Please ensure JavaScript is enabled for purposes of website accessibility PROCYSBI (Cysteamine Bitartrate) is Available in Capsules and Tear-open Packets

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TWO OPTIONS, SAME MEDICINE

PROCYSBI is available in capsules and in tear-open packets. Both options contain the same medicine.

CapsulesCapsules
PacketsPackets

PROCYSBI capsules and tear-open packets both contain the same PROCYSBI microbeads that are designed to provide 12 hours of continuous cystine control.

PROCYSBI is a prescription medicine used to treat 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. Click here for Patient Package Insert.

PROCYSBI Oral Granules in Packets:
Frequently Asked Questions

  • Are the oral granules in packets a different type of PROCYSBI?

    No. PROCYSBI oral granules in packets is just a different dosage form in different packaging. The same granules, also called microbeads, inside PROCYSBI capsules are in the tear-open packets. Amgen maintains a rigorous testing and evaluation process to ensure consistency of the granules whether delivered in capsule or packet form..

  • How do I get the oral granules in packets / How do I make the switch?

    If you and your cystinosis healthcare team decide that the oral granules in packets are right for you or your loved one, your healthcare team can guide you through the switch. If you have questions, you can reach out to your Patient Access Liaison at 1-855-888-4004.

  • What strengths are the oral granules in packets available in? / Will the 25 mg and 75 mg capsules still be available?

    PROCYSBI oral granules in packets are available in 75 mg and 300 mg strength options. The 25 mg and 75 mg PROCYSBI capsules will continue to be available. Both the capsules and the packets contain the same PROCYSBI granules, also called microbeads.

  • How do I adjust my dosage for PROCYSBI capsules to accommodate the new strengths of the oral granules in packets?

    It is best to talk with your physician about how to make the appropriate adjustments for the strengths if needed.

Amgen remains committed to ensuring patients prescribed our medicines, including PROCYSBI oral granules in packets, have access. We have support and assistance in place so that eligible patients are able to receive our medicines regardless of their ability to pay. Find out more about support and assistance here.

Helpful links

USE and IMPORTANT SAFETY INFORMATION

What is the most important safety information I should know about 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, such as 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 may develop ulcers and bleeding in their stomach or bowel. People treated with PROCYSBI may also develop abnormal swelling and narrowing of the large bowel which must be treated promptly. Tell your doctor right away if you get abdominal pain, bloody or persistent diarrhea, bloating, nausea, vomiting, loss of appetite, vomit blood, poor weight gain or weight loss.
  • 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.

What is PROCYSBI?

PROCYSBI (cysteamine bitartrate) delayed-release capsules and delayed-release oral granules is a prescription medicine used to treat 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.

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

Before taking PROCYSBI, tell your doctor about all your medical conditions, including 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.
  • 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 the medicines you take, including prescription and over the counter medicines, vitamins, dietary 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 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:

  • See “What is the most important information I should know about PROCYSBI?”

The most common side effects of PROCYSBI include: vomiting, nausea, stomach (abdominal) pain, pink eye, diarrhea, cold, tiredness, flu, headache, problems with body salts or electrolytes, infection of ear, nose or throat, joint pain.

These are not all the possible side effects of PROCYSBI. Call your doctor for medical information about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For additional important safety information, click here for the Patient Package Insert and discuss with your doctor.

USE and IMPORTANT SAFETY INFORMATION

What is the most important safety information I should know about 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, such as stretch marks, bone injuries (such as fractures), bone deformities, and joint problems. Check your skin while taking PROCYSBI. Tell your doctor if you notice