Opfolda Disease Interactions

The safety of treatment with miglustat has not been evaluated in patients with significant gastrointestinal disease, such as inflammatory bowel disease. Continued treatment of these patients with miglustat should occur only after careful consideration of the risks and benefits of treatment.

Peripheral neuropathy has been reported in patients treated with miglustat. It is recommended to assess all patients receiving miglustat for peripheral neuropathy at the beginning and at 6 months interval of starting treatment. Caution should be instituted in patients who develop symptoms of peripheral neuropathy and cessation of therapy may be considered if appropriate.

Miglustat is substantially excreted by the kidney. The use of miglustat in patients with severe renal impairment is not recommended (CrCl < 30 mL/min). In patients with moderate renal impairment miglustat administration should be initiated at a dose of 100 mg once a day, and in those patients with mild renal impairment, it should be started at 100 mg twice per day.

Miglustat can cause a mild reduction in platelet counts. Monitoring of platelet counts is recommended, especially in patients with preexisting thrombocytopenia.