Kalydeco* (ivacaftor)

Kalydeco* (ivacaftor) for sale – Buy Kalydeco* (ivacaftor) Online

What is Kalydeco (ivacaftor)* for?

Kalydeco (ivacaftor)* is for patients with cystic fibrosis (CF) aged 4 months and older who have at least one mutation in their CF gene that is responsive to Kalydeco.^[1,2].

 

 

It is available in tablet form containing 150 mg of ivacaftor.^[1]

How does Kalydeco (ivacaftor)* work

Cystic Fibrosis (CF) is a serious genetic disorder characterised by the formation of thick mucus which 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].

Kalydeco (ivacaftor)* boosts the activity of damaged CFTR protein, and by enhancing the transport of ions, it helps to reduce the symptoms of the disease by making the mucus and digestive juice less thick^[4]

Where has Kalydeco (ivacaftor)* been approved?

Kalydeco (ivacaftor)* was approved for the treatment of patients with cystic fibrosis who have mutations in CFTR gene by:

• Food and Drug Administration (FDA), USA, January 31, 2012^[1]
• European Medical Agency (EMA), European Union, August 6, 2012^[2].

Please note that this medicine may have also been approved in regions other 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 Kalydeco (ivacaftor)* taken?

The standard dosage for Kalydeco (ivacaftor)* is:

• When used as monotherapy for patients older than 4 months^[1,2]:
  • Taken orally twice a day
  • One tablet every 12 hours with fat containing food

• In combination regimen with tezacaftor/ivacaftor for adults and adolescents aged 6 and older^[2]:
  • Taken orally once a day
  • One tezacaftor 100 mg/ivacaftor 150 mg tablet taken orally in the morning, and one Kalydeco (ivacaftor) tablet taken in the evening approximately 12 hours apart with fat containing food

The dose of Kalydeco (ivacaftor)* should be reduced to:

• One tablet of ivacaftor 150 mg once daily for patients with moderate hepatic impairment
• One tablet of ivacaftor 150 mg every other day for patients with severe hepatic impairment. Dosing intervals should be modified according to clinical response and tolerability^[2].

The dose of Kalydeco (ivacaftor)* must be adjusted to^[1,2]:

• One tablet twice a week when co-administered with strong CYP3A inhibitors
• One tablet once daily co-administered with moderate CYP3A inhibitors.

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

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

Are there any known side effects or adverse reactions of Kalydeco (ivacaftor)*?

The most common adverse reactions listed in the prescribing information include^[1,2]:

• upper respiratory tract infection
• nasopharyngitis (contagious throat disease)
• headache
• dizziness
• oropharyngeal pain
• nasal congestion
• abdominal pain
• diarrhoea
• elevated liver enzymes
• rash
• bacteria in mucus.

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information^[1,2].

References

1. Summary of Product Characteristics [FDA]: Kalydeco (ivacaftor)[PDF]

Vertex Pharmaceuticals Incorporated, August 2018.

 

2. Summary of Product Characteristics [EMA]: Kalydeco (ivacaftor)[PDF]

Vertex Pharmaceuticals Ltd., October 2018.

 

3. US National Library of Medicine, Genetics Home Reference: Cystic fibrosis

Published: 12/02/2019, cited on 13/02/2019.

 

https://ghr.nlm.nih.gov/condition/cystic-fibrosis

4. EMA. Human Medicines: Kalydeco (ivacaftor)

06/08/2012, (last update: 03/01/2019), cited on 19/02/2019.

 

*Kalydeco is a registered trademark by Vertex Pharmaceuticals Incorporated.

 

 

 

 

This content has been reviewed by a Medical Doctor.