Esketamine – patient information leaflet

This leaflet is for anyone who wants to know more about esketamine. It looks at what esketamine is, why it is used, who can benefit from it, its effects, side effects and other relevant information. Please read this alongside the participant information leaflet, the link for which will be provided below. And if you are not sure about anything in this leaflet, please ask a member of staff.

Esketamine is an antidepressant medication.

You may have heard of ketamine, as an anaesthetic, pain killer, and recently as an antidepressant.

Esketamine is very similar drug to ketamine, but has some differences that make it a slightly different drug in how it works in the brain. These make esketamine slightly stronger as an antidepressant, while less likely to make people drowsy.

Esketamine has also been used as an anaesthetic. Recent studies have shown that when given in lower doses alongside conventional antidepressants, it can be effective for people with depression which does not respond to other treatments. Treatment with esketamine is reserved for these situations.

Esketamine acts on a different brain chemical than most antidepressants. This means that it might work when other antidepressants have not. It is thought to help the brain make new connections in areas affected by depression.

Esketamine has other advantages. It is quick acting, sometimes providing relief from depressive symptoms within a couple of days. It can also sometimes be helpful with specific symptoms of depression, like restoring people’s capacity for experiencing pleasure.

Esketamine is given to you in a different way to other antidepressants, a nasal spray is used and it must be taken in clinic under supervision with monitoring for a few hours afterwards. It is not taken daily, but follows a treatment timetable which is described below.

Other than its antidepressant effects, esketamine produces several effects on the mind and the body. These are short lived and usually subside completely within 90 minutes to two hours.

The most common effects on the body are headache, nausea, and vomiting. This can be helped by over the counter medications, and by not eating before your session. A less common but important effect is that esketamine increases blood pressure and heart rate. This also usually resolves within two hours, and is monitored as part of the treatment.

Esketamine can make you may feel different for a short while after taking it. For example, you might feel dizzy, drowsy, happy, or anxious. You may also experience something called dissociation. This is state in which you experience yourself and the world around you a bit differently.

For example, you can start seeing or hearing things differently, or experience space and time differently. It can also make you feel like you are separated from your body, which may be difficult to imagine until you experience it yourself. This can either be a pleasant or unpleasant experience, and usually decreases in intensity with each time you have the treatment. Some things can help make the experience more pleasant, like being in a controlled and safe environment, sitting in a room with dim lighting, or listening to music.

It is important to keep in mind that these effects are temporary and in the vast majority of cases subside within two hours. This is why we ask you to stay in the clinic with specialist nurses to support you until these effects pass.

Unlike most other antidepressants esketamine is administered in a special clinic under supervision from a nurse. You do not take it home with you.

You will have an allotted time for your appointment. We recommend that you set aside a whole morning or afternoon. Although the administration takes less than 20 minutes you will need to stay in the clinic until the temporary effects wear off, and we assess your readiness to leave. This can take up to 2 hours.

Esketamine is usually given:

• twice weekly for the first four weeks, then
• once a week for four weeks, then
• once a week or once a fortnight after that

 
Treatment usually continues for at least six months. Then we will have a discussion with you and your doctor to determine whether treatment should continue further. This will depend on your response to the medication, and how well you tolerate it.

Esketamine is given as a nasal spray. Most people are able to administer the esketamine themselves, but nurses will be monitoring administration and will help if needed. Esketamine comes in a single use, disposable plastic device specifically designed to dispense exact dose.

You will administer one spray in each nostril while sitting comfortably in a chair. This counts as one dose. You may need two or three doses per session, separated by a five-minute break.

After taking your final dose, you will be encouraged to relax in the chair until the temporary effects wear off, and you are ready to leave the clinic. This usually takes around 90 minutes to 2 hours. You can bring along your own music, book, or magazine to read while you wait. It might be difficult to read during the first few sessions, but it should get easier as you get used to the effects.

We will measure your blood pressure twice during the treatment session to ensure it is within the acceptable range. Once before you take the first dose, and then forty minutes after you take the last dose.

Esketamine will need to be taken alongside a conventional antidepressant. It is compatible with most other antidepressants, but this will be discussed with you and your doctor.

As esketamine can cause nausea, you are advised not to eat two hours before treatment, and not to drink 30 minutes before treatment. As it is administered via the nose, you are advised not to use corticosteroid or decongestant nasal sprays in the hour before administration. If you use any other nasal sprays, please discuss this with your doctor.

To avoid excessive sleepiness, you will be advised not to drink alcohol one day before, and one day after esketamine administration.

If you miss one session, the next session will carry on as normal, with your treatments continuing at the same dose and frequency. If you miss two sessions, you may need to re-start at a different dose or frequency for a while. This will depend on how you are doing and on how you respond.

You are advised not to drive or operate heavy machinery until the day after administration, once you’ve had a restful sleep.

As with all other drugs, there are certain people for whom esketamine will not be suitable. This includes people who are allergic to esketamine, or have heart conditions that could be made worse by the increase in heart rate and blood pressure. For example, people who have unstable high blood pressure or have recently had a heart attack, people with a disease of the blood vessels (aneurysms), a history of bleeding in the brain, conditions with increased pressure in the brain, or any clinically significant heart or lung problems.

