Your healthcare provider may do blood tests to check the liver more often if you have had high liver enzymes in your blood in the past or are experiencing signs or symptoms of liver injury.
Stop taking TRIKAFTA and call your healthcare provider right away if you have any of the following symptoms of liver problems:
- pain, swelling, or discomfort in the upper right stomach (abdominal) area
- yellowing of your skin or the white part of your eyes
- mental changes
- nausea or vomiting
- dark, amber-colored urine
- loss of appetite
- fluid in your stomach area (ascites)
- pain, swelling, or discomfort in the upper right stomach (abdominal) area
- yellowing of your skin or the white part of your eyes
- mental changes
- nausea or vomiting
- dark, amber-colored urine
- loss of appetite
- fluid in your stomach area (ascites)
What should I tell my healthcare provider before taking TRIKAFTA?
Before taking TRIKAFTA, tell your healthcare provider about all of your medical conditions, including if you:
- have or have had liver problems
- are allergic to TRIKAFTA or any ingredients in TRIKAFTA. See the end of the Medication Guide for a complete list of ingredients in TRIKAFTA
- have kidney problems
- are pregnant or plan to become pregnant. It is not known if TRIKAFTA will harm your unborn baby. You and your healthcare provider 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 healthcare provider should decide if you will take TRIKAFTA while you are breastfeeding
Tell your healthcare provider 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.
TRIKAFTA may affect the way other medicines work and other medicines may affect how TRIKAFTA works. The dose of TRIKAFTA may need to be adjusted when taken with certain medicines. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.
Especially tell your healthcare provider if you take:
- antibiotics such as rifampin (RIFAMATE®, RIFATER®) or rifabutin (MYCOBUTIN®)
- seizure medicines such as phenobarbital, carbamazepine (TEGRETOL®, CARBATROL®, EQUETRO®), or phenytoin (DILANTIN®, PHENYTEK®)
- St. John’s wort
- antifungal medicines including ketoconazole, itraconazole (such as SPORANOX®), posaconazole (such as NOXAFIL®), voriconazole (such as VFEND®), or fluconazole (such as DIFLUCAN®)
- antibiotics including telithromycin, clarithromycin (such as BIAXIN®), or erythromycin (such as ERY-TAB®)
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
What should I avoid while taking TRIKAFTA?
- Avoid food or drink that contains grapefruit while you are taking TRIKAFTA
What are the possible or reasonably likely side effects of TRIKAFTA?
TRIKAFTA can cause serious side effects, including:
- See “What is the most important information I should know about TRIKAFTA?”
- Serious Allergic Reactions can happen to people who are treated with TRIKAFTA. Call your healthcare provider or go to the emergency room right away if you have any symptoms of an allergic reaction. Symptoms of an allergic reaction may include:
- rash or hives
- tightness of the chest or throat or difficulty breathing
- swelling of the face, lips, and/or tongue, or difficulty swallowing
- light-headedness or dizziness
- Abnormality of the eye lens (cataract) has happened in some children and adolescents treated with TRIKAFTA. If you are a child or adolescent, your healthcare provider should perform eye examinations before and during treatment with TRIKAFTA to look for cataracts
The most common side effects of TRIKAFTA include:
- headache
- upper respiratory tract infection (common cold) including stuffy and runny nose
- stomach (abdominal) pain
- diarrhea
- rash
- increase in liver enzymes
- increase in a certain blood enzyme called creatine phosphokinase
- flu (influenza)
- inflamed sinuses
- increase in blood bilirubin
- constipation
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of TRIKAFTA. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-10881-800-FDA-1088.
For further information, please see full Prescribing Information, including Medication Guide with Important Warning.