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
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.