Spravato 28 mg solution for nasal spray: detailed information

Brand name Spravato 28 mg solution for nasal spray

Form solution, nasal spray

Active substance / Dosage

ESKETAMINE HYDROCHLORIDE · 37,1 mg

Prescription type Hospital Diagnosis. Psychotropic Medicine

ATC code

N06A N06AX N06AX27

Registration number 1191410001

Manufacturer Janssen-Cilag International N.V

Spravato 28 mg solution for nasal spray solution, nasal spray

Table of Contents

Package leaflet: Information for the user
Introduction
1. What Spravato is and what it is used for
2. What you need to know before starting Spravato
3. How to use Spravato
4. Possible adverse effects
5. Storage of Spravato
6. Contents of the container and other information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Spravato 28 mg nasal spray solution

esketamine

This medicinal product is subject to additional monitoring, which will allow quicker identification of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is included at the end of section 4.

Read the entire 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 questions, ask your doctor or pharmacist.
If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

What Spravato is and what it is used for
What you need to know before using Spravato
How to use Spravato
Possible side effects
How to store Spravato
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. It belongs to a group of medicines called antidepressants and has been given to you to treat your depression.

What Spravato is used for

Spravato is used in adults to reduce symptoms of depression, such as feeling sad, anxious, or worthless, difficulty sleeping, changes in appetite, loss of interest in favourite activities, and feeling slowed down. It is given together with another antidepressant when you have tried at least two other antidepressants without sufficient benefit.

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 starting Spravato

Do not use Spravato

if you are allergic to esketamine, to a similar medicine called ketamine used for anaesthesia, or to any of the other ingredients of this medicine (listed in section 6).
if you have ever had certain disorders such as:
an aneurysm (a weak spot in the wall of a blood vessel that bulges or dilates)
cerebral haemorrhage
if you have recently had a myocardial infarction (within the previous 6 weeks)

The reason is that Spravato may cause a temporary increase in blood pressure, which could lead to serious complications in these conditions.

Do not use Spravato if you are in any of the above situations. If you are unsure, speak with your doctor before using Spravato; your doctor will decide whether or not you can use this medicine.

Warnings and precautions

Talk to your doctor before starting Spravato if:

you have a heart condition that is not well controlled, such as: reduced blood flow in the blood vessels of the heart often with chest pain (e.g., angina), high blood pressure, heart valve disease, or heart failure
you have ever had problems with blood supply to the brain (such as a stroke)
you have ever had substance abuse problems (prescription medicines or illegal drugs)
you have ever had a condition called psychosis, in which you believe things that are not true (delusions) or see, feel, or hear things that do not exist (hallucinations)
you have ever had a condition called bipolar disorder, or symptoms of mania (where the person is hyperactive or overexcited)
you have ever had untreated or inadequately treated overactive thyroid (hyperthyroidism)
you have ever had lung problems causing difficulty breathing (respiratory insufficiency), including chronic obstructive pulmonary disease (COPD)
sleep apnoea and extreme obesity
you have ever had slow or fast heartbeats causing difficulty breathing, palpitations or chest discomfort, dizziness, or fainting
you have ever had a severe head injury or serious brain problems, especially when there is increased pressure in the brain
you have severe liver problems.

If you have any of the above conditions (or if you are unsure), consult your doctor before starting to use Spravato. Your doctor will decide whether you should use this medicine.

Worsening of depression

Tell your doctor or go immediately to the nearest hospital if at any time you have thoughts of harming yourself or of suicide.

It may be helpful for you to talk to a close family member or friend if you are depressed, and to ask them whether they think your depression is getting worse or if they are concerned about your behaviour. You may ask them to read this leaflet.

Blood pressure

Spravato may increase your blood pressure for about 1 to 2 hours after use, so your blood pressure will be measured before you start using Spravato and after you use it.

If your blood pressure is high before using this medicine, your doctor will decide whether to start treatment or wait until your blood pressure is lower. If your blood pressure increases after using this medicine and remains high for more than a few hours, you may need further tests.

This medicine may cause a temporary increase in blood pressure after a dose is given. Your blood pressure will be measured before and after using this medicine. Immediately inform medical staff if you experience chest pain, difficulty breathing, sudden severe headache, changes in vision, or seizures (fits) after using this medicine.

Tell your doctor if you experience any of the following symptoms while using Spravato

difficulties with attention, judgment, and thinking (see also “Driving and use of machines” and “Possible side effects”). During and after each use of this medicine, your doctor will monitor your condition and decide how long you need to be observed.
drowsiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling detached from yourself, your thoughts, sensations, space, and time (dissociation), difficulty breathing (respiratory depression). Immediately inform medical staff if you feel unable to stay awake or feel like you might faint.
pain when urinating or blood in your urine; these may be signs of bladder problems. These may occur with high doses of a similar medicine (called ketamine) used over a long period.

Tell your doctor if you experience any of the above symptoms while using Spravato.

Elderly patients (> 65 years)

If you are elderly (> 65 years), you will be closely monitored, as you may have an increased risk of falling when you start moving after treatment.

Children and adolescents

Do not give this medicine to children or adolescents under 18 years of age. This is because Spravato has not been studied in treatment-resistant depression in this age group.

Other medicines and Spravato

Tell your doctor if you are taking, have recently taken, or might need to take any other medicine.

