This product is taken orally.
Why is it prescribed?
Symdeko™ is used for the treatment of cystic fibrosis (CF) in patients 12 years of age and older who:
- are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or
- are heterozygous for the F508del mutation and have one of the following mutations in the CFTR gene: P67L, D110H, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G, and 3849+10kbC→T.
Symdeko™should always be taken with fat-containing food eg foods that have been prepared with butter or oils, eggs, nuts, whole-milk dairy products (such as whole-milk, cheese, and yogurt) or meats. Swallow whole.
If you miss your dose and:
- it is 6 hours or less from the time you usually take it, you should take the missed dose as soon as possible
- it has been more than 6 hours from the time you usually take it, do not take the missed dose. Wait until it is time for your next dose and take it at the usual time.
- Do not take 2 doses at the same time to make up for the missed dose
Store this medication at or below 30 degrees C.
Do not use after the indicated expiry date.
See other products used in the treatment of •cystic fibrosis •
The recommended dose for adults, adolescents, and children aged 12 years and older is: one yellow tablet (tezacaftor 100 mg/ivacaftor 150 mg) in the morning and one blue tablet (ivacaftor 150 mg) in the evening, approximately 12 hours apart with fat-containing food.
Various mutations of the cystic fibrosis gene block the "gates" that allow the flow of salt across the cell membranes. This causes mucus to become thick and clog the lungs. The CFTR protein is a channel at the surface of the cells that allows the movement of particles such as chloride in and out of the cell, contributing to salt and water balance. Symdeko™ contains two medications: tezacaftor and ivacaftor. Tezacaftor is a CFTR "Corrector" which increases the amount of the CFTR protein at the surface of the cell, and ivacaftor is a CFTR "Potentiator" which helps this CFTR protein channel or "open the gates" more often allowing more salt to pass through. The thick mucus is then reduced and cystic fibrosis symptoms lessen.
Contact your doctor if any of these side effects persists or are bothersome:
• Stomach (abdominal) pain
• Common cold
• Runny nose
• Upper respiratory tract infection
• Changes in the type of bacteria in your sputum
• Nasal congestion
• Sinus congestion
• Sore throat
• Joint pain
Use with caution if you:
- have kidney or liver problems
- have cataracts
Possible drug interactions:
- ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole
- some antibiotics such as clarithromycin, erythromycin, rifampin, rifabutin
- phenobarbital, carbamazepine, phenytoin
- midazolam, alprazolam, diazepam, triazolam
- cyclosporine, tacrolimus
- St. John’s wort
Use in pregnancy and breastfeeding. Little is known about the safety of this medication when used in pregnancy and breastfeeding. Consult your doctor or pharmacist before use.