Ketas (ibudilast)

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Ketas (ibudilast)

Ketas (ibudilast) is a medication used for the treatment of bronchial asthma and for cerebrovascular (brain and blood vessel) disorders.

How to buy Ketas (ibudilast): You can order Ketas (ibudilast) from TheSocialMedwork if the drug has not been approved or is not available in your country. 

For this product the estimated delivery time is usually between 10 and 20 working days.

Neurology Amyotrophic Lateral Sclerosis (ALS), Cerebral Infarction
Marketing Authorisation Holder Kyorin Pharmaceuticals Co
Mode of Action Phosphodiesterase inhibitor
Administration Oral
Regulatory agency approval Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Strength 10 milligram

What is Ketas (ibudilast)?

Ketas (ibudilast) is a phosphodiesterase inhibitor for the treatment of bronchial asthma and for cerebrovascular (brain and blood vessel) disorders, particularly the improvement of post-stroke dizziness1.

Who is Ketas (ibudilast) for?

Ketas (ibudilast) is for patients who have bronchial asthma or cerebrovascular disorders, dizziness after strokes in particular1.

Since 2016 the active ingredient ibudilast has the EMA orphan drug status for the treatment of patients affected by amyotrophic lateral sclerosis (ALS)2.

Note: This means the medicine has not been approved by the EMA or the FDA but due to the seriousness of the condition; the lack of alternatives for diagnosis, prevention or treatment; or the rarity of the condition, the medicine is treated with special care by the regulatory agencies of these regions4,5.

Ketas (ibudilast) should be taken with care in: patients who are in the acute phase of cerebral infarction (i.e. if they have had a sudden onset of the disease); patients with impaired hepatic (liver) function; and elderly patients1.

Ketas (ibudilast) doesn’t stop asthmatic attacks immediately if the patient is already having an asthmatic attack1. Patients who are also using steroids as part of their long-term treatment for asthma should only decrease the use of steroids slowly and under the supervision of their doctor1.

How does Ketas (ibudilast) work?

Ketas (ibudilast) is a phosphodiesterase (PDE) inhibitor1. It stops the action of enzymes known as phosphodiesterase enzymes1.

It has the following actions1:

  • bronchodilatory (increased airways to the lungs)

  • vasodilatory (widening of blood vessels)

  • neuroprotective (protection of parts of the brain)

  • anti-inflammatory.

The exact way ibudilast works in ALS is unclear but it blocks phosphodiesterases (PDEs) and a substance called macrophage migration inhibiting factor (MIF), which are involved in regulating certain functions of brain cells. By blocking MIF and PDEs, the medicine is expected to slow down the production of inflammatory molecules and to increase production of ‘protective’ molecules. In addition, ibudilast reduces activity of glial cells (a type of brain cell thought to be involved in the development of ALS). Together, these actions are expected to work on the symptoms of ALS2.

Where has Ketas (ibudilast) been approved?

Ketas (ibudilast) was approved for the treatment of patients with bronchial asthma and cerebrovascular disorders by:

  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan, May 19891

Ibudilast was granted orphan drug designation for the treatment of amyotrophic lateral sclerosis (ALS) by the European Medical Agency (EMA), European Union, on December 12, 20172 and by the Food and Drug Administration (FDA), USA, on June 10, 20163.

Note: This means the medicine has not been approved by the EMA or the FDA but due to the seriousness of the condition, the lack of alternatives for diagnosis, prevention or treatment or the rarity of the condition, the medicine is treated with special care by the regulatory agencies4,5.

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Ketas (ibudilast) taken?

The standard dosage is1:

  • For patients with bronchial asthma, 10mg ibudilast twice daily1.

  • For patients with cerebrovascular disorders, 10mg of ibudilast three times daily1. The dosage may be adjusted according to the patient’s symptoms1.


Warning: In the case of cerebral infarction, periods during which Ketas (ibudilast) is given should be decided carefully, taking into account how effective it is, as well as adverse reactions. If the expected effects of the medicine are not observed after 12 weeks of taking it, the medicine should be discontinued.

