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Elexacaftor, Tezacaftor, and Ivacaftor

Elexacaftor, tezacaftor, and ivacaftor is a three-medicine combination used to treat cystic fibrosis in patients aged 2 years and older who have at least one eligible CFTR gene variant.

Brand name Trikafta
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 6, 2026
Elexacaftor, Tezacaftor, and Ivacaftor at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Trikafta is a three-medicine combination that targets the root cause of cystic fibrosis: elexacaftor and tezacaftor help the faulty CFTR protein fold properly and reach the cell surface, and ivacaftor holds it open longer. Since arriving in 2019 it has become the usual first choice for people aged 2 and older with an eligible CFTR gene variant. Most people tolerate it well, and the side effects they notice are usually headache, a stuffy or runny nose, stomach upset or a rash (more common in females). The thing to watch is its boxed warning for serious, potentially fatal liver injury and liver failure, so keep every scheduled liver blood test and report yellow skin or eyes, stomach pain, nausea or confusion right away.

Clinical pearls

  • Swallow the tablets whole with fat-containing food like eggs, cheese, peanut butter or whole milk, or they absorb poorly.
  • Avoid grapefruit and St. John’s wort, and check with the pharmacy before azole antifungals, clarithromycin, rifampin or seizure medicines.
  • New anxiety, low mood, thoughts of self-harm or poor sleep have been reported in adults and children, so report them promptly.
  • Severe headache or vision changes can signal raised brain pressure, and children need regular eye exams for lens clouding.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Trikafta can cause serious and potentially fatal liver damage. Cases of liver failure — including patients who needed a liver transplant and patients who died — have been reported in people taking Trikafta, both in clinical trials and after the drug was on the market. This has happened in people with and without a previous history of liver problems, and can occur as early as the first month of treatment or up to 15 months after starting.

Because of this risk, liver function blood tests (ALT, AST, alkaline phosphatase, and bilirubin) must be checked before starting Trikafta, every month for the first 6 months, every 3 months for the next year, and at least once a year after that. If results are significantly abnormal, or if symptoms like yellowing of the skin or eyes, stomach pain, nausea, vomiting, or confusion appear, Trikafta must be stopped right away. Trikafta must not be used in patients with severe liver impairment, and is generally not recommended for those with moderate liver impairment.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet
Earliest FDA record2019
Companies listing it with the FDA1
FDA label last updatedJun 22, 2026
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Elexacaftor, Tezacaftor, and Ivacaftor, written from its FDA label.

What Elexacaftor, Tezacaftor, and Ivacaftor is used for

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Elexacaftor, tezacaftor, and ivacaftor (sold as Trikafta) is approved to treat cystic fibrosis (CF) in adults and children aged 2 years and older. Eligibility depends on having a clinical diagnosis of CF and carrying at least one CFTR gene variant that is expected to respond to this treatment.

  • Treats cystic fibrosis in patients aged 2 years and older with at least one eligible CFTR gene variant — based on clinical trial data or laboratory (in vitro) evidence
  • Approved for patients with the common F508del variant (on one or both copies of the gene) as well as many other CFTR variants listed in the prescribing information
  • If a patient's genetic type is unknown, an FDA-cleared CF genetic test should confirm eligibility before starting Trikafta
  • Trikafta should only be used when there is a confirmed clinical diagnosis of CF — having an eligible gene variant alone is not enough to justify treatment

How Elexacaftor, Tezacaftor, and Ivacaftor works

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In cystic fibrosis, a faulty gene causes the CFTR protein — which acts like a gate controlling the flow of chloride (salt) in and out of cells — to be misshapen, misrouted, or unable to open properly. Elexacaftor and tezacaftor each latch onto different spots on the defective CFTR protein and work together to help it fold into the right shape and travel to the cell surface in higher numbers. Ivacaftor then acts as a "potentiator" — it helps the gate stay open longer, improving chloride flow. The combined result is more functional CFTR protein at the cell surface, which addresses the root cause of CF rather than just managing symptoms.

Elexacaftor, Tezacaftor, and Ivacaftor dosage

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Trikafta is taken by mouth twice a day — a morning dose and an evening dose, approximately 12 hours apart. Both doses must be taken with fat-containing food to ensure the medicine is absorbed properly; good examples include eggs, peanut butter, cheese, nuts, whole milk, or anything prepared with butter or oils. The exact number of tablets (or, for young children, the oral granule formulation) depends on age and body weight — follow your prescriber's instructions exactly.

