PATIENT RESOURCES

Resources to Support You and Your Patients Every Step of the Way

Discover helpful resources to share with your office, patient, or their caregivers. These digital resources can help them get started or learn more about the support available while on ACTIMMUNE® (Interferon gamma-1b.) If you are a patient, you can learn more from these important tools or by visiting the ACTIMMUNE page for patients.

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Carol: When I'm going to be meeting with the patient and their family, explaining what my role is, I want them to understand that I will be a point person for them.

First and foremost, I'm there to listen to what their story is and then also let them know that I will be there to support them and ultimately to empower them.

I look at my role as being able to take as much off their plate as I can as they navigate that process, but also helping them understand in layman's terms where they are in the process and what they need to do on their end.

We don't want patients to feel that they're just out there alone and floating in the space of the unknown. We want patients to know they can reach out to us at any time or a family member or a caregiver, we're always available to them.

Amgen is definitely a company that puts patients first.

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ANNOUNCER: Get to know your Thyroid Eye Disease treatment.

Thyroid Eye Disease, or T-E-D, can be difficult to manage. But you haven’t let it stop you.

ANNOUNCER: You took control.

Got answers.

And found the help you needed.

You and your doctor chose TEPEZZA…

…a prescription medicine used to treat T-E-D. TEPEZZA is the only medicine that treats TED at its source.

Way to go! You’re on your way!

ANNOUNCER: Chapter 1: How TEPEZZA Works to Treat Thyroid Eye Disease.

To understand what causes T-E-D, you have to go behind the eye.

In the tissue behind the eye are cells that have receptors on their surface that act like switches.

But when you have T-E-D, your body’s immune system attacks this tissue, which causes molecules—known as autoantibodies—to turn these switches on.

This leads to swelling of the muscle and fat. This swelling can cause a number of symptoms like eye pain, redness in and around your eyes, and swollen eyelids.

The muscles and the fat tissue swell pushing the eyeball outward, which your doctor may call proptosis.

Similarly, it can cause double vision, which your doctor may call diplopia.

TEPEZZA is the first and only FDA-approved treatment for Thyroid Eye Disease. Unlike other medicines, TEPEZZA treats the cause of T-E-D not just the symptoms.

TEPEZZA is designed to bind to the switch and block it from turning on.

Since TEPEZZA blocks the switches so they can’t turn on, swelling of the muscle and fat tissue goes down.

This leads to reduced bulging and less redness, pain, and swelling of the eyes.

TEPEZZA can also improve double vision and, in some cases, make it completely go away.

ANNOUNCER: Chapter 2: The Insurance Approval Process

Now that you and your doctor have decided on TEPEZZA, the next step is to gain approval from your insurance provider.

TEPEZZA is a specialty medicine, which means it may require extra insurance approvals.

These approvals require steps like Benefits Investigation and Prior Authorization that usually take between 30 and 90 days, but in some cases may take longer.

If you’re not familiar with these insurance terms, don’t worry. In the next chapter of this video, you’ll learn about support services available to help you through the TEPEZZA insurance approval process.

Horizon Therapeutics, the developer of TEPEZZA, believes cost should never stop someone from getting the medicine they need.

They’re committed to helping you explore cost assistance options. That information will be in the next chapter as well.

ANNOUNCER: Chapter 3: Personalized Support with Horizon By Your Side

Horizon By Your Side, a patient support program, is here to help.

Once you and your doctor have decided TEPEZZA is right for you, you can sign up to be paired with a Patient Access Liaison, or PAL for short.

PALs from the Horizon By Your Side team are available for personal, non-medical and logistical assistance throughout your treatment, including:

Discussing what your doctor may have explained about starting treatment

Helping to understand the insurance process

Explaining financial assistance options

Helping you plan your first infusion

And more!

If you’re interested, ask your doctor if you can sign the Patient Enrollment Form before it is submitted to Horizon By Your Side. Once enrolled, you’ll receive a call from your PAL.

ANNOUNCER: Chapter 4: Getting Your TEPEZZA Infusion

TEPEZZA is an I-V, or intravenous, medicine. This means it’s delivered through a needle placed in your arm.

The process of delivering an IV medicine into the body is called an infusion. A full course of TEPEZZA treatment is 8 infusions. Each infusion is given 1 time every 3 weeks. That means that treatment with TEPEZZA will be ongoing for about 5 months.

TEPEZZA may be given at an infusion center, a type of clinic that specializes in giving infusions. It may also be given at a doctor’s office, hospital, or at home.

