PROCYSBI® (cysteamine bitartrate) Resources

Getting Started

Amgen By Your Side Program Overview
Amgen By Your Side is a patient support program designed specifically for you, someone prescribed PROCYSBI.

Who can make up a cystinosis care team?
As new symptoms arise, or to prevent damage, additional healthcare providers may be added to the team. Use this downloadable worksheet to track your doctors, specialists, and more.

Amgen By Your Side Brochure
Learn about the support and resources offered by the Amgen By Your Side program for patients prescribed PROCYSBI.

Financial Assistance

Insurance Approval Process

The insurance approval process may seem confusing at first. However, your Patient Access Liaison (PAL) can help you make sense of it.

Insurance Approval Guide
Get a better understanding of how insurance coverage of PROCYSBI is approved and how long it usually takes.

Understanding Health Plans
The Amgen By Your Side team is committed to partnering with you to help understand your insurance coverage criteria and all available cost assistance options.

Treatment

How to take PROCYSBI via G-tube
This video will walk you through the process, from preparing PROCYSBI for administration to giving the medicine through a G-tube.

Taking Charge of Your Health

Taking Charge of Your Health Is an A.R.T.

A resource to help you communicate with your healthcare team and use information to take charge of your health.

Making Changes That S.T.I.C.K.

A resource with real-life strategies to help you understand change and keep you motivated to stay on track.

How to Achieve G.O.A.L.S. That Matter to You

5 skills to help you meet your goals.

R.U.L.E.S. for Empowering Problem Solving

Learn how to help your loved ones find their own solutions.

Read Transcript

Kelly, Narrator: A new diagnosis can make you feel alone. Outside of just processing the change to your life, understanding everything that goes into your treatment can feel overwhelming.

Horizon By Your Side is a patient support program designed specifically for someone prescribed a Horizon medication. Our dedicated team is your partner, committed to providing non-medical, personalized support so you can start and continue treatment as your doctor recommends.

Once you are prescribed a Horizon medication, you will work with your doctor to be enrolled into Horizon By Your Side and get matched with a Patient Access Liaison, or PAL. Or in some cases, a clinical nurse educator – a CNE.

Lindsey (PAL) talking to Khash: … I’m available to help you as you need for anything that might come up. I’m basically your advocate, your cheerleader, your friend. I’m here to support you through the entire journey.

Khash: My primary care physician said, “We’re going to have a Patient Access Liaison get in contact with you to discuss it further with you, and tell you all the pluses, minuses and all that stuff. Lindsey, really took the time to explain it all to me, including the commitment it’s going to take on my side to get this done.

Kelly, Narrator: A PAL is your partner to support and champion you while accomplishing your treatment goals. Some of the ways your PAL can support you include:
- Learning about insurance coverage and the approval process
- Understanding potential costs or cost assistance options
- Sharing additional resources, connect to advocacy groups, or connect with others if interested

Roxie: I did work with the Patient Access Liaison, more commonly known as PALs, and she kept in touch with me. I was really worried about insurance and about out-of-pocket cost. Although I was willing to do whatever it took. She checked out my insurances and I am so blessed because it was 100% covered.

Randi: They assigned me a Patient Access Liaison after I was approved for treatment and just helped guide me through the process as far as what to expect, the process that I was going to go through and just to be there for general support for me.

Melanie: She really took the time to explain everything and go through it and has been there for me for every single question ever since.

Kelly, Narrator: With everything you and your caregivers have going on, it can be difficult to fit treatment into your routine. Your PAL can help you understand what to expect at the start of treatment, how treatment can fit into your routine and send reminders to help you stay on track.

Carol (PAL): I want them to understand that I will be a point person for them. First and foremost, I’m there to listen and also let them know I’m there to support them through the process. And ultimately to empower them.

Latoya: They remind you of things that you typically forget. Even like when it comes to testing kits, you know. I was able to work out a plan. The PAL also will also make sure, like when it’s time to renew insurance, that at the end of the year you know, they shoot you a text messages to call. So I think they’re a great resource. They really are.

Melanie: They call me to do refills earlier than I need them so that I don’t run out of the medication.

