Symdeko Tablet: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Symdeko Tablet (tezacaftor/ivacaftor and ivacaftor) is a prescription medicine used to treat cystic fibrosis in people aged 6 years and older who have specific gene mutations. It belongs to the CFTR combinations drug class and works by helping a faulty protein function more normally so salt and water move properly in the lungs. It is taken as two different tablets, one in the morning and one about 12 hours later, always with fat-containing food.

What is Symdeko Tablet

Symdeko is a prescription medicine used to treat cystic fibrosis in people aged 6 years and older who have specific gene mutations. It combines two medicines that help a faulty protein work better so that salt and water move more normally in the lungs.

Symdeko Tablet uses

• Cystic fibrosis (CF).
• Cystic fibrosis with eligible CFTR gene mutations.
• Cystic fibrosis involving the F508del mutation.
• Long-term management of eligible cystic fibrosis.
• Improving lung function in eligible patients with cystic fibrosis.

Benefits of Symdeko Tablet

• Helps improve CFTR protein function.
• May improve lung function.
• Helps support mucus clearance.
• May reduce respiratory symptoms.
• May reduce lung flare-ups.

How Symdeko Tablet works

Symdeko contains two medicines that work together. One helps move a faulty protein to the surface of cells, and the other helps that protein work better once it's there. Together they improve the flow of salt and water in and out of cells, which helps thin the sticky mucus that builds up in the lungs of people with cystic fibrosis.

Symdeko Tablet dosage

Swallow the tablets whole. Do not break, chew, or dissolve them. Always take with food that contains fat, such as butter, peanut butter, whole milk, cheese, yogurt, eggs, nuts, or cheese pizza, to help your body absorb the medicine.

Symdeko comes as two different tablets: one tablet is taken in the morning and a different tablet is taken about 12 hours later in the evening. Avoid food or drinks that contain grapefruit or Seville oranges while taking this medicine, as they can increase the amount of medicine in your body.

If you miss a dose and it has been 6 hours or less since your usual time, take the missed dose with fat-containing food as soon as possible, then continue your normal schedule. If more than 6 hours have passed since your usual dose time, skip the missed dose and take your next dose at the regular time. Do not take two doses at once.

If you miss doses or stop taking this medicine for more than a week, talk to your doctor before starting again, as your dose may need to be adjusted. Children taking this medicine may need frequent eye exams to check for cataracts. You will need regular blood tests to check how well your liver is working.

Available forms and strengths

• Tablet

Side effects of Symdeko Tablet

Common

• Headache
• Nausea
• Sinus congestion/pain
• Dizziness
• Throat and nose infections

Serious

• High liver enzymes / liver problems: pain or discomfort in the upper right stomach area, yellowing of skin or eyes, loss of appetite, nausea or vomiting, dark amber-colored urine, pale-colored stools
• Serious allergic reactions including anaphylaxis: rash or hives, tightness of the chest or throat, difficulty breathing, light-headedness or dizziness, swelling of face, lips, tongue, or throat
• Increased pressure around the brain (intracranial hypertension): unusual headache, blurred vision, double vision, vision loss
• Serious mental health problems: anxiety, depression, suicidal thoughts and behaviors, trouble sleeping
• Cataracts (abnormality of the eye lens) in children and adolescents

Warnings and precautions

This medicine can raise liver enzyme levels. Your doctor will check your liver with blood tests before starting treatment, every 3 months during the first year, and yearly after that.

Avoid taking this medicine with certain antibiotics, seizure medicines, St. John's wort, or antifungal medicines, as they can change how this medicine works. Avoid grapefruit and Seville oranges (and their juices) while taking this medicine, as they can raise the amount of medicine in your body and increase side effects.

Increased pressure around the brain has occurred with medicines containing the same or similar ingredients as this one. Cataracts without vision effects have been seen in some children treated with this medicine; eye exams may be needed before and during treatment.

Pregnancy: It is not known if this medicine will harm an unborn baby. Talk with your doctor about whether you should take it if you are pregnant or planning to become pregnant.

Breastfeeding: It is not known if this medicine passes into breast milk. Talk with your doctor about whether you should take it while breastfeeding.

Kidney: Tell your doctor if you have kidney problems before starting this medicine.

Liver: Tell your doctor if you have or have had liver problems. Your dose may need to be reduced, and you will need regular liver blood tests.

Alcohol: It is not known for certain how alcohol affects this medicine, but drinking alcohol may increase the risk of dizziness.

Driving: This medicine can cause dizziness. Do not drive or operate machinery until you know how it affects you.

Storage

• Store at room temperature between 68°F to 77°F (20°C to 25°C); brief exposure to 59°F to 86°F (15°C to 30°C) is permitted, such as during transport.
• Keep each tablet in its daily blister strip until you are ready to take your dose.
• Keep this medicine and all medicines out of the reach of children.
• If you no longer need the medicine or it is out of date, take it to a pharmacy for safe disposal.
• Do not store in the bathroom, near a sink, in the car, or on window sills.

When to see a doctor

• Get emergency medical help right away if you have signs of a serious allergic reaction, such as hives, difficulty breathing, or swelling of the face, lips, tongue, or throat.
• Call your doctor right away if you have signs of liver problems, such as pain in the upper right stomach area, loss of appetite, dark urine, or yellowing of the skin or eyes.
• Call your doctor right away if you have an unusual headache, blurred vision, double vision, or vision loss, which could be signs of increased pressure around the brain.
• Call your doctor right away if you have new or worsening mental health problems, such as anxiety, depression, suicidal thoughts, or trouble sleeping.
• If you think you or someone else has taken too much of this medicine, seek emergency medical help right away or contact a poison control center.

Alternatives

• Alyftrek
• Trikafta
• Kaftrio