What is Symkevi (tezacaftor/ivacaftor)*?

Symkevi (tezacaftor/ivacaftor) is available in tablet form and is used to treat cystic fibrosis in individuals aged 12 years and above. Each tablet contains 100 mg of tezacaftor and 150 mg of ivacaftor. Symkevi is indicated for use in combination with another medication that contains 150 mg ivacaftor alone. It is marketed under the brand name Symkevi in Europe and Symdeko in the United States.

What is Symkevi (tezacaftor/ivacaftor) for?

Symkevi (tezacaftor/ivacaftor) is a medication used to treat cystic fibrosis (CF) in patients aged 12 years and older who have specific mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. It is designed to improve the transport of ions across the cells, reducing the thickness of the secretions, and thus helping to improve symptoms associated with CF. Symkevi is typically used in combination with another medication containing ivacaftor.

How does Symkevi (tezacaftor/ivacaftor) work?

Cystic Fibrosis (CF) is a genetic disorder that causes the accumulation of thick mucus in the lungs, digestive tract, and other areas of the body, resulting in severe respiratory and digestive problems, infections, and diabetes. The CFTR gene is responsible for this condition, as it produces the cystic-fibrosis transmembrane conductance regulator (CFTR) protein, which regulates mucus and digestive juice production. Mutations in this gene lead to a reduction in the number of CFTR protein channels on the cell surface or a change in their function, resulting in thick and sticky mucus and digestive juices.

Symkevi (tezacaftor/ivacaftor)* approach this issue from two angles. Tezacaftor, one of the active ingredients, increases the number of CFTR proteins on the cell surface, while ivacaftor enhances the activity of the defective CFTR protein. This process normalizes the transport of charged atoms and molecules (ions) through the channels, which leads to less thick secretions.

How is Symkevi (tezacaftor/ivacaftor) taken?

The recommended dosage for Symkevi (tezacaftor/ivacaftor)* is as follows:

– A combination of ivacaftor 150 mg tablets taken orally twice a day with fat-containing food.
– One tablet should be taken every 12 hours.
– Each tablet contains 100 mg of tezacaftor and 150 mg of ivacaftor.
– Patients with moderate or severe liver impairment may require a reduction in dosage.
– When taken with strong CYP3A inhibitors, the dose should be adjusted to one Symkevi (tezacaftor/ivacaftor)* tablet twice a week, with a three to four-day gap between each tablet. In this case, the evening dose of ivacaftor should be avoided.
– Strong CYP3A inhibitors and strong CYP3A4 inducers should not be used during treatment with Symkevi (tezacaftor/ivacaftor).

For complete information on Symkevi (tezacaftor/ivacaftor)* dosage and administration, refer to the official prescribing information listed in the references section. Please consult your doctor for personalised dosage recommendations and potential drug interactions.

Are there any known side effects of Symkevi (tezacaftor/ivacaftor)?

Like all medications, Symkevi (tezacaftor/ivacaftor) can cause side effects. The following are some of the most common side effects experienced by patients taking Symkevi (tezacaftor/ivacaftor):

– Headache
– Nausea
– Abdominal pain
– Diarrhea
– Increased liver enzymes
– Rash
– Dizziness

These side effects are usually mild to moderate in severity and tend to resolve on their own within a few days. If you experience any of these side effects while taking Symkevi (tezacaftor/ivacaftor), contact your doctor or healthcare provider.

In rare cases, Symkevi (tezacaftor/ivacaftor) may cause more serious side

Clinical trials

The approval of Symkevi (tezacaftor/ivacaftor) in combination with ivacaftor for CF patients homozygous for the F508del mutation in the CFTR gene was based on a 24-week double-blind, placebo-controlled study of 504 patients aged 12 and older. The primary efficacy endpoint was the absolute change in percent predicted forced expiratory volume in 1 second (ppFEV1) from baseline through Week 24. The study found a 4.0% difference in ppFEV1 between Symkevi in combination with ivacaftor and placebo.

Furthermore, the approval of Symkevi in combination with ivacaftor for CF patients heterozygous for the F508del mutation and a second mutation associated with residual CFTR activity was based on an eight-week double-blind, placebo-controlled, crossover study of 244 patients aged 12 and older. The primary efficacy endpoint was the absolute change in ppFEV1 from baseline through Week 8. The study found a 6.8% difference in ppFEV1 between Symkevi in combination with ivacaftor and placebo, a 4.7% difference between ivacaftor alone and placebo, and a 2.1% difference between Symkevi in combination with ivacaftor and ivacaftor alone. Patients included in the study had specific CFTR gene mutations. Referencing the summary of product characteristics listed below and in the resource section can provide comprehensive information on the safety and effectiveness of Symkevi for the approved indication.