Symdeko (tezacaftor & ivacaftor) Cost, Side Effects, Dosage, Uses. US FDA granted approval of Symdeko to Vertex Pharmaceuticals Inc.
Symdeko drug is vertex’s third drug which is the combination of tezacaftor and ivacaftor. It is approved by Food drug authority for treatment of leading cause of cystic fibrosis. It is effective in patients with 12 years of age and older. It is specifically designed for patients having a pair of copies of F508del mutation in CFTR protein. CFTR is abbreviated as cystic fibrosis conductance regulator (It is a protein which works as a channel in transporting salt and water in and out of cell.) Symdeko is also effective in patients with at least one gene mutation.
It is approved after 3 global clinical trials involving 750 patients. Symdeko is contraindicated with some antibiotics like rifampin, rifabutin, medicines used in seizures i.e. phenobarbital, carbamazepine or phenytoin. Some of its factors are still unknown like if it pass on to infant during pregnancy and lactation. Dose adjustment of Symdeko is also required when other drugs are in prescription. Symdeko also have some side effect i.e. dizziness so patient should avoid activities which require attention like driving or running a machine. Other side effects involve abnormality of eye lens and high level liver enzymes in blood. Grapefruit juice and orange juice is contraindicated with Symdeko.
 Normally CFTR (cystic fibrosis conductance regulator) is a protein which acts as a channel on the cell surface. It is responsible for transportation of salt and water molecule. But in cystic fibrosis, this specific protein is missing or not in a working position. This improper working leads to formation of a thick, sticky mucus which can effect multiple organs including lungs. Active ingredients of Symdeko works separately i.e. tezacaftor helps CFTR protein to move towards cell surface and ivacaftor help this protein to be open for longer time.
Dose adjustment of Symdeko drug is important to get optimum response. As two drugs are combined in Symdeko, so dosage of each drug is designed to get desired effect. Tezacaftor 100 mg is adjusted with 150 mg of ivacaftor in single tablet of Symdeko. Dose adjustment is required If Symdeko is administered with other drugs like anti-fungal i.e. ketoconazole, itraconazole, posaconazole, voriconazole or fluconazole and some antibiotics like telithromycin, erythromycin or clarithromycin. Dosage adjustment is also required if patient is suffering from a kidney or liver disease. In pregnancy and lactation Symdeko should be avoided.
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Symdeko drug is specially designed to treat cystic fibrosis in patient with 12 years of age or above. A specific dosage combination is required for treating cystic fibrosis. In this drug, tezacaftor and ivacaftor are working collectively to regulate CFTR protein. But these two active ingredients if with different strength are combined, will be effective against HIV 1 infection. These are used as three months regimen for complete cure. These are the only two main diseases in which tezacaftor and ivacaftor are used in fixed dose combination for treatment. Further uses of tezacaftor and ivacaftor combination are not reported yet.
According to health authorities following side effects might be associated with use of this drug.
Symdeko drug is vertex’s third drug which is the combination of tezacaftor and ivacaftor. It is approved by Food drug authority for treatment of leading cause of cystic fibrosis. It is effective in patients with 12 years of age and older. It is specifically designed for patients having a pair of copies of F508del mutation in CFTR protein. CFTR is abbreviated as cystic fibrosis conductance regulator (It is a protein which works as a channel in transporting salt and water in and out of cell.) Symdeko is also effective in patients with at least one gene mutation.
It is approved after 3 global clinical trials involving 750 patients. Symdeko is contraindicated with some antibiotics like rifampin, rifabutin, medicines used in seizures i.e. phenobarbital, carbamazepine or phenytoin. Some of its factors are still unknown like if it pass on to infant during pregnancy and lactation. Dose adjustment of Symdeko is also required when other drugs are in prescription. Symdeko also have some side effect i.e. dizziness so patient should avoid activities which require attention like driving or running a machine. Other side effects involve abnormality of eye lens and high level liver enzymes in blood. Grapefruit juice and orange juice is contraindicated with Symdeko.
Symdeko Mechanism of Action
   Â Normally CFTR (cystic fibrosis conductance regulator) is a protein which acts as a channel on the cell surface. It is responsible for transportation of salt and water molecule. But in cystic fibrosis, this specific protein is missing or not in a working position. This improper working leads to formation of a thick, sticky mucus which can effect multiple organs including lungs. Active ingredients of Symdeko works separately i.e. tezacaftor helps CFTR protein to move towards cell surface and ivacaftor help this protein to be open for longer time.
Symdeko Dosage
   ÂDose adjustment of Symdeko drug is important to get optimum response. As two drugs are combined in Symdeko, so dosage of each drug is designed to get desired effect. Tezacaftor 100 mg is adjusted with 150 mg of ivacaftor in single tablet of Symdeko. Dose adjustment is required If Symdeko is administered with other drugs like anti-fungal i.e. ketoconazole, itraconazole, posaconazole, voriconazole or fluconazole and some antibiotics like telithromycin, erythromycin or clarithromycin. Dosage adjustment is also required if patient is suffering from a kidney or liver disease. In pregnancy and lactation Symdeko should be avoided.
Symdeko Uses
    Symdeko drug is specially designed to treat cystic fibrosis in patient with 12 years of age or above. A specific dosage combination is required for treating cystic fibrosis. In this drug, tezacaftor and ivacaftor are working collectively to regulate CFTR protein. But these two active ingredients if with different strength are combined, will be effective against HIV 1 infection. These are used as three months regimen for complete cure. These are the only two main diseases in which tezacaftor and ivacaftor are used in fixed dose combination for treatment. Further uses of tezacaftor and ivacaftor combination are not reported yet.
Symdeko Side effects
According to health authorities following side effects might be associated with use of this drug.
- Increased Liver Enzymes
- Nausea
- Vomiting
- Headache
- Sinus Congestion
- Dizziness
- Palpitation
- Rashes
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