Symdeko (tezacaftor / ivacaftor)
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Symdeko (tezacaftor/ivacaftor) is a medicine for the treatment of patients with cystic fibrosis (CF) aged 6 years and older. It is available in tablet form each containing 100 mg of tezacaftor and 150 mg of ivacaftor. It is indicated in combination with another medicine containing 150 mg ivacaftor alone.
It is commercialized in Europe under the brand name Symkevi and in United States under the brand name Symdeko.
Disease Indications
Cystic Fibrosis
Manufacturer
Vertex Pharmaceuticals (Europe) Ltd
Usage
Oral
Medicine approved by
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European Medical Agency (EMA)
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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
Tablets
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Daniela Figueira, PharmaD
Patient Support Agent
What is Symdeko (tezacaftor/ivacaftor)?
Symdeko (tezacaftor/ivacaftor) is a medicine for the treatment of patients with cystic fibrosis (CF) aged 6 years and older. It is available in tablet form each containing 100 mg of tezacaftor and 150 mg of ivacaftor. It is indicated in combination with another medicine containing 150 mg ivacaftor alone1,2. It is commercialized in Europe under the brand name Symkevi and in United States under the brand name Symdeko1,2.
Each tablet contains 100 mg of tezacaftor and 150 mg of ivacaftor.
Who is Symdeko (tezacaftor/ivacaftor) for?
Symdeko (tezacaftor/ivacaftor) is for patients with cystic fibrosis (CF) in patients age 6 years and older who have two copies of the F508del mutation, or who have at least one mutation in the CF gene that is responsive to treatment with Symdeko.1,2
Patients should talk to their doctor to learn if they have an indicated CF gene mutation.
How does Symdeko (tezacaftor/ivacaftor) work?
Cystic Fibrosis (CF) is a serious genetic disorder characterised by the formation of thick mucus that accumulates in the lungs, digestive tract and other parts of the body leading to severe respiratory and digestive problems, as well as other complications such as infections and diabetes3. Mutations in the CFTR gene are responsible for this disease. This gene makes a protein called ‘cystic-fibrosis transmembrane conductance regulator’ (CFTR), which is involved in regulating the production of mucus and digestive juices. These mutations reduce the number of CFTR protein channels on the cell surface or affect the way they work. These channels are used for the transport of ions (charged atoms and molecules) in and out of cells. When the channels are defective, mucus and digestive juices can become abnormally thick and sticky4.
Symdeko (tezacaftor/ivacaftor) addresses this problem from two sides. One of the active substances, tezacaftor, increases the number of CFTR proteins on the cell surface and the other, ivacaftor, increases the activity of the defective CFTR protein. This normalises the transport of ions through channels making the secretions less thick4.
Where has Symdeko (tezacaftor/ivacaftor) been approved?
Symdeko (tezacaftor/ivacaftor) was approved, in a combination regimen with ivacaftor for the treatment of patients with cystic fibrosis in presence of homozygous F508del mutation; or heterozygous F508del mutation plus another mutation in the CFTR gene, by1,2:
- Health Canada, June 28, 2018, commercialised under the brand name Symdeko6
- European Medical Agency (EMA), European Union, October 31, 2018, commercialised under the brand name Symkevi1
- Food and Drug Administration (FDA), USA, December 2, 2018, commercialised under the brand name Symdeko2. This indication was extended on December 21, 2020 for use in patients who have two copies of the F508del mutation, or who have at least one mutation in the CF gene that is responsive to treatment with Symdeko.
- Therapeutic Goods Administration (TGA), Australia, March 5, 2019, commercialised under the brand name Symdeko7.
Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.
How is Symdeko (tezacaftor/ivacaftor) taken?
The standard dosage is1,2:
- A combination regimen with ivacaftor 150 mg tablets
- Taken orally twice a day
- One tablet every 12 hours with fat containing food
Reduction in dose may be required in patients with moderate or severe hepatic impairment. When co-administered with strong CYP3A inhibitors, the dose should be adjusted to one Symdeko (tezacaftor/ivacaftor) tablet twice a week, taken approximately 3 to 4 days apart. In these cases, the evening dose of ivacaftor should not be taken1,2. During treatment with Symdeko (tezacaftor/ivacaftor), interactions with strong CYP3A inhibitors and strong CYP3A4 inducers should be avoided1,2.
Complete information about Symdeko (tezacaftor/ivacaftor) dosage and administration can be found in the official prescribing information listed in our references section1,2.
Note: Please consult with your treating doctor for personalised dosing and potential drug interactions.
Are there any known side effects or adverse reactions of Symdeko (tezacaftor/ivacaftor)?
The most common adverse reactions listed in the prescribing information include1,2:
- headache
- nasopharyngitis (upper respiratory infection)
- dizziness
- sinus congestion.
