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Cystagon

"The U.S. Food and Drug Administration today approved Procysbi (cysteamine bitartrate) for the management of nephropathic cystinosis in children and adults. Procysbi was granted orphan product designation because it is intended to treat a rare dis"...

Cystagon

Cystagon

Cystagon Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Cystagon (cysteamine bitartrate) is used to treat a condition called nephropathic cystinosis, a rare genetic condition. Children with this condition develop a build-up of cystine in the kidneys, which can lead to kidney failure and other medical problems. It works by reducing the amount of cystine in the kidneys. Common side effects include nausea, vomiting, fever, loss of appetite, tiredness, drowsiness, and diarrhea.

New patients should be started on ¼ to 1/6 of the maintenance dose of Cystagon. The dose should then be raised gradually over four to six weeks to avoid intolerance. The recommended maintenance dose for children up to age 12 years is 1.30 grams/m2/day of the free base, given in four divided doses. Other medicines may interact with Cystagon. Tell your doctor all medications and supplements your child uses. During pregnancy, Cystagon should be used only when prescribed. It is unknown if this drug passes into breast milk. It could have undesirable effects on a nursing infant. Breastfeeding is not recommended while using this drug.

Our Cystagon (cysteamine bitartrate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Cystagon in Detail - Patient Information: Side Effects

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using cysteamine and call your child's doctor at once if your child has any of these serious side effects (some of these may be caused by the cystinosis disorder and not by this medication):

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • the first sign of any skin rash, no matter how mild;
  • unusual bruising or streaks on the skin;
  • bone or joint problems;
  • weakness or fainting, black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • extreme drowsiness, loss of balance or coordination, seizure (convulsions);
  • confusion, hallucinations, bad dreams, or changes in mood or behavior;
  • urinating less than usual or not at all; or
  • headache, ringing in the ears, dizziness, nausea, vision problems, pain behind the eyes.

Less serious side effects may include:

  • nausea, vomiting, diarrhea, stomach pain;
  • loss of appetite;
  • fever, chills, body aches, flu symptoms; or
  • mild dizziness, nervous feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Cystagon (Cysteamine Bitartrate) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Cystagon Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, vomiting, fever, loss of appetite, tiredness, drowsiness, and diarrhea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., depression), deep sleep, seizures, unusual tiredness, headache, hearing problems (e.g., buzzing/ringing in the ears), dizziness, eye/vision problems (e.g., blurred vision, loss of vision, eye pain), skin problems (e.g., thinning of the skin, stretch marks, purple bleeding patches on the elbows), bone problems (e.g., bone/joint/back pain, leg pain, broken bones).

Seek immediate medical attention if any of these rare but very serious side effects occur: black/bloody stools, stomach/abdominal pain, vomit that looks like coffee grounds.

Cysteamine can commonly cause a rash that may not be serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Seek immediate medical attention if you or your child develops any rash.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Cystagon (Cysteamine Bitartrate)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Cystagon FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

In three clinical trials, cysteamine or phosphocysteamine have been administered to 246 children with cystinosis. Causality of side effects is sometimes difficult to determine because adverse effects may result from the underlying disease.

The most frequent adverse reactions seen involve the gastrointestinal and central nervous systems. These are especially prominent at the initiation of cysteamine therapy. Temporarily suspending treatment, then gradual re-introduction may be effective in improving tolerance.

Adverse reactions were not collected systematically in the NCCS, but were often listed by investigators. The following rates may therefore be underestimated. The most common events (> 5%) were vomiting 35%, anorexia 31%, fever 22%, diarrhea 16%, lethargy 11%, and rash 7%.

Less common adverse events are:

Body as a whole: Dehydration.

Cardiovascular: Hypertension.

Digestive: Nausea, bad breath, abdominal pain, dyspepsia, constipation, gastroenteritis, duodenitis, gastrointestinal ulceration and bleeding.

Central Nervous System: Somnolence, encephalopathy, headache, seizures, ataxia, confusion, tremor, hyperkinesia, decreasing hearing, dizziness, jitteriness.

Psychiatric: Nervousness, abnormal thinking, depression, emotional lability, hallucinations, nightmares.

Integumentary: Urticaria.

Urogenital: Interstitial nephritis, renal failure (see WARNINGS).

Clinical Laboratory: Abnormal liver function, anemia, leukopenia.

Adverse reactions or intolerance leading to cessation of treatment occurred in 8% of patients in the U.S. Studies.

Withdrawals due to intolerance, vomiting associated with medication, anorexia, lethargy, and fever appeared dose related, occurring more frequently in those patients receiving 1.95 grams/m2/day as compared to 1.30 grams/m2/day.

  Dose in Grams/m2/day
1.30
(n = 42)
%
1.95
(n = 51)
%
Vomiting Considered Related to Medicine 31 67
Anorexia 33 51
Lethargy 17 27
Diarrhea 31 31
Fever 28 45

Sudden deaths have been reported in this disease state.

Post-marketing surveillance

Benign intracranial hypertension (or pseudotumor cerebri; PTC) with papilledema; skin lesions, molluscoid pseudotumors, skin striae, skin fragility; joint hyperextension, leg pain, genu valgum, osteopenia, compression fracture and scoliosis have been reported (see PRECAUTIONS).

Drug Abuse and Dependence

CYSTAGON® (cysteamine bitartrate) has not been associated with abuse potential, psychological or physical dependence in humans.

Read the entire FDA prescribing information for Cystagon (Cysteamine Bitartrate) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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