Check with both your insurance provider and your doctor to see if home infusion may be an option for you.

For your first infusion, having someone take you to and from the appointment is recommended.

When it’s time to start your TEPEZZA treatment, you’ll be taken to an infusion chair, which is a lot like a recliner.

Once the IV is in, all you have to do is relax and receive the infusion.

Each infusion appointment usually lasts one and a half to two and a half hours but will vary, depending on where you get your infusion.

During this time, books, music, and movies can all provide a welcome distraction.

KAREN (on camera):

I was very scared at the beginning.

To avoid everything else that was on the road for me, such as the steroids and the surgery, the infusion didn't sound so bad.

For me, it wasn't such a bad experience and then of course three weeks later, I went back for the second and it was the same thing.

They would make me very comfortable. I didn't even think of it as, "Oh my gosh, I'm sitting here getting an infusion. This is terrible." I thought, "Hey, you know, this isn't bad."

ANNOUNCER: Chapter 5: The possible side effects of TEPEZZA

It’s important to note that almost all of the side effects patients experienced in clinical trials were mild

—uncomfortable, but didn’t stop normal activity, or moderate

—uncomfortable and might impact normal activity.

Some patients experienced severe side effects

—uncomfortable, and impact normal activity, but everyone experiences side effect differently.

Here’s a list of the most common side effects of TEPEZZA and the percentage of people that experienced them in clinical studies:

Muscle cramps or spasms—25 percent of patients.

Nausea—17 percent.

Hair loss—13 percent.

Diarrhea—12 percent.

Tiredness—12 percent.

High blood sugar—10 percent.

Hearing problems—10 percent.

Changes in taste—8 percent.

Headache—8 percent.

Dry skin—8 percent.

Weight loss—6 percent.

Nail Problems—5 percent.

Changes in Menstruation—23 percent.

TEPEZZA may increase your blood sugar levels, so ask your doctor about developing a plan to have your blood sugar tested and tracked during treatment.

Always reach out to your doctor to discuss how to manage side effects.

ANNOUNCER: Chapter 6: How TEPEZZA Can Help Thyroid Eye Disease

In clinical studies, TEPEZZA has been proven to reduce eye bulging, improve double vision, provide relief from eye pain, redness, and swelling, and improve visual ability and physical appearance.

Some people had less eye bulging, redness, pain, and swelling as soon as 6 weeks after treatment with TEPEZZA, and improvement continued over the full treatment course of 8 infusions.

Once you start seeing results with TEPEZZA, you may want to stop receiving infusions, but to get the full benefit, it is recommended you receive all 8 of them.

JEANNE (on camera):

It was a slow process, but with each infusion, I did feel more and more relief. It was amazing.

It just…each time, my eyes…the bulging became less.

The redness was gone.

The double vision was gone.

To not have the itchiness, the bulgy red eyes, to not look weird. It’s really nice.

ANNOUNCER: Follow TEPEZZA on Facebook or Instagram to join the community, get important updates, and stay connected.

Congratulations on taking the first step with TEPEZZA.

Please listen to the Important Safety Information at the end of this video.

ANNOUNCER:

TEPEZZA is a prescription medicine used to treat Thyroid Eye Disease.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about TEPEZZA?

Infusion reactions can happen during or within 24 hours after your infusion of TEPEZZA. If you have a reaction while receiving TEPEZZA, your doctor or nurse will slow or stop your infusion and treat your reaction. If you have a severe infusion reaction, your doctor may stop your treatment completely.

Tell your doctor or nurse right away if you have any of these symptoms during or after your treatment with TEPEZZA:

  • High blood pressure
  • Fast heartbeat
  • Redness of the face or Feeling hot
  • Difficulty breathing
  • Headache
  • Muscle pain

If you have inflammatory bowel disease I-B-D, such as Crohn's disease or ulcerative colitis, TEPEZZA may make your I-B-D symptoms worse. Symptoms of worsening I-B-D may include: an increased number of loose stools with stomach pain or cramps, and blood in your stools. After each TEPEZZA infusion, tell your doctor right away if you have worsening I-B-D symptoms.

TEPEZZA may cause an increase in your blood sugar. Before starting treatment with TEPEZZA, tell your doctor if you are currently being treated for diabetes, know your blood sugar is high, or have been diagnosed with diabetes. It is important for you to take your treatments and follow an appropriate diet for glucose control as prescribed by your doctor.

