28 mg nasal spray, solution
esketamine
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 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, e.g. feeling sad, anxious, or worthless, difficulty sleeping, change in appetite, loss of interest in favorite activities, and feeling sluggish. It is given together with another antidepressant if you have tried at least 2 other antidepressants without any help.
Spravato is also used in adults to quickly reduce the symptoms of depression in situations that require immediate treatment (a psychiatric emergency).
What you need to know before using Spravato
Do not use Spravato
- if you are allergic to esketamine, a similar medicine called ketamine used for anesthesia or any of the other ingredients of this medicine (listed in section 6).
- if you have ever had certain conditions such as:
- an aneurysm (a weak point in a blood vessel wall that is dilated or bulges)
- cerebral hemorrhage.
- if you have recently had a heart attack (in the last 6 weeks). This is because Spravato can cause a temporary increase in blood pressure et which can lead to serious complications for these conditions.
Do not use Spravato if any of the above apply to you. Talk to your doctor before using Spravato if you are not sure. Your doctor will decide whether you can use this medicine or not.
Warnings and precautions
Talk to your doctor before using Spravato if you
- have heart problems that are not well controlled, eg: poor blood flow in the blood vessels of the heart, often with chest pain (eg angina), high blood pressure, heart valve disease, or heart failure
- have ever had problems with the blood supply to the brain (e.g. a stroke )
- have ever had a problem with drug abuse – prescription drugs or illegal drugs
- have ever had a condition called psychosis where you believe things that are not real (delusions) or see, feel or hear things that are not there (hallucinations)
- have ever had a condition called bipolar disorder or symptoms of mania (where you become very overactive or excited)
- have ever had an overactive thyroid gland that is inadequately treated ( hyperthyroidism )
- have ever had lung problems that cause breathing difficulties (pulmonary insufficiency), including chronic obstructive pulmonary disease (COPD)
- have sleep apnea or are extremely overweight
- ever had a slow or fast heart rate that causes shortness of breath, palpitations or chest discomfort, dizziness or fainting
- have had a serious head injury or serious problems affecting the brain, especially where there is increased pressure in the brain
- have serious liver problems.
Talk to your doctor before using Spravato if any of the above apply to you (or if you are not sure). Your doctor will decide whether you should use this medicine.
Depression that gets worse
Tell a doctor or go to the nearest hospital if you have thoughts of harming yourself or committing suicide.
It may help to talk to a relative or close friend if you are depressed and ask them to tell you if they think you seem to be getting worse or if they think your behavior is changing. Please ask them to read this leaflet.
Blood pressure
Blood pressure may increase for about 1 to 2 hours after you take Spravato. Your blood pressure will be measured before you start using Spravato and after you have taken it.
If your blood pressure is high before using this medicine, your doctor will decide whether you should start using the medicine 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 more tests.
This medicine may cause a temporary increase in blood pressure after you have taken a dose. Your blood pressure will be checked before and after you take this medicine. Tell your healthcare provider right away if you get chest pain, shortness of breath, sudden severe headache, vision changes, or seizures after using this medicine.
Tell your doctor if you get any of the following while using Spravato
- difficulties with attention, judgment, and thinking skills (see also “Driving and using machines” and “Possible side effects”). During and after each use of this medicine, your doctor will check you and decide how long you will be under observation.
- sleepiness ( sedation ), fainting, dizziness, feeling that everything is spinning, anxiety or feeling of not being in touch with oneself, one’s thoughts, feelings, time and space (dissociation), difficulty breathing (respiratory failure). Tell the health care professional immediately if you feel that you cannot stay awake or if you feel that you are going to pass out.
- pain when urinating or blood in the urine – these may be signs of a problem with the bladder. These symptoms can occur with high doses of a similar drug (ketamine) used over a longer period.
Tell your doctor if you get any of the above while taking Spravato.
Elderly (> 65 years)
If you are elderly (> 65 years) you will be closely monitored as you are at higher risk of falling when you start moving after treatment.
Children and young people
Do not give this medicine to children or adolescents under 18 years of age. This is because Spravato has not been studied for treatment-resistant depression in this age group.
Other medicines and Spravato
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
If you use Spravato with certain medicines, it can cause side effects. You must especially inform your doctor if you are taking
- medicines used to treat neurological diseases or severe pain (for example benzodiazepines , opioids ) or medicines or drinks containing alcohol
- stimulants used for example in narcolepsy or drugs for ADHD (for example amphetamine, methylphenidate, modafinil, armodafinil)
- medicines that can raise your blood pressure, for example, thyroid hormones, asthma medicines such as xanthine derivatives, medicines for bleeding in childbirth (ergometrine), and heart medicines such as vasopressin.
- medicines for depression or Parkinson’s disease called monoamine oxidase inhibitors ( MAOIs ) (eg tranylcypromine, selegiline, phenelzine).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
Contraceptive
If you can become pregnant, you must use contraception during treatment. Talk to your doctor about which contraceptive methods can be used.
