Ketas (ibudilast)

Q: 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

Q: 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.

We can help with your prescription. Read the “Prescription Guide”.

You can access this medicine even if it's not approved in your country. Learn how.

Price Frequently Asked Questions Details Patient stories Import guides

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.

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Disease Indications

Amyotrophic Lateral Sclerosis (ALS), Cerebral Infarction

Manufacturer

Kyorin Pharmaceuticals Co

Usage

Oral

Medicine approved by

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

Is my personal information confidential?

Yes, TheSocialMedwork agrees to preserve the confidentiality of all customer and patient information and to not divulge this information in any form, except when authorised by the patient or required by law.

Where can I verify TheSocialMedwork's registration with the Dutch Ministry of Health?

TheSocialMedwork is registered with the Dutch Ministry of Health (registration number 6730 BEM) as an independent medicines intermediary. Our registration can be found here on Farmatec's website. Farmatec is the body within the Dutch Ministry of Health which is responsible for providing pharmaceutical permits, approvals, exemptions and registrations for medicines and medical devices in the Netherlands.If you follow the link you will see documents called “Overzicht geldige BEM-registraties XXXX” which translates to “Overview of valid BEM registrations XXXX” You can find The Social Medwork on page 2 of each of the documents.

Is TheSocialMedwork 100% safe and secure?

Yes. TheSocialMedwork is registered with the Dutch Ministry of Health as an independent medicines intermediary (registration number 6730 BEM). We always follow your country’s laws and regulations, and discuss the legal requirements with you. We only ship medicines when our patients have a prescription from their treating doctor.

What documents will I need to import a medicine?

You always need a prescription from a doctor based in your country. Other documents, such as an import license from the Ministry of Health, may be needed and depend on your country’s regulations. Contact usand we will provide you all the information about the required documents for your country.

Is it legal to import medicines from abroad?

Yes. Most countries have a Named Patient or Personal Import law or regulation which enables patients to import medicines from abroad that have not yet been approved in the patient’s country. This can only be done with a doctor's prescription and, depending on the country, some additional requirements. For more information, read our blog post here.

Finances

Payment

Why do I need to pay before receiving the medicine?

As we operate on the named patient import basis, every order is specifically processed for an individual patient for his/her personal use (only). Legally, neither we nor the supplier are allowed to hold stock of those medicines, instead we are obliged to source it on a case by case basis. We need to pay before we get the medicines, therefore we can only process your order after we receive your payment.

How can I be sure that I will receive the medicine?

We are a licensed company and have safely and legally delivered more than 9,000 medicines to 88 countries. You can read our patient reviews on Google, Facebook and we also have some of our Patient Stories on our blog. You can speak to us on the phone and personally visit our office. When you place an order with us, you will be informed of every step in the process. As soon as the medicines are shipped to you, you will receive an email with the detailed shipping information, so you can track your order.

How do I pay for the medicine?

After you place an order with us, you will receive an order confirmation with the payment details. Please make sure that you make the payment for the amount stated on the invoice in Euros (€). We accept bank transfers and online credit card payments (a 2.8% fee applies for credit card payments).

After I have received the order confirmation, how long is the quoted price valid for?

The price quoted on your order confirmation is valid for two weeks from the send date. If you do not pay within the two week time frame the prices may be subject to change. If you need more time, please let us know.

What payment methods do you offer?

Payments can be made by credit card or bank transfer. 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.

Can I pay in cash?

No. We only accept payments made by credit card or bank transfer. Payments are fully encrypted and secure.

Do I have to pay in Euros?

Yes. At this time we can only accept payment in Euros.

Will I receive proof of payment?

Yes, as soon as we see the payment is received in our bank account, you will receive a payment confirmation in the form of an invoice. This is also the confirmation that your order has been processed.

Can I pay when I pick up the medicines?

No. We can only process and find your order after having received your full payment. The medicines will not be sourced for you if you haven’t made the payment. You cannot pay in the pharmacy.

Why do I need to pay bank charges?

Your bank might calculate costs for the conversion of your currency to Euros. Please make sure you transfer the full amount of our fee as mentioned on our invoice and do not deduct the bank’s service charges.

Do I need to pay import taxes?

