YOUR PRIMARY HLH Hospital Experience Gamifant Patient Services · helpful as you and your family...

We're here to help guide you on your journey with Gamifant® (emapalumab-lzsg)

Gamifant Patient Services

833.597.6530

Personalized support is available, including dedicated Care Managers who can help provide guidance on your journey. Please reach out to learn more about:

• Starting treatment with Gamifant• Financial assistance programs, if eligible• Clarifying your health insurance options• Understanding primary HLH, and more

Gamifant is a registered trademark, owned by Sobi AG and is marketed by Sobi, Inc. PP-7210 © 2019 Swedish Orphan Biovitrum. All rights reserved.

Learn more at

GamifantCares.com

•

may increase your risk of serious infections that can lead to death. These infections include tuberculosis (TB), histoplasmosis, Herpes zoster infection (shingles) and other infections caused by viruses, fungi or bacteria that can spread throughout the body. Your healthcare provider will:

test you for TB before you start treatment with Gamifant.

treat you with a medicine for TB if you are at risk for TB or if you have a known positive TB test. Infections are common in people treated with Gamifant.

Please see full Important Safety Information and full Medication Guide.

• Your healthcare provider will give you medicine to help prevent certain infections before you receive Gamifant.

• After starting Gamifant, tell your healthcare provider if:

new symptoms of an infection appear.

symptoms of an infection that you already had when starting Gamifant worsen. Your healthcare provider will monitor you closely for signs and symptoms of infections during treatment with Gamifant.

Gamifant can cause serious infusion reactions, including:

• Infusion reactions. Infusion reactions are common with Gamifant, and can also be severe. Infusion reactions can happen during or shortly after treatment with Gamifant. Your healthcare provider may temporarily stop your infusion and treat your symptoms before continuing your infusion if you have severe infusion reactions. Tell your healthcare provider right away if you get any of the following symptoms:

skin redness

itching

fever

rash

excessive sweating

• high blood pressure (hypertension) and fever. These are

prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full Medication Guide for Gamifant.

You may also contact Sobi at [email protected] or 866-773-5274.

chills

chest pain

shortness of breath

nausea or vomiting

lightheadedness or dizziness

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Navigating YOUR PRIMARY HLH

Indication and selected Important Safety Information: GAMIFANT is a prescription medicine used for the treatment of adults and children (newborn and older) with primary hemophagocytic lymphohistiocytosis (HLH) whose disease has come back or progressed, or other medicines have not worked well enough or cannot be tolerated.

GAMIFANT can cause serious side effects including: • Infections. GAMIFANT is a medicine that affects your immune system and may

lower the ability of your immune system to fight infections. GAMIFANT may increase your risk of serious infections that can lead to death. These infections include tuberculosis (TB), histoplasmosis, Herpes zoster infection (shingles) and other infections caused by viruses, fungi or bacteria that can spread throughout the body. Your healthcare provider will:

• • test you for TB before you start treatment with GAMIFANT.• • treat you with a medicine for TB if you at risk for TB or if you have a known

positive TB test. Infections are common in people treated with GAMIFANT.

Please see full Important Safety Information and full Medication Guide at GamifantCares.com.

HLH=hemophagocytic lymphohistiocytosis.

Hospital Experience

https://www.gamifantcares.com/#safety

https://www.gamifantcares.com/pdf/Gamifant-Med-Guide.pdf

https://www.gamifantcares.com/

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• A change of comfortable clothes for overnight stays

• Your toothbrush and essential toiletries

• Any medications you will need to take

• A comfortable pillow and warm socks

• A notebook and pen

• Snacks

• A book, tablet, laptop, or craft project to help pass the time—don’t forget your device chargers!

• A list of their medications

• Books to read with them

• A framed family photo

• If your loved one is a small child, bring familiar items from home such as blankets, stuffed animals, music, and toys. If they’re old enough, let them help choose what to bring

For Your Loved One

This wasn’t part of the plan...

When your loved one started having symptoms such as fever, rash, or diarrhea, you were probably concerned. Those symptoms can come with many common illnesses. Your family doctor ran a series of tests, but when they couldn’t determine the cause, your hospital experience began.

You may have cycled in and out of the hospital while various medical specialists tried to figure out what was going on. Eventually, they arrived at a diagnosis—primary HLH. It may have been a relief to finally know what’s been causing the symptoms, but you weren’t prepared for something like this.

Treatment for primary HLH can take weeks to months, and your loved one may be staying in the hospital for a while. We know that this is a challenging time, and we hope you find this guide helpful as you and your family navigate your primary HLH journey together.

Prepar ing for the journey

Once primary HLH has been diagnosed, treatment usually begins right away. It may last for many months, and the journey can be mentally, physically, and emotionally draining for everyone in the family.

The first step in treatment is induction therapy. The goal is to get symptoms under control in preparation for a bone marrow transplant. The official name for this kind of transplant is hematopoietic stem cell transplantation, or HSCT. After induction therapy, the next step, which is called continuation therapy, begins.

If symptoms come back or progress, or other medicines have not worked well enough or cannot be tolerated, your doctor may try Gamifant® (emapalumab-lzsg). It is the first and only FDA-approved treatment made specifically for people with primary HLH who have refractory, recurrent, or progressive disease, or intolerance to conventional therapy.

Important Safety Information (continued)• Before starting GAMIFANT, tell your healthcare provider all of your medical conditions and if you:

• had TB in the past, or if you or a member of your family have been in recent close contact with someone with TB.

• have ever had a positive TB skin test (PPD).• currently have or have had history of infections, including histoplasmosis or Herpes zoster (shingles).• are being treated for an active infection.• have symptoms of an infection, such as fever, sweat and chills, cough, breathing problems, blood in

mucus (phlegm), warm, red, or painful skin or sores on your body.• are pregnant or plan to become pregnant. It is not known if GAMIFANT can harm your unborn baby.• are breastfeeding or plan to breastfeed. It is not known if GAMIFANT passes into your breast milk.

Talk to your healthcare provider about the best way to feed your baby during treatment with GAMIFANT.Important Safety Information (continued)

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

For You

Packing for the journey*

*Please consult with your treatment team for appropriate infection prevention protocol depending on your stage in the journey.


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People you’ve met along the way

During the diagnosis phase of primary HLH, you probably met many doctors, nurses, and other medical specialists. Some of those people may also be involved in the treatment phase. Knowing a bit about each of their professional roles may help you feel better informed and a little less overwhelmed.


Nurses Nurses are experts in the daily medical care that patients need. They do things such as give patients medications and keep track of their symptoms.

Genetic Counselors Genetic counselors specialize in knowing about our genes and diseases that children can inherit from their parents, such as primary HLH.

Transplant Team The team includes surgeons who perform transplants, nurses who keep an eye on a patient's progress, counselors who provide education to patients and their families, and experts in medical insurance.

Social Workers Hospital social workers help patients and their families understand illnesses such as primary HLH. They provide support as families deal with their emotions and provide counseling about the decisions that need to be made.

Important Safety Information (continued)• Your healthcare provider will give you medicine to help prevent certain infections before

you receive GAMIFANT® (emapalumab-lzsg).• After starting GAMIFANT, tell your healthcare provider if:

• new symptoms of an infection appear. • symptoms of an infection that you already had when starting GAMIFANT worsen. Your

healthcare provider will monitor you closely for signs and symptoms of infections during treatment with GAMIFANT.

Intensive Care Intensive care doctors specialize in treating symptoms that need immediate attention. Pediatric intensive care doctors and nurses have special training in treating infants and children.

Rheumatologist This kind of doctor specializes in treating autoimmune diseases. These are diseases, like primary HLH, where the immune system attacks the person’s own cells and organs.

Gastroenterologist/Hepatologist A gastroenterologist deals with illnesses that affect parts of the body that are involved in digestion such as the stomach, intestines, and esophagus. A hepatologist is a gastroenterologist with extra expertise in the liver, pancreas, and gallbladder.

Infectious Disease Specialist An infectious disease specialist diagnoses and treats potentially serious infections, such as those that might occur in a patient who has primary HLH.

Hematologist/Oncologist A “hem/onc” is a doctor who specializes in diseases of the blood and the wide variety of cancers that can attack us. Hem/oncs are also experts in primary HLH. Because of that, it was probably a hem/onc who diagnosed your loved one and who will be treating them moving forward.

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Layovers on the journey

Emergency Room (ER) This is the department where patients with the most urgent, sometimes life-threatening, symptoms go for care.

Pediatric Intensive Care Unit (also called the PICU) Infants, children, and teen patients are treated in the PICU when their symptoms are dangerous and need very close monitoring.

Rheumatology/Immunology Unit Specialists in this department diagnose and treat disorders of the immune system—the system of organs, cells, and chemicals that work together to protect the body.

Infectious Disease Unit This unit focuses on illnesses caused by organisms, such as bacteria, viruses, fungi, or parasites.


Hematology/Oncology Unit The Hematology/Oncology department diagnoses and treats patients who have cancer or blood disorders.

Infusion Center When patients have conditions that cannot be treated by medications that are taken by mouth, the Infusion Center provides medications that are given through a needle or catheter.