  • Tablets should be swallowed whole
  • Do not eat grapefruit or drink grapefruit juice during treatment
  • If you miss a dose, follow your prescriber's guidance — do not double up doses

Dosing details from the FDA-approved label

From the Elexacaftor, Tezacaftor, and Ivacaftor prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • 2 to less than 6 years, less than 14 kg
    • Morning: one packet containing elexacaftor 80 mg/tezacaftor 40 mg/ivacaftor 60 mg oral granules
    • Evening: one packet containing ivacaftor 59.5 mg oral granules
    • Take with fat-containing food, approximately 12 hours apart
  • 2 to less than 6 years, 14 kg or more
    • Morning: one packet containing elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg oral granules
    • Evening: one packet containing ivacaftor 75 mg oral granules
    • Take with fat-containing food, approximately 12 hours apart
  • 6 to less than 12 years, less than 30 kg
    • Morning: two tablets of elexacaftor 50 mg/tezacaftor 25 mg/ivacaftor 37.5 mg (total dose of elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg)
    • Evening: one tablet of ivacaftor 75 mg
    • Swallow tablets whole with fat-containing food, approximately 12 hours apart
  • 6 to less than 12 years, 30 kg or more
    • Morning: two tablets of elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg (total dose of elexacaftor 200 mg/tezacaftor 100 mg/ivacaftor 150 mg)
    • Evening: one tablet of ivacaftor 150 mg
    • Swallow tablets whole with fat-containing food, approximately 12 hours apart
  • 12 years and older
    • Morning: two tablets of elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg (total dose of elexacaftor 200 mg/tezacaftor 100 mg/ivacaftor 150 mg)
    • Evening: one tablet of ivacaftor 150 mg
    • Swallow tablets whole with fat-containing food, approximately 12 hours apart
  • Moderate hepatic impairment (Child-Pugh Class B), 12 years and older
    • Alternating daily dosing: Day 1: two tablets of elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg
    • Day 2: one tablet of elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg
    • No evening ivacaftor tablet dose
    • Treatment not recommended unless clear medical need and benefit outweighs risk; monitor liver function tests closely
  • Moderate hepatic impairment (Child-Pugh Class B), 2 to less than 6 years, 14 kg or more
    • Weekly: Days 1-3 one packet elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg each day
    • Day 4 no dose
    • Days 5-6 one packet each day
    • Day 7 no dose
    • No evening ivacaftor dose
    • Treatment not recommended unless clear medical need and benefit outweighs risk
  • Mild hepatic impairment (Child-Pugh Class A)
    • No dose adjustment is recommended
    • See Table 1 dosage
    • Liver function tests should be closely monitored
  • Severe hepatic impairment (Child-Pugh Class C)
    • Should not be used
  • Concomitant strong CYP3A inhibitors, 2 to less than 6 years, less than 14 kg
    • One packet (elexacaftor 80 mg/tezacaftor 40 mg/ivacaftor 60 mg) in the morning twice a week, approximately 3 to 4 days apart
    • No evening packet of ivacaftor oral granules
    • Take with fat-containing food; avoid grapefruit
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Prior to initiating TRIKAFTA obtain liver function tests (ALT, AST, alkaline phosphatase, and bilirubin) in all patients. Monitor liver function tests every month during the first 6 months of treatment, then every 3 months during the next 12 months, then at least annually thereafter. ( 2.1 , 5.1) Recommended Dosage for Adult and Pediatric Patients Aged 2 Years and Older (with fat-containing food ( 2.2 , 12.3 )) Age Weight Morning Dose Evening Dose 2 to less than 6 years Less than 14 kg One packet containing elexacaftor 80 mg/tezacaftor 40 mg/ivacaftor 60 mg oral granules One packet containing ivacaftor 59.5 mg oral granules 14 kg or more One packet containing elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg oral granules One packet containing ivacaftor 75 mg oral granules 6 to less than 12 years Less than 30 kg Two tablets, each containing elexacaftor 50 mg/tezacaftor 25 mg/ivacaftor 37.5 mg One tablet of ivacaftor 75 mg 30 kg or more Two tablets, each containing elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg One tablet of ivacaftor 150 mg 12 years and older - Two tablets, each containing elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg One tablet of ivacaftor 150 mg Should not be used in patients with severe hepatic impairment. Use not recommended in patients with moderate hepatic impairment unless the benefit outweighs the risk. Reduce dose if used in patients with moderate hepatic impairment. Liver function tests should be closely monitored. ( 2.3 , 5.1 , 6 , 8.7 , 12.3 ) See full prescribing information for dosage modifications due to drug interactions with TRIKAFTA. ( 2.4 , 5.6 , 7.1 , 12.3 ) 2.1 Recommended Laboratory Testing Prior to TRIKAFTA Initiation and During Treatment Prior to initiating TRIKAFTA, obtain liver function tests (ALT, AST, alkaline phosphatase, and bilirubin) for all patients. Monitor liver function tests every month during the first 6 months of treatment, then every 3 months for the next 12 months, then at least annually thereafter. Consider more frequent monitoring for patients with a history of liver disease or liver function test elevations at baseline [see Warnings and Precautions (5.1) and Use in Specific Populations (8.7) ] .

