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Designed to deliver continuous control

For PROCYSBI® to continuously control your cystine levels, it must be taken 2 times a day—once every 12 hours. For example, you might take PROCYSBI at 7:00 a.m. and again at 7:00 p.m. every day. This dosing allows you to fit PROCYSBI into your daily routine, even with school and work.


With PROCYSBI, you can create an every 12 hour dosing schedule that may be convenient for you and your daily routine.

See the role of cystine level testing.

One medical study showed that people who took their doses of cysteamine therapy on time had lower average cystine levels compared with people who missed a dose or took their medicine late.

PROCYSBI can be taken by mouth and by G-tube.


How to take PROCYSBI
by mouth

PROCYSBI bottles graphic

PROCYSBI® (cysteamine bitartrate) delayed-release capsules are available in 2 strengths: 25 mg and 75 mg. PROCYSBI may be swallowed as whole capsules with select liquids, or the capsules may be opened and their contents (coated microbeads) mixed with select foods or liquids.

Important notes about taking PROCYSBI

  • Take PROCYSBI the same way each time
  • Do not eat for at least 2 hours before taking PROCYSBI and at least 30 minutes after you take it
  • Take PROCYSBI at least 1 hour before or after you take medicines that contain bicarbonate or carbonate
  • If you can't take PROCYSBI without eating, take it with no more than a ½ cup (4 oz.) of food up to 1 hour before or after you take PROCYSBI
  • Whole capsules graphic

    Whole capsules

    STEPS REQUIRED
    1. Swallow with water or fruit juice (except grapefruit juice). Do not crush or chew the capsules
  • Contents of capsule with food graphic

    Contents of capsules with food

    STEPS REQUIRED
    1. Open the capsule(s). See instructions below
    2. Gently mix the contents with about ½ cup (4 oz.) of applesauce or berry jelly. Do not chew the microbeads. Do not mix with any food other than applesauce or berry jelly
    3. Eat the applesauce or berry jelly mixture within 30 minutes of mixing. Do not save the applesauce or berry jelly mixture for later use
  • Contents of capsule with liquid graphic

    Contents of capsules with liquid

    STEPS REQUIRED
    1. Open the capsule(s). See instructions below
    2. Gently mix the contents with about ½ cup (4 oz.) of any fruit juice (except grapefruit juice). Do not chew the microbeads
    3. Drink all of the fruit juice mixture within 30 minutes of mixing. Do not save the fruit juice mixture for later use

How to open PROCYSBI capsules:

  • Do not pinch the PROCYSBI capsule in the center
  • Do not crush or chew the PROCYSBI capsule
  • Use both hands to open the PROCYSBI capsule
  • Hold each end of the PROCYSBI capsule with your thumb and index (pointer) fingers, and gently twist the 2 ends in opposite directions to open

How to take PROCYSBI via G-tube

Read video transcript

You or your loved one may have decided with your doctor to take PROCYSBI cysteamine bitartrate through a gastrostomy tube, or G-tube. This video will walk you through the process, from preparing PROCYSBI for administration to giving the medicine through the feeding tube. If you have any questions about PROCYSBI or taking PROCYSBI through a G-tube, contact your doctor or your patient access manager. You should also look at the Instructions for Use, which are included when your PROCYSBI is sent to you.

Let’s get started.

Before you gather your materials and PROCYSBI capsules, always wash your hands to reduce the spread of germs. Now you’re ready to gather your materials.

Here's what you'll need: Catheter tip syringes and a feeding tube for a G-tube that is size 14 French or larger. A straight, or bolus, feeding tube is best. Strained applesauce. Do not use chunky applesauce. A clean bowl and measuring cup. Water. Fruit juice. And PROCYSBI capsules for the prescribed dose.

Now you're ready to start the preparation process. Unclasp the G-tube button and attach the feeding tube. Flush with 5 milliliters of water to clear the button.

Measure strained applesauce, and put it in a clean container.

