P or intracranial pressure poses a seriousrisk (e.g., aneurysmal vascular disease, arteriovenous malformation, history of intracerebralhemorrhage) [see Contraindications (4)]. Before prescribing SPRAVATO, patients with othercardiovascular and cerebrovascular conditions should be carefully assessed to determine whetherthe potential benefits of SPRAVATO outweigh its risks.
Assess BP prior to administration of SPRAVATO. In patients whose BP is elevated prior toSPRAVATO administration (as a general guide: >140/90 mmHg) a decision to delay
SPRAVATO therapy should take into account the balance of benefit and risk in individualpatients.
BP should be monitored for at least 2 hours after SPRAVATO administration [see Dosage andAdministration (2.1, 2.4)]. Measure blood pressure around 40 minutes post-dose andsubsequently as clinically warranted until values decline. If BP remains high, promptly seekassistance from practitioners experienced in BP management. Refer patients experiencingsymptoms of a hypertensive crisis (e.g., chest pain, shortness of breath) or hypertensiveencephalopathy (e.g., sudden severe headache, visual disturbances, seizures, diminishedconsciousness or focal neurological deficits) immediately for emergency care.
Closely monitor blood pressure with concomitant use of SPRAVATO with psychostimulants ormonoamine oxidase inhibitors (MAOIs) [see Drug Interactions (7.2, 7.3)].
In patients with history of hypertensive encephalopathy, more intensive monitoring, includingmore frequent blood pressure and symptom assessment, is warranted because these patients areat increased risk for developing encephalopathy with even small increases in blood pressure.
5.7 Cognitive Impairment
Short-Term Cognitive ImpairmentIn a study in healthy volunteers, a single dose of SPRAVATO caused cognitive performancedecline 40 minutes post-dose. Compared to placebo-treated subjects, SPRAVATO-treatedsubjects required a greater effort to complete cognitive tests at 40 minutes post-dose. Cognitiveperformance and mental effort were comparable between SPRAVATO and placebo at 2 hourspost-dose. Sleepiness was comparable after 4 hours post-dose.
Long-Term Cognitive Impairment
Long-term cognitive and memory impairment have been reported with repeated ketamine misuseor abuse. No adverse effects of SPRAVATO nasal spray on cognitive functioning were observedin a one-year open-label safety study; however, the long-term cognitive effects of SPRAVATOhave not been eva luated beyond one year.
5.8 Impaired Ability to Drive and Operate Machinery
Two placebo-controlled studies were conducted to assess the effects of SPRAVATO on theability to drive [see Clinical Studies (14.3)]. The effects of SPRAVATO 84 mg were comparableto placebo at 6 hours and 18 hours post-dose. However, two SPRAVATO-treated subjects in oneof the studies discontinued the driving test at 8 hours post-dose because of SPRAVATO-relatedadverse reactions.
Before SPRAVATO administration, instruct patients not to engage in potentially hazardousactivities requiring complete mental alertness and motor coordination, such as driving a motorvehicle or operating machinery, until the next day following a restful sleep. Patients will need toarrange transportation home following treatment with SPRAVATO.
5.9 Ulcerative or Interstitial Cystitis
Cases of ulcerative or interstitial cystitis have been reported in individuals with long-term o |
