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Cysteamine therapy with 12-hour dosing

What is PROCYSBI?

PROCYSBI® (cysteamine bitartrate) delayed-release capsules are the first and only cysteamine therapy with 12-hour dosing approved for the management of nephropathic cystinosis in adults and children at least one year old.

PROCYSBI helps reduce cystine levels with 2 doses in 24 hours, taken every 12 hours at the same time every day, allowing patients and caregivers to choose consistent times that work for them. For example, you might take PROCYSBI at 7:00 a.m. and again at 7:00 p.m. every day. This means you can make a routine that fits your schedule.

With PROCYSBI’s 12-hour dosing schedule, I can get more sleep, and I’m able to do more with my time.

—Jacob, adult with cystinosis

Clinical trials with PROCYSBI

In clinical trials with people with nephropathic cystinosis who took PROCYSBI every 12 hours as directed:

  • PROCYSBI controlled cystine levels for a full 12 hours
  • PROCYSBI maintained kidney function during 24 months or more of treatment
  • The safety and effectiveness of PROCYSBI have been established in children 1 year of age and older; cystine levels were maintained through the 18 months of the trial
  • PROCYSBI improved weight and height in children older than 1 year and younger than 6 years (comparisons were made based on the change in weight and height from day 1 to 12 months and 18 months of the trial)

How PROCYSBI works

How PROCYSBI works graphic

PROCYSBI is a delayed-release formulation of cysteamine bitartrate that was designed to release in the small intestine instead of the stomach. A coating on the microbeads helps control how and where the medicine is released in the body. The coating does not break down in acidic environments, such as the stomach. Instead it breaks down in less acidic environments like the small intestine.

PROCYSBI passes through the stomach before it reaches the small intestine. Once in the small intestine, the medicine in PROCYSBI is gradually released over 12 hours–just long enough for the next dose of PROCYSBI to reach the small intestine. This gradual release of cysteamine ensures continuous dosing.

When acid levels in your stomach are higher, the microbead coating works as it should and doesn’t release the medicine until it reaches the small intestine. What you eat and drink can affect acid levels. If acid levels are too low, it can result in the medicine releasing too soon (in the stomach).

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.

When taking PROCYSBI as directed, continuous cystine control may be achieved. Talk to your doctor about how to take PROCYSBI with foods that have an appropriate level of acidity to ensure that it doesn’t dissolve in the stomach.

IMPORTANT SAFETY INFORMATION

PROCYSBI® (cysteamine bitartrate)
delayed-release capsules

Who should not take PROCYSBI?

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

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What should I tell my doctor before taking PROCYSBI?

Before you take PROCYSBI, tell your doctor if you:

Tell your doctor about all medicines that you take, including prescription and over-the-counter medicines, vitamins, 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 heavy 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:

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.

The most common side effects with PROCYSBI include: vomiting, nausea, stomach (abdominal) pain, breath odor, diarrhea, skin odor, tiredness, skin rash, headache, and problems with body salts or electrolytes.

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of PROCYSBI. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088.

What is PROCYSBI (Pro-CIS-bee)?

PROCYSBI® (cysteamine bitartrate) delayed-release capsules is a prescription medicine used to treat a medical condition called 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.

IMPORTANT SAFETY INFORMATION

PROCYSBI® (cysteamine bitartrate)
delayed-release capsules

Who should not take PROCYSBI?

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

What should I tell my doctor before taking PROCYSBI?

Before you take PROCYSBI, tell your doctor if you:

Tell your doctor about all medicines that you take, including prescription and over-the-counter medicines, vitamins, 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 heavy 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:

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.

The most common side effects with PROCYSBI include: vomiting, nausea, stomach (abdominal) pain, breath odor, diarrhea, skin odor, tiredness, skin rash, headache, and problems with body salts or electrolytes.

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of PROCYSBI. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088.

What is PROCYSBI (Pro-CIS-bee)?

PROCYSBI® (cysteamine bitartrate) delayed-release capsules is a prescription medicine used to treat a medical condition called 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.