rmacies must be certified in the REMS and must only dispense SPRAVATO tohealthcare settings that are certified in the program.
Further information, including a list of certified pharmacies is available atwww.SPRAVATOrems.com or 1-855-382-6022.5.5 Suicidal Thoughts and Behaviors in Adolescents and Young AdultsIn pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and otherantidepressant classes) that included approximately 77,000 adult patients and 4,500 pediatricpatients (SPRAVATO is not approved in pediatric patients), the incidence of suicidal thoughtsand behaviors in patients age 24 years and younger was greater than in placebo-treated patients.
There was considerable variation in risk of suicidal thoughts and behaviors among drugs, butthere was an increased risk identified in young patients for most drugs studied.
There weredifferences in absolute risk of suicidal thoughts and behaviors across the different indications,with the highest incidence in patients with major depressive disorder (MDD). The drug-placebodifferences in the number of cases of suicidal thoughts and behaviors per 1000 patients treatedare provided in Table 2.
Table 2: Risk Differences of the Number of Patients with Suicidal Thoughts or Behaviors in the Pooled
Placebo-Controlled Trials of Antidepressants in Pediatric* and Adult Patients
Age Range (Years) Drug-Placebo Difference in Number of Patients of Suicidal Thoughts
or Behaviors per 1000 Patients Treated
Increases Compared to Placebo
<18 14 additional patients
18-24 5 additional patients
Decreases Compared to Placebo
25-64 1 fewer patient
≥65 6 fewer patients * SPRAVATO is not approved in pediatric patients.It is unknown whether the risk of suicidal thoughts and behaviors in children, adolescents, and
young adults extends to longer-term use, i.e., beyond four months. However, there is substantialevidence from placebo-controlled maintenance studies in adults with MDD that antidepressantsdelay the recurrence of depression and that depression itself is a risk factor for suicidal thoughtsand behaviors.
Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidalthoughts and behaviors, especially during the initial few months of drug therapy and at times ofdosage changes. Counsel family members or caregivers of patients to monitor for changes inbehavior and to alert the healthcare provider. Consider changing the therapeutic regimen,including possibly discontinuing SPRAVATO and/or the concomitant oral antidepressant, inpatients whose depression is persistently worse, or who are experiencing emergent suicidalthoughts or behaviors.
5.6 Increase in Blood Pressure
SPRAVATO causes increases in systolic and/or diastolic blood pressure (BP) at allrecommended doses. Increases in BP peak approximately 40 minutes after SPRAVATO
administration and last approximately 4 hours [see Adverse Reactions (6.1)].
Approximately 8% to 17% of SPRAVATO-treated patients and 1% to 3% of placebo-treatedpatients experienced an increase of more than 40 mmHg in systolic BP and/or 25 mmHg indiastolic BP in the first 1.5 hours after administration at least once during the first 4 weeks oftreatment. A substantial increase in blood pressure could occur after any dose administered evenif smaller blood pressure effects were observed with previous administrations.
SPRAVATO iscontraindicated in patients for whom an increase in B |
