Cysteamine delayed-release oral granules

What is this medication?

CYSTEAMINE (sis TEE a meen) treats nephropathic cystinosis. It works by breaking down cystine in the body.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): PROCYSBI

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bone problems
• Depression or other nervous system problems
• History of blood disease
• History of stomach bleeding
• Liver disease
• Seizures
• Skin conditions or sensitivity
• Stomach or intestine problems
• An unusual or allergic reaction to cysteamine, penicillamine, other medications, foods, dyes or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label at the same time every day. Take it on an empty stomach, at least 30 minutes before and 2 hours after food. If it upsets your stomach, you may take it within 1 hour before eating or after eating 4 ounces (1/2 cup) of a low fat food. Sprinkle the entire packet on 4 ounces (1/2 cup) of applesauce, berry jelly, orange juice, or apple juice. Do not take the medication with grapefruit juice. Eat or drink the mixture within 30 minutes of preparation, do not store for later use. Keep taking it unless your care team tells you to stop.

Take products with bicarbonate or carbonate in them at a different time of day than this medication. Take this medication 1 hour BEFORE or 1 hour AFTER these products.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 1 year for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can unless it is more than 8 hours late. If it is more than 8 hours late, skip the missed dose. Take the next dose at the normal time.

What may interact with this medication?

• Alcohol or any product that contains alcohol
• Certain medicines for stomach problems like antacids, cimetidine, famotidine, omeprazole, lansoprazole
• Sodium bicarbonate

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. You may need blood work while you are taking this medication.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medication affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

Alcohol may interfere with the effects of this medication. Avoid alcoholic drinks.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bone pain
• Increased pressure around the brain—severe headache, blurry vision, change in vision, nausea, vomiting
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Seizures
• Sudden or severe stomach pain, bloody diarrhea, fever, nausea, vomiting
• Unusual weakness or fatigue
• Worsening mood, feelings of depression

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Bad breath
• Diarrhea
• Fatigue
• Headache
• Stomach pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light and moisture. Keep this medication in the original packaging until you are ready to take it. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.