Kaftrio (elexacaftor/tezacaftor/ivacaftor)
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Kaftrio (elexacaftor/tezacaftor/ivacaftor) is a medication used in combination with ivacaftor 150 mg tablets for the treatment of cystic fibrosis (CF), indicated for CF patients aged 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
Ivacaftor 150 mg tablets are not included in the package, they are available to order here
The medicine is approved by the Food and Drugs Administration (FDA) under the brand-name Trikafta. We have it available to order as well. See [Trikafta (elexacaftor/tezacaftor/ivacaftor; ivacaftor)].
Please note that we have a generic form of edaravone available to order as well. See [Trixacar (elexacaftor/tezacaftor/ivacaftor; ivacaftor)].
Disease Indications
Cystic Fibrosis
Manufacturer
Vertex Pharmaceuticals Incorporated
Usage
Oral
Medicine approved by
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European Medical Agency (EMA)
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.
About 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)
Others
Available medicines
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
Kaftrio (elexacaftor/tezacaftor/ivacaftor)
Package
Tablets
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 .
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Make an enquiry to receive information about the cost, shipping time and import details for .
Yes, we have successfully delivered medicines to .
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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 Kaftrio (elexacaftor/tezacaftor/ivacaftor) for?
Kaftrio (elexacaftor/tezacaftor/ivacaftor) is a medication used in combination with ivacaftor 150 mg tablets for people with cystic fibrosis (CF) aged 12 years and older with at least one copy of the F508del mutation.
How effective is Kaftrio (elexacaftor/tezacaftor/ivacaftor) for cystic fibrosis?
The approval of Kaftrio (elexacaftor/tezacaftor/ivacaftor) for CF was based on two clinical studies.
Study 1
Included 403 people with CF, 12 years and older, with one copy of the F508del mutation and a mutation defined in the study. Kaftrio was compared with placebo (a dummy treatment).
According to the study results published:
After 24 weeks, lung function (FEV1) improved significantly.
Study 2
Included 107 people with CF, 12 years and older, with two copies of the F508del mutation. Kaftrio and ivacaftor was compared with ivacaftor and tezacaftor (Symdeko).
According to the study results published:
There was significant improvement in lung function (FEV1).
For more details refer to the prescribing information at the bottom of the page.
Which side effects can I expect with Kaftrio (elexacaftor/tezacaftor/ivacaftor)?
According to the studies published ,the main common side effects of Kaftrio (which may affect more than 1 in 10 people) in people with CF aged 12 years and older include headaches, upper respiratory tract infections, abdominal pains, diarrhea and rashes.
Please note this is not intended to be a comprehensive guide. Consult your treating doctor and the prescribing information at the bottom of the page for full details of side effects.
How is Kaftrio (elexacaftor/tezacaftor/ivacaftor) taken?
Administration: in the morning take two Kaftrio tablets. In the evening, take one ivacaftor tablet. Take these tablets approximately 12 hours apart.
Dosage: 150 mg ivacaftor, 100 mg tezacaftor and 200 mg elexacaftor in the morning and 150 mg ivacaftor in the evening.
Each dose must be taken with fat-containing food.
Please note this is not intended to be a treatment plan. For a personalised treatment plan, consult your doctor. For more details, you can also reference the full prescribing information at the bottom of the page.
Frequently Asked Questions about Kaftrio (elexacaftor/tezacaftor/ivacaftor)
How does Kaftrio (elexacaftor/tezacaftor/ivacaftor) work?
CF is caused by mutations in the CF gene. This leads to defects in the cystic fibrosis transmembrane conductance regulator (CFTR) protein. This protein works on the surface of cells and regulates the production of mucus in the lungs and digestive juices in the gut.
Kaftrio is a combination of three drugs (elexacaftor, tezacaftor and ivacaftor) that target the defective CFTR protein. It helps the CFTR protein function more effectively.
For more details about the way Kaftrio (elexacaftor/tezacaftor/ivacaftor) works, consult your doctor or see the prescribing information at the bottom of the page. This is not intended to be a comprehensive scientific explanation.
What are some contraindications to taking Kaftrio (elexacaftor/tezacaftor/ivacaftor)?
Do not take Kaftrio if you take certain medicines such as:
- Antibiotics such as rifampin or rifabutin
- Seizure medicines such as phenobarbital, carbamazepine or phenytoin
- Strong CYP3A inducers such as rifampin, St. John’s wort
Kaftrio may affect the way other medicines work, and other medicines may affect how Kaftrio works. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, hormonal contraceptives, vitamins, and herbal supplements. The dose of Kaftrio may need to be adjusted when taken with certain medicines.
What is the most important information you should know about Kaftrio (elexacaftor/tezacaftor/ivacaftor)?
