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Cystagon
Overview
What is Cystagon?
CYSTAGON (cysteamine bitartrate) Capsules for oral administration, contain cysteamine bitartrate, a cystine depleting agent which lowers the cystine content of cells in patients with cystinosis, an inherited defect of lysosomal transport. CYSTAGON is the bitartrate salt of cysteamine, an aminothiol, beta-mercaptoethylamine. Cysteamine bitartrate is a highly water soluble white powder with a molecular weight of 227 and the molecular formula CHNS • CHO. It has the following chemical structure:
Each CYSTAGON Capsule contains 50 mg or 150 mg of cysteamine free base as cysteamine bitartrate. CYSTAGON Capsules contain the following inactive ingredients: ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, pregelatinized starch, propylene glycol, sodium lauryl sulfate and titanium dioxide.
What does Cystagon look like?
What are the available doses of Cystagon?
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What should I talk to my health care provider before I take Cystagon?
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How should I use Cystagon?
CYSTAGON is indicated for the management of nephropathic cystinosis in children and adults.
For the management of nephropathic cystinosis, cysteamine therapy should be initiated promptly once the diagnosis is confirmed (i.e., increased white cell cystine).
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 CYSTAGON maintenance dose for children up to age 12 years is 1.30 grams/m/day of the free base, given in four divided doses. Intact CYSTAGON capsules should not be administered to children under the age of approximately six years due to the risk of aspiration. CYSTAGON capsules may be administered to children under the age of approximately six years by sprinkling the capsule contents over food. Patients over age 12 and over 110 pounds weight should receive 2.0 grams/day, divided four times daily.
If a dose is missed, it should be taken as soon as possible. If it is within two hours of the next dose, skip the missed dose and go back to the regular dosing schedule. Do not double dose.
When CYSTAGON is well tolerated, the goal of therapy is to keep leukocyte cystine levels below 1 nmol/½ cystine/mg protein five to six hours following administration of CYSTAGON. Patients with poorer tolerability still receive significant benefit if white cell cystine levels are below 2 nmol/½ cystine/mg protein. The CYSTAGON dose can be increased to a maximum of 1.95 grams/m/day to achieve this level. The dose of 1.95 grams/m/day has been associated with an increased rate of withdrawal from treatment due to intolerance and an increased incidence of adverse events.
Cystinotic patients taking cysteamine hydrochloride or phosphocysteamine solutions may be transferred to equimolar doses of CYSTAGON capsules.
The recommended maintenance dose of 1.30 grams/m/day can be approximated by administering CYSTAGON according to the following table, which takes surface area as well as weight into consideration.
Patients over age 12 and over 110 pounds should receive 2.0 grams/day given in four divided doses as a starting maintenance dose. This dose should be reached after 4 to 6 weeks of incremental dosage increases as stated above. The dose should be raised if the leukocyte cystine level remains > 2 nmol/½ cystine/mg/protein.
Leukocyte cystine measurements, taken 5 to 6 hours after dose administration, are recommended for new patients after the maintenance dose is achieved. Patients being transferred from cysteamine hydrochloride or phosphocysteamine solutions to capsules should have their white cell cystine levels measured in 2 weeks, and thereafter every 3 months to assess optimal dosage as described above.
If CYSTAGON is poorly tolerated initially due to gastrointestinal tract symptoms or transient skin rashes, therapy should be temporarily stopped, then re-instituted at a lower dose and gradually increased to the proper dose.
What interacts with Cystagon?
CYSTAGON is contraindicated in patients who have developed hypersensitivity to it or to cysteamine or penicillamine.
What are the warnings of Cystagon?
Lidocaine Ointment 5% should be used with extreme caution in the presence of sepsis or severely traumatized mucosa in the area of application, since under such conditions there is the potential for rapid systemic absorption.
If a skin rash develops, CYSTAGON should be withheld until the rash clears. CYSTAGON may be restarted at a lower dose under close supervision, then slowly titrated to the therapeutic dose. If a severe skin rash develops such as erythema multiforme bullosa or toxic epidermal necrolysis, CYSTAGON should not be readministered.