Carol (PAL): We don’t want patients to feel that they’re just out there alone and floating in the space of the unknown. They can reach out to us at any time. We’re always available to them.

Kelly, Narrator: The Horizon By Your Side team can also help you become more comfortable with your diagnosis, even visiting to teach you hands-on how to take your medication and help you find medicine in case of an emergency.

Jerry (CNE): As a Clinical Nurse Educator my responsibility and my job is to make sure that our patients are well taken care of and that their needs are met. We also have communication with their primary doctors to make sure that they know and they are up-to-date in their treatment.

Shannon (CNE): I teach them about lifestyle modifications needed to stay healthy, a lot of disease state education.

Kelly, Narrator: We can also help connect you with a peer mentor, who are other Horizon patients that are going through a similar experience.

Randi: I may talk to three or four newly diagnosed patients a week. They want to know what the experience was like for me.

Kelly, Narrator: Horizon By Your Side also has many other resources available to patients and caregivers through our website, HorizonByYourSide.com. There you’ll find information about enrollment, treatment cost assistance options, treatment planning, and many other resources to assist you during your treatment experience.

In the end, Horizon By Your Side is designed to be just that …. by your side.

Melanie: I was so happy because I was so scared. She was there from the very beginning, I am trying to manage this disease by myself, but I’m not really by myself because I have these people in my corner that are available to me at any time.

Roxanne: After being so dismissed and feeling like I was doing this by myself, it was so helpful to have somebody who understood, who knew it. It gave me hope and it let me know that at some point, I was going to be able to go on with my life and not be held back by this anymore.

Read Transcript

Narrator:If you’ve recently been prescribed a Amgen medicine, there are a few steps to the insurance approval process. This will look slightly different for each patient and the time it may take to get approval can vary.

Narrator:Fortunately, Amgen By Your Side, a patient support program designed specifically for you, will be there “by your side” every step of the way, to make the process as smooth as possible.

Narrator: When your health plan decides whether to cover a Amgen medication, their review process may include several steps.

Narrator:First – a benefits investigation. After your doctor prescribes your medicine and you provide permission through a patient consent form, a Amgen By Your Side team member will contact your health plan to review your coverage.

Your Patient Access Liaison, or PAL, or, in some cases, a Clinical Nurse Educator, a CNE will call you with information on the progress of your benefits investigation and review:

Whether the medicine is covered by your policy and prior authorization requirements.

Your estimated out-of-pocket costs and financial assistance that may be available to you

Narrator:Second – Prior Authorization or “PA”. While often needed, sometimes a “PA” may not be required. If a Prior Authorization IS required for you, this is a process your doctor must complete, describing the reasons you should be prescribed the medicine and why the costs should be covered.

Narrator: Third – Health Plan Decision – After receiving all required information, your health plan will determine whether it will cover your Amgen medicine. You and your doctor’s office should receive a written decision from the health plan.

If your health plan denies coverage, you can work with your doctor’s office to appeal this decision. The Amgen By Your Side Team can educate you and your doctor about the process

Narrator: Throughout the process, the Amgen By Your Side team will provide support by:

Contacting your health plan to review your insurance coverage
Providing your doctor with education on any requirements or PA decisions
Going over alternative options you may use to access your medicine while the insurance review is underway
Staying in touch with you throughout the process to keep you up to date on the status of the review.

Narrator: For more information on the insurance approval process and the services available to patients and healthcare providers from Amgen By Your Side, visit AmgenByYourSide.com

Read Transcript

Change is hard

You can all probably think of a change you've made in your life—or many changes—that took effort. Even just starting a change can be challenging.

There’s another part of the change process, though, that we don’t think about as much: How to maintain changes... how to stay consistent day after day. Maintaining change—sticking with it over time even when things get hard—is one of the real challenges of change.

Today the goal is to give you real-life strategies that are based on the newest science available, to help you make changes that stick.

Let’s explore a little bit about the process of change.

When we are thinking about change, it is normal for us to feel two ways about something – some good feelings, and some bad feelings.

