Amgen By Your Side is a patient support program designed specifically for you, someone prescribed an Amgen medication. Once your enrollment is complete, you will be paired with your own dedicated support partner called a Patient Access Liaison (PAL). Your PAL will serve as your partner providing resources outside of your doctor to help you navigate your unique experience, including information on insurance, cost assistance 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?
Paying for treatment shouldn’t get in the way of your health. Whether you have commercial insurance, government insurance, or no insurance, 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.
Will I be eligible for cost savings?
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 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:
Learning about insurance coverage criteria and approval process
Understanding cost assistance options
Discussing what to expect at the start of treatment
Determining how treatment can fit into your routine
Receiving reminders to help you stay on your Amgen medicine
Discovering ways to connect with others, if interested
For more information, or if you have specific questions, call 1-855-888-4004
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.
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.
