Cystadane

Cystadane is a prescription medication used to treat homocystinuria, which is an inherited condition in which the body cannot break down a certain protein, causing build-up of homocysteine in the blood. Increased amounts of homocysteine in the body can cause symptoms such as extreme tiredness, seizures, dislocation of the lens of the eye, abnormal bone structure, osteoporosis, blood clots, or decreased weight or rate of weight gain and slowed development in children.

Cystadane belongs to a class of medications called nutrients. It works by decreasing the amount of homocysteine in the blood.

This medication comes in powder form to be mixed into water, juice, milk or food. It is taken usually taken 2 times a day.

Common side effects of Cystadane include nausea and upset stomach.

Cystadane is a prescription medication used to treat homocystinuria, which is an inherited condition in which the body cannot break down a certain protein, causing build-up of homocysteine in the blood.  

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

• Jazz Pharmaceuticals, Inc.

• Rare Disease Therapeutics, Inc.

Serious side effects have been reported with Cystadane. See the “Cystadane Precautions” section.

Common side effects of Cystadane include the following:

• nausea
• gastrointestinal distress
• diarrhea

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

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

No Cystadane drug interactions have been determined by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Cystadane including the following:

Tell your healthcare provider right away if you have some or all of the following symptoms while taking Cystadane:

• confusion
• drowsiness
• behavior changes
• headache
• vomiting
• seizures
• loss of consciousness

Do not take Cystadane if you are allergic to Cystadane or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Cystadane, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Cystadane, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Cystadane or to any of its ingredients
• are pregnant or breastfeeding

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

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.

Cystadane falls into category C. No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Cystadane should be given to a pregnant woman only if clearly needed.

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

It is not known if Cystadane crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Cystadane.

Take Cystadane exactly as prescribed.

Cystadane comes in comes in powder form to be mixed into water, juice, milk or food. It is taken usually taken 2 times a day.

The prescribed amount of Cystadane should be measured with the measuring scoop provided and then dissolved in 4 to 6 ounces of water, juice, milk, or formula, or mixed with food for immediate ingestion.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Cystadane at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• how you respond to this medication
• your weight

The usual dosage of Cystadane in adult and pediatric patients is 6 grams per day administered orally in divided doses of 3 grams twice daily.

In pediatric patients less than 3 years of age, Cystadane may be started at a dosage of 100 mg/kg/day divided in 2 daily doses; the dose can be increased weekly by 50 mg/kg increments. Patient response to Cystadane can be monitored by measuring homocysteine plasma levels. The dosage can be gradually increased until desired therapeutic response is achieved.

If you take too much Cystadane, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Cystadane is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Cystadane at room temperature.
• Protect from exposure to excess moisture.
• Keep this and all medicines out of the reach of children.
• Therapy with Cystadane should be directed by physicians knowledgeable in the management of patients with homocystinuria.
• Follow all dietary recommendations made by your doctor or dietitian.