KEEP UP THE FIGHT AGAINST LUPUS Acthar Self-Injection Step-by-Step Guide 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 Safety Information on pages 5-6. Please see accompanying full Prescribing Information. LEARNING TO SELF-INJECT: A NURSE IS READY TO HELP hether you’re a first-timer or you’ve self-injected before, an Acthar W Home Injection Training Services (HITS) nurse can take you step-bystep through this guide and answer any questions you may have. Call 1-888-435-2284 to get your free, one-on-one injection training from a HITS nurse. Remember, never inject Acthar directly into a vein, and always take Acthar as prescribed by your doctor. COMMON QUESTIONS PEOPLE ASK OUR HITS NURSES Q: I’ve never self-injected before—will it hurt? A: Injections may hurt a little bit, but not as much as you’d expect. The needle is shorter and thinner than the needle used for, say, a flu shot. Ice can help reduce any pain after you inject. After your Acthar home injection training, you can self-inject or have a nurse or family member do it for you. Q: H ow do I choose whether to inject “under the skin” or “into the muscle?” A: Both methods work equally well—it’s a matter of what your doctor recommends for you. Your HITS nurse can explain the differences. Always follow your doctor’s instructions. Q: How do I dispose of my used needles? A: You’ll need to get a special puncture-proof container (called a sharps container) from a pharmacist or doctor. Or you can use an empty detergent bottle and the handy label you’ll find in your Acthar Keep Up the Fight Against Lupus welcome kit. When the container is full, dispose of it properly according to your local trash removal guidelines. GET NO-COST INJECTION TRAINING Be sure to get your injection training from a HITS nurse BEFORE you self-inject. Call 1-888-435-2284 to contact a nurse. Please see Important Safety Information on pages 5-6. Please see accompanying full Prescribing Information. 2 TIPS TO HELP YOU INJECT WITH CONFIDENCE Make sure you (or your helper) have received injection training from your doctor or a HITS nurse before you inject. Some tips: • Practice. As you get familiar, you’ll get more comfortable and it may take less time • Relax. Take slow deep breaths. You’ll find some relaxation techniques in your treatment journal • Think positive. Try to think about something pleasant while you inject—it may help take your mind off any pain you may feel • Ice it. If you do feel pain after injecting, put pressure on the area or use an ice pack for a few minutes. See your doctor if you notice any injection site reactions, like redness, pain or swelling • Buddy up. Ask someone to sit with you for moral support or to help you remember what to do • Ask for help. Talk to your doctor or an ActharPACT nurse coach at 1-888-983-1639 if worrying is getting in the way of taking your Acthar CALL YOUR DOCTOR RIGHT AWAY IF... • You can’t give yourself the injection and you don’t have someone to help you inject • The needle breaks off at the injection site • You inject medicine into the wrong area • The injection site doesn’t stop bleeding • The injection site is irritated or swollen • You experience a lot of pain, shortness of breath, fever or chills, allergic reaction or any other side effect 3 REMEMBER TO ROTATE! You can inject the same area more than once a week, but leave 1 inch between sites. BEFORE YOU INJECT • Make sure you have done all the steps on your self-injection preparation place mat before injecting. •R emember: Do not inject until you have been trained by your doctor or a nurse • DO NOT swallow Acthar or inject into: - A vein - The same site more than once a week - An area that is irritated, painful, red, swollen, hardened or sensitive to touch - Warts, tattoos, scars or birthmarks - Belly button - Knee or groin REMEMBER TO WRITE IT DOWN Be sure to record your injections in your Keep Up the Fight Against Lupus treatment journal Please see Important Safety Information on pages 5-6. Please see accompanying full Prescribing Information. 4 IMPORTANT SAFETY INFORMATION Who should NOT take H.P Acthar® Gel (repository corticotropin injection) 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 •U npredictable response to vaccines. Talk to your doctor about which vaccines are safe to use when you are taking Acthar •M asking 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 5 •C hanges in mood or behavior. Taking Acthar can make you feel irritable or depressed. You may also have mood swings or trouble sleeping •W orsening of other medical conditions. If you have other conditions, such as diabetes or muscle weakness, you may find they get worse • E ye problems. It’s possible that you may develop certain eye conditions, such as cataracts, glaucoma, or optic nerve damage •A llergic 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 •B one density loss. Acthar may cause osteoporosis at any age •P otential 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 similar to 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. 