Symkevi

Product Information:

Symkevi is a CFTR modulator. It contains two medicines:

• Tezacaftor – helps the CFTR protein form and reach the cell surface

• Ivacaftor – helps the CFTR protein work better once it’s there

Together, they improve salt and water movement in the lungs and other organs.

What it’s used for

Symkevi is used to treat cystic fibrosis in people who:

• Have specific CFTR gene mutations (for example, F508del in certain combinations)

• Are 12 years of age or older (in most approvals)

It can help:

• Improve lung function

• Reduce CF symptoms

• Lower the number of lung infections/exacerbations

• It only works for certain genetic types of CF, so genetic testing is required.

How to take Symkevi?

• Taken by mouth

• Must be taken with food that contains fat (for example: milk, yogurt, cheese, eggs, peanut butter)

• Tablets should be swallowed whole

• Taken on a regular daily schedule

Dosage:

For most people 12 years and older:

• Morning: 1 tablet of tezacaftor/ivacaftor

• Evening (about 12 hours later): 1 tablet of ivacaftor only

Symkevi side effects:

Contact a doctor if these happen:

• Headache

• Stomach pain

• Nausea or diarrhea

• Dizziness

• Cold-like symptoms (runny nose, sore throat)

• Liver problems (yellowing of skin/eyes, dark urine, unusual tiredness)

• Rash

• Chest tightness or breathing changes

Doctors usually do regular blood tests to monitor liver function.