Most people who need to make a change are unsure how to do it. We might want to look for a new job but also worry about leaving the one we currently have. We want to feel better with a new medicine but at the same time we don’t want to feel the hassles of taking it.

We see reasons to change and reasons not to. We want to change and we don’t want to change, all at the same time. We want two opposite things at the very same time. But it’s very normal to feel this way.

Despite the stickiness of this dilemma, we often decide to make a change, then we begin to do it, and then we take a step forward, followed by another step and another.

We can celebrate that we’ve made it over this initial uncertain hurdle, because that truly is a big win for us.

But this is often where things get even more tricky! Most changes require long-term attention and effort over time.

We will come to points in our life when we will have to decide if it is better to continue pursuing change or to accept what already is.

Here’s a non-trivial trivia question about change. Guess how many New Year’s resolutions are kept by February 1. Are you ready for this? Just 20% kept. 80% quit.

Today we will share with you five ways, based on the science of behavior change, to make change STICK. The word “STICK” is made up of letters to help you remember what is important to keep you on track and keep you motivated to succeed. We will now look at each of these strategies in more detail.

Let’s start with the ‘S’ in stick. First, imagine the change process as a road. Now, fast forward a few months or a year so that you are farther along that road. Now, suppose you turn around and look back on the change you’ve made, realizing that something got you off course. What would the obstacle or obstacles be? How might you avoid, escape, or overcome them? What can you do now, ahead of time, to develop a plan to deal with these obstacles and stay the course?

It’s a bit like having a fire escape plan. No one ever really expects a fire, but we all know it is a good idea to have an escape plan if there ever was one. You need to know where the exits are, and how to get to them.

The ‘T’ stands for ‘think of your why.’ Take a moment to think of your ‘why’—what really matters to you? What is most important in your life? How does this change connect with things that are most important to you?

By thinking of our why, we are reminding ourselves of the reasons we wanted to make this change and why we did it in the first place. We might also be reminding ourselves of what we have gained.

If we started a new exercise plan, we might think of the ways we’ve felt stronger lately and how that has made us feel about ourselves, such as: “I was able to carry those heavy grocery bags at one time. I felt strong,” or “I have been able to take a walk with my neighbor without stiffness or pain thanks to this medicine.”

Who is someone you might share your “why” with? Perhaps your doctor or a family member or friend? Sometimes simply saying things out loud, in the presence of someone you trust, can help us stay on track with changes.

The ‘I’ stands for ‘incorporating self-affirmations.’ Many times, we tend to look at what we are missing; what we have done wrong; how we have fallen short.

Self-affirmations are a way to change because they allow us to shift our perspective to what’s working—what strengths we have and what we can tap into when things become difficult.

Here are some words to describe strengths of successful changers. Take a look. Which ones do you think apply to you? In what ways are you like them? Where in your life have you particularly shown some of these qualities? What are some examples of how you show these positive qualities?

Everyone can find some words on this list that describe themselves.

The ‘C’ stands for ‘consider setbacks as learning experiences.’ With a setback, we imagine ourselves going back to square one. However, we actually start from a better place with helpful learnings gained from our last try—applying what was learned and making changes to correct what hadn’t worked before. You can ask yourself, “What positive lesson can I learn from this setback?”

This is because a setback can be a very good thing. It can be good because you now have more experience and more information that will help you move forward. And with more information, you are empowered. You learned what wasn’t working, and by incorporating what you learned, you will be better prepared for the next try.

Think about some of the setbacks you have faced as you attempted to stick with a change. When you were faced with a challenge, what lessons did you learn that will help you move forward?

The ‘K’ stands for ‘keeping your eye on progress rather than perfection.’ Changing a familiar behavior is usually not easy. Humans are not perfect, and if you happen to get off course, what matters is to get back on track, not allowing a mistake to become a disaster.

For example, imagine you set a goal for yourself such as “not eating sweets,” but then you find yourself on the couch with a pint of ice cream. And after the first bite you exclaim, “I ruined it all. I might as well stop this whole plan of not eating sweets!”

What’s happened is known as “the first rule violation”—something happens. And when it does, it can trigger a breakdown in self-control. Once the rule has been broken, it seems there is nothing to lose.