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. 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-01-12-1459(1) 11/15 Printed in USA. 6 SELECTING YOUR INJECTION SITE After you have selected your injection site, refer to the next pages for how to inject under the skin or into the muscle. WHERE TO INJECT? • For self-injection, use your thigh or abdomen • If someone else will be injecting you, go to actharlupus.com/injectionvideos for more information Please see Important Safety Information on pages 5-6. Please see accompanying full Prescribing Information. 7 H.P. Acthar® Gel (repository corticotropin injection) INJECTION UNDER THE SKIN SELF-INJECTING YOUR UPPER THIGH 1. Sit on a chair. Keep thigh relaxed. Place hands as shown—one hand on knee, one hand near hip. 2. Injections should be done in the shaded area between both hands, toward the outside of the thigh, as shown. 3. Go to HOW TO INJECT. SELF-INJECTING YOUR ABDOMEN 1. Sit on a firm chair. Place hands as shown, on lower ribs. Injections should be done below this area, where there is enough skin to pinch. 2. Do not inject within a 1-inch area around the belly button. 3. Go to HOW TO INJECT. 8 INJECTION INTO THE MUSCLE SELF-INJECTING YOUR UPPER THIGH MUSCLE 1. Sit on a chair. Keep thigh relaxed. Place your hands as shown—one with the fingertips on your knee, the other immediately behind it. You will inject the muscle that runs along the upper-outer edge of the thighbone. 2. Injections should be done in the shaded area between both hands, that is, the middle third of the outer thigh, as shown. 3. Go to HOW TO INJECT. VIDEO: SEE HOW IT’S DONE Go to actharlupus.com/resources to watch videos of a nurse demonstrating how to self-inject, as well as how to inject if someone is doing it for you. • Step-by-step injecting under the skin • Step-by-step injecting into the muscle • Self-injection refresher video Please see Important Safety Information on pages 5-6. Please see accompanying full Prescribing Information. 9 HOW TO INJECT Do these steps after you have prepared for your injection as described on your self-injection preparation place mat, and after you have selected your injection site as shown in this guide. 1. C lean the site to be injected with an alcohol swab. 2. P ress the plunger until a droplet forms on the tip of the needle. UNDER THE SKIN INTO THE MUSCLE or 3a. If injecting under the 3b. If injecting into the skin: pinch the skin around the injection site with your free hand. muscle: stretch and hold the skin around the injection between the thumb and fingers of your free hand. or NOTE: about 1/8” of the needle should be visible above the skin. 4. H old the syringe like a dart. Using a quick motion, insert the needle at a 90-degree angle through the skin as shown. 10 5. Check for blood by pulling the plunger slightly. • If no blood appears in the syringe, slowly push the plunger in until the syringe is empty, then pull the needle straight out • If blood appears in the syringe, withdraw the needle, press on the site with a gauze pad, and start over at a different site with a new needle 6. P ull needle out. • When the syringe is empty, pull the needle straight out • Press the injection site with a gauze pad • Use an ice cube if you feel pain at the injection site •W ipe the site clean of any blood and apply an adhesive bandage 7. B ravo! You did it! • P ut the used syringe, needle and needle cap in your needle disposal container • Wash your hands with soap and water CALL 1-888-435-2284 • Get one-on-one training with a HITS nurse Please see Important Safety Information on pages 5-6. Please see accompanying full Prescribing Information. 11 DISPOSING OF USED SYRINGES, NEEDLES AND VIALS Use a special leak-proof, puncture-resistant container (called a sharps container) from your pharmacist. Or you can use an empty detergent bottle labeled with your sharps container label (see below). When your container is full: • Label it clearly “not for recycling” • Seal the lid with heavy-duty tape • Store out of reach of children or pets • F ollow state laws for disposal DO NOT reuse or recycle syringes, needles and Acthar vials (once empty); do not throw them in the trash. BIOHAZARD SHARPS CONTAINER Do not recycle Sample. For your convenience, please find sharps container labels in the pocket of this booklet with the Prescribing Information. Please note that this content should be used as guidance only. Consult your doctor or nurse with any questions or concerns about injecting with Acthar. 12
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