please seeaccompanying full Prescribing Information.
IMPORTANT SAFETY INFORMATIONWho 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
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Please see accompanying full Prescribing Information for ImportantSafety Information.
• 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 similarto those of steroids. They include:
• Fluid retention• Changes in blood sugar• Increased blood pressure• Behavior and mood changes• Changes in appetite and weight
Specific side effects in children under 2 years of age include:
• Increased risk of infections• Increased blood pressure• Irritability• Symptoms of Cushing’s syndrome• Cardiac hypertrophy (thickening of the heart muscle)• Weight gain
The above side effects may also be seen in adults and children over 2 years of age.
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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.
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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-01-12-0967(2) 11/15 Printed in USA.
Please see Important Safety Information on pages 14-17. Please see accompanying full Prescribing Information.
To find out more about Acthar, visit us atactharlupus.com
LUPUS DOESN’T MEAN YOUR BODY HAS GIVEN UP ON YOU
