Spravato

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

esketamine hydrochloride

Available from:

Janssen-Cilag International NV

ATC code:

N06AX27

INN (International Name):

esketamine

Therapeutic group:

Other antidepressants

Therapeutic area:

Depressive Disorder

Therapeutic indications:

Spravato, in combination with a SSRI or SNRI, is indicated for adults with treatment-resistant Major Depressive Disorder, who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode.

Product summary:

Revision: 8

Authorization status:

Authorised

Authorization date:

2019-12-18

Patient Information leaflet

43
B. PACKAGE LEAFLET
44
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SPRAVATO 28 MG NASAL SPRAY, SOLUTION
esketamine
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how
to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
●
Keep this leaflet. You may need to read it again.
●
If you have any further questions, ask your doctor or pharmacist.
●
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Spravato is and what it is used for
2.
What you need to know before you use Spravato
3.
How to use Spravato
4.
Possible side effects
5.
How to store Spravato
6.
Contents of the pack and other information
1.
WHAT SPRAVATO IS AND WHAT IT IS USED FOR
WHAT SPRAVATO IS
Spravato contains the active substance esketamine. This belongs to a
group of medicines called
anti-depressants and you have been given this medicine to treat your
depression.
WHAT SPRAVATO IS USED FOR
Spravato is used in adults to reduce the symptoms of depression, such
as, feeling sad, anxious, or
worthless, sleeping difficulties, change in appetite, loss of interest
in favourite activities, feeling of
being slowed down. It is given, together with another antidepressant,
if you have tried at least 2 other
antidepressant medicines but they have not helped.
Spravato is also used in adults to rapidly reduce symptoms of
depression in a situation requiring
immediate treatment (also known as a psychiatric emergency).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SPRAVATO
DO NOT USE SPRAVATO
●
if you are allergic to esketamine, a similar medicine called ketamine
used for anaesthesia, or any
of the other ingredients of this medicine (listed in section 6).
●
if you have ever had certain conditions suc

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Spravato 28 mg nasal spray, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each nasal spray device contains esketamine hydrochloride
corresponding to 28 mg esketamine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nasal spray, solution.
Clear, colourless, aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Spravato, in combination with a SSRI or SNRI, is indicated for adults
with treatment-resistant Major
Depressive Disorder, who have not responded to at least two different
treatments with antidepressants
in the current moderate to severe depressive episode.
Spravato, co-administered with oral antidepressant therapy, is
indicated in adults with a moderate to
severe episode of Major Depressive Disorder, as acute short-term
treatment, for the rapid reduction of
depressive symptoms, which according to clinical judgement constitute
a psychiatric emergency.
See section 5.1 for a description of the populations studied.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The decision to prescribe Spravato should be determined by a
psychiatrist.
Spravato is intended to be self-administered by the patient under the
direct supervision of a healthcare
professional.
A treatment session consists of nasal administration of Spravato and a
post-administration observation
period. Both administration and post-administration observation of
Spravato should be carried out in
an appropriate clinical setting.
Assessment before treatment
Prior to dosing with Spravato blood pressure should be assessed.
If baseline blood pressure is elevated the risks of short-term
increases in blood pressure and benefit of
Spravato treatment should be considered (see section 4.4). Spra