For Platelet Control As Individual As You

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).

Please see Important Risk Information including boxed warning inside and full Prescribing Information at www.winrho.com. If you’re living with ITP, WinRho® SDF may be right for you.

What is WinRho® SDF? Hi, I’m Rose. I was diagnosed

WinRho® SDF is a protein product, called an “immune globulin,” which is made with ITP about a year ago, from human plasma.1 WinRho® SDF is used to increase the number of platelets in and after trying other options, the blood of Rh-positive individuals who have a bleeding disorder called immune I turned to WinRho® SDF. thrombocytopenic purpura (ITP).1 A normal platelet count is usually higher than 3 2 150,000/mm . 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 IMPORTANT SAFETY INFORMATION for WinRho® SDF blood to clot properly. If your blood doesn’t clot properly, there is an increased risk This is a summary of the important information you need to know about treatment for bruising and bleeding.1 for your Immune Thrombocytopenic Purpura (ITP) with WinRho® SDF. It does For most people, living with ITP means making not take the place of talking with your doctor and does not contain all of the ® ® WinRho SDF lifestyle changes. You probably had to either change information available about WinRho SDF. If you have any questions after reading this information, make sure you ask your doctor or nurse. is a type of therapy or stop some of the things you enjoy doing. that has been used to What is the most important information I should know about WinRho® SDF? In some people, ITP can go away in a few months. ® treat Others may have it for a year or longer. Some patients taking WinRho SDF for immune thrombocytopenic purpura (ITP) for nearly ITP have had severe, life threatening bleeding and clotting problems. For this reason, you 20 years. 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 www.winrho.com • Share results with your doctor and discuss WinRho® SDF

2 Please see Important Risk Information including boxed warning Please see Important Risk Information including boxed warning inside and full Prescribing Information at www.winrho.com. inside and full Prescribing Information at www.winrho.com. WinRho® SDF may be an effective, convenient treatment for you

When steroids don’t work, there are other effective treatment options. Hello, my name is Brian. A f te r WinRho® SDF works quickly. 7 years, my platelets were still • Platelet counts generally rise within 1 to 2 days and usually stay ® up for 30 days.1 stable with WinRho SDF. Want to • In some clinical trials, platelet counts were raised for up to 90 days.3 know more about my experience?

WinRho® SDF is convenient. Go to page 7. • 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. IMPORTANT SAFETY INFORMATION for WinRho® SDF • 8-hour monitoring period in a healthcare setting after it is given—you are Some patients taking WinRho® SDF have had problems with their kidneys and able to move around as you like1 other organs. WinRho® SDF offers individualized dosing. Problems usually occur within 4 to 8 hours after getting an infusion. Tell your doctor • Dosing is based on your individual response to the medicine. or healthcare provider right away if you have any of the following signs or symptoms after getting a WinRho® SDF infusion: - For example, you may receive WinRho® SDF every month, or every few months. • back pain • decreased urination ® • To receive WinRho SDF, you must have a spleen and an Rh-positive • shaking • swelling or sudden weight gain blood type.1 • chills • shortness of breath

WinRho® SDF is well tolerated. • fever • rash • Patients taking WinRho® SDF have few side effects, and doctors have • dark or oddly colored urine • dizziness been using WinRho® SDF for nearly 20 years to treat ITP.1

• Take the ITP treatment self-assessment at www.winrho.com The faster you gain control of your platelets, and the longer • Share results with your doctor and discuss WinRho® SDF they stay at healthy levels, the less limiting your ITP may be.

4 Please see Important Risk Information including boxed warning Please see Important Risk Information including boxed warning inside and full Prescribing Information at www.winrho.com. inside and full Prescribing Information at www.winrho.com. WinRho® SDF is proven effective in clinical trials

WinRho® SDF is recommended as a 1st-line treatment by the American Society of Hematology (ASH). ASH looked at different YEARS In clinical studies, 79-90 of people ways to treat ITP and experienced a successful rise in their platelet levels.1* included WinRho® SDF (anti-D OF CLINICAL EXPERIENCE immunoglobulin) as a 1st-line option, as well as steroids and IVIg.4

WinRho® SDF is designed to help protect platelets

• When you have ITP, your body destroys healthy platelets.

• WinRho ® SDF is an anti-D medicine that contains a high number of antibodies IMPORTANT SAFETY INFORMATION for WinRho® SDF that attach to red blood cells (RBCs). Who should not use WinRho® SDF? • WinRho ® SDF is thought to protect the platelets of Rh-positive people by ® coating their RBCs. You should not use WinRho SDF for any treatment if you: • have ever had a severe allergic reaction (such as trouble breathing, hives, - As a result, the coated RBCs are destroyed instead of the platelets. passing out) after getting any blood product or blood product transfusion. - This leads to an increased number of platelets in the blood and fewer • have an immune globulin A (IgA) deficiency. symptoms of ITP.