Complete information about Ketas (ibudilast) dosage and administration can be found in the official prescribing information listed in our resources section1.


Note: Please consult with your treating doctor for personalised dosing.

Are there any known side effects or adverse reactions of Ketas (ibudilast)?

Common adverse reactions

The most common adverse reactions listed in the prescribing information include:1

  • rash

  • dizziness

  • headache

  • anorexia

  • nausea (feeling sick)

  • vomiting

  • abdominal pain

  • elevation of liver enzymes (AST(GOT), ALT(GPT), ALP, γ -GTP)

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include1:

  • thrombocytopenia (low blood cell count)

  • hepatic dysfunction

  • jaundice

Use in specific populations

Ketas (ibudilast) is metabolised mainly by the liver.1 Because there is a possibility of high blood concentration in elderly patients, who often have liver hypofunction (reduced, low or inadequate function), this medicine should be given with caution and special attention to elderly patients1.


Ketas (ibudilast) is not recommended for use in pregnant women or women who are breastfeeding1.

The safety of this product in children has not yet been tested1.

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information1.

More Information
Working ingredient ibudilast
Shipping method Controlled room temperature (temperature controlled)
Therapeutic Area Neurology
Neurology Amyotrophic Lateral Sclerosis (ALS), Cerebral Infarction
Indication Amyotrophic Lateral Sclerosis (ALS)
Indication Cerebrovascular disorders
Administration Oral
Mode of Action Phosphodiesterase inhibitor
Regulatory agency approval Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Marketing Authorisation Holder Kyorin Pharmaceuticals Co

Cerebrovascular disorders

The Pharmaceuticals and Medical Devices Agency (PMDA), Japan, approvals of Ketas (ibudilast) for cerebrovascular disorders, in particular improvement of dizziness for patients with sequelae of cerebral infarction, was based on a double-blind clinical study1.

In this study, this product or a placebo was given to patients for 8 weeks after an initial observation period of 4 weeks1. During the observation period, placebo was given and patients with poor compliance or who didn’t have any symptoms were removed from the study1.

Results

The main outcome measured was improvement of dizziness1. Ketas (ibudilast) saw better results than placebo within the measured outcome1.


The improvement rate of dizziness was1:

  • 50.0% (47/94) for Ibudilast

  • 18.7% (20/107) for placebo.


Bronchial asthma

The Pharmaceuticals and Medical Devices Agency (PMDA), Japan, approvals of Ketas (ibudilast) for bronchial asthma was based on clinical studies including a double-blind study1.

Results

The efficacy outcome measured was improvement rate: from moderate to marked, and slight to marked1. The double-blind clinical study demonstrated that Ketas (ibudilast) is effective to treat bronchial asthma1.

The improvement rate (%) was1:

  • Atopy

    • 44.3% moderate to marked
    • 78.4% slight to marked
  • Mixed
    • 39.6% moderate to marked
    • 71.4% moderate to marked
  • Infective
    • 40.7% moderate to marked
    • 67.8% slight to marked
  • Total
    • 41.4% moderate to marked
    • 73.4% slight to marked


ALS

The effects of ibudilast on ALS patients have been evaluated in experimental models2. Clinical trials were ongoing at the time the orphan designation was granted2.


  1. Summary of Product Characteristics [PMDA]: Ketas (ibudilast) [PDF],
    Kyorin Pharmaceutical Co., Ltd, May 2013

  2. EMA Orphan Designation: ibudilast.
    www.EMA.europa.eu, 12/12/2016.

  3. FDA. Orphan Designation: ibudilast.
    www.accessdata.fda.gov, 10/06/2016.

  4. EMA. Orphan Designation,
    www.ema.europa.eu, cited on 15/06/2018.

  5. FDA. Designating an Orphan Drug,
    www.fda.gov, cited on 15/06/2018.

Shipping Type Standard
Shipping method Controlled room temperature (temperature controlled)
This content has been reviewed by our medical doctor Jan de Witt.

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