Ketas (ibudilast)
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You can access this medicine even if it's not approved in your country. Learn how.
Ketas (ibudilast) is a medication used for the treatment of bronchial asthma and for cerebrovascular (brain and blood vessel) disorders.
Ibudilast has received orphan drug status for the treatment of patients affected by amyotrophic lateral sclerosis (ALS) by EMA and FDA.
For this product the estimated delivery time is usually between 10 and 20 working days.
Disease Indications
Amyotrophic Lateral Sclerosis (ALS), Cerebral Infarction
Manufacturer
Kyorin Pharmaceuticals Co
Usage
Oral
Medicine approved by
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Pharmaceuticals and Medical Devices Agency (PMDA)
Patients helped
- Over 1.2 million patients reached
- More than 11,000 patients helped
- 100% successful deliveries to 88 countries
We can help with your import documents
We are experts in import regulations. Scroll below to download the import guide for your country.
FREQUENTLY ASKED QUESTIONS
We help you access approved medicines that are not approved or available in your country of residence.
Legal
Finances
Payment
- Your permanent residence is outside the European Union
- You take the medicines with you, unused within 90 days after purchase
- You have a full original receipt (which we provide you)
Unfortunately, we are unable to help with VAT refunds following delivery or collection from our partner pharmacies outside of the Netherlands.
- If you are residing within the European Union and you are not a company
- If you are coming to Amsterdam, Luxembourg or Dusseldorf to pick up your order
In case of pick up, you may be eligible for a VAT tax refund if you live outside the European Union.
Price
Reimbursement
- That you want to import an approved medicine from abroad
- The lack of reasonable treatment options available in your country (if you can, include a letter from a doctor confirming this) - no alternative to the treatment.
- That the medicine has already been approved in another country (state the name of the country)
- That your treating doctor states that this medicine is the best option for you (include a copy of the prescription in the letter to the healthcare insurance company)
Ordering and shipping
Ordering
- Name of the patient
- Contact details of patient(email and phone number)
- Copy of patient’s ID
- Contact details of the Doctor (name, address, email and phone number)
- Shipping address
- Copy of the doctor's prescription
Shipping: We can deliver to the patient's residence, a pharmacy, or doctor's office / hospital, but this depends on the country. If you’re not sure what the right choice is for you, please get in touch with our Patient Support Team and we can help you work out your exact requirements.
Once we have received this information, one of our Patient Support Team members will then check your prescription and contact you to follow up on your order. Please note that other documents may be needed for import, we will guide you through the ordering process.
Generally not, but we do provide you with an invoice after you make the payment that you may send to your medical insurance company so they can reimburse you. In some limited circumstances, we do accept insurance. Contact us for more details.
As part of our protocols we might reach out to your treating doctor for verification or information updates. By sending us your prescription you allow us to do so.
- Patient's name and date of birth
- Name of the medicine and dosage
- Required quantity
- Doctor's name and signature
- Doctor's registration number and/or stamp
Ideally, the prescription should be issued in English. Alternatively, a translation (unofficial is sufficient) must be provided.
Please be aware that your doctor may be contacted by one of our team members or by the processing pharmacy in order to verify the prescription.
Shipping
Please be aware that due to the COVID-19 situation worldwide and the country lockdowns, we will sometimes experience delays in shipping.
For EMA approved medicines with prescriptions from within the Schengen zone, you can pick the medicines up from our partner pharmacy in Amsterdam, Luxembourg or Dusseldorf. For non-EMA approved medicines, with prescriptions from within the Schengen zone, you can pick the medicines up in our partner pharmacy in Dusseldorf. If you have requested to collect your medicines, you will receive a notification when the medicines are in the pharmacy and ready for you.
There are also options to deliver the medicines to other countries. Please get in touch with our Patient Support Team to discuss which other pick-up and delivery options may be suitable for you.
- Copy of the ID/passport of the patient
- Copy of the ID/passport of the person who is coming to pick up the medicines
- Letter signed by the patient stating that he/she authorises this person to pick up the medicines on his/her behalf
- Step 1 - Customs may need to check the package to verify its contents. In order to streamline this step, we include a letter for customs with information about the contents. Any additional questions will be answered by TheSocialMedwork as and when we are contacted by customs.
- Step 2 - In some countries, there are additional questions from the medical regulatory agencies (i.e. the FDA, EMA, etc). We provide them with all the necessary information based on the information provided by the patient, such as: the prescription, copy of ID and a letter from the treating doctor to show that the medicines are for personal use.
- Step 3 - Customs fees. In some cases, the recipient will be requested to pay taxes and duties. These should be arranged by the patient or receiver and are not covered by TheSocialMedwork unless stated otherwise.
Please be aware that the import of the medicines always requires customs clearance and active cooperation from the importing party. We will help and guide you but are dependent on your cooperation and responsiveness.
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Medicine approval
The respective national and regional agencies, such as the Food and Drugs Administration (FDA) in the USA or the European Medical Authority (EMA) for the European Union assess these applications and make a decision on whether to approve new medicines. The review process is based on evaluation of the evidence provided by the company. Every agency uses a slightly different process.