- The way that WinRho® SDF works is not fully understood.1

• Take the ITP treatment self-assessment at www.winrho.com Your main goal is to increase your platelets quickly, and keep them • Share results with your doctor and discuss WinRho® SDF up for as long as possible. WinRho® SDF may help you do just that.

*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 Please see Important Risk Information including boxed warning Please see Important Risk Information including boxed warning inside and full Prescribing Information at www.winrho.com. inside and full Prescribing Information at www.winrho.com. 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/mm3, and then dropped to 5,000/mm3.

Then, Brian switched to WinRho® SDF

Results: Within a week of trying WinRho® SDF, Brian’s platelet count went up to 295,000/mm3.

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*

* Brian is based on an actual patient treated with WinRho® SDF as a maintenance therapy for chronic ITP. Age: 54 years3 • Weight: 142 lb Patient responses to individual treatment options may vary. † A normal platelet count is usually higher than 150,000/mm3.2 Baseline platelet count: 37,000/mm3† • Hemoglobin: 16.5 g/dL

Symptoms: Bruising and diffuse petechiae ® (round spots that are a result of bleeding under the skin) IMPORTANT SAFETY INFORMATION for WinRho SDF You should not use WinRho® SDF for treatment of ITP if you: Initial ITP therapies: Prednisone, IVIg • have Rh-negative blood. • have had your spleen removed. • have a problem called “autoimmune hemolytic anemia.” • have other preexisting bleeding problems.

8 Please see Important Risk Information including boxed warning Please see Important Risk Information including boxed warning inside and full Prescribing Information at www.winrho.com. inside and full Prescribing Information at www.winrho.com. 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*

* 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. Age: 26 years3 • Weight: 132 lb † A normal platelet count is usually higher than 150,000/mm3.2 ‡ Rituximab is not FDA-approved for ITP indication. Baseline platelet count: 5,000/mm3 • Hemoglobin: 13.9 g/dL

Symptoms: Petechiae (round spots that are a result of bleeding under ® the skin) and oral blood blisters IMPORTANT SAFETY INFORMATION for WinRho SDF What should I avoid while using WinRho® SDF? Initial ITP therapies: Prednisone, IVIg, rituximab‡ 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 Please see Important Risk Information including boxed warning Please see Important Risk Information including boxed warning inside and full Prescribing Information at www.winrho.com. inside and full Prescribing Information at www.winrho.com. 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/mm3 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*

* 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. Age: 13 years3 • Weight: 119 lb † A normal platelet count is usually higher than 150,000/mm3.2 Baseline platelet count: 2,000/mm3† • Hemoglobin: 10 g/dL

Symptoms: Menorrhagia (heavy periods) and diffuse petechiae, which are IMPORTANT SAFETY INFORMATION for WinRho® SDF round spots that are a result of bleeding under the skin. What are the possible or reasonably likely side effects of WinRho® SDF? Initial ITP therapies: Corticosteroids, IVIg The most common side effects of WinRho® SDF are

• headache • diarrhea • fainting • chills • nausea and vomiting • flushing • fever • achy muscles • rash • weakness • feeling light-headed • sweating or dizziness

12 Please see Important Risk Information including boxed warning Please see Important Risk Information including boxed warning inside and full Prescribing Information at www.winrho.com. inside and full Prescribing Information at www.winrho.com. 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 IMPORTANT SAFETY INFORMATION for WinRho® SDF

Tell your doctor right away if you have:

• a fever over 100°F • oddly colored urine • Take the ITP treatment self-assessment at www.winrho.com • shaking or chills that continue or • trouble urinating • Share results with your doctor and discuss WinRho® SDF get worse • severe back pain • a painful lump or swelling (because • severe abdominal pain this may be a sign of a blood clot) • swelling, especially around the ankles • bruising that is increasing in diameter • hives (because this may be a sign of a clotting problem) • shortness of breath

14 Please see Important Risk Information including boxed warning Please see Important Risk Information including boxed warning inside and full Prescribing Information at www.winrho.com. inside and full Prescribing Information at www.winrho.com. 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.

IMPORTANT SAFETY INFORMATION for WinRho® SDF Tips for talking with your doctor What other information do I need to know about WinRho® SDF? 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. 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. • Take the ITP treatment self-assessment at www.winrho.com • Share results with your doctor and discuss WinRho® SDF

