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Annual reassessment of the product
4.4 Special warnings and precautions for use
The efficacy and safety of Zavesca has not been specificallyevaluated in patients with severe Gaucher disease.
5.1 Pharmacodynamic properties
"...29 patients continued in the extension period. When compared to the measurements at 6 moths, disease control was unchanged after 18 and 24 months of Zavesca monotherapy (20 and 6 patients, respectively). No patient showed rapid deterioration of type 1 Gaucher disease following the switch to Zavesca monotherapy.
A total daily dose of 300 mg Zavesca administered in three divided doses was used in the above two studies. An additional monotherapy study was performed in 18 patients at a total daily dose of 150 mg, and results indicate reduced efficacy compared to a total daily dose of 300 mg.
Bone manifestations of type 1 Gaucher disease were evaluated in 3 open-label clinical studies in patients treated with miglustat 100 mg t.i.d. for up to 2 years (n = 72). In a pooled analysis of uncontrolled data, bone mineral density Z-scores at the lumbar spine and femoral neck increased by more than 0.1 units from baseline in 27 (57%) and 28 (65%) of the patients with longitudinal bone density measurements. There were no events of bone crisis, avascular necrosis or fracture during the treatment period."