- Phase I - performed in a small number of healthy volunteers or very sick patients with lack of treatment options, designed to study the effects of the medicine in the human body.
- Phase II - larger number of patients, designed to evaluate the safety and efficacy of the medicine and to determine if different dosages of the treatment have different effects.
- Phase III - large number of patient groups, designed to confirm the safety and efficacy of the medicine.
- Phase IV - after the medicine has received regulatory approval, designed to evaluate the long-term effects.
Updates
Ketas (ibudilast)
Package
Capsules
Where can we deliver?
We have delivered medicines to more than 88 countries. Check if we have sent medicines to yours.
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PICK-UP IN PERSON FROM A PARTNER PHARMACY
We can arrange for you to pick up this medicine from our partner pharmacy in Luxembourg. Read more.
Pick-up from Luxembourg.
Depending on your particular circumstance, this option can be cheaper and require less paperwork than direct delivery. You can ask someone else to pick up the medicine on your behalf.
In some cases, medicines can be picked up from partner pharmacies in Amsterdam (the Netherlands) or Dusseldorf (Germany).
Tell our Patient Support Team if you’re interested in pick-up options for your order.
Our Patient Support Team will personally assist you along the way
Dr. Akshi Sudan
Patient Support Team Lead
Daniela Figueira, PharmaD
Patient Support Agent
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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 dizziness.1
It is available in capsule form, each containing 10 mg ibudilast.
Ibudilast has received orphan drug status for the treatment of patients affected by amyotrophic lateral sclerosis (ALS) by EMA and FDA.2,3
Who is Ketas (ibudilast) for?
Ketas (ibudilast) is approved for patients who have bronchial asthma or cerebrovascular disorders, dizziness after strokes in particular.1
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 patients.1
Ketas (ibudilast) doesn’t stop asthmatic attacks immediately if the patient is already having an asthmatic attack.1 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 doctor.1
Since 2016 the active ingredient ibudilast has the EMA and FDA3 orphan drug status for the treatment of patients affected by amyotrophic lateral sclerosis (ALS).2 The ongoing clinical trial name of the drug is MN-166.
Note: This means the medicine has not yet 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 regions.4,5
How does Ketas (ibudilast) work?
Ketas (ibudilast) is a phosphodiesterase (PDE) inhibitor.1 It stops the action of enzymes known as phosphodiesterase enzymes.1
It has the following actions: 1
- Bronchodilatory (increased airways to the lungs)
- Vasodilatory (widening of blood vessels)
- Neuroprotective (protection of parts of the brain)
- Anti-inflammatory.
According to the EMA orphan drug designation, the exact way ibudilast works in ALS is unclear but it is assumed that 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 ALS.2
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, 20162 and by the Food and Drug Administration (FDA), USA, on June 10, 2016.3
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.4,5
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.
Please be aware that any decision to use a prescription generic or brand name medicine should always be taken in consultation with a medical professional. The FDA has sent warning letters to drugmakers in India or Pakistan concerning the quality of their medicines.
How is Ketas (ibudilast) taken?
The standard dosage is:1
- For patients with bronchial asthma, 10 mg ibudilast twice daily1
- For patients with cerebrovascular disorders, 10mg of ibudilast three times daily1The dosage may be adjusted according to the patient’s symptoms.1
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 below.4
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 include:1
- 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 patients.1>
Ketas (ibudilast) is not recommended for use in pregnant women or women who are breastfeeding.1
The safety of this product in children has not yet been tested.1
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.1
References
1. Summary of Product Characteristics [PMDA]: Ketas (ibudilast)[PDF] (Japanese)
Kyorin Pharmaceutical Co., Ltd, 2006
2. EMA Orphan Designation: ibudilast.
www.EMA.europa.eu, 12/12/2016.
3. Orphan Designation: ibudilast.
www.accessdata.fda.gov, 10/06/2016.
4. Orphan Designation
www.ema.europa.eu, cited on 15/06/2018.
5. Designating an Orphan Drug
www.fda.gov, cited on 15/06/2018.
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 study.1
In this study, this product or a placebo was given to patients for 8 weeks after an initial observation period of 4 weeks.1 During the observation period, placebo was given and patients with poor compliance or who didn’t have any symptoms were removed from the study.1
Results
The main outcome measured was improvement of dizziness.1 Ketas (ibudilast) saw better results than placebo within the measured outcome.1
The improvement rate of dizziness was:1
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50.0% (47/94) for Ibudilast
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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.
References
1. Summary of Product Characteristics [PMDA]: Ketas (ibudilast) [PDF],
Kyorin Pharmaceutical Co., Ltd, May 2013
2. MediciNova Announces Additional Analyses from Completed Clinical Trial of MN-166 (ibudilast) in ALS Presented at the 30th International Symposium on ALS/MND in Perth, Australia
Press release, Dec. 2019
Ketas (ibudilast) price in other currencies*
| Package | Euro | Argentine peso | Chilean peso | Colombian peso | Mexican peso | Peruvian sol |
|---|---|---|---|---|---|---|
| 1000 capsules of 10 mg | 504 EUR | 66058 ARS | 490845 CLP | 2213243 COP | 10664 MXN | 2014 PEN |
| 2100 capsules of 10 mg | 868 EUR | 113700 ARS | 844852 CLP | 3809480 COP | 18355 MXN | 3467 PEN |
*The prices listed above are based on the cheapest package size and strength TheSocialMedwork has access to. Please make an enquiry for more specific pricing. The prices listed above are a guide only, we operate in Euros.
