ZULRESSO SIDE EFFECTS

SIDE EFFECTS

The following adverse reactions are discussed in more detail in other sections of the labeling:

• Excessive Sedation and Sudden Loss of Consciousness

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in 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 clinical practice.

The data described below reflect exposure to ZULRESSO in 140 patients with postpartum depression (PPD). A titration to a target dosage of 90 mcg/kg/hour was evaluated in 102 patients and a titration to a target dose of 60 mcg/kg/hour was evaluated in 38 patients. Patients were then followed for 4 weeks.

The most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) were sedation/somnolence, dry mouth, loss of consciousness, and flushing/hot flush (Table 2).

Adverse Reactions Leading To Discontinuation, Dosage Interruption, Or Dosage Reduction

In the pooled placebo controlled-studies, the incidence of patients who discontinued due to any adverse reaction was 2% of ZULRESSO-treated patients compared to 1% of placebo-treated patients. The adverse reactions leading to treatment discontinuation in ZULRESSO-treated patients were sedationrelated (loss of consciousness, vertigo, syncope, and presyncope) or infusion site pain.

In the pooled placebo controlled-studies, the incidence of patients who had an interruption or reduction of the dosage due to any adverse reaction was 7% of ZULRESSO-treated patients compared to 3% of placebo-treated patients. The adverse reactions leading to dose reduction or interruption in ZULRESSO-treated patients were sedation-related (loss of consciousness, syncope, somnolence, dizziness, fatigue), infusion site events, changes in blood pressure, or medication error due to infusion pump malfunction. Three ZULRESSO-treated patients who had a dosage interruption because of loss of consciousness subsequently resumed and completed treatment after resolution of symptoms; two patients who had dosage interruption because of loss of consciousness did not resume the infusion.

Table 1 presents the adverse reactions that occurred in ZULRESSO-treated PPD patients at a rate of at least 2% and at a higher rate than in the placebotreated patients during the 60-hour treatment period.

Table 1: Adverse Reactions in Placebo-Controlled Studies in Patients with PPD Reported in ≥ 2% of ZULRESSO-Treated Patients and Greater than Placebo-Treated Patients