Others who may not be suitable include those with severe liver damage, women who are pregnant or can get pregnant and are not using birth control, people with a history of psychosis, mania, or bipolar disorder, and those who have a problem with addiction.

We will only be offering esketamine to adults.

Esketamine can potentially be addictive, especially in specific groups of people who are known to have problems with addiction.

To decrease the likelihood of this people are screened carefully for a history of addiction before treatment is offered. Additionally, esketamine is only provided in clinic, under supervision, and is dispensed in disposable devices which contain only one dose.

Moreover, those taking esketamine will be monitored carefully for any signs of addiction, and will followed up throughout their treatment process.

The effects of esketamine are short lived, and so it needs to be administered regularly. It is not yet clear how long the effects last after stopping treatment, and every person will react in a slightly different way. Current evidence suggests treatment for at least six months, with a review afterwards according to response.

You will remain in contact with your doctor and the rest of the team during treatment, so the rest of your treatment plan can be adjusted to ensure the optimum benefits.

Esketamine is considered to be a safe treatment, particularly when delivered intra-nasally. However, as with any medication, it can have side effects. Everyone will react to the medication in a slightly different way and some will have more side effects than others.

The vast majority of these side effects will resolve within two hours, with 90% of them resolving on the day of treatment.

• Around one in three people experience dizziness.
• Around one in four will experience nausea, headache or dissociation (described above).
• Around one in five will experience sleepiness, vertigo, or change in taste sensation.
• Around one in ten will experience limb numbness or vomiting.
• A less common, but important side effect is that esketamine increases blood pressure and heart rate. This needs careful monitoring, and may need treatment in clinic if it remains high. In the rare instances when this happens we will support you throughout.

 
People have also reported feeling euphoric, irritable or “a bit drunk”, seeing things that aren’t there, shakiness, difficulty speaking, tiredness, blurred vision, dry nose, dry mouth, and sweating.

Because esketamine has only recently been used in this way, we might still not know about all of its side-effects. This is why you will be monitored closely throughout your treatment. However, if any unexpected side-effects show up, we will take them seriously and will help you manage them, alongside your doctor.

Ketamine is known to cause bladder problems when used frequently in high doses for long periods of time. With esketamine, studies have not shown this effect. There was also no increase in rates of water infection in people taking esketamine in the studies.

However, people who have participated in the studies have reported more symptoms e.g frequent urination, feeling a need to urinate, having painful urination, waking up to empty the bladder, and bladder inflammation.

Similarly, there are some reports of memory problems with ketamine used for long periods of time and when abused. Studies with esketamine have not shown this. Results from long term studies have shown either a slight improvement in memory, or that it has remained stable.

As the full effects are not yet clear, we will monitor for any of these symptoms during your treatment.

In the days that you receive treatment, you should expect to be with us for the whole morning or afternoon. You will also be asked not to drive until the next day after treatment, and will be asked to abstain from alcohol the day before and the day after treatment.

Because esketamine is relatively new evidence of its benefits and side effects is still being collected. It is licenced and approved for use in the United Kingdom, however is not yet included in the national guidelines for depression. It is called a ‘non-formulary’ drug for this reason. However it has been approved by our Trust for use in these circumstances.

If you do choose to start esketamine treatment, your name will be listed on a register, and we will need to let the Trust know how the treatment is going. Your confidentiality will of course be respected as usual.

Yes. Like with any other treatment, we will ask for your informed consent before we start treatment. You can withdraw your consent at any time and treatment will stop.

If you decide to stop treatment for any reason, it is important to discuss your reasons for doing so with your doctor, so that you can consider alternative treatments.

Esketamine is just one of many available treatments for depression. If it doesn’t work, there are other options. Speak to your doctor about possible next steps if esketamine has not worked for you, or if you would like to stop taking it.

More information on esketamine can be found on its package leaflet, found here: https://www.medicines.org.uk/emc/files/pil.10977.pdf

Medicines.org.uk. 2020. Spravato 28 Mg Nasal Spray, Solution – Summary Of Product Characteristics (Smpc) – (Emc). [online] Available at: https://www.medicines.org.uk/emc/product/10977/smpc#gref [Accessed 18 November 2020].

Ema.europa.eu. 2020. [online] Available at: https://www.ema.europa.eu/en/documents/rmp-summary/spravato-epar-risk-management-plan-summary_en.pdf [Accessed 22 November 2020].

If you want to make a comment, suggestion, compliment or complaint you can:

• talk to the people directly involved in your care
• ask a member of staff for a feedback form, or complete a form on the Trust website
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• other options for sharing your feedback and experience www.cntw.nhs.uk/yourfeedback

 
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Published by the Patient Information Centre
2024 Copyright, Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
Ref, PIC/838/0124 January 2024 V2
www.cntw.nhs.uk Tel: 0191 246 7288
Review date 2027