CUSTOMIZED TREATMENT FOR YOUR SEVERE SPASTICITY

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1 CUSTOMIZED TREATMENT FOR YOUR SEVERE SPASTICITY FDA-approved Gablofen for ITB Therapy SM (Intrathecal Baclofen Therapy) WARNING: DO NOT STOP GABLOFEN SUDDENLY Suddenly stopping baclofen given into your spine can cause fever; changes in alertness, thoughts, or mood; an increase in spasms; and stiff muscles that in rare events can lead to muscle breakdown, failure of organs in the body, and death. It is very important that you keep scheduled refill visits and be able to recognize the early symptoms of baclofen withdrawal. Some people have a higher chance of having withdrawal, such as patients with certain spinal injuries, difficulty communicating, or a history of withdrawal symptoms from baclofen taken by mouth or given into the spine. Read the technical manual of the pump for additional patient information. See additional Important Risk Information, including boxed warning, inside and in enclosed Full Prescribing Information.

2 SPASTICITY AND ITB THERAPY SM (INTRATHECAL BACLOFEN THERAPY) WHAT IS SPASTICITY? Spasticity is a health problem. It causes you to have more muscle tone or stiffness than normal. It may make it hard to move or talk. It may also cause discomfort or pain. In most cases, spasticity is caused by damage to nerve pathways in the brain or spinal cord that control your muscles. A LOOK AT TREATMENT Spasticity treatment options may include use of baclofen, a muscle relaxant. Baclofen may be taken either orally (by mouth) or by injection. In cases of severe spasticity, your doctor may suggest an intrathecal baclofen (ITB) pump. If spasticity is caused by traumatic brain injury, wait at least 1 year after injury before you consider intrathecal baclofen treatment. A surgeon places the pump under the skin of your stomach. The medicine passes from the pump, through a tiny tube into a space around your spine (called the intrathecal space). This intrathecal space is filled with fluid. The pump is programmed to constantly deliver baclofen. This medicine gives ongoing relief of symptoms for weeks to months at a time. For some patients, ITB Therapy SM may help decrease spasticity and other symptoms. It may help improve certain daily activities. Suddenly stopping intrathecal baclofen may cause fever; changes in alertness, thoughts, or mood; more spasms; and stiff muscles. Rarely, this can lead to muscle breakdown, failure of organs in the body, and death. Be sure to talk to your doctor. Learn how to spot the signs and symptoms of getting too much or too little baclofen. ESTABLISHED TREATMENT ITB Therapy SM is an established and widely accepted treatment option. Over 60,000 baclofen pumps have been installed worldwide since Studies show that ITB Therapy SM lowers spasticity and spasms. HOW THE PUMP WORKS The sealed ITB pump has a chamber. It holds enough liquid baclofen to give up to 180 days of treatment for some patients. When it s time to refill your pump, your doctor can change the amount of baclofen you get. The pump is programmed to give medicine all the time. The goal is to control your spasticity in a way that meets your needs. SPINAL COLUMN CATHETER INSERTED INTO SPINAL COLUMN PUMP IMPLANTED UNDER SKIN Suddenly stopping baclofen therapy can lead to serious side effects such as high fever, confusion, stiffness in muscles, failure of organs in the body, and death. Early signs of baclofen withdrawal include an increase in muscle spasms, itching, and tingling feelings in the arms and legs. If you think you are experiencing baclofen withdrawal or your pump is not working correctly, you should go to a hospital immediately. The side effects of receiving too much baclofen can happen very quickly or can happen gradually and be difficult to notice. The side effects of receiving too much baclofen include confusion, tiredness, light-headedness, dizziness, slow or short breathing, seizures, less strength in the muscles, loss of consciousness, and coma. 2 3

3 UNDERSTANDING ITB THERAPY SM LONG-TERM MANAGEMENT ITB Therapy SM has proven useful for long-term control of severe spasticity: CATHETER TIP It works at a lower dose than oral baclofen. The pump is programmed to give you medicine all the time. PUMP WHY PUMP THERAPY IS DIFFERENT Baclofen taken by mouth must move through your digestive system before reaching a certain point in your central nervous system. An ITB pump sends the medicine right to the fluid around your spine. Because of this, it works at a lower dose than oral baclofen. You need to take oral baclofen as often as 3 to 4 times a day. An ITB pump is programmed to give medicine all the time. So you don t need to think about taking it. Baclofen can cause decreased activity in your brain, your heart not being able to pump enough blood, and severe breathing problems that can cause death. Trained medical professionals must be present during screening, dose changes, and pump refills. Taking too much baclofen can cause tiredness, light-headedness, dizziness, breathing problems, seizures, decreased muscle strength, and loss of consciousness that could lead to coma. 4 5