Kaftrio (elexacaftor/tezacaftor/ivacaftor) can cause serious side effects. Pay special attention to new or worsening symptoms as they may be related to:
- High liver enzymes in the blood
- Abnormality of the eye lens (cataract)
- Rash
Warnings and precautions: talk to your doctor if you have or have had liver problems or have kidney problems.
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.
Where has Kaftrio (elexacaftor/tezacaftor/ivacaftor) been approved?
Kaftrio (elexacaftor/tezacaftor/ivacaftor) with ivacaftor was approved for CF in patients aged 12 years and older who have at least one F508del mutation by:
- The European Medicines Agency (EMA), Europe, on August 21, 2020.
- The Food and Drug Administration (FDA), USA, on October 21, 2019, under the brand-name Kaftrio (ivacaftor/tezacaftor/elexacaftor)
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.
Downloads
References
1. Kaftrio (elexacaftor/ivacaftor/tezacaftor) [PDF].
Vertex Pharmaceuticals Incorporated, Aug 21, 2020.
2. New medicine for cystic fibrosis patients.
European Medicines Agency press release 26/06/2020.
3. Full prescribing information [FDA]: Trikafta (elexacaftor/ivacaftor/tezacaftor) [PDF].
Vertex Pharmaceuticals Incorporated, Oct 2019.
The efficacy of Kaftrio (elexacaftor/tezacaftor/ivacaftor) in patients with cystic fibrosis (CF) aged 12 years and older was shown in two clinical trials. The first trial was a randomized, double-blind, placebo-controlled trial (24 weeks) in 403 patients who had an F508del mutation and a mutation on the second allele that results in either no CFTR protein or a CFTR protein that is not responsive to ivacaftor or tezacaftor/ivacaftor alone. The second trial was a randomized, double-blind, active-controlled trial (4 weeks) in 107 patients who had two identical F508del mutations. 1
In both trials, the primary analysis looked at increases in the percent predicted forced expiratory volume in one second (ppFEV1), a widely used marker of CF lung disease progression. The ppFEV1 increased by an average of 13.8% compared to placebo in the first trial, and by 10% compared to tezacaftor/ivacaftor in the second trial. In the first trial, treatment with Kaftrio (elexacaftor/tezacaftor/ivacaftor) also resulted in improvements in sweat chloride, number of pulmonary exacerbations, and body mass index, compared with placebo. 1
Serious adverse drug reactions that occurred more frequently in patients receiving Kaftrio (elexacaftor/tezacaftor/ivacaftor) compared to placebo were rash and influenza (flu) events. The most common side effects of Kaftrio (elexacaftor/tezacaftor/ivacaftor) included headaches, upper respiratory tract infections, abdominal pains, diarrhea, among others. The label also includes warnings related to elevated liver function tests, use at the same time with other products that are inducers or inhibitors of another liver enzyme called Cytochrome P450 3A4 (CYP3A), and the risk of cataracts. 1
Please refer to the full prescribing information below for comprehensive information about the safety and effectiveness of Kaftrio (elexacaftor/tezacaftor/ivacaftor) for the approved indication 2.
References
1. New medicine for cystic fibrosis patients. European Medicines Agency press release 26/06/2020.
2. Kaftrio (elexacaftor/ivacaftor/tezacaftor) [PDF], Vertex Pharmaceuticals Incorporated, Aug 21, 2020.
Kaftrio (elexacaftor/tezacaftor/ivacaftor) price in other currencies*
| Package | Euro | Romanian leu |
|---|---|---|
| 56 tablets - 75 mg of ivacaftor, 50 mg of tezacaftor and 100 mg of elexacaftor | 14950 EUR | 73948 RON |
| 56 tablets - 37.5 mg of ivacaftor, 50 mg of tezacaftor and 100 mg of elexacaftor | 17057 EUR | 84370 RON |
*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.
Kaftrio (elexacaftor/tezacaftor/ivacaftor) treatment costs
The cost for a monthly or yearly treatment of Kaftrio (elexacaftor/tezacaftor/ivacaftor) depends on your prescription requirements which includes the dosage in g/mg/ml/etc and medicine type (Tablets).
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 Kaftrio (elexacaftor/tezacaftor/ivacaftor) 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.
Kaftrio (elexacaftor/tezacaftor/ivacaftor) price and additional costs
The price of Kaftrio (elexacaftor/tezacaftor/ivacaftor)
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 Kaftrio (elexacaftor/tezacaftor/ivacaftor) 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 Kaftrio (elexacaftor/tezacaftor/ivacaftor)
When you buy Kaftrio (elexacaftor/tezacaftor/ivacaftor), 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.
Kaftrio (elexacaftor/tezacaftor/ivacaftor) reimbursement
It might be possible for you to claim the cost of Kaftrio (elexacaftor/tezacaftor/ivacaftor) 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 Kaftrio: You can access Kaftrio 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.