We tend to have unhelpful negative thoughts like, “You blew it,” “You just can’t do it,” “What’s the point in trying?”

Repeating statements like this to ourselves is not helpful. Feeling bad doesn’t make things any better.

Instead, we can think of some “comeback” replies to keep our eye on progress.

Rather than the all-or-nothing view, you can view it from the perspective of progress. A way of thinking about what positive steps have been made. Perhaps you put the spoon away and the ice cream back in the refrigerator and then say, “Now wait a minute…in the past I would have just eaten this whole thing….today I stopped myself,” or “What can I do to get back on track?”

So... these are the steps in STICK:

Stay the course
Think of your why
Incorporate self-affirmations
Consider setbacks and learning experiences
Keep your eye on progress not perfection

And that is what you need to know when Making Changes Stick!

USE and IMPORTANT SAFETY INFORMATION

What is the most important safety information I should know about PROCYSBI?

PROCYSBI can cause serious side effects, including:

Skin, bone, and joint problems. People treated with high doses of cysteamine bitartrate may develop abnormal changes of their skin and bones, such as stretch marks, bone injuries (such as fractures), bone deformities, and joint problems. Check your skin while taking PROCYSBI. Tell your doctor if you notice any skin changes or problems with your bones or joints. Your doctor will check you for these problems.
Skin rash. Skin rash is common with cysteamine bitartrate and may sometimes be severe. Tell your doctor right away if you get a skin rash. Your dose of PROCYSBI may need to be decreased until the rash goes away. If the rash is severe, your doctor may tell you to stop taking PROCYSBI.
Stomach and bowel (intestinal) problems. Some people who take other medicines that contain cysteamine bitartrate may develop ulcers and bleeding in their stomach or bowel. People treated with PROCYSBI may also develop abnormal swelling and narrowing of the large bowel which must be treated promptly. Tell your doctor right away if you get abdominal pain, bloody or persistent diarrhea, bloating, nausea, vomiting, loss of appetite, vomit blood, poor weight gain or weight loss.
Central nervous system symptoms. Some people who take other medicines that contain cysteamine bitartrate develop seizures, depression, and become very sleepy. The medicine may affect how your brain is working (encephalopathy). Tell your doctor right away if you develop any of these symptoms.
Low white blood cell count and certain abnormal liver function blood tests. Your doctor should check you for these problems.
Benign intracranial hypertension (pseudotumor cerebri) has happened in some people who take immediate-release cysteamine bitartrate. This is a condition where there is high pressure in the fluid around the brain. Your doctor should do eye examinations to find and treat this problem early.

Tell your doctor right away if you develop any of the following symptoms while taking PROCYSBI: headache, buzzing or “whooshing” sound in the ear, dizziness, nausea, double vision, blurry vision, loss of vision, pain behind the eye, or pain with eye movement.

What is PROCYSBI?

PROCYSBI (cysteamine bitartrate) delayed-release capsules and delayed-release oral granules is a prescription medicine used to treat nephropathic cystinosis in adults and children 1 year of age and older. It is not known if PROCYSBI is safe and effective in children under 1 year of age.

Do not take PROCYSBI if you are allergic to penicillamine or cysteamine.

Before taking PROCYSBI, tell your doctor about all your medical conditions, including if you:

drink alcohol.
have a skin rash or bone problems.
have or have had stomach or bowel (intestinal) problems including ulcers or bleeding.
have a history of seizures, lack of energy, unusual sleepiness, depression, or changes in your ability to think clearly.
have liver or blood problems.
are pregnant or plan to become pregnant. It is not known if PROCYSBI will harm your unborn baby. Tell your doctor right away if you think that you are pregnant. Talk with your doctor about the benefits and risks of taking PROCYSBI during pregnancy.
are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with PROCYSBI. Talk with your doctor about the best way to feed your baby if you take PROCYSBI.

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 should I avoid while taking PROCYSBI?

