PERSONALIZED SUPPORT

Support When You Need It

The Amgen By Your Side team is led by a Patient Access Liaison (PAL). The PAL is a dedicated support partner who helps investigate, explain, and educate on each step of your treatment experience. They will be your partner to support and champion you while accomplishing your treatment goals.

The PAL can educate and assist you with:
Picture of Patient Access Liaison
Dori, Patient Access Liaison

  • Learning about insurance coverage criteria and approval process
  • Understanding cost assistance options
  • Discussing what to expect at the start of treatment
  • Coordinate delivery with the specialty pharmacy to schedule shipments of your medicine
  • Receiving refill reminders to help you stay on PROCYSBI® (cysteamine bitartrate) as your doctor has instructed
  • Discovering ways to connect with others living with nephropathic cystinosis, if interested (examples include in-person gatherings, online/virtual meetings, and even getting introduced to patient groups and mentors)

Watch how Amgen By Your Side can help you with your PROCYSBI treatment
  • 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.

    Amgen By Your Side is a patient support program designed specifically for someone prescribed a Amgen 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 Amgen medication, you will work with your doctor to be enrolled into Amgen 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 Amgen 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 Amgen 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: Amgen By Your Side also has many other resources available to patients and caregivers through our website, AmgenByYourSide.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, Amgen 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.

INDICATION and IMPORTANT SAFETY INFORMATION

INDICATION

PROCYSBI (cysteamine bitartrate) delayed-release capsules and delayed-release oral granules is a cystine-depleting agent indicated for the treatment of nephropathic cystinosis in adults and pediatric patients 1 year of age and older.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • Patients with serious hypersensitivity reaction, including anaphylaxis to penicillamine or cysteamine.

WARNINGS AND PRECAUTIONS

  • Ehlers-Danlos-like Syndrome: Skin and bone lesions that resemble clinical findings for Ehlers-Danlos-like syndrome have been reported in patients treated with high doses of immediate-release cysteamine bitartrate or other cysteamine salts. Monitor patients for development of skin or bone lesions and reduce PROCYSBI dosing if patients develop these lesions.
  • Skin Rash: Severe skin rashes such as erythema multiforme bullosa or toxic epidermal necrolysis have been reported in patients receiving immediate-release cysteamine bitartrate. Discontinue use if severe skin rash occurs.
  • Gastrointestinal (GI) Ulcers and Bleeding: GI ulceration and bleeding have been reported in patients receiving immediate-release cysteamine bitartrate. Monitor for GI symptoms and consider decreasing the dose if severe symptoms occur.
  • Fibrosing Colonopathy: Fibrosing colonopathy has been reported with postmarketing use of PROCYSBI. Evaluate patients with severe, persistent, and/or worsening abdominal symptoms for fibrosing colonopathy. If the diagnosis is confirmed, permanently discontinue PROCYSBI and switch to immediate-release cysteamine bitartrate capsules.
  • Central Nervous System (CNS) Symptoms: CNS symptoms such as seizures, lethargy, somnolence, depression, and encephalopathy have been associated with immediate-release cysteamine. Monitor for CNS symptoms; interrupt or reduce the dose for severe symptoms or those that persist or progress.
  • Leukopenia and/or Elevated Alkaline Phosphatase Levels: Cysteamine has been associated with reversible leukopenia and elevated alkaline phosphatase levels. Monitor white blood cell counts and alkaline phosphatase levels; decrease or discontinue the dose until values revert to normal.
  • Benign lntracranial Hypertension: Benign intracranial hypertension (pseudotumor cerebri; PTC) and/or papilledema has been reported in patients receiving immediate-release cysteamine bitartrate treatment. Monitor for signs and symptoms of PTC; interrupt or reduce the dose for signs/symptoms that persist, or discontinue if diagnosis is confirmed.

ADVERSE REACTIONS

The most common adverse reactions reported in PROCYSBI clinical trials (≥ 5%) were:

 

  • Patients 2 years of age and older previously treated with cysteamine: vomiting, nausea, abdominal pain, headache, conjunctivitis, influenza, gastroenteritis, nasopharyngitis, dehydration, ear infection, upper respiratory tract infection, fatigue, arthralgia, cough, and pain in extremity.
  • Patients 1 year of age and older naïve to cysteamine treatment: vomiting, gastroenteritis/viral gastroenteritis, diarrhea, breath odor, nausea, electrolyte imbalance, headache.