Import taxes might apply to shipping medicines to the destination country. Import taxes normally consist of import VAT and a fee that customs may charge. Since these are different per country (in some countries, the import taxes might even be exempt for pharmaceuticals) and per customs office we often cannot calculate them in advance. Import taxes must be paid by the receiver. They are not included in our invoice. You can contact your local customs office to find out if they apply import taxes and how they can be paid.

Am I eligible for a VAT refund?

Yes, we can help you to get a VAT refund if you collect your order from our partner pharmacy in the Netherlands and you meet the following conditions:

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.

Do I need to pay VAT in The Netherlands?

You need to pay Dutch VAT in two situations:

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.

How much VAT do I have to pay in The Netherlands?

If Dutch VAT applies, you will need to pay 9% on the medicine and 9% on services, such as on the Named Patient fee, shipping costs and pharmacy fee.

Price

How can I see how much a medicine costs?

The price of every medicine is listed on our website. Our Named Patient handling fee, shipping costs and any tax (if applicable) are not included in the product prices unless stated otherwise. Contact us and we will compile a quote which includes all of these costs and send that to you.

Why are the prices of the medicines so high?

The price is determined by the manufacturer. When a medicine is innovative and new, the price is usually high. Over time, the production levels may go up and the price may change, but most of our patients don't have the time to wait. Therefore we offer the medicines as soon as possible, for the lowest possible price we can negotiate.

Can I get a quote online?

No. Please contact us to receive a detailed quote. If you have questions about the medicine, such as strength, dosage, price, or any questions about our service, do not hesitate to ask.

How is the cost of each medicine determined?

The base cost of each medicine is set by the manufacturer. On top of that, we add a fee to cover the cost of our services, enabling us to continue functioning as a social enterprise. Profits will be reinvested into maintaining our high level of service, and expanding our medicines portfolio and partner network globally. We strive to cut out as many middle men as possible and always aim for the best price possible.

Reimbursement

Can I claim the cost of the medicine via my 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.

Will my health insurance cover the treatment?

In some cases, health insurance companies may partially or fully cover the cost of the medicine. We recommend checking this directly with your health insurance company.

What information should I provide to my health insurance company?

Each health insurance company has their own procedures for submitting a request or claim. However, as a starting point, we recommend writing a letter to them outlining the following:

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)

What is crowdfunding?

Crowdfunding 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, GiveFoward, FundRazr and Watsi,.

Ordering and shipping

Ordering

How can I order my medicines?

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.

Do you accept insurance?

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.

Why do I need a prescription?

It is important that your treating doctor is fully aware and supports your treatment. Your doctor needs to monitor the treatment for safety reasons. The prescription is the evidence that your treating doctor supports you. It is also legally required by customs for import, and for collection from the pharmacy.

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.

What information should the prescription contain?

The prescription should include:

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.

How far in advance should I place a new order?

The ordering procedure can take up to 3 weeks. In addition, you may need to apply for a new license or get a new prescription from your doctor. We advise you to contact us as early as possible to make sure your documents are valid. This is the only way that you can ensure that your treatment commences on time.

Can I cancel my order if I change my mind?

If you would like to cancel your order, please get in touch with our Patient Support team immediately. Generally, if you have already paid the invoice, the order has been processed by us and cannot be cancelled. We start sourcing the medicines as soon as we receive payment, and once the medicine has been ordered on behalf of the patient we cannot return the medicines. However, in some cases, there may be a delay in the sourcing process in which case we will have a small window for cancellations.

What happens if the payment is made after 14 days and the costs have changed?

As stated, the price quoted on your order confirmation is valid for two weeks from the send date. If you pay after this date and the prices have changed, you will be required to pay the price difference.

If I want to place another order, do I need a new prescription or a new import license?

This depends on the situation. In some cases the prescription is only valid for one order, while in others it can be used multiple times. This is only the case if it is a repeat prescription. In the case of import licenses, they vary from country to country, but they usually have an expiration date and a maximum number of medicine units that can be imported. Please confirm with a member of our Patient Support Team) when you place a new order.

Can I order as a company?

Yes. To place an order with us as a company, you need to provide us the company's license to import medicines from abroad.

Shipping

How does the shipping process work?

Once we have sourced your medicines, we can ship them to you. During the shipping process, your parcel is exported from its original country and imported into your country. We include all the necessary documents in the package. Different countries have different regulations for importing medicines, and we ensure that the documentation relevant for your country is included. When it comes to the actual import, we use our international knowledge, connections and experience in importing and sending prescription medication to process your order.

