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May 2024 | UK-EMY-CNS-2400007

This website provides you with information about Emylif® and why it has been prescribed for you. You will also find guidance on how to take Emylif® and why riluzole is used to treat amyotrophic lateral sclerosis (ALS).

Emylif® orodispersible films are a dissolvable oral film that contains the medicine riluzole.

May 2024 | UK-EMY-CNS-2400008

You have been prescribed Emylif® as a simple way for you to take riluzole.

Emylif® orodispersible films are designed to dissolve on the top of your tongue, so you will be able to take your medicine even if you have difficulty with swallowing.

Visit the section ‘How to take Emylif’ for simple instructions on how to properly take your Emylif®

References

  1. Emylif® 50 mg orodispersible film. Patient Information Leaflet, June 2023. Available at:
    https://www.medicines.org.uk/emc/product/14754/pil (Accessed May 2024).

  2. Di Stefano AFD, Radicioni MM, Segantin A, Gentili A, Baroglio C, Marjanović I, Cattaneo C (2022) Randomised,
    2-Sequence, 4-Period Replicate Cross-Over Bioequivalence Study of A New Riluzole Orodispersible Film Vs.
    A Reference Tablet in Healthy Volunteers. J Bioeq Stud 8(1): 101.

  3. Emylif® (riluzole 50 mg orodispersible film) Summary of Product Characteristics, 2023. Available at:
    https://www.medicines.org.uk/emc/product/14754/smpc (Accessed May 2024).

Your Emylif® treatment provides you with:

a medication and dose that is the same as riluzole tablets

a different way to take riluzole without having to swallow
a tablet or oral suspension

After it has dissolved on your tongue and swallowed in the saliva, Emylif® orodispersible film is absorbed by your body at a similar rate as a riluzole tablet.
Emylif® may cause side effects in some people
Common side effects that may affect more than 1 in 10 people include:1-3

Increased levels of liver enzymes in the blood
Your doctor may do regular blood tests to monitor this

Tiredness

Feeling sick

Reduced sensitivity or numbness in the mouth

It is likely that this is related to the mechanism of action of riluzole, as it inhibits the release of glutamate which is an excitatory chemical messenger in the brain and spinal cord. However, the exact mechanism of action is unclear.

This sensation was reported by everyone who took Emylif in a clinical study, but it was mild and transient, appearing 1 minute after Emylif was taken, and lasting for 40 minutes on average.

If you experience this feeling, it is recommended to be careful when eating or drinking during this time.

Emylif® may cause side effects in some people
Serious side effects can include:1-3

Neutropenia

What is it?
a decrease in the number of white
blood cells

Signs to watch out for
any fever (increase in temperature )

Hepatitis

What is it?
a liver disease characterised by
inflammation of the liver

Signs to watch out for
yellowing of the skin or the white of your eyes (jaundice), itching all over, feeling sick, being sick

Interstitial lung disease

What is it?
a lung disease characterised by
inflammation and scarring in the lungs

Signs to watch out for
cough, difficulties in breathing

It is important that you speak to your doctor if you experience any symptoms of these side effects.

These are not all the possible side effects of Emylif®, so please ask your doctor for advice about side effects, or read the patient information leaflet that came with your medicine and is also available here.

References

  1. Emylif® 50 mg orodispersible film. Patient Information Leaflet, June 2023. Available at:
    https://www.medicines.org.uk/emc/product/14754/pil (Accessed May 2024).

  2. Di Stefano AFD, Radicioni MM, Segantin A, Gentili A, Baroglio C, Marjanović I, Cattaneo C (2022) Randomised,
    2-Sequence, 4-Period Replicate Cross-Over Bioequivalence Study of A New Riluzole Orodispersible Film Vs.
    A Reference Tablet in Healthy Volunteers. J Bioeq Stud 8(1): 101.

  3. Emylif® (riluzole 50 mg orodispersible film) Summary of Product Characteristics, 2023. Available at:
    https://www.medicines.org.uk/emc/product/14754/smpc (Accessed May 2024).

May 2024 | UK-EMY-CNS-2400009

Emylif® dissolves once placed on the top of your tongue.

Just like the tablet form of riluzole, an Emylif® orodispersible film contains a 50mg dose, and one film should be taken twice a day.1

References

  1. Emylif® 50 mg orodispersible film. Patient Information Leaflet, June 2023. Available at:
    https://www.medicines.org.uk/emc/product/14754/pil (Accessed May 2024).

