Cysteamine

Cysteamine is a prescription medication used to treat cystinosis of the kidneys and eyes. Cystinosis is a rare condition that causes cystine, a protein building block, to build up in the cells of the body. Cysteamine belongs to a class of medications called anti-cystine agents, which help by decreasing the levels of cystine in the body.

This medication comes as immediate- and delayed-release capsules to be taken by mouth or by gastric tube (feeding tube inserted into the stomach) every 6 hours or every 12 hours.

The most common side effects with the capsules include nausea, bad breath, abdominal pain, constipation, indigestion or upset stomach, and headache. Cysteamine capsules may also cause drowsiness or dizziness. Do not drive or operate heavy machinery until you know how this medication will affect you.

The most common side effects with the eye drops include sensitivity to light, redness, eye pain/irritation, headache and visual field defects. Do not drive or operate heavy machinery until you know how this medication will affect you.

Cysteamine is a prescription medication used to treat cystinosis of the kidneys and eyes. Cystinosis is a rare condition that causes cystine, a protein building block, to build up in the cells of the body.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Oral:

Serious side effects have been reported with cysteamine including:

• Skin, bone, and joint problems: People treated with high doses of this medication may develop problems such as stretch marks, bone injuries (such as fractures), bone deformities, and joint problems. Check your skin while taking cysteamine. Tell your doctor if you notice any skin changes. Your doctor will check you for these problems.
• Skin rash: Skin rash is common with cysteamine and may sometimes be severe. Tell your doctor right away if you get a skin rash.
• Central nervous system symptoms: Some people who take other medicines that contain cysteamine 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.
• Stomach and bowel (intestinal) problems: Some people who take other medicines that contain cysteamine 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.
• Low white blood cell count and certain abnormal liver function blood tests: Your doctor should check you for these problems.
• Intracranial hypertension (pseudotumor cerebri) has happened in some people who take immediate-release cysteamine. 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 cysteamine: 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.

Cysteamine can cause dizziness. Do not drive or operate heavy machinery until you know how cysteamine affects you.

Do not take cysteamine if you have an allergic or hypersensitive reaction to penicillamine.

Topical:

• To minimize the risk of contamination, do not touch the dropper tip to any surface. Keep bottle tightly closed when not in use.

Oral:

• The most common side effects with the capsules include nausea, bad breath, abdominal pain, constipation, indigestion or upset stomach, and headache. Cysteamine capsules may also cause drowsiness or dizziness. Do not drive or operate heavy machinery until you know how this medication will affect you.

Topical:

• The most common side effects with the eye drops include sensitivity to light, redness, eye pain/irritation, headache and visual field defects. Do not drive or operate heavy machinery until you know how this medication will affect you.

This is not a complete list of cysteamine side effects. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with cysteamine. See “Drug Precautions” section.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• bicarbonate, an electrolyte found in products such as Arm & Hammer Baking Soda, Soda Mint, sodium bicarbonate injection, and sodium bicarbonate tablets

This is not a complete list of cysteamine drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Cysteamine falls into category C. This medication may be given to a pregnant woman if her healthcare provider believes that its benefits to the pregnant woman outweigh any possible risks to her unborn baby. It is not known if cysteamine will harm your unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if cysteamine is excreted in human breast milk or if it will harm your nursing baby. Because many drugs are present in human milk and because of the potential for serious adverse reactions in nursing infants from cysteamine, nursing is not recommended.