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. © 2017 Mallinckrodt. ARDUS/01-01/0217/0005 2/17 Printed in USA IMPORTANT FACTS ABOUT H.P. Acthar Gel Please read this summary carefully and ask your doctor about Acthar. No advertisement can provide all the information needed to determine if a drug is right for you or take the place of careful discussions with your healthcare provider. What is H.P. Acthar Gel used for? Acthar is a prescription medicine used to treat acute relapses or flares of multiple sclerosis (MS) in adults. Studies have shown H.P. Acthar Gel to be effective in speeding recovery from an MS relapse. However, there is no evidence that Acthar affects the ultimate outcome or natural history of the disease. Acthar is injected beneath the skin or into the muscle. Acthar should NEVER be injected directly into a vein. When should I not take H.P. Acthar Gel? DO NOT take Acthar until you have talked to your doctor if you have any of the following conditions: • A skin condition called scleroderma • Bone density loss or osteoporosis • Any infections, including fungal, bacterial or viral • Eye infections such as ocular herpes simplex • Had recent surgery • Stomach ulcers or a history of stomach ulcers • Heart failure • Uncontrolled high blood pressure • Allergies to pig-derived proteins • Have been given or are about to receive a live or live attenuated vaccine • Suspected congenital infections (in children under 2 years of age) • Cushing’s syndrome or Addison’s disease What warnings should I know about H.P. Acthar Gel? Infections: You may be more likely to get new infections. Also, old infections may become active. Tell your doctor if you see any signs of an infection or 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. Cushing’s syndrome or adrenal insufficiency: When taking Acthar long term, your adrenal gland may produce too much of a hormone called cortisol. This can result in symptoms of Cushing’s syndrome including increased upper body fat, a rounded “moon” face, bruising easily and muscle weakness. Adrenal insufficiency may occur after you stop taking Acthar. Signs of adrenal insufficiency include weakness, patches of darker skin, weight loss, low blood pressure and belly pain. Recovery from adrenal insufficiency may take from days to months. Your doctor may prescribe steroids during this period. You should not stop taking Acthar suddenly. Follow your doctor’s instructions when stopping Acthar treatment. High blood pressure: You might develop high blood pressure or retain too much fluid. As a result of this your doctor may recommend some changes to your diet, such as eating less salt and taking certain supplements. Vaccination: Vaccines may not work well when you are on Acthar. Talk to your doctor about which vaccines are safe to use when you are taking Acthar. Hiding symptoms of other diseases: Acthar may hide symptoms of other diseases without changing the course of the other disease. You should be monitored during and for a while after you stop taking Acthar for signs of infection, abnormal heart function, high blood pressure, high blood sugar, change in weight and bloody or black stools. Stomach or intestinal problems: Acthar may increase the risk of bleeding 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, trouble sleeping or personality changes. Also, existing emotional instability may be worsened. Worsening of pre-existing conditions: If you have other conditions, such as diabetes or muscle weakness, you may find they get worse. Eye conditions: You might develop certain eye conditions, such as cataracts, glaucoma or optic nerve damage. Allergies to Acthar: Long-term use may increase the risk of developing an allergic reaction to Acthar. Signs of allergic reaction include: skin rash and itching; swelling of the face, tongue, lips or throat, trouble breathing. Weak bones: Acthar may cause osteoporosis at any age. Post- menopausal women are at increased risk of osteoporosis and bone density should be monitored before starting Acthar and during long-term therapy on Acthar. Are there special considerations for certain groups of people taking Acthar? Use in pregnancy: Acthar might harm an unborn baby. Tell your doctor if you are pregnant or plan on becoming pregnant. Nursing mothers: You and your doctor should decide whether to discontinue nursing or discontinue Acthar, considering the risk to the nursing infant and the benefit to the mother. Children: Long-term use of Acthar can affect growth and physical development in children and should be carefully monitored. This can be reversed when Acthar is no longer needed. What are the most common side effects of Acthar? The most common side effects of Acthar are similar to those of steroids, including: fluid retention, high blood sugar, high 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, high blood pressure, irritability, symptoms of Cushing’s syndrome, thickening of the heart muscle (cardiac hypertrophy) and 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 You may also report side effects by calling 1-800-778-7898. BRIEF SUMMARY OF IMPORTANT SAFETY INFORMATION