16 Please see Important Risk Information including boxed warning Please see Important Risk Information including boxed warning inside and full Prescribing Information at www.winrho.com. inside and full Prescribing Information at www.winrho.com. Important Risk Information 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 WARNING: INTRAVASCULAR HEMOLYSIS (IVH) with WinRho® SDF and your doctor will ask you to take blood and urine tests before and after infusion with WinRho® SDF. Intravascular hemolysis (IVH) leading to death has been reported in patients treated Some patients taking WinRho® SDF have had problems with their kidneys and for immune thrombocytopenic purpura (ITP) with WinRho® SDF. other organs. IVH can lead to clinically compromising anemia and multi-system organ failure Problems usually occur within 4 to 8 hours after getting an infusion. Tell your doctor including acute respiratory distress syndrome (ARDS). or healthcare provider right away if you have any of the following signs or symptoms Serious complications including severe anemia, acute renal insufficiency, renal after getting a WinRho® SDF infusion: failure and disseminated intravascular coagulation (DIC) have also been reported. Continue monitoring for these signs and symptoms for 72 hours after each treatment ® Closely monitor patients treated with WinRho SDF for ITP in a healthcare setting with WinRho® SDF. for at least eight hours after administration. Perform a dipstick urinalysis to monitor • back pain • decreased urination 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 • shaking • swelling or sudden weight gain monitor the signs and symptoms of IVH including back pain, shaking chills, fever, • chills • shortness of breath and discolored urine or hematuria. Absence of these signs and/or symptoms of IVH • fever • rash within eight hours do not indicate IVH cannot occur subsequently. If signs and/or • dark or oddly colored urine • dizziness symptoms of IVH are present or suspected after WinRho® SDF administration, post- WinRho® SDF contains maltose, which can give false readings on some glucose treatment laboratory tests should be performed including plasma hemoglobin, testing meters. If you are diabetic, ask your doctor what types of glucose testing haptoglobin, LDH, and plasma bilirubin (direct and indirect). meters can be used safely while you are getting WinRho® SDF.

2. Who should not use WinRho® SDF? Indication and important information for people being treated with WinRho® SDF You should not use WinRho® SDF for any treatment if you: What is WinRho® SDF? • have ever had a severe allergic reaction (such as trouble breathing, hives, passing WinRho® SDF is a protein product, called an “immune globulin,” which is made out) after getting any blood product or blood product transfusion. from human plasma. WinRho® SDF is used to increase the number of platelets in • have an immune globulin A (IgA) deficiency. the blood of Rh-positive individuals who have a bleeding disorder called immune thrombocytopenic purpura (ITP), which results in an abnormally low number of You should not use WinRho® SDF for treatment of ITP if you: platelets. Platelets are needed for your blood to clot properly. If your blood doesn’t • have Rh-negative blood. clot properly, there is an increased risk for bruising and bleeding. • have had your spleen removed. IMPORTANT SAFETY INFORMATION for WinRho® SDF • have a problem called “autoimmune hemolytic anemia.” This is a summary of the important information you need to know about treatment • have other pre-existing bleeding problems. for your Immune Thrombocytopenic Purpura (ITP) with WinRho® SDF. It does not 3. What should I avoid while using WinRho® SDF? 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, WinRho® SDF may interfere with your immune response to routine immunizations. make sure you ask your doctor or nurse. 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 1. What is the most important information I should know about WinRho® SDF? taking your blood and the doctor that you got WinRho® SDF. Some patients taking WinRho® SDF for immune thrombocytopenic purpura (ITP)

18 Please see full Prescribing Information at www.winrho.com Please see full Prescribing Information at www.winrho.com 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 • oddly colored urine • shaking or chills that continue or get • trouble urinating worse • severe back pain • a painful lump or swelling (because this • severe abdominal pain may be a sign of a blood clot) • swelling, especially around the ankles • bruising that is increasing in diameter • hives (because this may be a sign of a • shortness of breath clotting problem)

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 ITP Support from the donor. Talk to your doctor if you have any symptoms that concern you.

You may report side effects to Cangene Corporation at 1-800-768-2304 or FDA’s MedWatch reporting system by phone (1-800-FDA-1088). Platelet Disorder Support Association Phone: 1-87-PLATELET (1-877-528-3538) or 301-770-6636 E-mail: [email protected] • Website: www.pdsa.org

20 Please see full Prescribing Information at www.winrho.com Please see Important Risk Information including boxed warning inside and full Prescribing Information at www.winrho.com. 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/mm3 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/mm3 (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/mm3. 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/mm3) with a mean peak platelet count of 319,500/mm3 (range 61,000 to 892,000), with no statistically significant differences compared to other treatment arms. The mean times to achieving ≥20,000/mm3 or ≥50,000/mm3 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/mm3 or ≥50,000/mm3, 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/mm3 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/mm3) during the first two courses of therapy for an overall response rate of 88% with a mean peak platelet count of 92,300/mm3 (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/mm3 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/mm3) 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/mm3 (range 2,000 to 565,000), and the mean peak platelet count was 81,700/mm3 (range 16,000 to 593,000).

References: 1. WinRho SDF Prescribing Information: Baltimore, MD: Cangene bioPharma, Inc; December 2010. 2. Mayo Clinic website. Disease and conditions: Idiopathic thrombocytopenic purpura (ITP). http://www.mayoclinic.org/diseases- conditions/idiopathic-thrombocytopenic-purpura/basics/causes/con-20034239. Accessed on October 1, 2014. 3. 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):4190-4207.

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