Pregnancy
Do not use Spravato if you are pregnant.
If you become pregnant while being treated with Spravato, you should talk to your doctor immediately to decide whether to stop treatment and to learn about other treatment options.
Breast-feeding
Do not use Spravato if you are breastfeeding. Talk to your doctor before using Spravato if you are breastfeeding. The doctor will discuss with you whether you should stop breastfeeding or stop taking this medicine. The doctor weighs the benefit of breastfeeding for you and the baby and the benefit of the treatment for you in the decision.
Driving ability and use of machinery
Spravato can make you sleepy, and dizzy and cause other side effects that may temporarily affect your ability to drive or operate machinery and perform other activities that require your full attention. After you have been treated with this medicine, you should not engage in any such activity until the next day after a good night’s sleep.
How to use Spravato
Always use this medicine as directed by your doctor. Consult a doctor if you are unsure.
You use Spravato nasal spray yourself under the supervision of a doctor or other healthcare professional in a healthcare environment, e.g. doctor’s office or clinic.
The doctor or other healthcare professional will show you how to use the nasal spray container ( see also User instructions ).
How much to use
The doctor will decide whether you need 1, 2, or 3 nasal spray containers and how often you will go to the doctor’s office or clinic to get the medicine.
- Each nasal spray container delivers two sprays (one spray per nostril).
- Spravato is used twice a week for the first 4 weeks.
In case of continued treatment:
- Spravato is usually used once a week for the following 4 weeks.
- After that, Spravato is usually used once a week or once every two weeks.
During and after each use of this medicine, your doctor will check you and decide how long you will be under observation.
Food and drinks
Some patients using Spravato may experience nausea or vomiting. You should avoid eating 2 hours before treatment and avoid drinking 30 minutes before using this medicine.
Nasal sprays
If you need to take steroids or decongestant medicines such as nasal sprays, you should avoid taking this 1 hour before being treated with Spravato.
If you have used too much Spravato
You use this medicine under the guidance of your doctor at 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 have side effects (see “Possible side effects”).
If you stop using Spravato
You must attend all scheduled visits for the medicine to be effective for you.
If you have any further questions about this medicine, ask your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell the doctor if you observe any of the following side effects.
Very common (may affect more than 1 in 10 people)
- the feeling of not being in touch with yourself, your thoughts, feelings, and things around you
- feel dizzy
- headache
- feeling sleepy
- altered sense of taste
- decreased sensation or sensitivity, including the area around the mouth
- feeling that everything is spinning (“vertigo”)
- vomiting
- nausea
- increased blood pressure.
Common (may affect up to 1 in 10 people)
- feeling anxious
- feeling excessively happy (“euphoria”)
- feeling confused
- feeling cut off from reality
- feel irritated
- seeing, feeling, hearing, or smelling things that are not there (hallucinations)
- feel upset
- eyes, ears, and senses are deceived or misleadingly perceive things (something is not what it appears to be)
- panic attacks
- changed perception of time
- unusual sensation in the mouth (such as a tickling or crawling sensation)
- muscle tremors
- problems with thinking
- feeling very sleepy and having low energy
- difficulty speaking
- difficulty concentrating
- blurred vision
- persistent ringing in the ears ( tinnitus )
- increased sensitivity to sound
- rapid pulse
- high blood pressure
- discomfort in the nose
- irritated throat
- sore throat
- dry nose, including dry crusts in the nose
- itchy nose
- decreased sensation or sensitivity in the mouth
- dry mouth
- sweat excessively
- need to pee often
- pain when you urinate
- Urgent need to urinate
- not feeling normal
- feel drunk
- feel weak
- cry
- feel changes in body temperature.
Uncommon (may affect up to 1 in 100 people)
- thoughts, speech, and physical movements are slowed down
- emotional discomfort
- feel uneasy or tense
- rapid eye movements that you cannot control
- hyperactivity
- increased salivation
- cold sweats
- trouble walking.
How to store Spravato
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton and label. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is ketamine.
Each nasal spray container contains ketamine hydrochloride equivalent to 28 mg of ketamine.
Other ingredients are:
Citric acid monohydrate
Disodium edetate
Sodium hydroxide (for pH adjustment)
Appearance and package sizes of the medicine
Spravato is a nasal spray, solution. The medicine is a clear, colorless solution, supplied in a single-use nasal spray container.
Spravato is available in pack sizes of 1, 2, 3, or 6 nasal spray canisters and as a multipack containing 24 (8 packs of 3) nasal spray canisters.
Each nasal spray container has been packaged separately in a sealed blister.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Janssen‑Cilag International NV
Turnhoutseweg 30
B‑2340 Beerse
Belgium
Manufacturer
Janssen Pharmaceutica NV
Turnhoutseweg 30
B‑2340 Beerse
Belgium