CNS symptoms such as seizures, lethargy, somnolence, depression, and encephalopathy have been associated with cysteamine. If CNS symptoms develop, the patient should be carefully evaluated and the dose adjusted as necessary. Neurological complications have been described in some cystinotic patients not on cysteamine treatment. This may be a manifestation of the primary disorder. Patients should not engage in hazardous activities until the effects of CYSTAGON on mental performance are known.
Gastrointestinal ulceration and bleeding have been reported in patients receiving cysteamine bitartrate. Physicians should remain alert for signs of ulceration and bleeding and should inform patients and/or guardians about the signs and symptoms of serious G.I. toxicity and what steps to take if they occur.
Post marketing reports include one report of interstitial nephritis with early renal failure. A causal relationship between this event and cysteamine bitartrate therapy has not been established.
What are the precautions of Cystagon?
General
Gastrointestinal tract symptoms including nausea, vomiting, anorexia and abdominal pain have been associated with cysteamine, sometimes severe. In addition, gastrointestinal ulceration and bleeding have been reported in patients on cysteamine therapy. If these develop, therapy may have to be interrupted and the dose adjusted. A cysteamine dose of 1.95 grams/m/day (approximately 80 to 90 mg/kg/day) was associated with an increased number of withdrawals from treatment due to intolerance and an increased incidence of adverse events.
Cysteamine has occasionally been associated with reversible leukopenia and abnormal liver function studies. Therefore, blood counts and liver function studies should be monitored.
There have been reports of benign intracranial hypertension (or pseudotumor cerebri; PTC) and/or papilledema associated with CYSTAGON treatment that has resolved with the addition of diuretic therapy. PTC may be more common in cystinotic patients because of concurrent medication and renal transplantation. Although a causal relationship of PTC to CYSTAGON has not been established, physicians should monitor patients receiving CYSTAGON for this condition. Physicians should instruct patients to report any of the following symptoms: headache, tinnitus, dizziness, nausea, diplopia, blurry vision, loss of vision, pain behind the eye or pain with eye movement. A periodic eye examination is needed to identify this condition early and timely treatment should be provided when it occurs to prevent vision loss.
There have been reports of serious skin lesions in patients treated with high doses of CYSTAGON or other cysteamine salts that have responded to cysteamine dose reduction. These skin lesions are purplish hemorrhagic lesions over the elbow area on both arms and have been described as molluscoid pseudotumors. Skin striae, bone lesions (that have been described as osteopenia, compression fractures, scoliosis and genu valgum) along with leg pain and joint hyperextension may also be present. One patient with serious skin lesions subsequently died of acute cerebral ischemia with marked vasculopathy. Physicians should routinely monitor the skin and bones of patients receiving CYSTAGON. If similar skin or bone abnormalities appear, the dose of CYSTAGON should be reduced.
Information for Patients and Parents and/or Guardians
See attached information for patients and parents and/or guardians.
Laboratory Tests
Leukocyte cystine measurements are useful to determine adequate dosage and compliance. When measured 5 to 6 hours after CYSTAGON administration, the goal should be a level < 1 nmol/½ cystine/mg protein. In some patients with poorer tolerability for CYSTAGON, patients may still receive benefit with a white cell cystine level of less than 2 nmol/½ cystine/mg protein. Measurements should be done every three months, more frequently when patients are transferred from cysteamine hydrochloride or phosphocysteamine solutions to CYSTAGON.
Physicians should follow patients for signs and symptoms of gastrointestinal ulceration and bleeding, and should inform patients and/or guardians of the importance of this follow-up.
Drug Interactions
None have been described. CYSTAGON can be administered with electrolyte and mineral replacements necessary for management of the Fanconi Syndrome as well as vitamin D and thyroid hormone.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Cysteamine has not been tested for its carcinogenic potential in long-term animal studies.