How long does it take to ship my medicines?

Delivery times vary from country to country and are also dependent on the medicines you order, and on custom clearance, but a rough guide would be 1-2 weeks. Once the medicines have been shipped, we will send you a tracking number and keep you informed about your delivery. For a more detailed estimate for your desired medicine, please get in touch with our Patient Support Team.

Please be aware that due to the COVID-19 situation worldwide and the country lockdowns, we will sometimes experience delays in shipping.

How can I track my order?

When your order is shipped to you, you will receive a tracking number and a link to track your shipment online. This will allow you to be able to track your order.

How will my order be shipped?

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.

What is a cold chain shipment?

Some medicines need to be stored between 2 and 8 degrees Celsius. These are called “temperature controlled medicines”. This means that their shipment needs to be via an unbroken cold chain. When delivering these medicines, we ensure the medicines are packed properly, in a special transport box which regulates the temperature for sufficient time to arrive safely at the destination.

Will I be contacted when my order is on its way?

You may be contacted by our courier partners before your order is delivered, for example to inform you about the delivery time. Your contact details are always included on the parcel.

Can I pick up my medicines?

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.

Can someone else pick up the medicines on my behalf?

Yes. You can authorise anyone to pick up the medicines on your behalf. In that case, you need to provide us the following documents:

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

Where is the pharmacy in Amsterdam located?

The Amsterdam pharmacy is located in Amsterdam Central Station, approximately 15 minutes from Schiphol Airport by train. You will receive the full pharmacy details when the medicines are ready for you. We will be happy to help you with advice for your stay in Amsterdam should you need it.

If I pick up my medicines, how will I take them home?

We will help package the medicines for travel. Please make sure you have the ability to take the medicines home safely. If the medicines require special transport conditions we will inform you in advance.

What if I pick up a medicine that needs to be transported in a temperature controlled way?

We will ensure the medicines are packed properly, in a special transportation box (at additional cost) that regulates the temperature for sufficient time. We will inform and instruct you on how to get your medicines home with the right temperature.

Can I take the medicines in my hand luggage?

Yes. We recommend you always keep the medicines with you in your hand luggage. We will provide a letter for your airline company stating that the medicine is for personal use and as it is delicate it needs to be transported carefully in the hand luggage (carry on luggage). We recommend that you contact the airline in advance to inform them.

How big will the parcel of medicines be?

The size of the parcel depends on the medicine and the number of boxes that you order. If you are collecting the medicines, we can inform you about the size of the parcel as soon as the parcel is ready to be picked up.

What happens if my medicines are held by customs?

Don’t worry, our team will be available to help you every step of the way to get the medicines released. There can be three steps to the clearings process:

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.

About us

How can I contact you?

There are a few ways you can reach us:

Complete the enquiry form on our Contact Us page
Send an email: [email protected]
Call us on:
- +31 20 808 4414 (EU)
- +1 646 381 0675 (US)
- +61 28 417 2910 (AUS)

We are also on Whatsapp, Telegram and WeChat. You can find us by adding this number: +31 61 553 5558.

Who is the TheSocialMedwork team?

Our team is made up of legal, logistical and patient support experts ready to help you access the latest approved medicines. Click here to meet the team.

Which languages do you speak?

Our operational language is English. However, we speak 9 other languages: Arabic, Afrikaans, Croatian, Dutch, French, German, Hindi, Italian and Romanian.

What type of medicines do you have in your offering?

At the moment, our main focus is on oncological, neurological and rare diseases. However, if you are looking for a medicine which is not currently in our offering, please get in touch and we’ll do our best to help.

Can you provide medical advice?

No. Only your treating doctor can provide medical advice specific to your case. We highly value the doctor-patient relationship; our role is to support access to a medicine when requested by both patient and doctor.

Where are you located and what are your contact hours?

We are based in Amsterdam and our office hours are from 09.00 to 18.00 CET from Monday to Friday.

Why were you founded?

TheSocialMedwork was started after three of our founders lost family members and friends to Cancer and ALS and one was diagnosed with ALS themselves. This made them realise how important it is to have access to the best, and newest medicines, regardless of their location. Click here to read more about our founders.

Others

Available medicines

Can you help me import a medicine that is already approved in my country?