4 TREATMENT STARTING TREATMENT REFILLING AND PROGRAMMING THE PUMP A surgeon will implant the pump. In the few weeks following, your doctor will change the dose of baclofen to meet your needs. Your doctor may adjust your other medicines too. Your doctor will explain to you how to spot the signs and symptoms of getting too much or too little baclofen. You will need to see your doctor and healthcare team for refills. Your doctor will make sure the pump is working the right way and change the dose to meet your needs. A trained healthcare worker will empty your pump and then refill it using a needle that goes through your skin and into the pump chamber. The pump battery can last 4 to 7 years before it needs to be replaced. The pump can be replaced or removed by your surgeon if needed. PROGRAMMING HEAD EXTERNAL PUMP PROGRAMMER It is very important that you keep scheduled refill visits and be able to recognize the early symptoms of baclofen withdrawal. Some people have a higher chance of having withdrawal, such as patients with certain spinal injuries, difficulty communicating, or a history of withdrawal symptoms from baclofen taken by mouth or given into the spine. Read the technical manual of the pump for additional patient information. 6 7

5 GABLOFEN IS FDA APPROVED FOR ITB THERAPY SM CHOOSING AN INTRATHECAL BACLOFEN You and your doctor have chosen ITB Therapy SM. Now it s time to talk about the details of treatment, including the medicine. Gablofen (baclofen injection) is a type of intrathecal baclofen that can be used in your pump. Features include more strengths, prefilled syringes, and vials. WHAT S IN IT FOR YOU? Gablofen is for patients aged 4 years and older with severe spasms caused by problems in the brain or spine. It may be an option if oral baclofen does not relieve your spasms or causes side effects that you can t tolerate. Inspired by feedback from patients and healthcare professionals, Gablofen is designed to make pump refills faster and easier. Here are some of the features: Ease of use: Gablofen comes in prefilled syringes and vials that give the right dose with no measuring or mixing. Safety: Gablofen packaging may help reduce the risk of contamination of your medicine during pump refills. Time savings: Gablofen saves time with fewer steps and faster refill prep than medications provided in glass ampules. This may mean less time in your doctor s office. More refill options: Gablofen comes in 3 strengths including the first new refill strength in 20 years. Three different strengths mean that you can get refills on a schedule that works better for you. Equivalent: Gablofen is rated equivalent to Lioresal. Your doctor may have prescribed this medicine for you. The FDA says that both medicines can be used in an ITB pump.* That means it s OK to start treatment with one medicine and switch to the other. FDA approved Each batch tested 3 strengths to fit your needs Prefilled syringes mean no mixing or measuring Factory-sealed vials Approved for use In Medtronic SynchroMed II Pump Gablofen can be used for up to 180 days in the Medtronic SynchroMed II Programmable Pump. An overdose that can kill you can occur if Gablofen is injected into the wrong place in your pump. May cause tiredness. Be careful when driving and performing other tasks in which you should be fully alert. Tiredness may become more severe when Gablofen is used with alcohol or other medications that make you less alert. Ask your doctor about ITB Therapy SM with Gablofen. *Use only with Medtronic SynchroMed II Programmable Pump (or other pumps labeled for intrathecal administration of Gablofen (baclofen injection)). 8 9

