For platelet control as individual as you

Transcription

1 For platelet control as individual as you Explore the possibilities of Immune Thrombocytopenic Purpura (ITP) treatment. Important Risk Information WARNING: INTRAVASCULAR HEMOLYSIS (IVH) Intravascular hemolysis (IVH) leading to death has been reported in patients treated for immune thrombocytopenic purpura (ITP) with WinRho SDF. IVH can lead to clinically compromising anemia and multi-system organ failure including acute respiratory distress syndrome (ARDS). Serious complications including severe anemia, acute renal insufficiency, renal failure and disseminated intravascular coagulation (DIC) have also been reported. Closely monitor patients treated with WinRho SDF for ITP in a healthcare setting for at least eight hours after administration. Perform a dipstick urinalysis to monitor for hematuria and hemoglobinuria at baseline and then after administration at 2 hours, 4 hours and prior to the end of the monitoring period. Alert patients and monitor the signs and symptoms of IVH including back pain, shaking chills, fever, and discolored urine or hematuria. Absence of these signs and/or symptoms of IVH within eight hours do not indicate IVH cannot occur subsequently. If signs and/or symptoms of IVH are present or suspected after WinRho SDF administration, post-treatment laboratory tests should be performed including plasma hemoglobin, haptoglobin, LDH, and plasma bilirubin (direct and indirect).

2 If you re living with ITP, WinRho SDF may be right for you. What is WinRho SDF? WinRho SDF is a protein product, called an immune globulin, which is made from human plasma. 1 WinRho SDF is used to increase the number of platelets in the blood of Rh-positive individuals who have a bleeding disorder called immune thrombocytopenic purpura (ITP). 1 A normal platelet count is usually higher than 150,000/mm 3. 2 Hi, I m Rose. I was diagnosed with ITP about a year ago, and after trying other options, I turned to WinRho SDF. Read my story on page 8. Living with ITP can be challenging ITP results in an abnormally low number of platelets. Platelets are needed for your blood to clot properly. If your blood doesn t clot properly, there is an increased risk for bruising and bleeding. 1 WinRho SDF is a type of therapy that has been used to treat ITP for nearly 20 years. For most people, living with ITP means making lifestyle changes. You probably had to either change or stop some of the things you enjoy doing. In some people, ITP can go away in a few months. Others may have it for a year or longer. This is a summary of the important information you need to know about treatment for your Immune Thrombocytopenic Purpura (ITP) with WinRho SDF. It does not take the place of talking with your doctor and does not contain all of the information available about WinRho SDF. If you have any questions after reading this information, make sure you ask your doctor or nurse. What is the most important information I should know about WinRho SDF? Some patients taking WinRho SDF for immune thrombocytopenic purpura (ITP) have had severe, life threatening bleeding and clotting problems. For this reason, you need to remain under observation for at least 8 hours following each treatment with WinRho SDF and your doctor will ask you to take blood and urine tests before and after infusion with WinRho SDF. Take the ITP treatment self-assessment at Share results with your doctor and discuss WinRho SDF 2

3 WinRho SDF may be an effective, convenient treatment for you When steroids don t work, there are other effective treatment options. WinRho SDF works quickly. Platelet counts generally rise within 1 to 2 days and usually stay up for 30 days. 1 In some clinical trials, platelet counts were raised for up to 90 days. 3 WinRho SDF is convenient. 3 to 5 minutes to receive an entire dose of WinRho SDF - Some doctors may prefer to administer the dose over longer periods of time, such as 30 minutes. 8-hour monitoring period in a healthcare setting after it is given you are able to move around as you like 1 WinRho SDF offers individualized dosing. Dosing is based on your individual response to the medicine. - For example, you may receive WinRho SDF every month, or every few months. To receive WinRho SDF, you must have a spleen and an Rh-positive blood type. 1 WinRho SDF is well tolerated. Patients taking WinRho SDF have few side effects, and doctors have been using WinRho SDF for nearly 20 years to treat ITP. 1 Hello, my name is Brian. A f ter 7 years, my platelets were still stable with WinRho SDF. Want to know more about my experience? Go to page 7. Some patients taking WinRho SDF have had problems with their kidneys and other organs. Problems usually occur within 4 to 8 hours after getting an infusion. Tell your doctor or healthcare provider right away if you have any of the following signs or symptoms after getting a WinRho SDF infusion: back pain shaking chills fever dark or oddly colored urine decreased urination swelling or sudden weight gain shortness of breath rash dizziness The faster you gain control of your platelets, and the longer they stay at healthy levels, the less limiting your ITP may be. Take the ITP treatment self-assessment at Share results with your doctor and discuss WinRho SDF 4

