What Is the Important Safety Information?

ERIC: Hannah.

HANNAH: Eric, what’s up?

ERIC: Just left my CF Center.

HANNAH: How’d it go?

ERIC: My doc and I talked about TRIKAFTA, the triple combination therapy. TRIKAFTA is for people with CF aged 6 or older, who have an F508del mutation or another mutation responsive to TRIKAFTA.

HANNAH: Oh. I have the F508del mutation.

ERIC: I have another mutation that is responsive to TRIKAFTA.

HANNAH: What did your doc say about TRIKAFTA?

ERIC: She walked me through this brochure on the TRIKAFTA site. It’s got a lot of key info.

HANNAH: Any details on safety? What about side effects? I’m thinking of bringing it up with my CF Center.

ERIC: Yeah, it’s got all that and more. Let me send you the link.

VOICE-OVER: TRIKAFTA^® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is a prescription medicine used for the treatment of cystic fibrosis, or CF, in patients aged 6 years and older who have at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator, or CFTR, gene or another mutation that is responsive to treatment with TRIKAFTA.

Talk to your doctor to learn if you have an indicated CF gene mutation.

It is not known if TRIKAFTA is safe and effective in children under 6 years of age.

Do not take TRIKAFTA if you take certain medicines such as: antibiotics such as rifampin or rifabutin; seizure medicines such as phenobarbital, carbamazepine, or phenytoin; St. John’s wort.

Talk to your doctor before taking TRIKAFTA if you take any of the medicines or herbal supplements listed above.

Before taking TRIKAFTA, tell your doctor about all of your medical conditions, including if you have kidney problems, have or have had liver problems, are pregnant or plan to become pregnant. It is not known if TRIKAFTA will harm your unborn baby. You and your doctor should decide if you will take TRIKAFTA while you are pregnant, are breastfeeding, or planning to breastfeed. It is not known if TRIKAFTA passes into your breast milk. You and your doctor should decide if you will take TRIKAFTA while you are breastfeeding.

TRIKAFTA may affect the way other medicines work, and other medicines may affect how TRIKAFTA works. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. The dose of TRIKAFTA may need to be adjusted when taken with certain medicines. Ask your doctor or pharmacist for a list of these medicines if you are not sure. Make sure the list includes medicines from all your pharmacies, if you have more than one.

Especially tell your doctor if you take: antifungal medicines, including ketoconazole, itraconazole, posaconazole, voriconazole, or fluconazole; antibiotics including: telithromycin, clarithromycin, or erythromycin; other medicines including rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, and St. John’s wort. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

What should I avoid while taking TRIKAFTA?

TRIKAFTA can cause dizziness in some people who take it. Do not drive a car, use machinery, or do anything that needs you to be alert until you know how TRIKAFTA affects you. Avoid food or drink that contains grapefruit while you are taking TRIKAFTA.

HANNAH: Okay, got it.

ERIC: My doc also told me about some possible side effects. Some of them could be serious.

VOICE-OVER: TRIKAFTA can cause serious side effects, including liver damage and worsening of liver function in people with severe liver disease that can be serious and may require transplantation. Liver damage has also happened in people without liver disease.

High liver enzymes in the blood is a common side effect in people treated with TRIKAFTA. These can be serious and may be a sign of liver injury. Your doctor will do blood tests to check your liver before you start TRIKAFTA, every 3 months during your first year of taking TRIKAFTA, and every year while you are taking TRIKAFTA. Your doctor may do blood tests to check the liver more often if you have had high liver enzymes in your blood in the past.

HANNAH: Hmm. Okay, that makes sense.

VOICE-OVER: Call your doctor right away if you have any of the following symptoms of liver problems: pain or discomfort in the upper right stomach, or abdominal, area; yellowing of your skin or the white part of your eyes; loss of appetite; nausea or vomiting; dark, amber-colored urine.

ERIC: Oh, and she said some people need eye exams before starting and during treatment with TRIKAFTA. Check with your doc to see if you’d need one.

HANNAH: Hmm. What’s the exam for?

ERIC: Here’s what the brochure says.

VOICE-OVER: TRIKAFTA can cause serious side effects, including:

• Abnormality of the eye lens (cataract) has happened in some children and adolescents treated with TRIKAFTA. If you are a child or adolescent, your doctor should perform eye examinations before and during treatment with TRIKAFTA to look for cataracts

HANNAH: Okay, got it. The brochure only recommends an eye exam for kids and adolescents.

ERIC: Yeah, my doc said the same thing. Then she talked about the most common side effects.

VOICE-OVER: The most common side effects of TRIKAFTA include headache; upper respiratory tract infection, or common cold, including stuffy and runny nose; stomach, or abdominal, pain; diarrhea; rash; increase in liver enzymes; increase in a certain blood enzyme called creatine phosphokinase; flu, or influenza; inflamed sinuses; or increase in blood bilirubin.

These are not all the possible side effects of TRIKAFTA. Call your doctor for medical advice about side effects. You are encouraged to report side effects to the FDA at 1-800-FDA-1088.

HANNAH: Okay, I finished reading the safety info. Thanks for sharing.

ERIC: That’s all the info I’ve got.

HANNAH: This was super helpful. I’m going to talk to my doc about TRIKAFTA.

ERIC: Let me know how it goes.

HANNAH: Will do. Thanks.

VOICE-OVER: To learn more about TRIKAFTA and if it could be right for you, please talk to your healthcare provider and visit TRIKAFTA.com.

Please see the links for Important Safety Information and full Prescribing Information, including Patient Information, below.

This video is brought to you by Vertex Pharmaceuticals Incorporated.