6 USE Gablofen (baclofen injection) is used to treat severe spasms caused by problems in the brain or spine in adults and children 4 years and older. Gablofen is for patients who do not have relief or have side effects they cannot tolerate from taking baclofen by mouth. WARNING: DO NOT STOP GABLOFEN SUDDENLY Suddenly stopping baclofen given into your spine can cause fever; changes in alertness, thoughts, or mood; an increase in spasms; and stiff muscles that in rare events can lead to muscle breakdown, failure of organs in the body, and death. It is very important that you keep scheduled refill visits and be able to recognize the early symptoms of baclofen withdrawal. Some people have a higher chance of having withdrawal, such as patients with certain spinal injuries, difficulty communicating, or a history of withdrawal symptoms from baclofen taken by mouth or given into the spine. Read the technical manual of the pump for additional patient information. MEDICAL REASONS NOT TO USE GABLOFEN You are allergic to baclofen. Gablofen should not be injected into a vein, muscle, under the skin, or as an epidural. WARNINGS An overdose that can kill you can occur if Gablofen is injected into the wrong place in your pump. Gablofen can cause decreased activity in your brain, your heart not being able to pump enough blood, and severe breathing problems that can cause death. Trained medical professionals must be present during screening, dose changes, and pump refills. Taking too much Gablofen can cause tiredness, lightheadedness, dizziness, breathing problems, seizures, decreased muscle strength, and loss of consciousness that could lead to coma. If you have psychotic problems, schizophrenia, or other mental problems, Gablofen could make these problems worse. People have died while receiving Gablofen into their spine. Suddenly stopping Gablofen can cause a condition that can lead to uncontrolled high blood pressure. Gablofen dosing may be more difficult if you are sick. Having an infection when your pump is placed may increase the risk of complications from the surgery. May cause tiredness. Be careful when driving and performing other tasks in which you should be fully alert. Tiredness may become more severe when Gablofen is used with alcohol or other medications that make you less alert. May cause a mass to form in your spine. May cause cysts to form on the ovaries in women. SIDE EFFECTS Serious Side Effects Suddenly stopping Gablofen can lead to serious side effects such as high fever, confusion, stiffness in muscles, failure of organs in the body, and death. Early signs of Gablofen withdrawal include an increase in muscle spasms, itching, and tingling feelings in the arms and legs. If you think you are experiencing Gablofen withdrawal or your pump is not working correctly, you should go to a hospital immediately. The side effects of receiving too much Gablofen can happen very quickly or can happen gradually and be difficult to notice. The side effects of receiving too much Gablofen include confusion, tiredness, light-headedness, dizziness, slow or short breathing, seizures, less strength in the muscles, loss of consciousness, and coma. Other serious side effects: may cause a mass to form in your spine, drainage, infection, infection in your spine (meningitis), difficulty in controlling the middle part of your body, leakage of fluid from the spine, coma, and death. Common Side Effects The most common side effects in patients with muscle spasms that come from the spine were less strength in the muscles (25.3%), tiredness (20.9%), dizziness, nausea/ vomiting, low blood pressure, headache, and convulsions. The most common side effects in patients with muscle spasms that come from the brain were less strength in the muscles (34.7%), tiredness (18.7%), headache (10.7%), feeling agitated, constipation, low number of white blood cells, feeling cold, and difficulty urinating. Other common side effects are breathing that is too shallow or too slow, stiffness in the muscles, feelings of tingling, pricking, or burning, increased salivation, back pain, itching, diarrhea, swelling in the arms or legs, less strength, pain, confusion, difficulty talking, lazy eye, accidental injury, and dry mouth. USE IN SPECIFIC POPULATIONS Pregnancy: The effect of baclofen in labor and delivery is unknown. Baclofen passes into the breast milk and may cause serious side effects in your baby. Gablofen is not approved for children below the age of 4 years old. For additional Important Risk Information, including boxed warning, see enclosed Full Prescribing Information

7 Learn more about Gablofen Talk to your doctor about whether Gablofen (baclofen injection) is the right choice for treating your severe spasticity. The side effects of receiving too much Gablofen can happen very quickly or can happen gradually and be difficult to notice. The side effects of receiving too much Gablofen include confusion, tiredness, lightheadedness, dizziness, slow or short breathing, seizures, less strength in the muscles, loss of consciousness, and coma. The most common side effects in patients with muscle spasms that come from the spine were less strength in the muscles (25.3%), tiredness (20.9%), dizziness, nausea/vomiting, low blood pressure, headache, and convulsions. The most common side effects in patients with muscle spasms that come from the brain were less strength in the muscles (34.7%), tiredness (18.7%), headache (10.7%), feeling agitated, constipation, low number of white blood cells, feeling cold, and difficulty urinating. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call FDA gablofen.com Mallinckrodt, the M brand mark, the Mallinckrodt Pharmaceuticals logo and other brands are trademarks of a Mallinckrodt company. Lioresal and SynchroMed are registered trademarks of Medtronic, Inc. ITB Therapy is a service mark of Medtronic, Inc Mallinckrodt. MK50514 September 2014 Printed in USA.

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