Make sure your hands are dry before opening the PROCYSBI capsules. Grab the ends, and twist slowly. Be careful not to pinch the capsules in the center or crush them. Sprinkle the granules on top of the applesauce.

Use a syringe to gently stir the PROCYSBI granules into the applesauce.

Draw the mixture up into the syringe. Draw up at least 10 milliliters for children and about 40 milliliters for adults.

Next, connect the syringe to the feeding tube. Fill the feeding tube with the mixture.

Hold the syringe and feeding tube in a horizontal position—straight across—to administer the mixture. Give the mixture at a quick and steady pace.

Repeat as needed to give all of the mixture.

Give all of the mixture within 30 minutes of mixing. None of the mixture should be saved.

To be sure all of the mixture has been given, pour some liquid into the bowl, and swirl it around to get the remaining applesauce.. You can use water or juice, but do not use grapefruit juice. Draw the liquid up into another syringe.

Gently swirl the syringe and flush the G-tube to be sure that none of the applesauce and granule mixture remains.

You’re finished. Although there are a number of steps in the process, it becomes more natural over time. Be sure to clean all your equipment for your next use. Use this video to go through the steps whenever you need to.

If you have any questions about giving PROCYSBI through a G-tube, see the PROCYSBI Instructions For Use, or contact your doctor or a patient access manager at Horizon Pharma. Support is always available.

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.

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:

  • drink alcohol
  • have a skin rash or bone problems
  • have or have had stomach or bowel (intestinal) problems including ulcers or bleeding
  • have a history of seizures, lack of energy, unusual sleepiness, depression or changes in your ability to think clearly
  • have liver or blood problems
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if PROCYSBI will harm your unborn baby. Tell your doctor right away if you think that you are pregnant. Talk with your doctor about the benefits and risks of taking PROCYSBI during pregnancy.
  • are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with PROCYSBI. Talk with your doctor about the best way to feed your baby if you take PROCYSBI.

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:

  • Skin, bone, and joint problems.People treated with high doses of cysteamine bitartrate may develop abnormal changes of their skin and bones. These changes may include stretch marks, bone injuries (such as fractures), bone deformities, and joint problems. Check your skin while taking PROCYSBI. Tell your doctor if you notice any skin changes or problems with your bones or joints. Your doctor will check you for these problems.

  • Skin rash. Skin rash is common with cysteamine bitartrate and may sometimes be severe. Tell your doctor right away if you get a skin rash. Your dose of PROCYSBI may need to be decreased until the rash goes away. If the rash is severe, your doctor may tell you to stop taking PROCYSBI.

  • Stomach and bowel (intestinal) problems. Some people who take other medicines that contain cysteamine bitartrate develop ulcers and bleeding in their stomach or bowel. Tell your doctor right away if you get stomach-area pain, nausea, vomiting, loss of appetite, or vomit blood.

  • Central nervous system symptoms. Some people who take other medicines that contain cysteamine bitartrate develop seizures, depression, and become very sleepy. The medicine may affect how your brain is working (encephalopathy). Tell your doctor right away if you develop any of these symptoms.

  • Low white blood cell count and certain abnormal liver function blood tests. Your doctor should check you for these problems.

  • Benign intracranial hypertension (pseudotumor cerebri) has happened in some people who take immediate-release cysteamine bitartrate. This is a condition where there is high pressure in the fluid around the brain. Your doctor should do eye examinations to find and treat this problem early.

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.

For individuals with a gastrostomy tube (G-tube) that is size 14 French or larger, PROCYSBI® (cysteamine bitartrate) delayed-release capsules may be opened and their contents mixed with strained applesauce with no chunks.