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Elexacaftor, Tezacaftor, and Ivacaftor side effects

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The most common side effects reported in clinical trials include:

Common side effects

  • Headache
  • Upper respiratory tract infection
  • Abdominal pain
  • Diarrhea
  • Rash (more common in females)
  • Nasal congestion or runny nose
  • Elevated liver enzymes on blood tests
  • Constipation
  • Elevated creatine phosphokinase (a muscle enzyme) on blood tests

When to get medical help

  • Call your doctor right away if you notice yellowing of the skin or eyes, severe stomach pain, nausea, vomiting, or confusion — these may be signs of liver injury
  • Seek emergency help immediately for signs of a serious allergic reaction: swelling of the face, lips, or throat, or difficulty breathing (anaphylaxis or angioedema)
  • Tell your doctor if you develop an unusual or severe headache or changes in vision — this could indicate increased pressure in the brain (intracranial hypertension)
  • Contact your doctor if you or your child develop new or worsening anxiety, depression, thoughts of self-harm, or significant sleep problems
  • Report unusual muscle pain or weakness, especially after exercise — in rare cases this has been linked to a condition called rhabdomyolysis

Serious reactions — including liver injury, severe allergic reactions (anaphylaxis, angioedema), increased brain pressure (intracranial hypertension), and neuropsychiatric symptoms such as anxiety, depression, or suicidal thoughts — require prompt medical attention. Contact your doctor or seek emergency care right away if any of these develop.

Elexacaftor, Tezacaftor, and Ivacaftor warnings and precautions

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  • Liver injury and liver failure: This is the most serious risk. Fatal liver failure and cases requiring liver transplantation have been reported. Liver function tests must be checked before starting, then monthly for 6 months, every 3 months for the next year, and at least annually after that. Stop Trikafta and call your doctor if you notice yellowing of the skin or eyes, severe stomach pain, nausea, vomiting, or confusion.
  • Serious allergic reactions: Anaphylaxis and angioedema (severe swelling) have been reported after Trikafta was approved. Seek emergency help immediately if breathing becomes difficult or severe swelling develops.
  • Intracranial hypertension (increased brain pressure): Reported post-approval. Symptoms include unusual headache, blurred or double vision, or vision loss. If these occur, stop Trikafta and get evaluated promptly.
  • Neuropsychiatric events: Anxiety, depression, suicidal thoughts or behavior, and sleep problems have been reported — in adults and children, with or without prior mental health history. Monitor closely, especially in the first few months of treatment.
  • Cataracts in children: Lens clouding has been reported in pediatric patients taking ivacaftor-containing regimens. Eye exams are recommended at baseline and during follow-up for children starting Trikafta.