4 WinRho SDF is proven effective in clinical trials In clinical studies, of people experienced a successful rise in their platelet levels. 1* WinRho SDF is designed to help protect platelets When you have ITP, your body destroys healthy platelets. WinRho SDF is recommended as a 1 st -line treatment by the American Society of Hematology (ASH). ASH looked at different ways to treat ITP and included WinRho SDF (anti-d immunoglobulin) as a 1 st -line option, as well as steroids and IVIg. 4 YEARS OF CLINICAL EXPERIENCE WinRho SDF is an anti-d medicine that contains a high number of antibodies that attach to red blood cells (RBCs). WinRho SDF is thought to protect the platelets of Rh-positive people by coating their RBCs. - As a result, the coated RBCs are destroyed instead of the platelets. - This leads to an increased number of platelets in the blood and fewer symptoms of ITP. Who should not use WinRho SDF? You should not use WinRho SDF for any treatment if you: have ever had a severe allergic reaction (such as trouble breathing, hives, passing out) after getting any blood product or blood product transfusion. have an immune globulin A (IgA) deficiency. - The way that WinRho SDF works is not fully understood. 1 Your main goal is to increase your platelets quickly, and keep them up for as long as possible. WinRho SDF may help you do just that. Take the ITP treatment self-assessment at Share results with your doctor and discuss WinRho SDF * Studies of non-splenectomized (spleen not removed), Rho(D)-positive patients included 24 children with chronic ITP, 146 children with acute ITP, 24 adults with chronic ITP, and 11 children and 52 adults with ITP caused by HIV infection. For more detail on the studies and results, see the back cover. 6

5 Brian stopped responding to prednisone and IVIg Brian s doctor started him on prednisone, but he stopped responding after 1 week. Over the next 5 months, Brian tried increasing doses of IVIg, but his platelets only increased to a maximum of 50,000/mm 3, and then dropped to 5,000/mm 3. Then, Brian switched to WinRho SDF Results: Within a week of trying WinRho SDF, Brian s platelet count went up to 295,000/mm 3. Status: After 7 years, Brian received monthly doses of WinRho SDF, and his platelets stayed at a safe level with no active bleeding. Real WinRho SDF results for Brian* Age: 54 years 3 Weight: 142 lb Baseline platelet count: 37,000/mm 3 Hemoglobin: 16.5 g/dl Symptoms: Bruising and diffuse petechiae (round spots that are a result of bleeding under the skin) Initial ITP therapies: Prednisone, IVIg * Brian is based on an actual patient treated with WinRho SDF as a maintenance therapy for chronic ITP. Patient responses to individual treatment options may vary. A normal platelet count is usually higher than 150,000/mm 3. 2 You should not use WinRho SDF for treatment of ITP if you: have Rh-negative blood. have had your spleen removed. have a problem called autoimmune hemolytic anemia. have other preexisting bleeding problems. 8

6 Rose s ITP wasn t controlled with prednisone, IVIg, or rituximab After trying different therapies for her chronic ITP for over a year, Rose and her doctor turned to WinRho SDF. Then, Rose switched to WinRho SDF Results: Rose s doctor transitioned her to WinRho SDF as a maintenance therapy. With its individualized maintenance dosing, Rose s doctor was able to monitor her platelet count and administer infusions based on her platelet response. Status: After receiving periodic doses of WinRho SDF, Rose s chronic ITP was stabilized. Real WinRho SDF results for Rose* Age: 26 years 3 Weight: 132 lb Baseline platelet count: 5,000/mm 3 Hemoglobin: 13.9 g/dl Symptoms: Petechiae (round spots that are a result of bleeding under the skin) and oral blood blisters Initial ITP therapies: Prednisone, IVIg, rituximab * Rose is based on an actual patient treated with WinRho SDF as a maintenance therapy for chronic ITP. Patient responses to individual treatment options may vary. A normal platelet count is usually higher than 150,000/mm 3. 2 Rituximab is not FDA-approved for ITP indication. What should I avoid while using WinRho SDF? WinRho SDF may interfere with your immune response to routine immunizations. Tell your doctor if you have recently been vaccinated or are planning to be vaccinated. WinRho SDF can interfere with certain blood tests. It is important to tell the person taking your blood and the doctor that you got WinRho SDF. 10