Cysteamine was not mutagenic in the Ames test. It produced a negative response in an sister chromatid exchange assay in human lymphocytes, but a positive response in a similar assay in hamster ovarian cells.
Repeat breeding reproduction studies were conducted in male and female rats. Cysteamine was found to have no effect on fertility and reproductive performance at an oral dose of 75 mg/kg/day (450 mg/m/day, 0.4 times the recommended human dose based on body surface area). At an oral dose of 375 mg/kg/day (2,250 mg/m/day, 1.7 times the recommended human dose based on body surface area), it reduced the fertility of the adult rats and the survival of their offspring.
Pregnancy
Nursing Mothers
It is not known whether cysteamine is excreted in human milk. Because many drugs are excreted in human milk and because of the manifested potential of cysteamine for developmental toxicity in suckling rat pups when it was administered to their lactating mothers at an oral dose of 375 mg/kg/day (2,250 mg/m/day, 1.7 times the recommended human dose based on body surface area), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
The safety and effectiveness of CYSTAGON for cystinotic children have been established. Cysteamine therapy should be initiated as soon as the diagnosis of nephropathic cystinosis has been confirmed.
What are the side effects of Cystagon?
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:
Cardiovascular:
Digestive:
Central Nervous System:
Psychiatric:
Integumentary:
Urogenital:
Clinical Laboratory:
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/m/day as compared to 1.30 grams/m/day.
Sudden deaths have been reported in this disease state.
| Vomiting Considered Related to Medicine | 31 | 67 |
| Anorexia | 33 | 51 |
| Lethargy | 17 | 27 |
| Diarrhea | 31 | 31 |
| Fever | 28 | 45 |
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 ).
What should I look out for while using Cystagon?
CYSTAGON is contraindicated in patients who have developed hypersensitivity to it or to cysteamine or penicillamine.
If a skin rash develops, CYSTAGON should be withheld until the rash clears. CYSTAGON may be restarted at a lower dose under close supervision, then slowly titrated to the therapeutic dose. If a severe skin rash develops such as erythema multiforme bullosa or toxic epidermal necrolysis, CYSTAGON should not be readministered.
CNS symptoms such as seizures, lethargy, somnolence, depression, and encephalopathy have been associated with cysteamine. If CNS symptoms develop, the patient should be carefully evaluated and the dose adjusted as necessary. Neurological complications have been described in some cystinotic patients not on cysteamine treatment. This may be a manifestation of the primary disorder. Patients should not engage in hazardous activities until the effects of CYSTAGON on mental performance are known.
Gastrointestinal ulceration and bleeding have been reported in patients receiving cysteamine bitartrate. Physicians should remain alert for signs of ulceration and bleeding and should inform patients and/or guardians about the signs and symptoms of serious G.I. toxicity and what steps to take if they occur.
Post marketing reports include one report of interstitial nephritis with early renal failure. A causal relationship between this event and cysteamine bitartrate therapy has not been established.
What might happen if I take too much Cystagon?
A single oral dose of cysteamine at 660 mg/kg was lethal to rats. Symptoms of acute toxicity were reduction of motor activity and generalized hemorrhage in gastrointestinal tract and kidneys.
Two cases of human overdosage have been reported. In one case, the patient immediately vomited the drug and did not develop any symptoms. The second incident involved an accidental ingestion of a 200 to 250 mg/kg dose by a healthy 13 month old child. Vomiting and dehydration were experienced. The child was hospitalized and fluids were administered. A full recovery was made. Should overdose occur, the respiratory and cardiovascular systems should be supported appropriately. No specific antidote is known. Hemodialysis may be considered since cysteamine is poorly bound to plasma proteins.
How should I store and handle Cystagon?
Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Keep out of the reach of children.Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Keep out of the reach of children.Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Keep out of the reach of children.Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Keep out of the reach of children. CYSTAGON (cysteamine bitartrate) Capsules are hard gelatin capsules which provide 50 mg or 150 mg of cysteamine free base as cysteamine bitartrate:CYSTAGON Capsules, 50 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9040-05bottles of 500 capsulesCYSTAGON Capsules, 150 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9045-05bottles of 500 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:The following information is available for patients and/or guardians in the patient leaflet. CYSTAGON (cysteamine bitartrate) Capsules are hard gelatin capsules which provide 50 mg or 150 mg of cysteamine free base as cysteamine bitartrate:CYSTAGON Capsules, 50 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9040-05bottles of 500 capsulesCYSTAGON Capsules, 150 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9045-05bottles of 500 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:The following information is available for patients and/or guardians in the patient leaflet. CYSTAGON (cysteamine bitartrate) Capsules are hard gelatin capsules which provide 50 mg or 150 mg of cysteamine free base as cysteamine bitartrate:CYSTAGON Capsules, 50 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9040-05bottles of 500 capsulesCYSTAGON Capsules, 150 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9045-05bottles of 500 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:The following information is available for patients and/or guardians in the patient leaflet. CYSTAGON (cysteamine bitartrate) Capsules are hard gelatin capsules which provide 50 mg or 150 mg of cysteamine free base as cysteamine bitartrate:CYSTAGON Capsules, 50 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9040-05bottles of 500 capsulesCYSTAGON Capsules, 150 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9045-05bottles of 500 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:The following information is available for patients and/or guardians in the patient leaflet. CYSTAGON (cysteamine bitartrate) Capsules are hard gelatin capsules which provide 50 mg or 150 mg of cysteamine free base as cysteamine bitartrate:CYSTAGON Capsules, 50 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9040-05bottles of 500 capsulesCYSTAGON Capsules, 150 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9045-05bottles of 500 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:The following information is available for patients and/or guardians in the patient leaflet. CYSTAGON (cysteamine bitartrate) Capsules are hard gelatin capsules which provide 50 mg or 150 mg of cysteamine free base as cysteamine bitartrate:CYSTAGON Capsules, 50 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9040-05bottles of 500 capsulesCYSTAGON Capsules, 150 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9045-05bottles of 500 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:The following information is available for patients and/or guardians in the patient leaflet. CYSTAGON (cysteamine bitartrate) Capsules are hard gelatin capsules which provide 50 mg or 150 mg of cysteamine free base as cysteamine bitartrate:CYSTAGON Capsules, 50 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9040-05bottles of 500 capsulesCYSTAGON Capsules, 150 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9045-05bottles of 500 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:The following information is available for patients and/or guardians in the patient leaflet. CYSTAGON (cysteamine bitartrate) Capsules are hard gelatin capsules which provide 50 mg or 150 mg of cysteamine free base as cysteamine bitartrate:CYSTAGON Capsules, 50 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9040-05bottles of 500 capsulesCYSTAGON Capsules, 150 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9045-05bottles of 500 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:The following information is available for patients and/or guardians in the patient leaflet. CYSTAGON (cysteamine bitartrate) Capsules are hard gelatin capsules which provide 50 mg or 150 mg of cysteamine free base as cysteamine bitartrate:CYSTAGON Capsules, 50 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9040-05bottles of 500 capsulesCYSTAGON Capsules, 150 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9045-05bottles of 500 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:The following information is available for patients and/or guardians in the patient leaflet. CYSTAGON (cysteamine bitartrate) Capsules are hard gelatin capsules which provide 50 mg or 150 mg of cysteamine free base as cysteamine bitartrate:CYSTAGON Capsules, 50 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9040-05bottles of 500 capsulesCYSTAGON Capsules, 150 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9045-05bottles of 500 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:The following information is available for patients and/or guardians in the patient leaflet.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Cystinosis is an autosomal recessive inborn error of metabolism in which the transport of cystine out of lysosomes is abnormal; in the nephropathic form, accumulation of cystine and formation of crystals damage various organs, especially the kidney, leading to renal tubular Fanconi Syndrome and progressive glomerular failure, with end stage renal failure by the end of the first decade of life. In four studies of cystinosis patients before cysteamine was available, renal death (need for transplant or dialysis) occurred at median age of less than 10 years. Patients with cystinosis also experience growth failure, rickets, and photophobia due to cystine deposits in the cornea. With time most organs are damaged, including the retina, muscles and central nervous system.
