Take the next step with Strensiq.

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Agnes Douglas
5 years ago
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Introducing Strensiq : the first and only treatment for people with perinatal/infantile- and juvenile-onset

Strensiq can improve bone health in children with HPP.

The on treatment image (far right) represents the average improvement that a patient with HPP saw over time

1 Introducing Strensiq : the first and only treatment for people with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP) Take the next step with Strensiq. Strensiq can improve bone health in children with HPP. X-ray images are from a child who was receiving Strensiq in clinical trials. The on treatment image (far right) represents the average improvement that a patient with HPP saw over time while on treatment. Baseline On treatment Strensiq is indicated for the treatment of patients with perinatal/infantile- and juvenile-onset HPP. Please see accompanying full Prescribing Information, including FDA-approved Patient Labeling.

2 Strensiq treats the underlying cause of HPP. How can Strensiq help you or your child? What is HPP? HPP is an inherited, lifelong condition that impacts bones and bodies. People with HPP have low levels of an enzyme called alkaline phosphatase (ALP) that is naturally present in the body and necessary for bone creation and maintenance. What is Strensiq? Strensiq is a prescription medicine that works by replacing ALP. It is used to treat people with perinatal/infantile- and juvenile-onset HPP Perinatal/infantile-onset HPP: children whose first symptoms started before 6 months of age Juvenile-onset HPP: children whose first symptoms started between 6 months and 18 years of age How Strensiq works in the body Strensiq can improve bone health in children with HPP and has demonstrated other improvements, such as Improved survival in children with perinatal/infantile-onset HPP Improved growth, including height and weight, in children with perinatal/infantile- and juvenile-onset HPP Improved mobility and gait in children with juvenile-onset HPP By replacing ALP, Strensiq allows phosphate and calcium to bond and improve bone health. Strensiq improved survival in children with perinatal/infantile-onset HPP. Before treatment was available, less than half of infants with HPP lived to their first birthday. During clinical trials, almost all children with perinatal/infantile-onset HPP treated with Strensiq survived. Strensiq may cause serious side effects, including calcium buildup in your eyes and kidneys. Your healthcare provider should check your eyes and kidneys while you use Strensiq. 2 3

3 How is Strensiq given? Tips for injecting Strensiq Strensiq is given as an injection under the skin (called a subcutaneous injection). Depending on a person s age and ability, Strensiq can be self-injected or injected by a caregiver. How is Strensiq dosed? Your child s doctor will prescribe a specific dose of Strensiq based on your child s weight and will decide how often it should be given. If there are any significant changes in your child s weight, your child s doctor will adjust the dose. It is important to use Strensiq as described in the Patient Prescribing Information and Instructions for Use, or as instructed by your child s doctor, nurse, or pharmacist. Carefully read the Patient Labeling and Instructions for Use Strensiq is best injected in areas with a substantial amount of fat. It can be injected under the skin of the stomach, upper arms, or upper legs Choose a different area each time you administer an injection to help avoid irritation and reactions at the injection site Do not inject Strensiq into skin that is red, hot, or swollen Always give the exact dose of Strensiq prescribed by your doctor. Before starting Strensiq, your doctor will speak with you about how often Strensiq should be injected UPPER ARMS Refrigerate Strensiq until you are ready to use it. You should use Strensiq within 1 hour of removing it from the refrigerator. Do not freeze. STOMACH AREA (ABDOMEN) Questions about Strensiq or HPP? OneSource is a support program staffed by Alexion nurse case managers who are here to help you every step of the way. If you or your doctor think supplemental injection training would be helpful, please reach out to your Alexion nurse case manager. Call to enroll. UPPER LEGS Talk to your doctor, nurse, or pharmacist about the best areas to inject Strensiq for your child. Strensiq may cause serious side effects, including skin thickening or pits at the injection site (lipodystrophy). Lipodystrophy at the injection site has happened several months after using Strensiq. 4 5

4 What should you tell your healthcare provider? Before using Strensiq, healthcare providers need to know if their patients are Allergic to asfotase alfa or any of the ingredients in Strensiq Pregnant or planning to become pregnant; it is not known if Strensiq will harm unborn babies Breastfeeding or plan to breastfeed; it is not known if Strensiq passes into breast milk. Women being treated with Strensiq should speak with their doctors about the best way to feed their infant children Important information you should know about Strensiq What is Strensiq used for? Strensiq is a prescription medicine used to treat people with perinatal/infantileand juvenile-onset HPP. What are the side effects of Strensiq? Strensiq may cause serious side effects, including Serious allergic (hypersensitivity) reactions. Serious allergic reactions have happened in some people who use Strensiq. Stop using Strensiq and go to the nearest hospital emergency room right away if you have any of the signs and symptoms of a serious allergic reaction Skin thickening or pits at the injection site (lipodystrophy). Lipodystrophy at the injection site has happened several months after using Strensiq Keep a list of your child s medications. Tell your child s doctor about any medications your child is taking, including prescription and nonprescription medications, vitamins, and herbal supplements. Keep a list of all your child s medications to show your child s doctor at his or her next appointment. Calcium buildup in your eyes and kidneys. Your healthcare provider should check your eyes and kidneys while you use Strensiq 6 7

Get the most out of your medical visits. Important Safety Information When your child is affected by a rare disease such as HPP, it is important to take an active role in his or her healthcare.