7 On IVIg, Lori kept having ITP symptoms When her ITP persisted, Lori needed a treatment that would help her sustain a healthy platelet level. Then, Lori switched to WinRho SDF Results: Lori s doctor chose to initiate WinRho SDF at an individualized dose that was based on her personal profile and goals. After her first dose, Lori s platelet count increased to 74,000/mm 3 after 48 hours. Thankfully, she didn t have the severe headaches she experienced with IVIg. Status: Following her first treatment, Lori s platelets remained at a healthy level for 6 weeks, after which she went to an infusion center to receive her next dose of WinRho SDF. Her doctor planned to give her additional WinRho SDF doses in the future. Real WinRho SDF results for Lori* Age: 13 years 3 Weight: 119 lb Baseline platelet count: 2,000/mm 3 Hemoglobin: 10 g/dl Symptoms: Menorrhagia (heavy periods) and diffuse petechiae, which are round spots that are a result of bleeding under the skin. Initial ITP therapies: Corticosteroids, IVIg * Lori is based on an actual pediatric patient treated with WinRho SDF as a maintenance therapy for chronic ITP. Patient responses to individual treatment options may vary. A normal platelet count is usually higher than 150,000/mm 3. 2 What are the possible or reasonably likely side effects of WinRho SDF? The most common side effects of WinRho SDF are headache chills fever weakness diarrhea nausea and vomiting achy muscles feeling light-headed or dizziness fainting flushing rash sweating 12

8 WinRho SDF is generally well tolerated The safety and tolerability profile of WinRho SDF has been proven in many patients. Like most medicines, WinRho SDF is not free of side effects. They usually occur within 4 to 8 hours after receiving an infusion. If you experience any of these symptoms, talk with your doctor right away: back pain, shaking, chills, fever, dark or oddly colored urine, decreased urination, swelling or sudden weight gain, shortness of breath, rash, and/or dizziness. 1 Continue monitoring for these signs and symptoms for 72 hours after each treatment with WinRho SDF. 1 To help ensure your well-being, there is an 8-hour monitoring period in a healthcare setting after WinRho SDF is given. You can move around as you like during the monitoring period. 1 Tell your doctor right away if you have: Take the ITP treatment self-assessment at Share results with your doctor and discuss WinRho SDF a fever over 100 F shaking or chills that continue or get worse a painful lump or swelling (because this may be a sign of a blood clot) bruising that is increasing in diameter (because this may be a sign of a clotting problem) oddly colored urine trouble urinating severe back pain severe abdominal pain swelling, especially around the ankles hives shortness of breath 14

9 Cover these points about WinRho SDF with your doctor The quick infusion time of 3 to 5 minutes (unless the doctor wants to infuse for a longer period of time, such as 30 minutes). The ability for platelet levels to double in as little as 24 hours. The potential for platelet counts to be increased for 30 to 90 days. The 8-hour mobile monitoring period, in which you are able to move around as you like in the healthcare setting. Tips for talking with your doctor about WinRho SDF When it comes to managing ITP, you and your doctor are a team, working together to figure out the best treatment for you. Be your own advocate. If you think WinRho SDF may be the best option for you, talk to your doctor about it. What other information do I need to know about WinRho SDF? WinRho SDF is made from human plasma. Donors are carefully screened and the plasma is carefully cleaned, but it does have a very small risk of giving you viruses from the donor. Talk to your doctor if you have any symptoms that concern you. Take the ITP treatment self-assessment at Share results with your doctor and discuss WinRho SDF 16