Do not drive or operate machinery until you know how PROCYSBI affects you. PROCYSBI can make you sleepy or less alert than normal.
Do not drink alcohol if you take PROCYSBI. Drinking alcohol while taking PROCYSBI may change how PROCYSBI works and may cause an increase in the amount of PROCYSBI in your blood that may cause serious side effects.

What are the possible side effects of PROCYSBI?

PROCYSBI can cause serious side effects, including:

See "What is the most important information I should know about PROCYSBI?"

The most common side effects of PROCYSBI include: vomiting, nausea, stomach (abdominal) pain, pink eye, diarrhea, cold, tiredness, flu, headache, problems with body salts or electrolytes, infection of ear, nose or throat, joint pain.

These are not all the possible side effects of PROCYSBI. Call your doctor for medical information about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For additional important safety information, click here for the Patient Package Insert and discuss with your doctor.

USE and IMPORTANT SAFETY INFORMATION

What is the most important safety information I should know about PROCYSBI?

PROCYSBI can cause serious side effects, including:

Skin, bone, and joint problems. People treated with high doses of cysteamine bitartrate may develop abnormal changes of their skin and bones, such as stretch marks, bone injuries (such as fractures), bone deformities, and joint problems. Check your skin while taking PROCYSBI. Tell your doctor if you notice any skin changes or problems with your bones or joints. Your doctor will check you for these problems.
Skin rash. Skin rash is common with cysteamine bitartrate and may sometimes be severe. Tell your doctor right away if you get a skin rash. Your dose of PROCYSBI may need to be decreased until the rash goes away. If the rash is severe, your doctor may tell you to stop taking PROCYSBI.
Stomach and bowel (intestinal) problems. Some people who take other medicines that contain cysteamine bitartrate may develop ulcers and bleeding in their stomach or bowel. People treated with PROCYSBI may also develop abnormal swelling and narrowing of the large bowel which must be treated promptly. Tell your doctor right away if you get abdominal pain, bloody or persistent diarrhea, bloating, nausea, vomiting, loss of appetite, vomit blood, poor weight gain or weight loss.
Central nervous system symptoms. Some people who take other medicines that contain cysteamine bitartrate develop seizures, depression, and become very sleepy. The medicine may affect how your brain is working (encephalopathy). Tell your doctor right away if you develop any of these symptoms.
Low white blood cell count and certain abnormal liver function blood tests. Your doctor should check you for these problems.
Benign intracranial hypertension (pseudotumor cerebri) has happened in some people who take immediate-release cysteamine bitartrate. This is a condition where there is high pressure in the fluid around the brain. Your doctor should do eye examinations to find and treat this problem early.

What is PROCYSBI?

Do not take PROCYSBI if you are allergic to penicillamine or cysteamine.

Before taking PROCYSBI, tell your doctor about all your medical conditions, including if you:

drink alcohol.
have a skin rash or bone problems.
have or have had stomach or bowel (intestinal) problems including ulcers or bleeding.
have a history of seizures, lack of energy, unusual sleepiness, depression, or changes in your ability to think clearly.
have liver or blood problems.
are pregnant or plan to become pregnant. It is not known if PROCYSBI will harm your unborn baby. Tell your doctor right away if you think that you are pregnant. Talk with your doctor about the benefits and risks of taking PROCYSBI during pregnancy.
are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with PROCYSBI. Talk with your doctor about the best way to feed your baby if you take PROCYSBI.

What should I avoid while taking PROCYSBI?

Do not drive or operate machinery until you know how PROCYSBI affects you. PROCYSBI can make you sleepy or less alert than normal.
Do not drink alcohol if you take PROCYSBI. Drinking alcohol while taking PROCYSBI may change how PROCYSBI works and may cause an increase in the amount of PROCYSBI in your blood that may cause serious side effects.

What are the possible side effects of PROCYSBI?

PROCYSBI can cause serious side effects, including:

See "What is the most important information I should know about PROCYSBI?"

These are not all the possible side effects of PROCYSBI. Call your doctor for medical information about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For additional important safety information, click here for the Patient Package Insert and discuss with your doctor.

Resources to Support You Every Step of the Way

On this page:

Getting Started

Amgen By Your Side Program Overview
Amgen By Your Side is a patient support program designed specifically for you, someone prescribed PROCYSBI.

