r.
• Patients must be monitored by a healthcare provider for at least 2 hours after administrationof SPRAVATO.
Suicidal Thoughts and Behaviors
Advise patients and caregivers to look for the emergence of suicidality, especially early during
treatment and when the dosage is adjusted [see Boxed Warning and Warnings and Precautions
(5.5)].
Increases in Blood Pressure
Advise patients that SPRAVATO can cause increases in blood pressure. Inform patients that
after treatment sessions they should be advised that they may need to be observed by a healthcare
provider until these effects resolve [see Warnings and Precautions (5.6)].
Impaired Ability to Drive and Operate Machinery
Caution patients that SPRAVATO may impair their ability to drive or operate machinery.
Instruct patients not to engage in potentially hazardous activities requiring complete mentalalertness and motor coordination such as driving a motor vehicle or operating machinery untilthe next day after a restful sleep. Advise patients that they will need someone to drive them homeafter each treatment session [see Warnings and Precautions (5.8)].
Pregnancy
Advise pregnant women and women of reproductive potential of the potential risk to a fetus.
Advise patients to notify their healthcare provider if they are pregnant or intend to becomepregnant during treatment with SPRAVATO. Advise patients that there is a pregnancy exposureregistry that monitors pregnancy outcomes in women exposed to SPRAVATO during pregnancy.
[See Use in Specific Populations (8.1)].
Lactation
Advise women not to breastfeed during treatment with SPRAVATO [see Use in SpecificPopulations (8.2)].
Manufactured by:
Renaissance Lakewood LLC
Lakewood, NJ 08701
Manufactured for:
Janssen Pharmaceuticals, Inc.
Titusville, NJ 08560
© 2019 Janssen Pharmaceutical Companies
http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/SPRAVATO-pi.pdf |