10 Important Risk Information WARNING: INTRAVASCULAR HEMOLYSIS (IVH) Intravascular hemolysis (IVH) leading to death has been reported in patients treated for immune thrombocytopenic purpura (ITP) with WinRho SDF. IVH can lead to clinically compromising anemia and multi-system organ failure including acute respiratory distress syndrome (ARDS). Serious complications including severe anemia, acute renal insufficiency, renal failure and disseminated intravascular coagulation (DIC) have also been reported. Closely monitor patients treated with WinRho SDF for ITP in a healthcare setting for at least eight hours after administration. Perform a dipstick urinalysis to monitor for hematuria and hemoglobinuria at baseline and then after administration at 2 hours, 4 hours and prior to the end of the monitoring period. Alert patients and monitor the signs and symptoms of IVH including back pain, shaking chills, fever, and discolored urine or hematuria. Absence of these signs and/or symptoms of IVH within eight hours do not indicate IVH cannot occur subsequently. If signs and/or symptoms of IVH are present or suspected after WinRho SDF administration, posttreatment laboratory tests should be performed including plasma hemoglobin, haptoglobin, LDH, and plasma bilirubin (direct and indirect). Indication and important information for people being treated with WinRho SDF What is WinRho SDF? WinRho SDF is a protein product, called an immune globulin, which is made from human plasma. WinRho SDF is used to increase the number of platelets in the blood of Rh-positive individuals who have a bleeding disorder called immune thrombocytopenic purpura (ITP), which results in an abnormally low number of platelets. Platelets are needed for your blood to clot properly. If your blood doesn t clot properly, there is an increased risk for bruising and bleeding. This is a summary of the important information you need to know about treatment for your Immune Thrombocytopenic Purpura (ITP) with WinRho SDF. It does not take the place of talking with your doctor and does not contain all of the information available about WinRho SDF. If you have any questions after reading this information, make sure you ask your doctor or nurse. 1. What is the most important information I should know about WinRho SDF? Some patients taking WinRho SDF for immune thrombocytopenic purpura (ITP) have had severe, life threatening bleeding and clotting problems. For this reason, you need to remain under observation for at least 8 hours following each treatment with WinRho SDF and your doctor will ask you to take blood and urine tests before and after infusion with WinRho SDF. Some patients taking WinRho SDF have had problems with their kidneys and other organs. Problems usually occur within 4 to 8 hours after getting an infusion. Tell your doctor or healthcare provider right away if you have any of the following signs or symptoms after getting a WinRho SDF infusion: Continue monitoring for these signs and symptoms for 72 hours after each treatment with WinRho SDF. back pain shaking chills fever dark or oddly colored urine decreased urination swelling or sudden weight gain shortness of breath rash dizziness WinRho SDF contains maltose, which can give false readings on some glucose testing meters. If you are diabetic, ask your doctor what types of glucose testing meters can be used safely while you are getting WinRho SDF. 2. Who should not use WinRho SDF? You should not use WinRho SDF for any treatment if you: have ever had a severe allergic reaction (such as trouble breathing, hives, passing out) after getting any blood product or blood product transfusion. have an immune globulin A (IgA) deficiency. You should not use WinRho SDF for treatment of ITP if you: have Rh-negative blood. have had your spleen removed. have a problem called autoimmune hemolytic anemia. have other pre-existing bleeding problems. 3. What should I avoid while using WinRho SDF? WinRho SDF may interfere with your immune response to routine immunizations. Tell your doctor if you have recently been vaccinated or are planning to be vaccinated. WinRho SDF can interfere with certain blood tests. It is important to tell the person taking your blood and the doctor that you got WinRho SDF. 18 Please see full Prescribing Information at Please see full Prescribing Information at

11 4. What are the possible or reasonably likely side effects of WinRho SDF? The most common side effects of WinRho SDF are headache achy muscles chills feeling light-headed or dizziness fever fainting weakness flushing diarrhea rash nausea and vomiting sweating Tell your doctor right away if you have: a fever over 100 F shaking or chills that continue or get worse a painful lump or swelling (because this may be a sign of a blood clot) bruising that is increasing in diameter (because this may be a sign of a clotting problem) oddly colored urine trouble urinating severe back pain severe abdominal pain swelling, especially around the ankles hives shortness of breath Talk to your doctor about any side effects that concern you. Additional prescribing information is available to healthcare professionals. 5. What other information do I need to know about WinRho SDF? WinRho SDF is made from human plasma. Donors are carefully screened and the plasma is carefully cleaned, but it does have a very small risk of giving you viruses from the donor. Talk to your doctor if you have any symptoms that concern you. You may report side effects to Cangene Corporation at or FDA s MedWatch reporting system by phone (1-800-FDA-1088). ITP Support Platelet Disorder Support Association Phone: 1-87-PLATELET ( ) or pdsa@pdsa.org Website: 20 Please see full Prescribing Information at