Who can make up a cystinosis care team?
As new symptoms arise, or to prevent damage, additional healthcare providers may be added to the team. Use this downloadable worksheet to track your doctors, specialists, and more.

Amgen By Your Side Brochure
Learn about the support and resources offered by the Amgen By Your Side program for patients prescribed PROCYSBI.

Financial Assistance

Insurance Approval Process

Insurance Approval Guide
Get a better understanding of how insurance coverage of PROCYSBI is approved and how long it usually takes.

Understanding Health Plans
The Amgen By Your Side team is committed to partnering with you to help understand your insurance coverage criteria and all available cost assistance options.

Treatment

How to take PROCYSBI via G-tube
This video will walk you through the process, from preparing PROCYSBI for administration to giving the medicine through a G-tube.

Taking Charge of Your Health

Taking Charge of Your Health Is an A.R.T.

Making Changes That S.T.I.C.K.

How to Achieve G.O.A.L.S. That Matter to You

R.U.L.E.S. for Empowering Problem Solving

Spanish Videos

Tres maneras de hacerse cargo de su salud

Mejorar la comunicación con su médico

REGLAS (R.U.L.E.S.) para potenciar la resolución de problemas

What is PROCYSBI?

What should I avoid while taking PROCYSBI?

What are the possible side effects of PROCYSBI?

USE and IMPORTANT SAFETY INFORMATION

What is PROCYSBI?

What should I avoid while taking PROCYSBI?

What are the possible side effects of PROCYSBI?

Resources to Support You Every Step of the Way

On this page:

On this page:

Getting Started

Amgen By Your Side Program OverviewAmgen By Your Side is a patient support program designed specifically for you, someone prescribed PROCYSBI.

Who can make up a cystinosis care team? As new symptoms arise, or to prevent damage, additional healthcare providers may be added to the team. Use this downloadable worksheet to track your doctors, specialists, and more.

Amgen By Your Side BrochureLearn about the support and resources offered by the Amgen By Your Side program for patients prescribed PROCYSBI.

Financial Assistance

Insurance Approval Process

Insurance Approval GuideGet a better understanding of how insurance coverage of PROCYSBI is approved and how long it usually takes.

Understanding Health PlansThe Amgen By Your Side team is committed to partnering with you to help understand your insurance coverage criteria and all available cost assistance options.

Treatment

How to take PROCYSBI via G-tubeThis video will walk you through the process, from preparing PROCYSBI for administration to giving the medicine through a G-tube.

Taking Charge of Your Health

Taking Charge of Your Health Is an A.R.T.

Making Changes That S.T.I.C.K.

How to Achieve G.O.A.L.S. That Matter to You

R.U.L.E.S. for Empowering Problem Solving

Spanish Videos

Tres maneras de hacerse cargo de su salud

Mejorar la comunicación con su médico

REGLAS (R.U.L.E.S.) para potenciar la resolución de problemas

What is PROCYSBI?

What should I avoid while taking PROCYSBI?

What are the possible side effects of PROCYSBI?

USE and IMPORTANT SAFETY INFORMATION

What is PROCYSBI?

What should I avoid while taking PROCYSBI?

What are the possible side effects of PROCYSBI?

Amgen By Your Side Program Overview
Amgen By Your Side is a patient support program designed specifically for you, someone prescribed PROCYSBI.

Who can make up a cystinosis care team?
As new symptoms arise, or to prevent damage, additional healthcare providers may be added to the team. Use this downloadable worksheet to track your doctors, specialists, and more.

Amgen By Your Side Brochure
Learn about the support and resources offered by the Amgen By Your Side program for patients prescribed PROCYSBI.

Insurance Approval Guide
Get a better understanding of how insurance coverage of PROCYSBI is approved and how long it usually takes.

Understanding Health Plans
The Amgen By Your Side team is committed to partnering with you to help understand your insurance coverage criteria and all available cost assistance options.

How to take PROCYSBI via G-tube
This video will walk you through the process, from preparing PROCYSBI for administration to giving the medicine through a G-tube.