Trikafta (elexacaftor/tezacaftor/ivacaftor; ivacaftor)
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Trikafta (elexacaftor/tezacaftor/ivacaftor; ivacaftor) is a medication used for the treatment of cystic fibrosis (CF), indicated for CF patients aged 12 years and older with certain mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that are responsive to Trikafta based on in vitro data.
The medicine is approved by the European Medicines Agency (EMA) under the brand-name Kaftrio. We have it available to order as well. See [Kaftrio (elexacaftor/tezacaftor/ivacaftor; ivacaftor)].
Disease Indications
Cystic Fibrosis
Manufacturer
Vertex Pharmaceuticals Incorporated
Usage
Oral
Medicine approved by
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Food and Drug Administration (FDA)
Patients helped
- Over 2 million patients reached
- More than 11,000 patients helped
- 100% successful deliveries to 87 countries
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Package
Co-packaged blister pack
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Patient Support Team Lead
Daniela Figueira, PharmaD
Patient Support Agent
What is Trikafta (elexacaftor/tezacaftor/ivacaftor; ivacaftor) for?
Trikafta (elexacaftor/tezacaftor/ivacaftor; ivacaftor) is a combination of ivacaftor, tezacaftor, and elexacaftor indicated for the treatment of cystic fibrosis (CF) in patients aged 12 years and older with certain mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that are responsive to Trikafta based on in vitro data. 1,4
It is available in co-packaged fixed-dose combination tablets containing elexacaftor 100 mg, tezacaftor 50 mg and ivacaftor 75 mg, and tablets containing ivacaftor 150 mg. 1
How does Trikafta (elexacaftor/tezacaftor/ivacaftor; ivacaftor) work?
Trikafta is a combination of three drugs (ivacaftor, tezacaftor, and elexacaftor) that target the defective cystic fibrosis transmembrane conductance regulator (CFTR) protein. It helps the protein made by the CFTR gene mutation function more effectively. 2
Where has Trikafta (elexacaftor/tezacaftor/ivacaftor; ivacaftor) been approved?
Trikafta (elexacaftor/tezacaftor/ivacaftor; ivacaftor) was approved for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene by:
- The Food and Drug Administration (FDA), USA, on October 21, 2019. 1 This indication got extended to include people with certain mutations in the CFTR gene that are responsive to Trikafta based on in vitro data on December 21, 2020.4
- The European Medicines Agency (EMA), Europe, on August 21, 2020, under the brand-name Kaftrio (ivacaftor/tezacaftor/elexacaftor).3
Please note that this medication 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 for assistance.
We have supported patients from various countries access Trikafta. The majority of our patients who have requested access to this medicine come from:
- United Kingdom (UK)
- Netherlands
- India
- Belgium
- France
- Argentina
How is Trikafta (elexacaftor/tezacaftor/ivacaftor; ivacaftor) taken?
Trikafta (elexacaftor/tezacaftor/ivacaftor; ivacaftor) should be taken orally, together with fat-containing food. The recommended dose is:
- Two tablets (each containing elexacaftor 100 mg, tezacaftor 50 mg and ivacaftor 75 mg) taken in the morning and one ivacaftor tablet (containing ivacaftor 150 mg) taken in the evening, approximately 12 hours apart. 1
Reduction in dose may be required based on symptoms and experienced side effects. Complete information about Trikafta (elexacaftor/tezacaftor/ivacaftor; ivacaftor) dosage and administration can be found in the official prescribing information listed in our references section 1.
Note: Please consult with your treating doctor for personalised dosing and potential drug interactions.
Are there any known side effects or adverse reactions of Trikafta (elexacaftor/tezacaftor/ivacaftor; ivacaftor)?
Common adverse reactions1
The most common adverse reactions listed in the prescribing information include:
- headaches
- upper respiratory tract
- infections
- abdominal pains
- diarrhea rashes.
Serious adverse reactions1
The serious adverse reactions listed in the prescribing information include:
- high liver enzymes in the blood
- abnormality of the eye lens (cataract)
- rash
- influenza (flu) events.
