Zulresso
- Generic Name: brexanolone injection, for intravenous use
- Brand Name: Zulresso
Zulresso (Brexanolone Injection, for Intravenous Use) side effects drug center
Zulresso Side Effects Center
What Is Zulresso?
Zulresso (brexanolone) Injection is a type of antidepressant called a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator indicated for the treatment of postpartum depression (PPD) in adults. Zulresso is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Zulresso REMS.
What Are Side Effects of Zulresso?
Common side effects of Zulresso include:
- drowsiness,
- sleepiness,
- dry mouth,
- loss of consciousness,
- flushing, and
- hot flushes
Dosage for Zulresso
Zulresso is administered as a continuous intravenous infusion over 60 hours (2.5 days) and healthcare provider must be available on site to continuously monitor the patient, and intervene as necessary, for the duration of the infusion.
What Drugs, Substances, or Supplements Interact with Zulresso?
Zulresso may interact with CNS depressants (e.g., opioids, benzodiazepines) and other antidepressants. Tell your doctor all medications and supplements you use.
Zulresso During Pregnancy or Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Zulresso; it may harm a fetus. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants such as Zulresso during pregnancy. Zulresso passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Zulresso (brexanolone) Injection, for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Zulresso Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- excessive drowsiness (feeling like you cannot stay awake, or feeling like you might pass out);
- sudden changes in mood or behavior;
- new or worsening depression; or
- thoughts of hurting yourself.
Common side effects may include:
- drowsiness;
- feeling like you might pass out;
- dry mouth; or
- flushing (sudden warmth, redness, or tingly feeling).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Zulresso (Brexanolone Injection, for Intravenous Use)
Zulresso Professional Information
SIDE EFFECTS
The following adverse reactions are discussed in more detail in other sections of the labeling:
- Excessive Sedation and Sudden Loss of Consciousness [see BOX WARNING, WARNINGS AND PRECAUTIONS]
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 [see Clinical Studies]. 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 2 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 2: Adverse Reactions in Placebo-Controlled Studies in Patients with PPD Reported in ≥ 2% of ZULRESSO-Treated Patients and Greater than Placebo-Treated Patients
| Placebo (n=107) |
Maximum dosage 60 mcg/kg/hour (n=38) |
Maximum dosage 90 mcg/kg/hour (Recommended dosage) (n=102) |
|
| Cardiac Disorders | |||
| Tachycardia | - | - | 3% |
| Gastrointestinal Disorders | |||
| Diarrhea | 1% | 3% | 2% |
| Dry mouth | 1% | 11% | 3% |
| Dyspepsia | - | - | 2% |
| Oropharyngeal pain | - | 3% | 2% |
| Nervous System Disorders | |||
| Dizziness, presyncope, vertigo | 7% | 13% | 12% |
| Loss of consciousness | - | 5% |
3% |
| Sedation, somnolence | 6% | 21% | 13% |
| Vascular Disorders | |||
| Flushing, hot flush | - | 5% | 2% |
DRUG INTERACTIONS
CNS Depressants
Concomitant use of ZULRESSO with CNS depressants (e.g., opioids, benzodiazepines) may increase the likelihood or severity of adverse reactions related to sedation [see WARNINGS AND PRECAUTIONS].
Antidepressants
In the placebo-controlled studies, a higher percentage of ZULRESSO-treated patients who used concomitant antidepressants reported sedation-related events [see WARNINGS AND PRECAUTIONS].
Drug Abuse And Dependence
Controlled Substance
ZULRESSO contains brexanolone, a Schedule IV controlled substance under the Controlled Substances Act.
Abuse
In a human abuse potential study, 90 mcg/kg, 180 mcg/kg (two times the maximum recommended infusion rate), and 270 mcg/kg (three times the maximum recommended infusion rate) ZULRESSO infusions over a one-hour period were compared to oral alprazolam administration (1.5 mg and 3 mg). On positive subjective measures of "drug liking", "overall drug liking", "high" and "good drug effects", the 90 mcg/kg dosage produced scores that were similar to placebo. Scores on these positive subjective measures for both dosages of ZULRESSO 90 mcg/kg and 180 mcg/kg were lower than both alprazolam doses. However, the scores on the positive subjective measures for ZULRESSO 270 mcg/kg dosage were similar to those produced by both doses of alprazolam. In this study, 3% of subjects administered ZULRESSO 90 mcg/kg and 13% administered ZULRESSO 270 mcg/kg reported euphoric mood, compared to none administered placebo during the one-hour administration.
Dependence
In the PPD clinical studies conducted with ZULRESSO, end of treatment occurred through tapering. Thus, in these studies it was not possible to assess whether abrupt discontinuation of ZULRESSO produced withdrawal symptoms indicative of physical dependence. It is recommended that ZULRESSO be tapered according to the dosage recommendations, unless symptoms warrant immediate discontinuation [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS].
Read the entire FDA prescribing information for Zulresso (Brexanolone Injection, for Intravenous Use)
&Copy; Zulresso Patient Information is supplied by Cerner Multum, Inc. and Zulresso Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.