5 Get the most out of your medical visits. Important Safety Information When your child is affected by a rare disease such as HPP, it is important to take an active role in his or her healthcare. The same is true even after starting Strensiq. One way to make the most of every doctor s visit is to make a list of questions. Suggested questions to ask your child s doctor, nurse, or pharmacist What improvements can be expected with Strensiq? How will you measure these improvements? What are the possible side effects of Strensiq? How can the side effects of Strensiq be managed? Will the dose of Strensiq change as my child grows? Will Strensiq affect any of the other medications my child takes? Once Strensiq is started, how often should we visit the doctor? Are there any side effects that should prompt me to call the doctor? Keep a list of any other questions you may have for your doctor and bring them to your child s next appointment. What is Strensiq (asfotase alfa)? Strensiq is a prescription medicine used to treat people with perinatal-, infantile-, and juvenile-onset hypophosphatasia (HPP). What are the possible side effects of Strensiq? Strensiq may cause serious side effects, including Serious allergic (hypersensitivity) reactions. Serious allergic reactions have happened in some people who use Strensiq. Stop using Strensiq and go to the nearest hospital emergency room right away if you have any of the signs and symptoms of a serious allergic reaction, including Difficulty breathing Nausea or vomiting Swelling of your eyes, lips, or tongue Dizziness Hives Itching of your lips, tongue, or throat Feeling faint Skin thickening or pits at the injection site (lipodystrophy). Lipodystrophy at the injection site has happened several months after using Strensiq Calcium buildup in your eyes and kidneys. Your healthcare provider should check your eyes and kidneys while you use Strensiq The most common side effects of Strensiq include local skin injection-site reactions (including red skin patches, bruising, color change, pain, itching, thinning, swelling, pits, and bumps) and calcium buildup in your eyes and kidneys. These are not all of the possible side effects of Strensiq. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to the US Food and Drug Administration at FDA Please see accompanying full Prescribing Information and Instructions for Use. 8 9

6 Personalized support every step of the way As you are getting started on your Strensiq treatment, OneSource is here to help. OneSource is made up of a team of Alexion nurse case managers who are registered nurses with healthcare and insurance experience. Whether you want to learn more about HPP or have questions about treatment with Strensiq, OneSource is only a phone call away. After enrolling, you ll be matched with a dedicated Alexion nurse case manager who can help throughout your treatment journey. Advocacy groups Get to know the groups and organizations that are dedicated to HPP and other rare diseases. Softbones.org The US Hypophosphatasia Foundation and Soft Bones Canada provide information and a community to educate, empower, and connect people, families, and caregivers living with HPP Education and tools to help with your disease and treatment Connections with other people living with HPP Information on co-pay support and financial assistance programs Treatment support from dedicated Alexion nurse case managers Alexion Access Foundation for those without insurance Specialized medication refrigerator to help safely store Strensiq and track injections Supplemental in-home injection training by trained professionals A safe and convenient mail-back program to help dispose of needles Rarediseases.org The National Organization for Rare Disorders (NORD) provides education, advocacy, research, and patient services for people with rare diseases and the organizations that serve them Rarediseases.info.nih.gov The Office of Rare Diseases Research (ORDR) is a part of the National Institutes of Health (NIH). This site provides information on HPP as well as the opportunity to ask a specialist questions about your experiences with HPP Magicfoundation.org The MAGIC Foundation provides support and education to families of children with growth disorders and affected adults with endocrine disorders Globalgenes.org Call to enroll in OneSource today. Global Genes builds awareness, educates the global community, and provides critical connections and resources that equip advocates to become activists for their disease Some patients may not be eligible for all support services

7 Take the next step with Strensiq. There has never been an approved therapy to treat patients with perinatal/infantile- and juvenile-onset HPP until now. Strensiq can improve bone health in children with HPP, which can improve Survival in children with perinatal- and infantile-onset HPP Growth, including height and weight, in children with perinatal/infantile- and juvenile-onset HPP Mobility and gait in children with juvenile-onset HPP SUPPORT IS JUST A CALL AWAY. OneSource can provide personalized support to you and your healthcare team every step of the way. Call to enroll today! Strensiq may cause serious side effects, including serious allergic (hypersensitivity) reactions. Serious allergic reactions have happened in some people who use Strensiq. Stop using Strensiq and go to the nearest hospital emergency room right away if you have any of the signs and symptoms of a serious allergic reaction. Strensiq and OneSource are trademarks and Alexion is a registered trademark of Alexion Pharmaceuticals, Inc. Copyright 2015, Alexion Pharmaceuticals, Inc. All rights reserved. US/STQ-HPP/15/0061

PATIENT SAFETY BROCHURE; IMPORTANT SAFETY INFORMATION FOR PATIENTS. Before starting on Soliris Important safety information for patients

PATIENT SAFETY BROCHURE; IMPORTANT SAFETY INFORMATION FOR PATIENTS Before starting on Soliris Important safety information for patients Before you begin Soliris (eculizumab) treatment, your physician will