Use in specific populations
Pediatric Use
The safety and effectiveness of Trikafta (elexacaftor/tezacaftor/ivacaftor; ivacaftor) in patients with cystic fibrosis (CF) younger than 12 years of age have not been established. 1
In some children and adolescents treated with Trikafta (elexacaftor/tezacaftor/ivacaftor; ivacaftor), abnormality of the eye lens (cataract) have been observed. Eye examinations before and during treatment with Trikafta (elexacaftor/tezacaftor/ivacaftor; ivacaftor) are therefore recommended in pediatric patients. 1
Elevated liver function tests
Elevated liver function tests (transaminases and bilirubin) have been observed in patients treated with Trikafta (elexacaftor/tezacaftor/ivacaftor; ivacaftor). Therefore, assessments of liver function tests (ALT, AST, and bilirubin) are recommended for all patients prior to initiating Trikafta (elexacaftor/tezacaftor/ivacaftor; ivacaftor). For patients with a history of hepatobiliary disease or liver function test elevations, more frequent monitoring should be considered. Depending on the results of the liver function tests, dosing should be interrupted. 1
Hepatic Impairment
Patients with severe hepatic impairment (Child-Pugh Class C) should not be treated with Trikafta (elexacaftor/tezacaftor/ivacaftor; ivacaftor). Use of Trikafta (elexacaftor/tezacaftor/ivacaftor; ivacaftor) is not recommended in patients with moderate hepatic impairment (Child-Pugh Class B) unless the benefit exceeds the risk. If used in patients with moderate hepatic impairment, Trikafta (elexacaftor/tezacaftor/ivacaftor; ivacaftor) should be used with caution and at a reduced dose. Liver function tests should be closely monitored. No dose modification is recommended for patients with mild hepatic impairment (Child-Pugh Class A). 1
Use with CYP3A inducers
Co-administration with strong CYP3A inducers (e.g., rifampin, St. John’s wort) may reduce Trikafta (elexacaftor/tezacaftor/ivacaftor; ivacaftor) efficacy. Therefore, co-administration is not recommended. 1
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information 1.
References
1. Full prescribing information [FDA]: Trikafta (elexacaftor/ivacaftor/tezacaftor) [PDF], Vertex Pharmaceuticals Incorporated, Oct.2019.
2. U.S. Food and Drug Administration. FDA approves new breakthrough therapy for cystic fibrosis. 21/10/2019 (last update: 21/10/2019), cited on 10/01/2020.
3. Kaftrio product page. European Medicines Agency, last checked on Sept 2, 2020.
4. Vertex Announces FDA Approvals of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor), Symdeko (tezacaftor/ivacaftor and ivacaftor) and Kalydeco (ivacaftor) for Use in People With CF With Certain Rare Mutations . Press release, Dec 21, 2020.
The efficacy of Trikafta (elexacaftor/tezacaftor/ivacaftor; 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 Trikafta (elexacaftor/tezacaftor/ivacaftor; 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 Trikafta (elexacaftor/tezacaftor/ivacaftor; ivacaftor) compared to placebo were rash and influenza (flu) events. The most common side effects of Trikafta (elexacaftor/tezacaftor/ivacaftor; 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 Trikafta (elexacaftor/tezacaftor/ivacaftor; ivacaftor) for the approved indication 2.
References
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U.S. Food and Drug Administration. FDA approves new breakthrough therapy for cystic fibrosis. 21/10/2019 (last update: 21/10/2019), cited on 10/01/2020.
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Full prescribing information [FDA]: Trikafta (elexacaftor/tezacaftor/ivacaftor; ivacaftor) [PDF], Vertex Pharmaceuticals Incorporated, Oct.2019.
Trikafta (elexacaftor/tezacaftor/ivacaftor; ivacaftor) treatment costs
The cost for a monthly or yearly treatment of Trikafta (elexacaftor/tezacaftor/ivacaftor; ivacaftor) depends on your prescription requirements which includes the dosage in g/mg/ml/etc and medicine type (Co-packaged blister pack).
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 Trikafta (elexacaftor/tezacaftor/ivacaftor; 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.
Trikafta (elexacaftor/tezacaftor/ivacaftor; ivacaftor) price and additional costs
The price of Trikafta (elexacaftor/tezacaftor/ivacaftor; 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 Trikafta (elexacaftor/tezacaftor/ivacaftor; 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 Trikafta (elexacaftor/tezacaftor/ivacaftor; ivacaftor)
When you buy Trikafta (elexacaftor/tezacaftor/ivacaftor; 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.
Trikafta (elexacaftor/tezacaftor/ivacaftor; ivacaftor) reimbursement
It might be possible for you to claim the cost of Trikafta (elexacaftor/tezacaftor/ivacaftor; 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 buy Trikafta: You can order Trikafta 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.
