- Dissociation
- Dizziness
- Nausea
- Sedation
- Spinning sensation
- Numbness
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Serious side effects of SPRAVATO® include feeling sleepy (sedation or loss of consciousness); feeling disconnected from yourself, your thoughts, feelings and things around you (dissociation); breathing problems (respiratory depression and respiratory arrest); abuse and misuse; increased risk of suicidal thoughts and behavior; increased blood pressure; problems with thinking clearly and bladder problems.
The most common side effects that can occur during and after taking SPRAVATO® include:
- Feeling anxious
- Lack of energy
- Increased blood pressure
- Vomiting
- Feeling drunk
- Feeling very happy or excited
If SPRAVATO® side effects occur, they usually happen right after taking SPRAVATO® and go away the same day
Less than 7% of patients stopped SPRAVATO® treatment due to side effects in short- and long-term clinical studies
These are not all the possible side effects of SPRAVATO®. Please see the SPRAVATO® Medication Guide for the complete safety information.
Tolerability
SPRAVATO® plus oral antidepressant offers a similar safety profile to previous trials with a minimal risk for sexual dysfunction compared to placebo plus oral antidepressant
Sexual dysfunction was not seen in more than 2% of patients in the SPRAVATO® clinical trials
6-Year Clinical Study Results
Please review the following information on how the study was designed and the limitations of the study before viewing the 6-year data.
The following data is from a, Phase 3, open-label, long-term safety extension study in adults with treatment-resistant depression (TRD).
Limitations:
- The patients and physicians were aware of the treatment being given, and there was no comparator group. Statistical analyses were not done for the efficacy data, which means no conclusions can be drawn from the results
- The results from this study may not represent what every patient may experience. This study only included patients who chose to continue from the previous parent study and the patients in the study did not have two or more significant co-existing diseases (psychiatric or medical, or substance dependence). In addition, the study size got smaller later on in the clinical trial
6-Year Clinical Study Results
Please review the following information on how the study was designed and the limitations of the study before viewing the 6-year data.
The following data is from a, Phase 3, open-label, long-term safety extension study in adults with treatment-resistant depression (TRD).
Limitations:
- The patients and physicians were aware of the treatment being given, and there was no comparator group. Statistical analyses were not done for the efficacy data, which means no conclusions can be drawn from the results
- The results from this study may not represent what every patient may experience. This study only included patients who chose to continue from the previous parent study and the patients in the study did not have two or more significant co-existing diseases (psychiatric or medical, or substance dependence). In addition, the study size got smaller later on in the clinical trial
TRD long-term safety extension study
Study Design
A subgroup analysis was conducted on a cohort of 1,021 patients who met criteria consistent with the on-label population.
- Patients in this subgroup analysis were between 18-64 years of age and received SPRAVATO® 56 mg or 84 mg twice weekly during induction (IND) phase and flexible dosing during optimization/maintenance (OP/M) phase; all patients should have taken an approved oral antidepressant throughout the study
- The primary purpose of this study was to determine how many patients experienced treatment-emergent adverse events (TEAEs) over time while on SPRAVATO®
Safety Results
- 94.7% of patients experienced ≥1 TEAE
- 184 patients (18.0%) experienced serious TEAEs
- Six deaths (0.6%) related to TEAEs occurred; investigator assessment determined none were considered to be related to SPRAVATO®
- A total of 74 patients (7.2.%) experienced one or more TEAE related to suicide
SPRAVATO® has been studied in patients with treatment-resistant depression (TRD) for up to six years
In the six year study, the discontinuation rate due to adverse events was 6%
SPRAVATO® has been studied in patients with treatment-resistant depression (TRD) for up to six years
In the six year study, the discontinuation rate due to adverse events was 6%
To help ensure your safety, SPRAVATO® has a program called SPRAVATO® REMS
(Risk Evaluation and Mitigation Strategy), which requires close monitoring of safety.
Because of the risks for sedation or loss of consciousness, dissociation, respiratory depression and abuse and misuse, SPRAVATO® is only available through a restricted program called the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program. SPRAVATO® can only be administered at healthcare settings certified in the SPRAVATO® REMS Program. Patients treated in outpatient healthcare settings (e.g., medical offices and clinics) must be enrolled in the program.
There’s an increased risk of suicidal thoughts and behavior with SPRAVATO®
Call your healthcare provider right away if you have new or sudden changes in mood,
behavior, thoughts or feelings, or if you develop suicidal thoughts or behavior.
Call your healthcare provider right away if you have new or sudden changes in mood, behavior, thoughts or feelings, or if you develop suicidal thoughts or behavior.
Help is available 24/7. If you’re struggling with
suicidal thoughts, call 988 Suicide & Crisis Lifeline
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