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The following adverse reactions are also discussed in other sections of the labeling:
- Ehlers-Danlos-like Syndrome [see WARNINGS AND PRECAUTIONS]
- Skin Rash [see WARNINGS AND PRECAUTIONS]
- Gastrointestinal (GI) Ulcers and Bleeding [see WARNINGS AND PRECAUTIONS]
- Central Nervous System Symptoms [see WARNINGS AND PRECAUTIONS]
- Leukopenia and/or Elevated Phosphatase Levels [see WARNINGS AND PRECAUTIONS]
- Benign Intracranial Hypertension [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The data described below reflect exposure to cysteamine in 328 patients with nephropathic cystinosis (246 patients receiving immediate-release cysteamine as cysteamine hydrochloride or phosphocysteamine, and 63 patients receiving PROCYSBI) in open-label clinical trials.
Clinical Trials Experience with PROCYSBI
Sixty-two patients with cystinosis (38 males and 24 females) received PROCYSBI in two clinical trials at doses ranging from 0.29 grams/m² per day to 2.19 grams/m² per day [see Clinical Studies]. All patients were switched from immediate-release cysteamine to PROCYSBI. Forty-three patients, ages 7 to 24 years old, received PROCYSBI in an 8-week, open-label, randomized, cross-over trial comparing PROCYSBI to immediate-release cysteamine bitartrate. Forty of 43 patients continued PROCYSBI treatment in an open-label extension trial, and were treated with PROCYSBI for longer than 2 years. An additional 19 patients (6 transplanted patients and 13 patients aged 2 to 6 years) were enrolled directly into this trial and were treated with PROCYSBI for up to 18 months.
In the open-label, randomized, cross-over trial, a higher incidence of adverse reactions was reported in patients during the PROCYSBI treatment period compared with the immediate-release cysteamine treatment period (see Table 3). Other significant adverse reactions reported during clinical trials included hypersensitivity reactions, including anaphylaxis.
Table 3: Adverse reactions that occurred in ≥ 5%
of patients in the randomized, cross-over clinical trial
|Adverse Reaction||Immediate-release cysteamine
(n = 41) %
(n = 43) %
|Anorexia/loss of appetite||5||2|
For all patients treated with PROCYSBI in both trials (N=62), the most commonly reported adverse reactions ( > 5%) were vomiting, nausea, abdominal pain, breath odor, diarrhea, skin odor, fatigue, rash, and headache.
Clinical Trials Experience with Immediate-Release Cysteamine
The most frequent adverse reactions involved the gastrointestinal and central nervous systems and were especially prominent at the initiation of cysteamine therapy. Most patients were able to resume therapy at lower doses. The most common reactions ( > 5%) were vomiting, anorexia, fever, diarrhea, lethargy, and rash. Other adverse reactions included nausea, bad breath, abdominal pain, headache, dizziness, and urticaria.
Withdrawals due to intolerance, vomiting, anorexia, lethargy, and fever occurred more frequently in those patients receiving 1.95 grams/m² per day as compared with 1.3 grams/m² per day of immediate-release cysteamine bitartrate.
The following adverse reactions have been identified during post-approval use of immediate-release cysteamine bitartrate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Musculoskeletal: Joint hyperextension, leg pain, osteopenia, compression fracture, scoliosis, genu valgum [see WARNINGS AND PRECAUTIONS].
- Skin: Erythema multiforme bullosa, toxic epidermal necrolysis, Ehlers-Danlos-like syndrome, molluscoid pseudotumors, skin striae, skin fragility [see WARNINGS AND PRECAUTIONS].
- Central Nervous System: seizures, lethargy, somnolence, depression.and encephalopathy [see WARNINGS AND PRECAUTIONS], benign intracranial hypertension (or PTC) and/or papilledema [see WARNINGS AND PRECAUTIONS].
Read the Procysbi (cysteamine bitartrate delayed-release capsules) Side Effects Center for a complete guide to possible side effects
Drugs That Increase Gastric pH
Drugs that increase the gastric pH (e.g., proton pump inhibitors, medications containing bicarbonate or carbonate) may alter the pharmacokinetics of cysteamine due to the premature release of cysteamine from PROCYSBI and increase WBC cystine concentration. Concomitant administration of 20 mg omeprazole did not significantly affect the pharmacokinetics of cysteamine when PROCYSBI was administered with 240 mL of orange juice [CLINICAL PHARMACOLOGY]. The effect of omeprazole on the pharmacokinetics of cysteamine was not studied after PROCYSBI administration with water. Monitor WBC cystine concentration when drugs that increase the gastric pH are concomitantly used [see DOSAGE AND ADMINISTRATION)].
Use With Alcohol
Consumption of alcohol with PROCYSBI may increase the rate of cysteamine release and/or adversely alter the pharmacokinetic properties, as well as the effectiveness and safety of PROCYSBI. Therefore, do not consume alcoholic beverages during treatment with PROCYSBI [see DOSAGE AND ADMINISTRATION].
Other Medications Used For The Management Of Fanconi syndrome
Last reviewed on RxList: 8/28/2015
Additional Procysbi Information
Report Problems to the Food and Drug Administration
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