12 Summary of 4 studies of WinRho SDF in a range of children and adults. 1 Childhood Chronic ITP In an open-label, single arm, multicenter study, 24 non-splenectomized, Rho(D)-positive children with ITP of greater than six months duration were treated initially with 250 international unit/kg (50 mcg/kg) WinRho SDF [125 international unit/kg (25 mcg/kg) on days 1 and 2, with subsequent doses ranging from 125 to 275 international unit/kg (25 to 55 mcg/kg)]. Response was defined as a platelet increase to at least 50,000/mm 3 and a doubling of the baseline. Nineteen of 24 patients responded for an overall response rate of 79%, an overall mean peak platelet count of 229,400/mm 3 (range 43,300 to 456,000), and a mean duration of response of 36.5 days (range 6 to 84). Childhood Acute ITP A multicenter, randomized, controlled trial comparing WinRho SDF to high dose and low dose Immune Globulin Intravenous (Human) (IGIV) and prednisone was conducted in 146 non-splenectomized, Rho(D)-positive children with acute ITP and platelet counts less than 20,000/mm 3. Of 38 patients receiving WinRho SDF [125 international unit/kg (25 mcg/kg) on days 1 and 2], 32 patients (84%) responded (platelet count 50,000/mm 3 ) with a mean peak platelet count of 319,500/mm 3 (range 61,000 to 892,000), with no statistically significant differences compared to other treatment arms. The mean times to achieving 20,000/mm 3 or 50,000/mm 3 platelets for patients receiving WinRho SDF were 1.9 and 2.8 days respectively. When comparing the different therapies for time to platelet count 20,000/mm 3 or 50,000/mm 3, no statistically significant differences among treatment groups were detected, with a range of 1.3 to 1.9 days and 2.0 to 3.2 days, for IGIV and prednisone respectively. Adult Chronic ITP Twenty-four non-splenectomized Rho(D)-positive adults with ITP of greater than six months duration and platelet counts <30,000/mm 3 or requiring therapy enrolled in a single-arm, open-label trial were treated with 100 to 375 international unit/kg (20 to 75 mcg/kg) WinRho SDF [mean dose 231 international unit/kg (46.2 mcg/kg)]. Twenty-one of 24 patients responded (increase 20,000/mm 3 ) during the first two courses of therapy for an overall response rate of 88% with a mean peak platelet count of 92,300/mm 3 (range 8,000 to 229,000). ITP Secondary to HIV Infection Eleven children and 52 adults, who were non-splenectomized and Rho(D)-positive, with all Walter Reed classes of HIV infection and ITP, with initial platelet counts of 30,000/mm 3 or requiring therapy, were treated with 100 to 375 international unit/kg (20 to 75 mcg/kg) WinRho SDF in an open label trial. WinRho SDF was administered for an average of 7.3 courses (range 1 to 57) over a mean period of 407 days (range 6 to 1,952). Fifty-seven of 63 patients responded (increase 220,000/mm 3 ) during the first six courses of therapy for an overall response rate of 90%. The overall mean change in platelet count for six courses was 60,900/mm 3 (range 2,000 to 565,000), and the mean peak platelet count was 81,700/mm 3 (range 16,000 to 593,000). References: 1. WinRho SDF Prescribing Information: Baltimore, MD: Cangene biopharma, Inc; December Mayo Clinic website. Disease and conditions: Idiopathic thrombocytopenic purpura (ITP). Accessed on October 1, Data on file. Berwyn, PA, Emergent BioSolutions. 4. Neunert C, Lim W, Crowther M, Cohen A, Solberg L, Crowther MA. The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia. Blood. 2011;117(16): Manufactured by Cangene Corporation and distributed by Cangene biopharma, Inc. WinRho SDF and any and all Emergent BioSolutions Inc. brand, product, service and feature names, logos and slogans are trademarks or registered trademarks of Emergent BioSolutions Inc. or its subsidiaries in the United States or other countries Emergent BioSolutions Inc. All rights reserved. XXXXXXXX Phone: WINRHO ( )