Symkevi* (tezacaftor/ivacaftor)

$6,996.95

Symkevi (tezacaftor/ivacaftor)* is a medicine for the treatment of patients with cystic fibrosis (CF) aged 12 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.

*Symkevi is a registered trademark by Vertex Pharmaceuticals Incorporated.

DISEASE INDICATIONS

Cystic Fibrosis

MANUFACTURER

Vertex Pharmaceuticals (Europe) Ltd

USAGE

Oral

MEDICINE APPROVED BY

European Medical Agency (EMA)
Food and Drug Administration (FDA)

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.

SYMKEVI (TEZACAFTOR/IVACAFTOR) Package

Clear

SKU: N/A Category: Buy Pulmonology Medicines & Drugs Online Tags: Buy Symkevi* (tezacaftor/ivacaftor) Online, Symkevi* (tezacaftor/ivacaftor), Symkevi* (tezacaftor/ivacaftor) for sale

Symkevi* (tezacaftor/ivacaftor) for sale – Buy Symkevi* (tezacaftor/ivacaftor) Online

What is Symkevi (tezacaftor/ivacaftor)*?

Who is Symkevi (tezacaftor/ivacaftor)* for?

Symkevi (tezacaftor/ivacaftor)* is for patients with cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation.

The F508del mutation can either be on both copies (homozygous) of CFTR gene; or one copy of F508del mutation (heterozygous) and another copy of following mutations in the CFTR gene: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G, and 3849+10kbC→T^[1,2]. Symkevi (tezacaftor/ivacaftor) is only for patients who harbour one of the above mutations.

How does Symkevi (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 diabetes^[3]. 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 sticky^[4].

Symkevi (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 thick^[4].

Where has Symkevi (tezacaftor/ivacaftor)* been approved?

Symkevi (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, by^[1,2]:

Health Canada, June 28, 2018, commercialised under the brand name Symdeko^[6]
European Medical Agency (EMA), European Union, October 31, 2018, commercialised under the brand name Symkevi^[1]
Food and Drug Administration (FDA), USA, December 2, 2018, commercialised under the brand name Symdeko^[2]
Therapeutic Goods Administration (TGA), Australia, March 5, 2019, commercialised under the brand name Symdeko^[7].

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 Symkevi (tezacaftor/ivacaftor)* taken?

The standard dosage is^[1,2]:

A combination regimen with ivacaftor 150 mg tablets
Taken orally twice a day
One tablet every 12 hours with fat containing food
Each tablet contains 100 mg of tezacaftor and 150 mg of ivacaftor.

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 Symkevi (tezacaftor/ivacaftor)* tablet twice a week, taken approximately 3 to 4 days apart. In these cases, the evening dose of ivacaftor should not be taken^[1,2]. During treatment with Symkevi (tezacaftor/ivacaftor)*, interactions with strong CYP3A inhibitors and strong CYP3A4 inducers should be avoided^[1,2].

Complete information about Symkevi (tezacaftor/ivacaftor)* dosage and administration can be found in the official prescribing information listed in our references section^[1,2].

Note: Please consult with your treating doctor for personalised dosing and potential drug interactions.