What is ALS?

Amyotrophic lateral sclerosis (ALS) is a rapidly progressing neurological (nervous system) disease. Sometimes called Lou Gehrig's disease, ALS belongs to a group of disorders known as motor neuron diseases.

ALS attacks nerve cells, called motor neurons, that control voluntary muscles (the muscles we are able to control). This leads to progressive weakness and disability. When these cells die, voluntary muscle control and movement are lost. People with ALS eventually lose their strength, ability to move their arms, legs, and body, and the ability to breathe on their own. In most cases, their minds remain sharp and alert.

The average life expectancy for people with ALS is 2 to 5 years. However, ALS is a variable disease that progresses at different rates for different people.

If you think you or your loved one has ALS, or you have already been diagnosed with ALS, it is important to talk to your healthcare provider (HCP) and ask about your treatment options as soon as possible.

Who gets ALS?

While ALS is a rare disease, it is one of the most common neuromuscular conditions. Sometimes ALS is inherited, but in most cases, there is no known cause. ALS is not contagious.

ALS more commonly affects white men, non-Hispanics, and people aged 60 to 69. But younger and older people can develop ALS. Men are more likely to develop ALS than women.

The ALS Association reports that:

  • 6000 people per year are diagnosed with ALS in the US
  • 20,000 people in the US may currently have ALS
  • 5% to 10% of ALS cases are inherited
  • 90% to 95% of ALS cases have no clearly associated risk factors and their family members are not at increased risk for developing it

What are the symptoms of ALS?

Not all people experience the same symptoms or progression with ALS. Some early signs and symptoms of ALS include:

  • Difficulty walking or doing normal daily activities
  • Tripping, falling, and dropping things
  • Abnormal weakness or tiredness in your arms, legs, feet, or ankles
  • Hand weakness or clumsiness
  • Slurred speech or trouble swallowing
  • Muscle cramps and twitches in your arms, shoulders, and tongue
  • Difficulty holding your head up or keeping good posture

How is ALS treated?

There is currently no cure for ALS. However, there are many medications that are used to help relieve symptoms, such as muscle cramps and fatigue, although they are not indicated to treat the disease. There are also 2 prescription medications that are FDA-approved for the treatment of ALS:

  • Riluzole (also known as Rilutek®) was approved in 1995
  • Radicava® (edaravone) was approved in 2017

In clinical trials, Radicava® was shown to slow decline in the loss of functional ability in people with ALS (learn more). Radicava® may be received on its own or along with riluzole.

Managing ALS takes a multidisciplinary approach, which allows people with ALS to receive care from professionals with different areas of expertise. If you think you have ALS, talk to your HCP today. He or she will assess your condition and may refer you to an ALS clinic, where you can meet with many different medical experts during a single visit.

Also, be sure to ask your HCP about available treatments, such as Radicava®. Your HCP can help you decide which options are right for you.


Receiving a Diagnosis

Working with your healthcare provider

If you are experiencing early signs and symptoms or you think you may have ALS, it's important to talk to your healthcare provider (HCP) as soon as possible. Your HCP can help:

  • Assess your condition
  • Provide a proper diagnosis
  • Discuss appropriate treatment options

Receiving a diagnosis of ALS can be overwhelming. But getting an answer as early as you can may allow you to start treatment as soon as possible.

Assessing ALS progression

To assess the progression of ALS, your HCP may ask questions about your daily functioning and any problems with speech, swallowing, or breathing. One tool your HCP may use is the ALS Functional Rating Scale–Revised (ALSFRS-R). This scale was used in clinical trials to show that Radicava® was effective (learn more).

The ALSFRS-R measures the loss of functional ability in people with ALS. The scale consists of 12 items: speech, salivation, swallowing, handwriting, cutting food, dressing and hygiene, turning in bed, walking, climbing stairs, dyspnea (difficulty breathing or shortness of breath), orthopnea (trouble breathing when lying down), and respiratory insufficiency.

Each item of the ALSFRS-R is scored between 4 and 0. Higher scores represent greater functional ability. A maximum total score is 48 and the minimum total score is 0.

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

Important Safety Information

Before you receive Radicava® (edaravone), tell your healthcare provider about all of your medical conditions, including if you:

  • have asthma.
  • are allergic to other medicines.
  • are pregnant or plan to become pregnant. It is not known if Radicava® will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Radicava® passes into your breastmilk. You and your healthcare provider should decide if you will receive Radicava® or breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of Radicava®?

  • Radicava® may cause serious side effects, including hypersensitivity (allergic) reactions and sulfite allergic reactions.
  • Hypersensitivity reactions have happened in people receiving Radicava® and can happen after your infusion is finished.
  • Radicava® contains sodium bisulfite, a sulfite that may cause a type of allergic reaction that can be serious and life-threatening. Sodium bisulfite can also cause less severe asthma episodes in certain people. Sulfite sensitivity can happen more often in people who have asthma than in people who do not have asthma.
  • Tell your healthcare provider right away or go to the nearest emergency room if you have any of the following symptoms: hives; swelling of the lips, tongue, or face; fainting; breathing problems; wheezing; trouble swallowing; dizziness; itching; or an asthma attack (in people with asthma).
  • Your healthcare provider will monitor you during treatment to watch for signs and symptoms of all the serious side effects.

The most common side effects of Radicava® include bruising (contusion), problems walking (gait disturbance), and headache.

These are not all the possible side effects of Radicava®. Call your healthcare provider for medical advice about side effects. You may report side effects to Mitsubishi Tanabe Pharma America, Inc. at 1-888-292-0058 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Indication

Radicava® is indicated for the treatment of amyotrophic lateral sclerosis (ALS).

Please see full Prescribing Information and Patient Information.