Tap here to control the video

Follow the simple steps below to make sure you are taking your Emylif® correctly.1

Wash and dry your hands

Make sure your hands are clean and dry before touching the orodispersible film, so the film does not stick to your fingers
Follow the simple steps below to make sure you are taking your Emylif® correctly.1

Open the foil sachet

Fold the foil sachet along the solid line at the top as shown

While keeping the top of the sachet folded over at the solid line, tear down at the slit along the arrow on the side of the sachet to open
Follow the simple steps below to make sure you are taking your Emylif® correctly.1

Remove the film

Remove the film from the foil sachet, being careful not to fold the film
Follow the simple steps below to make sure you are taking your Emylif® correctly.1

Place the film on your tongue

Place the film on top of your tongue. The film will stick to your tongue and start to dissolve
Follow the simple steps below to make sure you are taking your Emylif® correctly.1

Wait for the film to dissolve

Close your mouth and swallow saliva normally while the film dissolves

Avoid pressing your tongue to the roof of your mouth while the film dissolves

While the film dissolves, do not chew, spit or talk

The film will dissolve within 3 minutes
Follow the simple steps below to make sure you are taking your Emylif® correctly.1

Wash your hands

After taking the
Orodispersible Film
wash your hands
When handling Emylif® orodispersible films1

Wash your hands before and after handling Emylif® orodispersible films

Do not fold the film

Do not use Emylif® if expired

Storing Emylif® orodispersible films1

Store Emylif® orodispersible films at below 30°C

Keep Emylif® orodispersible films in the foil sachet until you are ready to use. Use right away after opening foil sachet

As for all medicines, keep Emylif® orodispersible films out of the reach of children.

References

  1. Emylif® 50 mg orodispersible film. Patient Information Leaflet, June 2023. Available at:
    https://www.medicines.org.uk/emc/product/14754/pil (Accessed May 2024).

May 2024 | UK-EMY-CNS-2400010

Riluzole is the only licenced therapy for amyotrophic lateral sclerosis (ALS) in the UK.1,2

ALS is a type of motor neurone disease where nerve cells that control muscle movement are attacked, causing weakness, muscle wasting and paralysis.3

References

  1. NICE. Guidance on the use of riluzole (Rilutek) for the treatment of motor neurone disease (TA20). Available at: https://www.nice.org.uk/guidance/ta20 (Accessed May 2024).

  2. Masrori P, Van Damme P. Amyotrophic lateral sclerosis: a clinical review. Eur J Neurol. 2020;27(10):1918–1929.

  3. Emylif® 50 mg orodispersible film. Patient Information Leaflet, June 2023. Available at:
    https://www.medicines.org.uk/emc/product/14754/pil (Accessed May 2024).

  4. Andrews JA, et al. Real-world evidence of riluzole effectiveness in treating amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2020;21(7–8):509–518.

  5. Fang T, et al. Stage at which riluzole treatment prolongs survival in patients with amyotrophic lateral sclerosis:
    a retrospective analysis of data from a dose-ranging study. Lancet Neurol. 2018;17(5):416–422.

  6. ALS Association. Adjusting to swallowing changes and nutritional management in ALS. Availabe at:
    https://www.als.org/sites/default/files/2020-04/lwals_08_2017.pdf (Accessed May 2024).

How does riluzole work?

The cause of ALS is not fully understood, but it is believed that the destruction of nerve cells in ALS may be caused by too much of a chemical messenger called glutamate in the brain and spinal cord.3

The way that riluzole works is unclear. However, it is understood that riluzole stops the release of glutamate, and this may help to prevent the nerve cells being damaged.3

What are the benefits of riluzole?

Riluzole is often prescribed as soon as someone has been diagnosed with ALS, and many studies have looked into its effects.4,5

Studies have shown that riluzole can slow down the progression of the disease and increase patient survival.4,5

How effective is riluzole?

Clinical trials have shown that riluzole can provide benefits throughout the progression of ALS and increase patient survival by 3 to 6 months on average.4

A recent review of several studies involving patients who were prescribed riluzole showed that riluzole increased patient survival by 6 to 19 months on average.4

Therefore, as soon as a patient is diagnosed doctors will often prescribe a continuous course of riluzole treatment.
Taking riluzole can be challenging for some people with ALS
The symptoms of ALS can include difficulties with swallowing, also known as dysphagia, and over time some patients may need to consider different ways of taking their medicine.
Signs to watch out for
As ALS progresses, subtle changes can be signs that someone could be developing difficulty swallowing. People with ALS might learn to adapt, but these are signs to look for and talk to their care team about:6

Taking smaller bites or sips

Shortness of breath while eating

Longer mealtimes

Signs to watch out for
As ALS progresses, subtle changes can be signs that someone could be developing difficulty swallowing. People with ALS might learn to adapt, but these are signs to look for and talk to their care team about:6

Frequent coughing or choking on food while swallowing

Weight loss

A gurgling-sounding voice after swallowing

References

  1. NICE. Guidance on the use of riluzole (Rilutek) for the treatment of motor neurone disease (TA20). Available at: https://www.nice.org.uk/guidance/ta20 (Accessed May 2024).

