Important Safety Information
Lubiprostone is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be thoroughly evaluated by the treating healthcare provider to confirm the absence of such an obstruction prior to initiating lubiprostone treatment.
There are no or limited data from the use of lubiprostone in pregnant women. Patients who become pregnant or are planning a pregnancy should be advised to consider the risks and benefits of continued AMITIZA therapy during pregnancy.
Nausea is the most commonly reported adverse drug reaction observed in pivotal clinical studies of AMITIZA, with 23.6% of patients experiencing at least one treatment related nausea event; however, of those patients, 93% reported only a single event during treatment with AMITIZA. Of all reported nausea events, 93.7% were mild to moderate in severity, and 4.0% discontinued treatment as a result of nausea. Administration of AMITIZA with food has been shown to reduce symptoms of nausea.
AMITIZA should not be prescribed to patients that have severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment. Patients should be instructed to inform their physician if severe diarrhea occurs.
Dyspnea or chest discomfort/pain (usually described as a sensation of chest tightness and/or difficulty taking in a breath) has been reported shortly after taking AMITIZA, and some patients have discontinued treatment. These symptoms generally resolve within a few hours of dosing, but recurrence has been frequently reported with subsequent doses. If these symptoms occur, the patient should seek medical advice before resuming treatment.
The safety of AMITIZA has been investigated in 301 patients in 3 pivotal clinical studies. During the pivotal clinical studies conducted on AMITIZA, a number of ADRs have been reported. The most common ADR reported by patients taking AMITIZA was nausea, with diarrhoea and headache also being commonly reported. Treatment-emergent adverse events led to premature study discontinuation for 8% of patients in the pivotal clinical studies.