Diagnostic Imaging Unit In this unit, special tools such as X-rays, ultrasound, CT, and MRI scans are used to take pictures of what’s going on inside a person’s body. These pictures, or images, can help doctors diagnose diseases.

Your loved one is sick, and you’ll do anything to make them better. But if you don’t take care of yourself, you won’t be as able to take care of them. Here are some tips to help you get through this difficult journey:

Take care of yourself too

• Take breaks, even for just an hour or two. Ask a family member, friend, or health aide to stay with your loved one while you do something relaxing

• Eat right. Carry nutritious snacks with you, like fruit, granola bars, or nuts

• Exercise. A brisk walk, a bike ride, or yoga can help clear your mind and boost your energy level

Important Safety Information (continued)

Gamifant® (emapalumab-lzsg) can cause serious infusion reactions, including: • Infusion reactions. Infusion reactions are common with GAMIFANT, and can also be severe.

Infusion reactions can happen during or shortly after treatment with GAMIFANT. Your healthcare provider may temporarily stop your infusion and treat your symptoms before continuing your infusion if you have severe infusion reactions. Tell your healthcare provider right away if you get any of the following symptoms:

• skin redness • itching • fever • rash

• excessive sweating• chills • chest pain

• shortness of breath• nausea or vomiting

• lightheadedness or dizziness

CT=computed tomography; MRI=magnetic resonance imaging.

Just as you‘ve met and talked with many medical specialists, you’ve probably spent time in different parts of the hospital. Here is some information about what usually happens in various hospital units.

76




We're here to help guide you on your journey with Gamifant® (emapalumab-lzsg)

Gamifant Patient Services

833.597.6530

Personalized support is available, including dedicated Care Managers who can help provide guidance on your journey. Please reach out to learn more about:

• Starting treatment with Gamifant• Financial assistance programs, if eligible• Clarifying your health insurance options• Understanding primary HLH, and more

Gamifant is a registered trademark, owned by Sobi AG and is marketed by Sobi, Inc. PP-7210 © 2019 Swedish Orphan Biovitrum. All rights reserved.

Learn more at

GamifantCares.com

•

may increase your risk of serious infections that can lead to death. These infections include tuberculosis (TB), histoplasmosis, Herpes zoster infection (shingles) and other infections caused by viruses, fungi or bacteria that can spread throughout the body. Your healthcare provider will:

test you for TB before you start treatment with Gamifant.

treat you with a medicine for TB if you are at risk for TB or if you have a known positive TB test. Infections are common in people treated with Gamifant.

Please see full Important Safety Information and full Medication Guide.

• Your healthcare provider will give you medicine to help prevent certain infections before you receive Gamifant.

• After starting Gamifant, tell your healthcare provider if:

new symptoms of an infection appear.

symptoms of an infection that you already had when starting Gamifant worsen. Your healthcare provider will monitor you closely for signs and symptoms of infections during treatment with Gamifant.

Gamifant can cause serious infusion reactions, including:

• Infusion reactions. Infusion reactions are common with Gamifant, and can also be severe. Infusion reactions can happen during or shortly after treatment with Gamifant. Your healthcare provider may temporarily stop your infusion and treat your symptoms before continuing your infusion if you have severe infusion reactions. Tell your healthcare provider right away if you get any of the following symptoms:

skin redness

itching

fever

rash

excessive sweating

• high blood pressure (hypertension) and fever. These are

prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full Medication Guide for Gamifant.


chills

chest pain

shortness of breath

nausea or vomiting

lightheadedness or dizziness

19

Gamifant is a registered trademark, owned by Sobi AG and is marketed by Sobi, Inc. © 2020 Swedish Orphan Biovitrum. All rights reserved. PP-8505 06/20

Stopping for directions

When your family is dealing with primary HLH, it’s important to know that you are not alone.

If your doctor decides that Gamifant is right for your loved one, you will have access to Gamifant Patient Services. Personalized support is available throughout your treatment journey to help with things like:

• Understanding health insurance coverage for treatment with Gamifant

• Knowing if you or your child is eligible for financial support programs, including the Patient Assistance Program and commercial co-pay program

• Learning about dedicated Care Managers who can assist you every step of the way, and more

We hope the information in this guide helps you and your loved one cope with this hospital experience and your primary HLH journey.

Important Safety Information (continued)

The most common side effects of GAMIFANT include: • high blood pressure (hypertension) and fever. These are not all of the possible side effects

of GAMIFANT.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.



Learnmore at

GamifantCares.com833-597-6530




YOUR PRIMARY HLH Hospital Experience Gamifant Patient Services · helpful as you and your family...

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