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Concomitant Use with Monoamine Oxidase Inhibitors

Last Updated: 11/22/2024

SUMMARY

  • There are no studies evaluating the efficacy or safety of concurrent treatment with monoamine oxidase inhibitors (MAOIs) and SPRAVATO nasal spray.
  • Concomitant use with MAOIs may increase blood pressure. Closely monitor blood pressure with concomitant use of SPRAVATO with MAOIs.1
    • A case series reported the safety results of concomitant use of SPRAVATO and MAOIs in 3 patients with treatment-resistant depression (TRD).2
    • A case report described the experience of a 61-year-old female who was taking tranylcypromine and SPRAVATO for TRD.3
  • Please contact the manufacturers of MAOIs for more information regarding their safety and drug-drug interactions.

CLINICAL DATA

Case Series

Wallner et al (2023)2 reported 3 cases of concomitant use of SPRAVATO with MAOIs to treat patients with TRD.

  • Case 1: A 74-year-old female patient initially treated with phenelzine was started on concomitant SPRAVATO after failing to achieve remission after 6 months of treatment with phenelzine. During the first treatment with 56 mg SPRAVATO, an increase in the patient’s blood pressure was noted at 40 minutes (137/85 mmHg) and 2 hours (200/99 mmHg) after SPRAVATO administration from baseline (116/79 mmHg). Although the patient remained asymptomatic, she was administered 10 mg amlodipine; blood pressure measurement taken at approximately 3 hours after administration was 110/66 mmHg. At the next SPRAVATO treatment 4 days later, the patient was administered 84 mg SPRAVATO and her afternoon dose of phenelzine (15 mg) was held. In the subsequent blood pressure measurements, an increase was noted at 40 minutes (128/80 mmHg) and 2 hours (142/78 mmHg) after SPRAVATO administration from baseline (101/59 mmHg). Ultimately, the patient was switched from phenelzine to tranylcypromine due to a lack of treatment efficacy with tolerable doses of phenelzine and a decline in cognitive functions. In the remaining 37 SPRAVATO treatments over ~11 months with concomitant phenelzine or tranylcypromine, no significant elevations in blood pressure readings were reported.
  • Case 2: A 32-year-old female patient initially treated with 73 SPRAVATO treatments over 1.5 years was started on concomitant therapy with tranylcypromine due to persistent suicidal ideation. In the subsequent 49 SPRAVATO treatments over ~14 months with concomitant tranylcypromine, no significant elevations in blood pressure readings were reported.
  • Case 3: A 61-year-old female patient initiated on SPRAVATO in the SUSTAIN-3 study was augmented with tranylcypromine after failing to achieve remission after 152 SPRAVATO treatments over 3 years. In the subsequent 9 SPRAVATO treatments over ~2 months with concomitant tranylcypromine, no significant elevations in blood pressure readings were reported.

Case Report

Dunner et al (2020)3 reported on a 61-year-old female patient treated with SPRAVATO concomitantly with tranylcypromine 60 mg. Pertinent medical history included persistent chronic major depressive disorder that was refractory to adequate trials of escitalopram, fluoxetine, bupropion, duloxetine, mirtazapine, augmentation with quetiapine, electroconvulsive therapy, and psychotherapy. The patient experienced a partial response to tranylcypromine therapy initiated at age 57 after a depressive episode.

Treatment was initiated with 28 mg SPRAVATO on the first 2 visits, with blood pressure monitoring every 10 minutes during the first visit. Improvement in anxiety and depression were noted on the first visit. At the third visit, the patient experienced nausea, dizziness, and agitation, with a 56 mg dose resulting in a dose reduction of the final 4 doses of the 4-week treatment. At the end of the acute treatment period, ratings on both patient- and clinician-rated depression and anxiety scales improved and were in the normal range.

Baseline blood pressure ranged from 91-108 mmHg systolic and 56-70 mmHg diastolic. At 40 minutes after dosing, her blood pressure ranged from 99-135 mmHg systolic and       60-82 mmHg diastolic. During treatment, there was no evidence of serotonin syndrome. Mild side effects of dissociation and sedation were observed and dissipated during the 2-hour monitoring period after dosing.

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT Drug File (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 12 November 2024.

References

1 Center for Drug Evaluation and Research. Summary Review. 211243 - SPRAVATO (esketamine) - Reference ID: 4398871. 2019-[cited 2024 November 12]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211243Orig1s000SumR.pdf
2 Wallner MA, Eloge JC, Mackey IV, et al. Safety and tolerability of concomitant intranasal esketamine treatment with irreversible, nonselective MAOIs: a case series. J Clin Psychiatry. 2023;84(2):22cr14598.  
3 Dunner DL, Fugate RM, Demopulos CM. Safety and efficacy of esketamine nasal spray in a depressed patient who was being treated with tranylcypromine: a case report. Neurol Psychiatry Brain Res. 2020;36:30-31.