Before receiving TEPEZZA, tell your doctor if you:

  • Have inflammatory bowel disease (Crohn's disease or ulcerative colitis).
  • Are currently being treated for diabetes, have been diagnosed with diabetes, or know your blood sugar is high.
  • Are pregnant or plan to become pregnant. TEPEZZA may harm your unborn baby. Tell your doctor if you become pregnant or suspect you are pregnant during treatment with TEPEZZA.
    • Women who are able to become pregnant should use an effective form of birth control (contraception) prior to starting treatment, during treatment and for at least 6 months after the final dose of TEPEZZA.
  • Are breastfeeding or plan to breastfeed. It is not known if TEPEZZA passes into your breast milk. Talk to your doctor about the best ways to feed your baby during treatment with TEPEZZA.
  • Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, dietary and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

What are the possible side effects of TEPEZZA?

The most common side effects of TEPEZZA include muscle cramps or spasms, nausea, hair loss, diarrhea, feeling tired, high blood sugar, hearing problems, taste changes, headache, dry skin, weight loss, nail problems, and changes in menstruation.

This is not a complete list of all possible side effects. Tell your doctor or treatment team about any side effect you may have.

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

Please visit TEPEZZA.com for more information.

ACTIMMUNE Patient Advocacy Organizations for Those Living With Chronic Granulomatous Disease (CGD)

  • CGD Association of America

    CGD Association of America is an independent, nonprofit organization that is committed to advocating for patients and carriers with CGD.

    cgdaa.org

  • Immune Deficiency Foundation

    The Immune Deficiency Foundation (IDF) is a national nonprofit patient organization dedicated to improving the lives of people with different kinds of primary immunodeficiency diseases, such as CGD. IDF provides a wide variety of resources for people with CGD, including information about diagnosis and treatment options.

    primaryimmune.org

  • Jeffrey Modell Foundation

    The Jeffrey Modell Foundation is a nonprofit organization devoted to diagnosis, meaningful treatments, and cures for primary immunodeficiency diseases. Thirty years after its creation, the organization continues its mission of hope, advocacy, and action by supporting the medical and global patient community.

    info4pi.org

  • Remember the Girls

    The mission of Remember the Girls is to raise awareness of the many issues facing female carriers of X-linked genetic disorders; to provide a forum for X-linked females to share their stories, ask questions, provide and receive emotional support; and to advocate for increased attention of the medical community to the physical and emotional issues of females who carry X-linked disorders.

    rememberthegirls.org

ACTIMMUNE Patient Advocacy Organizations for Those Living With a Rare Disease

  • Global Genes

    Global Genes is a leading nonprofit organization for patients and families fighting rare and genetic diseases like CGD. Their mission is to provide connections and resources so people can become activists for their disease and feel empowered to keep moving forward.

    globalgenes.org
  • National Organization for Rare Disorders (NORD)

    NORD is a patient advocacy organization dedicated to people with rare diseases and the groups that help them. NORD provides patients and families with advocacy information, assistance programs, and connections to patient organizations.

    rarediseases.org

  • EveryLife Foundation for Rare Diseases

    The EveryLife Foundation for Rare Diseases is dedicated to accelerating biotech innovation for rare disease treatments through science-driven public policy policy.

    EveryLifeFoundation.org

  • ANGEL AID connects rare communities to teach the tools of self-care and how to be listened to without judgement.

    angelaidcares.org

  • Our Odyssey

    Our Odyssey’s mission is connecting young adults impacted by a rare or chronic condition with social and emotional support in the hope of improving their quality of life.

    ourodyssey.org

  • Next Step is a non-profit that shatters limitations and elevates aspirations of young people with serious illness during their transition to adulthood through campferences, mentorship, music therapy, and other tailored programming.

    nextstepnet.org

Important Safety Information

INDICATIONS AND USAGE

ACTIMMUNE® (Interferon gamma-1b) is indicated:

  • For reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease
  • For delaying time to disease progression in patients with severe, malignant osteopetrosis

Important Safety Information

CONTRAINDICATIONS

  • In patients who develop or have known hypersensitivity to interferon-gamma, E. coli derived products, or any component of the product