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information1,2.
References
1. Summary of Product Characteristics [EMA]: Symkevi (tezacaftor/ivacaftor) [PDF]
Vertex Pharmaceuticals Limited, October 2018.
2. Summary of Product Characteristics [FDA]: Symdeko (tezacaftor/ivacaftor) [PDF]
Vertex Pharmaceuticals Incorporated, December 2018.
3. US National Library of Medicine, Genetics Home Reference: Cystic fibrosis
Published: 12/02/2019, cited on 13/02/2019.
4. EMA. Human Medicines: Symkevi (tezacaftor/ivacaftor)
27/07/2018, (last update: 27/07/2018), cited on 13/02/2019.
5. Naylor, M.G., et al. Recommendations for using standardised phenotypes in genetic association studies
Hum Genomics. 2009; 3 (4): 308–319
6. Summary of Product Characteristics [Health Canada]: Symdeko (tezacaftor/ivacaftor) [PDF]
Vertex Pharmaceuticals Incorporated, June 2018.
7. Summary of Product Characteristics [TGA]: Symdeko (tezacaftor/ivacaftor) [PDF]
Vertex Pharmaceuticals, March 2019.
Study in patients with CF who were homozygous for the F508del mutation in CFTR gene
The Food and Drug Administration (FDA), USA, and European Medical Agency (EMA), European Union, approvals of Symdeko (tezacaftor/ivacaftor) in combination with ivacaftor for patients with cystic fibrosis who were homozygous for the F508del mutation in CFTR gene were based on a 24-week, randomised, double-blind, placebo controlled study. The study involved a total of 504 patients with CF aged 12 years and older1,2.
The primary efficacy endpoint was the change in lung function through Week 24, as determined by an absolute change from baseline in percent predicted forced expiratory volume in 1 second (ppFEV1). This is the amount of air a person can blow out in one second divided by the expected amount, calculated by taking into account several factors such as the person's sex and height5.
The primary efficacy endpoint was the absolute change from baseline in ppFEV1 through Week 241,2:
- 4.0% [95% CI: 3.1, 4.8] difference between Symdeko (tezacaftor/ivacaftor) in combination with ivacaftor, and placebo.
Study in patients with CF who were heterozygous for the F508del mutation and a second mutation predicted to be responsive to tezacaftor/ivacaftor
The Food and Drug Administration (FDA), USA, and European Medical Agency (EMA), European Union, approvals of Symdeko (tezacaftor/ivacaftor), in combination with ivacaftor for patients with cystic fibrosis who were heterozygous for the F508del mutation and a second mutation associated with residual CFTR activity, were based on a randomised, double-blind, placebo-controlled, 2-period, 3-treatment, 8-week crossover study. The study involved a total of 244 patients with CF aged 12 years and older who received sequences of treatment that include Symdeko (tezacaftor/ivacaftor) in combination with ivacaftor, ivacaftor and placebo. Patients with following mutations in CFTR gene were enrolled in the study: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G, and 3849+10kbC→T1,2.
The primary efficacy endpoint was the absolute change from baseline in ppFEV1 through Week 81,2:
- 6.8% [95% CI: 5.7, 7.8] difference between Symdeko (tezacaftor/ivacaftor) in combination with ivacaftor, and placebo
- 4.7% [95% CI: 3.7, 5.8] difference between ivacaftor alone and placebo
- 2.1% [95% CI: 1.2, 2.9] difference between Symdeko (tezacaftor/ivacaftor) in combination with ivacaftor, and ivacaftor alone.
Please refer to the summary of product characteristics below and in the resource section for comprehensive information about the safety and effectiveness of Symdeko (tezacaftor/ivacaftor) for the approved indication1,2.
References
1. Summary of Product Characteristics [EMA]: Symkevi (tezacaftor/ivacaftor) [PDF]
Vertex Pharmaceuticals Limited, October 2018.
2. Summary of Product Characteristics [FDA]: Symdeko (tezacaftor/ivacaftor) [PDF]
Vertex Pharmaceuticals Incorporated, December 2018.
Symdeko (tezacaftor / ivacaftor) treatment costs
The cost for a monthly or yearly treatment of Symdeko (tezacaftor / ivacaftor) depends on your prescription requirements which includes the dosage in mg 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 Symdeko (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.
Symdeko (tezacaftor / ivacaftor) price and additional costs
The price of Symdeko (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 Symdeko (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 Symdeko (tezacaftor / ivacaftor)
When you buy Symdeko (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.
Symdeko (tezacaftor / ivacaftor) reimbursement
It might be possible for you to claim the cost of Symdeko (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 buy Symdeko: You can order Symdeko 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.
