Buy Symdeko (tezacaftor / ivacaftor) Online For Sale
DISEASE INDICATIONS: Cystic Fibrosis
MANUFACTURER: Vertex Pharmaceuticals (Europe) Ltd
MEDICINE APPROVED BY:
European Medical Agency (EMA)
Food and Drug Administration (FDA)
Symdeko (tezacaftor/ivacaftor) is a medication intended for the treatment of cystic fibrosis (CF) patients who are 6 years and older. Available in tablet form, each tablet contains 100mg of tezacaftor and 150mg of ivacaftor and is recommended to be taken with another medicine containing ivacaftor alone, which has a strength of 150mg. The medication is marketed in the United States as Symdeko and in Europe as Symkevi.
What is Symdeko (tezacaftor / ivacaftor) for?
Symdeko (tezacaftor/ivacaftor) is used to treat cystic fibrosis (CF), a genetic disorder that affects various organs, but most commonly the lungs, pancreas, and digestive system. Symdeko helps to improve lung function by reducing the thickness of mucus in the airways, making it easier to breathe. It is indicated for use in patients with CF aged 6 years and older and is typically administered in combination with another medication containing ivacaftor. Symdeko has been shown to improve lung function and reduce the frequency of pulmonary exacerbations in people with CF.
How does Symdeko (tezacaftor / ivacaftor) work?
Symdeko works by targeting the underlying genetic defect in cystic fibrosis (CF). CF is caused by mutations in the CFTR gene that reduce the number of functional CFTR proteins on the cell surface or affect the way they work. CFTR proteins are involved in regulating the production of mucus and digestive juices. When these proteins are defective, mucus and digestive juices become abnormally thick and sticky, leading to severe respiratory and digestive problems.
Symdeko combines two active ingredients, tezacaftor and ivacaftor, which work together from two different sides to address this problem. Tezacaftor increases the number of functional CFTR proteins on the cell surface, while ivacaftor increases the activity of the defective CFTR proteins. By normalizing the transport of ions through channels, Symdeko reduces the thickness of secretions, improving respiratory and digestive function in individuals with CF.
How is Symdeko (tezacaftor / ivacaftor) taken?
The recommended dosage for Symdeko (tezacaftor/ivacaftor)* is as follows[1,2]:
– It is taken orally twice a day in combination with ivacaftor 150 mg tablets.
– Consume one tablet every 12 hours with a meal containing fat.
– Patients with moderate or severe liver impairment may require a reduced dose.
– Ingest one Symdeko (tezacaftor/ivacaftor)* tablet twice a week, taken approximately 3 to 4 days apart, when co-administered with strong CYP3A inhibitors. In these cases, the evening dose of ivacaftor should be skipped.
– Strong CYP3A inhibitors and strong CYP3A4 inducers must be avoided during Symdeko (tezacaftor/ivacaftor)* treatment.
For personalized dosing and to learn about potential drug interactions, patients must consult with their treating doctor. Refer to the official prescribing information in our references section for comprehensive information on the dosage and administration of Symdeko (tezacaftor/ivacaftor)*.
Are there any known side effects of Symdeko (tezacaftor / ivacaftor)?
Yes, there are possible side effects of Symdeko (tezacaftor / ivacaftor), although not everyone may experience them. Common side effects include:
– sinus congestion
– abdominal pain
– increased blood uric acid levels
Less common but more serious side effects may include:
– severe chest pain or discomfort
– shortness of breath or difficulty breathing
– irregular or fast heartbeat
– increased blood pressure
– eye pain or discomfort, vision changes, sensitivity to light
– liver function changes
If you experience any of the above serious side effects, seek immediate medical attention. It is important to discuss any potential side effects with your doctor before taking Symdeko (tezacaftor / ivacaftor).
A 24-week, double-blind, placebo-controlled study was conducted to determine the approval of Symdeko (tezacaftor/ivacaftor) in combination with ivacaftor by the FDA and EMA for the treatment of cystic fibrosis in patients aged 12 years and above who were homozygous for the F508del mutation in the CFTR gene. The study included 504 patients as participants, and the primary efficacy endpoint was the change in lung function after 24 weeks, measured by the absolute change from baseline in percent predicted forced expiratory volume in one second (ppFEV1). The study revealed that the Symdeko (tezacaftor/ivacaftor) combination with ivacaftor was 4.0% [95% CI: 3.1, 4.8] more effective than the placebo.
For patients with cystic fibrosis who were heterozygous for the F508del mutation and a second mutation linked to residual CFTR activity, the FDA and EMA granted approval for Symdeko (tezacaftor/ivacaftor) in combination with ivacaftor based on a randomized, double-blind, placebo-controlled, 2-period, 3-treatment, 8-week crossover study conducted with 244 participants aged 12 years and above. The study included patients with mutations in 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. The primary efficacy endpoint was the absolute change from baseline in ppFEV1 through Week 8. In this study, Symdeko (tezacaftor/ivacaftor) in combination with ivacaftor was 6.8% [95% CI: 5.7, 7.8] more effective than the placebo, ivacaftor alone was 4.7% [95% CI: 3.7, 5.8] more effective than the placebo, and Symdeko (tezacaftor/ivacaftor) in combination with ivacaftor was 2.1% [95% CI: 1.2, 2.9] more effective than ivacaftor alone.
Refer to the summary of product characteristics in the resource section and below for detailed information about the effectiveness and safety of Symdeko (tezacaftor/ivacaftor) for its approved indication.
28 tablets of 100 mg/150 mg