Using Spravato with certain medicines may cause side effects. Tell your doctor especially if you are taking:

Medicines used to treat nervous disorders or severe pain (e.g., benzodiazepines, opioids), or medicines or drinks containing alcohol
Stimulants such as those used for conditions like narcolepsy or medicines for ADHD (e.g., amphetamines, methylphenidate, modafinil, armodafinilo)
Medicines that may increase your blood pressure, such as thyroid hormones, asthma medicines like xanthine derivatives, medicines for postpartum bleeding (ergometrine), and heart medicines such as vasopressin.
Medicines for depression or Parkinson’s disease called monoamine oxidase inhibitors (MAOIs) (e.g., tranilcypramine, selegiline, phenelzine).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Contraception

If you can become pregnant, you should use contraception during treatment. Talk to your doctor about suitable contraceptive methods.

Pregnancy

Do not use Spravato if you are pregnant.

If you become pregnant while receiving treatment with Spravato, speak immediately with your doctor to decide whether treatment should be stopped and to discuss other treatment options.

Breastfeeding

Do not use Spravato if you are breastfeeding your child. Talk to your doctor before using Spravato if you are breastfeeding. Your doctor will discuss with you whether you should stop breastfeeding or stop using this medicine. Your doctor will consider the benefit of breastfeeding for you and your child, and the benefit of treatment for you.

Driving and use of machines

Spravato may make you feel drowsy, dizzy, and cause other side effects that may temporarily affect your ability to drive or operate machinery and perform activities requiring full alertness. After receiving treatment with this medicine, do not carry out these activities until the following day after a restful sleep.

3. How to use Spravato

Follow exactly the administration instructions for this medicine given by your doctor.

If in doubt, consult your doctor.

You will use the Spravato nasal spray yourself under the supervision of a doctor or other healthcare professional in a healthcare setting, such as your doctor's office or clinic.

Your doctor or other healthcare professional will teach you how to use the nasal spray (see also Instructions for Use).

Recommended dose

Your doctor will decide whether you need 1, 2, or 3 nasal sprays and how often you should go to your doctor's office or clinic to receive the medicine.

One nasal spray delivers two sprays (one into each nostril)
Spravato is used twice a week for the first 4 weeks

If your treatment is continued:

Spravato is usually used once a week for the following 4 weeks
Afterwards, Spravato is usually used once a week or once every 2 weeks.

During and after each use of this medicine, your doctor will monitor you and decide how long you should be observed.

Food and drink

Some patients using Spravato may experience nausea or vomiting. You should avoid eating for 2 hours before treatment and avoid drinking liquids for 30 minutes before using this medicine.

Nasal sprays

If you require steroid or decongestant medications in the form of a nasal spray, avoid using them during the hour before treatment with Spravato.

If you use more Spravato than you should

You will use this medicine under the supervision of your doctor in the doctor's office or clinic. Therefore, it is unlikely that you will use too much.

If you use too much Spravato, you are more likely to experience side effects (see “Possible adverse effects”).

If you stop using Spravato

It is important that you make sure to attend your scheduled appointments for this medicine to be effective for you.

If you have any further questions about the use of this medicine, ask your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.

Inform your doctor if you notice any of the following adverse effects.

Very common (may affect more than 1 in 10 people)

feeling detached from yourself, your thoughts, feelings, and surroundings
dizziness
headache
drowsiness
altered sense of taste
decreased sensation or sensitivity, including around the mouth area
sensation of spinning or surroundings spinning ("vertigo")
vomiting
nausea
increased blood pressure

Common (may affect up to 1 in 10 people)

feeling of anxiety
feeling of extreme happiness ("euphoria")
feeling confused
feeling detached from reality
feeling irritable
seeing, feeling, hearing, or smelling things that are not there (hallucinations)
feeling restless
senses of sight, hearing, or touch are deceived or distorted in some way (something is not what it seems)
panic attacks
altered perception of time
unusual sensation in the mouth (such as tingling or prickling)
muscle tremors
problems with thinking
unusual drowsiness with low energy
difficulty speaking
difficulty concentrating
blurred vision
persistent ringing in the ears (tinnitus)
increased sensitivity to noise or sounds
rapid heartbeat
high blood pressure
nasal discomfort
throat irritation
sore throat
nasal dryness, including dry crusts in the nose
nasal itching
decreased sensation or sensitivity in the mouth
dry mouth
excessive sweating
frequent need to urinate
pain when urinating
urgent need to urinate
abnormal sensation
feeling of drunkenness
feeling of weakness
crying
sensation of body temperature changes

Uncommon (may affect up to 1 in 100 people)

slowed thinking, speech, and physical movements
emotional stress
feeling of restlessness or tension
uncontrolled rapid eye movements
hyperactivity
increased saliva
cold sweats
difficulty walking

Rare (may affect up to 1 in 1,000 people)

difficulty breathing (respiratory depression)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Spravato

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and label.

The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Spravato

The active substance is esketamine.

Each nasal spray contains esketamine hydrochloride equivalent to 28 mg of esketamine.

The other components are:

Monohydrate citric acid

Disodium edetate

Sodium hydroxide (for pH adjustment)

Water for injections

Appearance of the product and contents of the container

Spravato is a nasal spray solution. This medicine is a clear, colourless solution supplied in a single-use nasal spray device.

Spravato is available in packages containing 1, 2, 3 or 6 nasal sprays, and as a multiple pack containing 24 (8 packs of 3) nasal sprays.

Each nasal spray is individually packaged in a sealed blister.

Only certain package sizes may be marketed.

Marketing Authorization Holder

Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer

Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

More information on this medicine can be obtained by contacting the local representative of the Marketing Authorization Holder:

Belgium/Belgium/Belgium

Janssen-Cilag NV

Tel/Tel: +32 14 64 94 11

	Instruct the patient to blow their nose only before the first device.
	Confirm the required number of devices.