For Patients and Caregivers For Healthcare Professionals Important Safety Information Prescribing Information PROCYSBI.com

This information is intended for U.S. healthcare professionals

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FREQUENTLY ASKED QUESTIONS

Amgen By Your Side FAQs

  • What is Amgen By Your Side?
    Amgen By Your Side is a patient support program designed specifically for you, someone prescribed PROCYSBI® (cysteamine bitartrate). After you have enrolled, you will be paired with a dedicated support partner, called a Patient Access Liaison (PAL). Your PAL will serve as your partner, providing nonmedical, personalized support to help as you navigate your unique experience, including information on insurance, financial support options, upcoming appointments, and other patient support services.
  • Is Amgen By Your Side free of charge?
    There is no cost to enroll, and there are two ways to join:
    • Option 1: Connect with a Patient Access Liaison (PAL) to help you explore enrollment options. Call 1-855-888-4004.
    • Option 2: Sign up through your doctor’s office. They can start the enrollment on AmgenByYourSide.com and submit it on your behalf. Patient consent is required.
  • Will my treatment be covered by my insurance?
    No matter your current financial situation, we are here to help. Whether you have commercial, government, or no insurance, the Amgen By Your Side team is committed to helping you understand your insurance coverage criteria and all available financial support options.
  • Will I be eligible for financial support?
    You may be eligible to pay $0 through our Amgen Commercial Co-Pay Program.* Patients with commercial insurance only.*
  • How do I enroll?
    Once you and your doctor (and/or healthcare team) decide that an Amgen treatment is right for you, enrolling in Amgen By Your Side is easy. There is no cost to enroll, and there are two ways to join:
    • Option 1: Connect with a Patient Access Liaison (PAL) to help you explore enrollment options. Call 1-855-888-4004.
    • Option 2: Sign up through your doctor’s office. They can start the enrollment on AmgenByYourSide.com and submit it on your behalf. Patient consent is required.
    Once enrollment is complete, your PAL will be your dedicated partner to help you get started and continue on your treatment, as prescribed by your doctor.
  • What is a Patient Access Liaison (PAL)?

    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 the steps in your treatment experience. They are your partner to support and champion you while accomplishing your treatment goals.

    The PAL can educate and assist you with:

    • Learning about insurance coverage criteria and approval process
    • Understanding financial support options
    • Discussing what to expect at the start of treatment
    • Determining how treatment, as prescribed, can fit into your routine
    • Receiving reminders to help you stay on your Amgen rare disease medicine, as prescribed
    • Discovering ways to connect with others, if interested
    • Providing information about additional resources or advocacy groups

For more information, or if you have specific
questions, call 1-855-888-4004

*The Amgen Commercial Co-Pay Program may be available to patients who meet the following minimum criteria:

  • Patient’s prescription cannot be paid in part or in full by any government-funded program including but not limited to: Medicare, Medicare Part D, Medicaid, Medigap, VA, CHAMPUS, Department of Defense (DOD), TRICARE, or any state, patient foundation, or other pharmaceutical program
  • Patient is prescribed a covered Amgen rare disease medication for an indication approved by the Food and Drug Administration; the indication for each product is shown in its prescribing information
  • Patient is a resident of the United States
  • Patient must be commercially insured and have financial responsibility for a portion of the drug and/or infusion cost if applicable

The assistance offered under this co-pay program is subject to additional terms and conditions, including but not limited to the following:

Terms and Conditions: Offer cannot be combined with any rebate or coupon, free trial, or similar offer for the specified prescription. Not valid for prescriptions reimbursed in whole or in part by any government-funded program including but not limited to Medicare, Medicare Part D, Medicaid, Medigap, VA, CHAMPUS, DOD, TRICARE, or any state, patient foundation, or other pharmaceutical program. Patients who are residents of Massachusetts or Rhode Island are not eligible for administration support. Offer good only in the United States at participating specialty pharmacies or sites of care. Offer not valid where otherwise prohibited by law, for example by applicable state law prohibiting co-pay cards. Amgen reserves the right to rescind, revoke, or amend offer without notice. The selling, purchasing, trading, or counterfeiting of any co-pay card or benefits is prohibited by law. This co-pay program is not insurance and is not intended to substitute for insurance. Age for eligibility is dependent on product indication.

Participating Pharmacies or Healthcare Providers: By using this co-pay program, you acknowledge and confirm that the prescription will not be reimbursed in whole or in part by any government-funded program (such as, without limitation, Medicare, Medicaid, VA, DOD, TRICARE) and the patient and prescription meet the eligibility criteria set forth in the terms and conditions. You are responsible for reporting the receipt of the co-pay program benefits as required by an insurer, payor, or applicable law or regulation.

Patients: By enrolling in this co-pay program, you acknowledge and confirm that you and the prescription meet the eligibility requirements set forth in the terms and conditions, including that the prescription will not be reimbursed in whole or in part by any government-funded program (such as, without limitation, Medicare, Medicaid, VA, DOD, TRICARE). You may not seek any claims to government payors or other payors or insurers for this prescription. You may not seek reimbursement from any health savings, flexible savings, or other healthcare reimbursement account for any amounts received from the co-pay program. You are responsible for reporting the receipt of the co-pay program benefits as required by an insurer, payor, or applicable law or regulation.

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.