WARNINGS AND PRECAUTIONS

  • ACTIMMUNE should be used with caution in patients with:
    • Pre-existing cardiac conditions, including ischemia, congestive heart failure, or arrhythmia
    • Seizure disorders or compromised central nervous system function; reduce dose or discontinue
    • Myelosuppression, or receiving other potentially myelosuppressive agents; consider dose reduction or discontinuation of therapy
    • Severe renal insufficiency
    • Age <1 year
  • Monitoring:
    • Patients begun on ACTIMMUNE before age 1 year should receive monthly assessments of liver function. If severe hepatic enzyme elevations develop, ACTIMMUNE dosage should be modified
    • Monitor renal function regularly when administering ACTIMMUNE in patients with severe renal insufficiency; accumulation of interferon gamma-1b may occur with repeated administration. Renal toxicity has been reported in patients receiving ACTIMMUNE
  • Pregnancy, Lactation, and Fertility:
    • ACTIMMUNE should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus
    • Use of ACTIMMUNE by lactating mothers is not recommended. ACTIMMUNE or nursing should be discontinued dependent on the importance of the drug to the mother
    • Long-term effects of ACTIMMUNE on fertility are not known

DRUG INTERACTIONS

  • Concomitant use of drugs with neurotoxic, hematotoxic, or cardiotoxic effects may increase the toxicity of interferons
  • Avoid simultaneous administration of ACTIMMUNE with other heterologous serum protein or immunological preparations (eg, vaccines)

ADVERSE REACTIONS

  • The most common adverse experiences occurring with ACTIMMUNE therapy are “flu-like” symptoms such as fever, headache, chills, myalgia, or fatigue, which may decrease in severity as treatment continues, and may be minimized by bedtime administration of ACTIMMUNE. Acetaminophen may be used to prevent or partially alleviate the fever and headache
  • Isolated cases of acute serious hypersensitivity reactions have been observed in patients receiving ACTIMMUNE
  • Reversible neutropenia, thrombocytopenia, and elevations of AST and/or ALT have been observed during ACTIMMUNE therapy
  • At doses 10 times greater than the weekly recommended dose, ACTIMMUNE may exacerbate pre-existing cardiac conditions, or may cause reversible neurological effects such as decreased mental status, gait disturbance, and dizziness

Approved Uses and Important Safety Information

INDICATIONS AND USAGE

ACTIMMUNE® (Interferon gamma-1b) is indicated:

  • For reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease
  • For delaying time to disease progression in patients with severe, malignant osteopetrosis

Important Safety Information

CONTRAINDICATIONS

  • In patients who develop or have known hypersensitivity to interferon-gamma, E. coli derived products, or any component of the product

WARNINGS AND PRECAUTIONS

  • ACTIMMUNE should be used with caution in patients with:
    • Pre-existing cardiac conditions, including ischemia, congestive heart failure, or arrhythmia
    • Seizure disorders or compromised central nervous system function; reduce dose or discontinue
    • Myelosuppression, or receiving other potentially myelosuppressive agents; consider dose reduction or discontinuation of therapy
    • Severe renal insufficiency
    • Age <1 year
  • Monitoring:
    • Patients begun on ACTIMMUNE before age 1 year should receive monthly assessments of liver function. If severe hepatic enzyme elevations develop, ACTIMMUNE dosage should be modified
    • Monitor renal function regularly when administering ACTIMMUNE in patients with severe renal insufficiency; accumulation of interferon gamma-1b may occur with repeated administration. Renal toxicity has been reported in patients receiving ACTIMMUNE
  • Pregnancy, Lactation, and Fertility:
    • ACTIMMUNE should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus
    • Use of ACTIMMUNE by lactating mothers is not recommended. ACTIMMUNE or nursing should be discontinued dependent on the importance of the drug to the mother
    • Long-term effects of ACTIMMUNE on fertility are not known

DRUG INTERACTIONS

  • Concomitant use of drugs with neurotoxic, hematotoxic, or cardiotoxic effects may increase the toxicity of interferons
  • Avoid simultaneous administration of ACTIMMUNE with other heterologous serum protein or immunological preparations (eg, vaccines)

ADVERSE REACTIONS

  • The most common adverse experiences occurring with ACTIMMUNE therapy are “flu-like” symptoms such as fever, headache, chills, myalgia, or fatigue, which may decrease in severity as treatment continues, and may be minimized by bedtime administration of ACTIMMUNE. Acetaminophen may be used to prevent or partially alleviate the fever and headache
  • Isolated cases of acute serious hypersensitivity reactions have been observed in patients receiving ACTIMMUNE
  • Reversible neutropenia, thrombocytopenia, and elevations of AST and/or ALT have been observed during ACTIMMUNE therapy
  • At doses 10 times greater than the weekly recommended dose, ACTIMMUNE may exacerbate pre-existing cardiac conditions, or may cause reversible neurological effects such as decreased mental status, gait disturbance, and dizziness