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Resources for Your Practice and Your Patients

These downloadable resources provide important information about PROCYSBI, getting your patient started on treatment, and the correct use of PROCYSBI.

  • Treatment Initiation

  • Payor Access

  • Patient Resources

Patient Enrollment Form
patient-enrollment-form-

Patient Enrollment Form

Download the form, complete it with your patient, including HCP signature, and submit by fax or email.

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Annotated Patient Enrollment Form
Annotated Patient Enrollment Form

Annotated Patient Enrollment Form

Use this annotated form to help guide you through the Patient Enrollment Form.

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Full Prescribing Information
Full prescribing information

Full Prescribing Information

Complete information explaining the safe and effective use of PROCYSBI in patients with nephropathic cystinosis.

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Letter of Medical Necessity Template
Letter of medical neccesity template

Letter of Medical Necessity Template

A customizable letter template for HCPs who are submitting a Prior Authorization (PA) for specific PROCYSBI patient cases seeking payor access.

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Payor Access Roadmap
Payor Access Roadmap

Payor Access Roadmap

A resource to help educate healthcare providers about patient access and coverage.

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Letter of Medical Necessity Template
Prior Authorisation Checklist

Prior Authorization Checklist

A checklist that provides the common criteria that may be requested for PROCYSBI.

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Payor Appeal Letter Template
Payor Appeal Letter Template

Payor Appeal Letter Template

A customizable letter template for HCPs who are submitting an appeal for specific PROCYSBI patient cases that were denied Prior Authorization.

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Payor Appeal Letter Checklist and Tips
Payor appeal letter checklist and tips

Payor Appeal Letter Checklist and Tips

A resource that provides a checklist and tips that may be useful when creating an appeal letter after a prior authorization request is denied by your patient’s health plan.

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Letter of Medical Necessity Companion Piece
Lettwer of Medical Necessity

Letter of Medical Necessity Companion Piece

A resource for healthcare providers to use when developing a letter of medical necessity for patient cases seeking payor access to PROCYSBI.

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Instructions for Use
Instructions of use

Instructions for Use

Directions and steps for correct administration of PROCYSBI capsules and oral granules in easy-to-understand language.

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PROCYSBI Administration Fact Sheet
PROCYSBI Administration Fact Sheet

PROCYSBI Administration Fact Sheet

Summary sheet to help patients understand safe and correct administration of PROCYSBI.

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Patient Package Insert
Instructions of use

Patient Package Insert

A resource summarizing the safe and effective use of PROCYSBI for patients.

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Taking Control of Cystinosis
TakingControlofCystinosisThmbnl2x

Taking Control of Cystinosis

Use this visual aid to help facilitate conversations with your patients who have cystinosis.

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Group 75569
To learn more, call 1 (844) 469-4297 or visit https://
www.amgenbyyourside.com/PROCYSBI/hcp.
Amgen By Your Side is a patient support program for patients prescribed PROCYSBI. The dedicated members of the Amgen By Your Side team provide personalized service to these cystinosis patients so they can access PROCYSBI.
Patient Access Liaisons (PALs) work directly with individual patients to answer non-medical, logistical questions and provide support upon enrollment. Additionally, the PAL educates about navigating insurance processes and accessing treatment on your patient’s behalf. The PAL has the expertise and tools to support the patient by educating on patient benefits, Prior Authorization requirements, payor policies, and coding and claim submissions.
These services are offered to PROCYSBI patients upon enrollment with the Patient Enrollment Form (PEF) and completed patient consent and are built around 3 components: connect, coordinate, and champion.

The Amgen By Your Side team will:

Connect-1

Connect your patient to:

  • Live events
  • Online resources
  • Advocacy groups
Coordinate-2

Coordinate:

  • Help patients understand their insurance coverage and address financial barriers
  • Assist in connecting patients with their specialty pharmacy to schedule the shipment of their medicine to avoid running out of supply
Champion-1

Champion:

  • Educate your patients
  • Answer your patients’ non-medical and logistical questions
  • Support your patients with resources during their treatment journey
Group 75570

Determine correct dosing for your patient

View the Guide
Group 75571

Help patients get payor access to PROCYSBI

Download Payor Access Roadmap
Stay informed about PROCYSBI and cystinosis
Sign Up for Emails

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.