Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: • Peripheral Neuropathy [ see Warnings and Precautions (5.1) ] • Tremor [ see Warnings and Precautions (5.2) ] • Diarrhea and weight loss [ see Warnings and Precautions (5.3) ] • Reductions in platelet count [ see Warnings and Precautions (5.4) ] The most common adverse reactions (incidence ≥ to 5%) are: diarrhea, weight loss, stomach pain, gas, nausea and vomiting, headache including migraine, tremor, leg cramps, dizziness, weakness, vision problems, thrombocytopenia, muscle cramps, back pain, constipation, dry mouth, heaviness in arms and legs, memory loss, unsteady walking, anorexia, indigestion, paresthesia, stomach bloating, stomach pain not related to food, and menstrual changes ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact Edenbridge Pharmaceuticals, LLC at 1-877-381-3336 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure of 80 patients with type 1 Gaucher disease in two open-label, uncontrolled, monotherapy trials, one open-label, active-controlled trial, and two extensions, who received miglustat capsules at doses ranging from 50 mg to 200 mg three times daily.
Patients were aged 18 to 69 years at first treatment.
The population was evenly distributed by gender.
The most common serious adverse reaction reported with miglustat capsules treatment in clinical trials was peripheral neuropathy [ see Warnings and Precautions (5.1) ].
The most commonly reported adverse reactions in patients treated with miglustat capsules (occurring in ≥ to 5%) that were considered related to miglustat capsules are shown in Tables 1 and
[ see Warnings and Precautions (5.2 , 5.3) ].
The most common adverse reactions requiring intervention were diarrhea and tremor.
5 WARNINGS AND PRECAUTIONS • Peripheral neuropathy: Perform baseline and follow-up neurological evaluations at 6-month intervals in all patients ( 5.1 ).
• Tremor: Reduce dose to ameliorate tremor or discontinue treatment if tremor does not resolve within days of dose reduction ( 5.2 ).
• Diarrhea and weight loss: Evaluate for underlying gastrointestinal disease in patients who do not respond to usual interventions (e.g.
diet modification) ( 5.3 ).
• Reductions in Platelet count: Mild reductions in platelet counts without association with bleeding were observed in some patients.
Like all medications, Yargesa can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: