Cysteamine Bitartrate, Oral

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KEY POINTS

• This medicine is taken by mouth to treat a buildup of cystine that causes severe kidney and other problems throughout the body. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: cystine-depleting medicine

Generic and brand names: cysteamine bitartrate, oral; Cystagon; Procysbi

What is this medicine used for?

This medicine is taken by mouth to treat nephropathic cystinosis, a buildup of cystine that causes severe kidney and other problems throughout the body.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Bleeding problems or a blood disorder
• Bone or joint problems such as weak bones, broken bones, or joint pain
• Depression or other mental health problems
• Liver disease
• Seizures
• Skin problems
• Stomach ulcer

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Check the label on the medicine for directions about your specific dose. Use this medicine exactly as your healthcare provider prescribes. Do not use more or less than prescribed. Do not stop taking this medicine without your healthcare provider's approval.

This medicine comes in different forms, immediate-release capsules (Cystagon) and delayed-release capsules (Procysbi). Ask your pharmacist if you are not sure which kind of capsules you take.

Immediate-release capsules (Cystagon): This medicine may be used in children as directed by your healthcare provider. For children who cannot swallow capsules or for children under the age of 6 years, open the capsules and sprinkle the contents into the child's food.

Delayed-release capsules (Procysbi): Take this medicine at least 30 minutes before you eat or at least 2 hours after you eat. Swallow the capsules whole. Do not crush or chew the capsules. If you have trouble swallowing, open the capsules and sprinkle the contents on soft food such as applesauce. Check with your healthcare provider before using this medicine in children under age 6.

Ask your pharmacist or healthcare provider if you have any questions about how to take this medicine.

What if I miss a dose?

If you have the immediate-release capsules and miss a dose, take it as soon as you remember unless it is less than 2 hours until the next scheduled dose. In that case, skip the missed dose and take the next one as directed.

If you have the delayed-release capsules and miss a dose, take it as soon as you remember unless it is less than 4 hours until the next scheduled dose. In that case, skip the missed dose and take the next one as directed.

Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222

Symptoms of an acute overdose may include: vomiting, dry mouth, weakness.

What should I watch out for?

You need to have eye exams, blood tests, and checkups regularly to see how this medicine affects you. Keep all appointments.

This medicine may cause blurred vision, dizziness, or drowsiness. Do not drive or operate machinery unless you are fully alert. Contact your healthcare provider if these problems continue or get worse.

Take other medicines or supplements as prescribed by your healthcare provider.

Contact your healthcare provider if your condition does not improve in a few days or if it gets worse.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are using this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Severe rash or purple spots on skin; blistering or peeling skin rash or other skin changes; joint pain; bloody or black tarry bowel movements; seizures; tremors; depression; eye pain, loss of vision, or sudden vision changes; dark urine; light-colored bowel movements; decreased urination or trouble urinating; severe headache or dizziness; severe nausea, vomiting, or stomach pain; unusual bruising or bleeding; severe weakness; fainting; yellowing of your skin or eyes; ringing in the ears or other hearing problems; confusion; hallucinations; nightmares; severe drowsiness; unexplained fever, sore throat, or cough.

Other: Mild nausea, vomiting, diarrhea, constipation, or stomach pain; decreased appetite, mild dizziness or tiredness, drowsiness, skin or breath odor.

What products might interact with this medicine?

No significant drug interactions have been reported.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.