  2. Masrori P, Van Damme P. Amyotrophic lateral sclerosis: a clinical review. Eur J Neurol. 2020;27(10):1918–1929.

  3. Emylif® 50 mg orodispersible film. Patient Information Leaflet, June 2023. Available at:
    https://www.medicines.org.uk/emc/product/14754/pil (Accessed May 2024).

  4. Andrews JA, et al. Real-world evidence of riluzole effectiveness in treating amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2020;21(7–8):509–518.

  5. Fang T, et al. Stage at which riluzole treatment prolongs survival in patients with amyotrophic lateral sclerosis:
    a retrospective analysis of data from a dose-ranging study. Lancet Neurol. 2018;17(5):416–422.

  6. ALS Association. Adjusting to swallowing changes and nutritional management in ALS. Availabe at:
    https://www.als.org/sites/default/files/2020-04/lwals_08_2017.pdf (Accessed May 2024).

May 2024 | UK-EMY-CNS-2400011

These Frequently Asked Questions (FAQs) about Emylif® orodispersible films give you helpful and concise answers while offering links to additional information.

Be sure to talk to your doctor about all diagnosis, medical advice, treatment decisions, or any concerns you may have with Emylif® orodispersible films.

The information provided here is general in nature and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. You are strongly encouraged to seek the advice of your doctor with any questions regarding your medical condition.

References

  1. Emylif® 50 mg orodispersible film. Patient Information Leaflet, June 2023. Available at:
    https://www.medicines.org.uk/emc/product/14754/pil (Accessed May 2024).

  2. Emylif® (riluzole 50 mg orodispersible film) Summary of Product Characteristics, April 2023. Available at:
    https://www.medicines.org.uk/emc/product/14754/smpc (Accessed May 2024).

about Emylif® orodispersible films

How is Emylif® orodispersible film different from other riluzole medication?

Emylif® orodispersible film is the first and only oral film of riluzole. It is designed to help people with ALS including those who may have difficulty swallowing some forms of medications.

How do I take Emylif® orodispersible film?

The Emylif® orodispersible film is placed on the top of the tongue where it begins to dissolve. As you swallow saliva normally, you receive 50 mg of riluzole. Emylif® orodispersible film dissolves within 3 minutes and is taken twice a day. It is taken without liquid or food.1 You can find administration information in the ‘How to take Emylif’ section. You will also find instructions in the Package Leaflet.

about taking Emylif® orodispersible film

How often do I take Emylif® orodispersible film?

Your doctor will prescribe when and how often to take Emylif® orodispersible film. The recommended dose is a single 50 mg oral film taken twice a day.2

What should I tell my doctor before taking Emylif® orodispersible film?

Before using Emylif® orodispersible film, you should tell your doctor about all the medications you take and all your health conditions, including if you have liver problems. You should also let your doctor know if you are pregnant or intend to become pregnant; or, if you are breastfeeding or intend to breastfeed during your treatment.2

about taking Emylif® orodispersible film

Are there special instructions for handling Emylif® orodispersible films?

Make sure to store Emylif® orodispersible film pouches at below 30°C. You should also read the Package Leaflet to find out how to handle Emylif® orodispersible film when taking it.1

Can I take Emylif® orodispersible film with other medication?

You should talk to your doctor about all medications you take before taking Emylif® orodispersible film.

Emylif® orodispersible films may affect the activities of certain types of drugs known as CYP1A2 inhibitors or inducers. Also, taking Emylif® orodispersible films with other drugs that may cause liver problems may make these problems worse.2

about getting Emylif® orodispersible film

How will I receive my prescription of Emylif® orodispersible films?

Your doctor will complete a prescription for Emylif® orodispersible films, which you can use to obtain your treatment from your local or hospital pharmacist.

Resources

MNDA:
The Motor Neurone Disease Association focuses on improving access to care, research and campaigning for those people living with or affected by motor neurone disease in England, Wales and Northern Ireland.
https://www.mndassociation.org/

NHS:
Read more about MND on the NHS website.
https://www.nhs.uk/conditions/motor-neurone-disease/

Healthtalk:
Video interviews with MND patients and their carers, detailing their experiences of all aspects of the condition.
https://healthtalk.org/introduction/motor-neurone-disease-mnd/

Find out about the experiences of families living with inherited forms of motor neurone disease (MND).
https://healthtalk.org/introduction/inherited-motor-neurone-disease-mnd/

HerALS:
Young women revolutionizing how to end ALS.
https://heralsstory.org/about-has

References

  1. Emylif® 50 mg orodispersible film. Patient Information Leaflet, June 2023. Available at:
    https://www.medicines.org.uk/emc/product/14754/pil (Accessed May 2024).

  2. Emylif® (riluzole 50 mg orodispersible film) Summary of Product Characteristics, April 2023. Available at:
    https://www.medicines.org.uk/emc/product/14754/smpc (Accessed May 2024).