Cysteamine is an aminothiol that participates within lysosomes in a thiol-disulfide interchange reaction converting cystine into cysteine and cysteine-cysteamine mixed disulfide, both of which can exit the lysosome in patients with cystinosis.
Non-Clinical Toxicology
CYSTAGON is contraindicated in patients who have developed hypersensitivity to it or to cysteamine or penicillamine.If a skin rash develops, CYSTAGON should be withheld until the rash clears. CYSTAGON may be restarted at a lower dose under close supervision, then slowly titrated to the therapeutic dose. If a severe skin rash develops such as erythema multiforme bullosa or toxic epidermal necrolysis, CYSTAGON should not be readministered.
CNS symptoms such as seizures, lethargy, somnolence, depression, and encephalopathy have been associated with cysteamine. If CNS symptoms develop, the patient should be carefully evaluated and the dose adjusted as necessary. Neurological complications have been described in some cystinotic patients not on cysteamine treatment. This may be a manifestation of the primary disorder. Patients should not engage in hazardous activities until the effects of CYSTAGON on mental performance are known.
Gastrointestinal ulceration and bleeding have been reported in patients receiving cysteamine bitartrate. Physicians should remain alert for signs of ulceration and bleeding and should inform patients and/or guardians about the signs and symptoms of serious G.I. toxicity and what steps to take if they occur.
Post marketing reports include one report of interstitial nephritis with early renal failure. A causal relationship between this event and cysteamine bitartrate therapy has not been established.
None have been described. CYSTAGON can be administered with electrolyte and mineral replacements necessary for management of the Fanconi Syndrome as well as vitamin D and thyroid hormone.
Gastrointestinal tract symptoms including nausea, vomiting, anorexia and abdominal pain have been associated with cysteamine, sometimes severe. In addition, gastrointestinal ulceration and bleeding have been reported in patients on cysteamine therapy. If these develop, therapy may have to be interrupted and the dose adjusted. A cysteamine dose of 1.95 grams/m/day (approximately 80 to 90 mg/kg/day) was associated with an increased number of withdrawals from treatment due to intolerance and an increased incidence of adverse events.
Cysteamine has occasionally been associated with reversible leukopenia and abnormal liver function studies. Therefore, blood counts and liver function studies should be monitored.
There have been reports of benign intracranial hypertension (or pseudotumor cerebri; PTC) and/or papilledema associated with CYSTAGON treatment that has resolved with the addition of diuretic therapy. PTC may be more common in cystinotic patients because of concurrent medication and renal transplantation. Although a causal relationship of PTC to CYSTAGON has not been established, physicians should monitor patients receiving CYSTAGON for this condition. Physicians should instruct patients to report any of the following symptoms: headache, tinnitus, dizziness, nausea, diplopia, blurry vision, loss of vision, pain behind the eye or pain with eye movement. A periodic eye examination is needed to identify this condition early and timely treatment should be provided when it occurs to prevent vision loss.
There have been reports of serious skin lesions in patients treated with high doses of CYSTAGON or other cysteamine salts that have responded to cysteamine dose reduction. These skin lesions are purplish hemorrhagic lesions over the elbow area on both arms and have been described as molluscoid pseudotumors. Skin striae, bone lesions (that have been described as osteopenia, compression fractures, scoliosis and genu valgum) along with leg pain and joint hyperextension may also be present. One patient with serious skin lesions subsequently died of acute cerebral ischemia with marked vasculopathy. Physicians should routinely monitor the skin and bones of patients receiving CYSTAGON. If similar skin or bone abnormalities appear, the dose of CYSTAGON should be reduced.
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:
Cardiovascular:
Digestive:
Central Nervous System:
Psychiatric:
Integumentary:
Urogenital:
Clinical Laboratory:
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/m/day as compared to 1.30 grams/m/day.
Sudden deaths have been reported in this disease state.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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