Ketas (ibudilast) treatment costs
The cost for a monthly or yearly treatment of Ketas (ibudilast) depends on your prescription requirements which includes the dosage in mg and medicine type (Capsules).
The price of the medicines you see on sale is the cost set by the manufacturer. In addition, shipping costs and a Named Patient support fee will apply.
Make an enquiry and we will help you calculate the total price to buy Ketas (ibudilast) online and have it delivered where you live. From your side, we’ll simply need a prescription from your treating doctor. In some countries we might also need an import license. Our Patient Support team will guide you throughout the process.
Ketas (ibudilast) price and additional costs
The price of Ketas (ibudilast)
The base cost of each medicine is set by the manufacturer. Generally, our Named Patient support fee, shipping costs and any local tax (if applicable) are not included in the product price that is displayed on our website unless stated otherwise.
Our Named Patient support fee
TheSocialMedwork provides access to Ketas (ibudilast) on the Named Patient import basis, which means that we work on behalf of the patient in cooperation with their treating doctor. Our Named Patient support fee covers sourcing, logistics and following up to make sure that the order is received safely and in perfect condition. The Named Patient support fee is tiered relative to the cost of the medicine.
Shipping costs
The shipping prices are dependent on the type of shipping necessary for the particular medicine (regular or cold chain) and upon the destination country. The shipping fees may include the shipping from our supplier to our partner pharmacy as well as the shipping costs to deliver the medicine to the patient’s country of residence. The shipping fee might also include the cost of special packaging, such as coolboxes, cool packs and data loggers, as well as transport insurance to guarantee that you receive your medicine in good order.
You can read a detailed overview of prices and costs here.
Payment methods when you buy Ketas (ibudilast)
When you buy Ketas (ibudilast), you can make the payment by bank transfer or by credit card. Payments are fully encrypted and secure. When paying by credit card, you can pay online once you have received your order confirmation. Please be aware that a 2.8% fee applies when paying by credit card.
Ketas (ibudilast) reimbursement
It might be possible for you to claim the cost of Ketas (ibudilast) via your country's healthcare system. Some countries have a government fund providing financial assistance for citizens to access lifesaving medical treatment abroad. The best thing would be to check with your country's own health ministry. We also highly recommend checking out local patient blogs, communities and patient organisations to find out more about your options.
Medical insurance
Generally, we do not support medical insurance, but we do provide you with an invoice after you make the payment that you may send to your medical insurance company so they can reimburse you. In some limited circumstances, we do accept insurance. Contact us for more details. You can pay by bank transfer or credit card.
Crowdfunding
Crowdfunding might also be an option for you. It is a means of raising funds by using an online platform to group together many small donations from friends, family and others, in order to help you afford medical treatment. Here are some crowdfunding platforms where you can seek support: GoFundMe, GiveForward, FundRazr and Watsi.
Room temperature shipping
For this medication, standard shipping applies. This means that a consistent room temperature of 15 to 25°C is maintained during transit.
Your order will be shipped to you by our partner couriers, such as DHL, UPS and specialised cold chain couriers. If you would like your order to be shipped by a specific courier, please inform us when you place the order.
Our standard delivery time varies from 5 to 10 working days.
The shipping cost depends on the medicine and the destination country. After making an enquiry, you will receive a detailed quote that includes the shipping costs.
You can also pick up your medicine from our partner pharmacy in Amsterdam or our partner pharmacy in Luxembourg after the order has been paid for.
Four steps to access the medicines you need
How and where to access and buy Ketas: You can access Ketas from TheSocialMedwork if the drug has not been approved or is not available in your country.
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Step 1
You send a request for your medicine online
Submit a request for a specific medicine, or a general request, and your Patient Support Manager will contact you within 24 hours. They will be there to support and guide you in anyway possible to help you get the medicine you need.
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Step 2
We verify your prescription and medical details
Since we help patients access medicines not available in their home country, our first step is to check that the medicine you need is not currently available in your home country. Next we will also verify that you have a prescription from a doctor in your home country for the medicine you need.
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Step 3
We source your medicine
Once we have verified your prescription and medical details, our expert sourcing team will work with our global network of suppliers to find you the best price. Once we have found you the lowest possible cost for your medicine, we will present you with a final offer for your approval.
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Step 4
We deliver your medicine
After you have accepted our offer, our experienced logistics team will arrange all the shipping and transportation of your medicine. We will work hard to keep you informed at every step along the way and get your medicine to you quickly and safely. To date we have successfully delivered packages to over 75 countries around the world.
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Disclaimer
Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.