DRUG INTERACTIONS

  • Drugs that increase gastric pH may alter the pharmacokinetics of cysteamine due to the premature release of cysteamine from PROCYSBI and increase WBC cystine concentration. Monitor WBC cystine concentration with concomitant use.
  • Consumption of alcohol with PROCYSBI may increase the rate of cysteamine release and/or adversely alter the pharmacokinetic properties, as well as the effectiveness and safety of PROCYSBI.
  • PROCYSBI can be administered with electrolyte (except bicarbonate) and mineral replacements necessary for management of Fanconi Syndrome as well as vitamin D and thyroid hormone.

USE IN SPECIFIC POPULATIONS

  • Lactation: Because of the potential risk for serious adverse reactions in breastfed children from cysteamine, breastfeeding is not recommended during treatment with PROCYSBI.

Please see Full Prescribing Information.

INDICATION and IMPORTANT SAFETY INFORMATION

INDICATION

PROCYSBI (cysteamine bitartrate) delayed-release capsules and delayed-release oral granules is a cystine-depleting agent indicated for the treatment of nephropathic cystinosis in adults and pediatric patients 1 year of age and older.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • Patients with serious hypersensitivity reaction, including anaphylaxis to penicillamine or cysteamine.

WARNINGS AND PRECAUTIONS

  • Ehlers-Danlos-like Syndrome: Skin and bone lesions that resemble clinical findings for Ehlers-Danlos-like syndrome have been reported in patients treated with high doses of immediate-release cysteamine bitartrate or other cysteamine salts. Monitor patients for development of skin or bone lesions and reduce PROCYSBI dosing if patients develop these lesions.
  • Skin Rash: Severe skin rashes such as erythema multiforme bullosa or toxic epidermal necrolysis have been reported in patients receiving immediate-release cysteamine bitartrate. Discontinue use if severe skin rash occurs.
  • Gastrointestinal (GI) Ulcers and Bleeding: GI ulceration and bleeding have been reported in patients receiving immediate-release cysteamine bitartrate. Monitor for GI symptoms and consider decreasing the dose if severe symptoms occur.
  • Fibrosing Colonopathy: Fibrosing colonopathy has been reported with postmarketing use of PROCYSBI. Evaluate patients with severe, persistent, and/or worsening abdominal symptoms for fibrosing colonopathy. If the diagnosis is confirmed, permanently discontinue PROCYSBI and switch to immediate-release cysteamine bitartrate capsules.
  • Central Nervous System (CNS) Symptoms: CNS symptoms such as seizures, lethargy, somnolence, depression, and encephalopathy have been associated with immediate-release cysteamine. Monitor for CNS symptoms; interrupt or reduce the dose for severe symptoms or those that persist or progress.
  • Leukopenia and/or Elevated Alkaline Phosphatase Levels: Cysteamine has been associated with reversible leukopenia and elevated alkaline phosphatase levels. Monitor white blood cell counts and alkaline phosphatase levels; decrease or discontinue the dose until values revert to normal.
  • Benign lntracranial Hypertension: Benign intracranial hypertension (pseudotumor cerebri; PTC) and/or papilledema has been reported in patients receiving immediate-release cysteamine bitartrate treatment. Monitor for signs and symptoms of PTC; interrupt or reduce the dose for signs/symptoms that persist, or discontinue if diagnosis is confirmed.

ADVERSE REACTIONS

The most common adverse reactions reported in PROCYSBI clinical trials (≥ 5%) were:

  • Patients 2 years of age and older previously treated with cysteamine: vomiting, nausea, abdominal pain, headache, conjunctivitis, influenza, gastroenteritis, nasopharyngitis, dehydration, ear infection, upper respiratory tract infection, fatigue, arthralgia, cough, and pain in extremity.
  • Patients 1 year of age and older naïve to cysteamine treatment: vomiting, gastroenteritis/viral gastroenteritis, diarrhea, breath odor, nausea, electrolyte imbalance, headache.

DRUG INTERACTIONS

  • Drugs that increase gastric pH may alter the pharmacokinetics of cysteamine due to the premature release of cysteamine from PROCYSBI and increase WBC cystine concentration. Monitor WBC cystine concentration with concomitant use.
  • Consumption of alcohol with PROCYSBI may increase the rate of cysteamine release and/or adversely alter the pharmacokinetic properties, as well as the effectiveness and safety of PROCYSBI.
  • PROCYSBI can be administered with electrolyte (except bicarbonate) and mineral replacements necessary for management of Fanconi Syndrome as well as vitamin D and thyroid hormone.

USE IN SPECIFIC POPULATIONS

  • Lactation: Because of the potential risk for serious adverse reactions in breastfed children from cysteamine, breastfeeding is not recommended during treatment with PROCYSBI.

Please see Full Prescribing Information.