Our service can only help you import medicines that are either not approved or not available in your country. Sometimes, a medicine is approved but not (yet) available. In those cases we can help you access the medicines. But when a medicine is available in your country, we cannot supply you. If the medicine you are looking for is not available, please get in touch with our Patient Support Team to discuss further.

If a medicine is approved and available in my country, what are my next steps?

In this case, we cannot help you or the patient access the medicines. Your next step would be to talk with the doctor in your country and get a prescription. If you already have a prescription, then a pharmacy or hospital pharmacy will be able to help you find the medicine.

What if the medicines cost more in my country than what it says on your website?

Unfortunately, we are not allowed to provide medicines to people who already have access to them. The prices are determined by pharmaceutical companies and government agencies.

What if the medicine I’m looking for isn’t on your website?

Please contact us. If your doctor has recommended a specific medicine and it's been approved somewhere in the world we'll normally be able to find it for you.

How long does the process of finding new medicines take?

Some medicines are not easily available, so the process of gathering information is generally available within a couple of days but in exceptional cases can take up to two weeks. If you wish to place an order, delivery can take another 1-2 weeks, but we will keep you informed on the estimated delivery date.

Medicine approval

How does the process of approving medicines work?

The development of new medicines involves a lot of research and clinical studies. After the studies have been concluded and the results are promising, the manufacturer can apply for approval in order to introduce the medicine to the public. The manufacturer decides which country they file the approval in.

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.

How long does the approval process take?

The approval process can take over a year, depending on which national agency is reviewing the medicine. Even if one national agency approves a medicine, there is unfortunately no guarantee that another agency will ever approve the same medicine. Even after approval, it can still take time before the medicines are available in a country. We are able to help patients to access medicines up until the medicine is available in their country.

If the medicine that I need is not yet approved anywhere, are there any alternative medicines for me?

There may be another treatment option which is already approved and available in your country. We advise you to consult with your doctor in order to assess alternatives.

What is a clinical trial?

A clinical trial is a study designed to determine whether a new medicine is safe and effective. There are 4 phases within a clinical trial:

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.

We are also on Whatsapp, Telegram and WeChat. You can find us by adding this number: +31 61 553 5558.

How can I access a clinical trial?

Sometimes patients are able to access the medicine they're seeking through a clinical trial. Patients can check for clinical trials at ClinicalTrials.gov or Antidote.me. Unfortunately, the requirements for taking part in a clinical trial are often very strict. Statistics show that approximately 95% of patients are excluded from such programs.

What are the advantages and disadvantages of accessing a clinical trial?

An advantage of accessing a clinical trial is that the medicine is free of charge – pharmaceutical companies are not allowed to charge participants. A disadvantage is that many trials are 'placebo-controlled', which means that there is a chance that the participant does not receive the medicine but a placebo.

Updates

Do you have a newsletter?

At this time, we don't have a newsletter. However, we plan to have one in the current year. If you wish to receive any updates, send us an email and we will keep you informed.

How can I receive updates regarding the products that are coming soon?

Some products, although approved, are not yet available to purchase via TheSocialMedwork. If you are interested in staying informed, please contact us and we will update you as soon as we are able to source it and offer it for purchase.

Read full FAQ

Ketas (ibudilast)

Package

Capsules

Enquire

Package Content

1000 capsules of 10 mg

2100 capsules of 10 mg + €364.00

Quantity

Price estimate:

€504.70

The price, packaging size and strength may vary due to product availability. Click Request details for more information.

EUR

Where can we deliver?

We have delivered medicines to more than 88 countries. Check if we have sent medicines to yours.

We currently can’t ship medicines to - contact us for alternative options.

Make an enquiry to receive information about the different options of obtaining for a patient in .

We haven’t shipped medicines to yet. You can count on us to make it happen.

Make an enquiry to receive information about the cost, shipping time and import details for .

Yes, we have successfully delivered medicines to .

Make an enquiry to receive information about the cost, shipping time and import details for .

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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

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.

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) 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.

Please be aware that due to the COVID-19 situation worldwide and the country lockdowns, we will sometimes experience delays in shipping and shortages in availability.

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.

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.
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.
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.
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.

This content has been reviewed by a Medical Doctor.

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We are TheSocialMedwork, a registered medical intermediary that helps you access elsewhere approved medicines, no matter where you live. To date, we have assisted patients in over 88 countries to access thousands of life-improving medicines.
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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.