STEPS REQUIRED
  1. Flush the G-tube button with 5 mL of water to clear the button
  2. Open the PROCYSBI capsule(s)
  3. In a clean container, sprinkle the contents of the PROCYSBI capsule(s) on about ½ cup (4 oz.) of strained applesauce with no chunks, and mix gently*
  4. Place the tip of a catheter tip syringe at the bottom of the container of the mixture. For an adult dose, draw up about 40 mL of the mixture. When giving to a child, draw up at least 10 mL of the mixture
  5. Place the tip of the catheter tip syringe into a feeding tube, and fill it with the mixture
  6. Holding the feeding tube in a horizontal position, push the mixture through the G-tube at a quick and steady rate of 10 mL over 10 seconds. Repeat until all the mixture is given
  7. Be sure to push all of the mixture through the G-tube within 30 minutes of mixing. Do not save the mixture for later use
  8. Draw up at least 10 mL of fruit juice (except grapefruit juice) or water into another catheter tip syringe. Gently swirl the syringe. Flush the G-tube with the fruit juice or water until there is no mixture left in the G-tube

* A minimum of 1/8 cup (1 oz.) of applesauce may be used for children who are 55 lbs (25 kg) or less and starting PROCYSBI at a dose of 1 or 2 capsules.

For best results, administer the applesauce and microbeads mixture through a G-tube that is size 14 French or larger and use a straight (bolus) feeding tube.

For questions about how to take PROCYSBI, review the Instructions for Use or contact your doctor or pharmacist.


What to do if you miss a dose

If you realize you missed a dose of PROCYSBI…Then...
Within 8 hours of when you were scheduled to take itTake it as soon as possible
When your next dose is due in less than 4 hoursTake the next dose at your regularly scheduled time

Do not take 2 doses at one time to make up for a missed dose.

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). Talk to your doctor about how to take PROCYSBI with highly acidic foods to ensure that it doesn’t dissolve in the stomach.

To maintain acid levels, you should:

  • Take PROCYSBI at least 1 hour before or 1 hour after you take medicines that contain bicarbonate or carbonate
  • If you can’t take PROCYSBI without eating, take it with no more than ½ cup (4 oz.) of food up to 1 hour before or after you take PROCYSBI
  • Avoid high-fat foods (such as avocados, cheese, and nuts) right before and after dosing

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.

We chose PROCYSBI for Eden just because of our daily routine. Now she only takes her CDT twice a day, every 12 hours, which allows her more time to do the things she wants to do

—Nicolai, Eden's father

How to fill a prescription for PROCYSBI

PROCYSBI is only available through a specialty pharmacy. Your PROCYSBI prescription is filled and sent to your home through a package delivery service. Before you start taking PROCYSBI, your doctor will submit a form to enroll you in Horizon Patient Services for support. A Horizon Patient Services representative will help you connect with the specialty pharmacy.

To get started with Horizon Patient Services, call 855-888-4004

Talk to your doctor about a PROCYSBI prescription. The Prescription Enrollment Form found here is required, and your doctor will assist you in filling it out.

Horizon Patient Services offers access and reimbursement support for eligible patients

How should I store and dispose of PROCYSBI?

Keep PROCYSBI and all medicines out of the reach of children. Keep PROCYSBI tightly closed in the original bottle.

Store at room temperature (68°F-77°F) in a dry place away from light.

To keep the medicine dry, PROCYSBI is bottled with a small canister that absorbs moisture.Keep the canister in the bottle with the medicine. Do not eat or throw it away.

PROCYSBI may not work as intended after the discard date written by your pharmacist.

Dispose of any unused PROCYSBI after the expiration date on the bottle. Ask your pharmacist or contact the Drug Enforcement Administration (DEA) at http://deadiversion.usdoj.gov/drug_disposal/index.html or 1-800-882-9539 to find out how to properly dispose of PROCYSBI in your area.

Possible side effects of PROCYSBI

Side effects may be dose-related. The most common side effects with PROCYSBI include:

  • Vomiting
  • Nausea
  • Stomach (abdominal) pain
  • Breath odor
  • Diarrhea
  • Skin odor
  • Tiredness
  • Skin rash
  • Headache
  • Problems with electrolytes (body salts)

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.

EXPAND CLOSE

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.