Elexacaftor, Tezacaftor, and Ivacaftor interactions

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Trikafta is processed by a liver enzyme called CYP3A, which means several common drugs and foods can significantly raise or lower Trikafta levels in the body:

  • Strong CYP3A inducers (rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, St. John's wort): Drastically lower Trikafta levels — avoid combining these with Trikafta
  • Strong CYP3A inhibitors (ketoconazole, itraconazole, posaconazole, voriconazole, clarithromycin, telithromycin): Greatly raise Trikafta levels — a significant dose reduction is required
  • Moderate CYP3A inhibitors (fluconazole, erythromycin): Also raise Trikafta levels — dose reduction needed
  • Grapefruit and grapefruit juice: Contain natural CYP3A inhibitors — avoid entirely during treatment
  • Warfarin: Trikafta may increase warfarin levels — INR should be monitored regularly
  • Digoxin, cyclosporine, sirolimus, tacrolimus, everolimus: Trikafta may raise their levels — use with caution and monitor closely
  • Certain diabetes medications (glimepiride, glipizide, glyburide, repaglinide, nateglinide) and statins: Trikafta may increase exposure to these drugs — monitor and use with caution
  • Hormonal contraceptives: Trikafta does not reduce contraceptive effectiveness, but hormonal contraceptives may contribute to rash — inform your doctor if rash develops

Interactions listed in the FDA-approved label

From the Elexacaftor, Tezacaftor, and Ivacaftor prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Strong CYP3A inducers (e.g., rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, St. John's wort): May result in reduced exposures and thus reduced TRIKAFTA efficacy; rifampin decreased ivacaftor AUC by 89%. Concomitant use is not recommended; avoid.
  • Strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, posaconazole, voriconazole, telithromycin, clarithromycin): Itraconazole increased elexacaftor AUC by 2.8-fold and tezacaftor AUC by 4.0- to 4.5-fold; ivacaftor AUC increased by 15.6-fold with itraconazole and 8.5-fold with ketoconazole. Reduce the TRIKAFTA dosage.
  • Moderate CYP3A inhibitors (e.g., fluconazole, erythromycin): May increase elexacaftor and tezacaftor AUC by approximately 1.9- to 2.3-fold and 2.1-fold; fluconazole increased ivacaftor AUC by 2.9-fold. Reduce the TRIKAFTA dosage.
  • Grapefruit: Grapefruit juice may increase exposure of elexacaftor, tezacaftor and ivacaftor. Avoid food or drink containing grapefruit during treatment.
  • CYP2C9 substrates (warfarin, glimepiride, glipizide): Ivacaftor may inhibit CYP2C9, which may increase exposure of these drugs. Monitor INR with warfarin; use glimepiride and glipizide with caution.
  • P-gp substrates (digoxin, cyclosporine, everolimus, sirolimus, tacrolimus): May increase systemic exposure of sensitive P-gp substrates; digoxin AUC increased 1.3-fold with ivacaftor or tezacaftor/ivacaftor. Use caution and appropriate monitoring.
  • OATP1B1/OATP1B3 substrates (statins, glyburide, nateglinide, repaglinide): Elexacaftor and M23-ELX inhibit OATP1B1 and OATP1B3 uptake in vitro and may increase exposures of these drugs. Use caution and appropriate monitoring.
  • Ciprofloxacin: No clinically relevant effect on exposure of tezacaftor or ivacaftor; not expected to affect elexacaftor. No dose adjustment is necessary.
  • Hormonal contraceptives: No clinically relevant effect on exposures of ethinyl estradiol/levonorgestrel; hormonal contraceptives may play a role in rash and cannot be excluded. If rash develops, consider interrupting TRIKAFTA and hormonal contraceptives; after resolution consider resuming TRIKAFTA without the contraceptives, and if rash does not recur, consider resuming them.
Read the label’s full interactions text

7 DRUG INTERACTIONS Strong CYP3A inducers: Avoid concomitant use. ( 5.5 , 7.1 , 12.3 ) Strong or moderate CYP3A inhibitors: Reduce TRIKAFTA dosage when used concomitantly. Avoid food or drink containing grapefruit. ( 2.4 , 5.6 , 7.1 , 12.3 ) 7.1 Effect of Other Drugs and Grapefruit on TRIKAFTA Strong CYP3A Inducers Concomitant use of TRIKAFTA with strong CYP3A inducers is not recommended. Elexacaftor, tezacaftor and ivacaftor are substrates of CYP3A (ivacaftor is a sensitive substrate of CYP3A). Concomitant use of CYP3A inducers may result in reduced exposures and thus reduced TRIKAFTA efficacy [see Warnings and Precautions (5.5) ] . Concomitant use of ivacaftor with rifampin, a strong CYP3A inducer, significantly decreased ivacaftor area under the curve (AUC) by 89%. Elexacaftor and tezacaftor exposures are expected to decrease during concomitant use with strong CYP3A inducers [see Clinical Pharmacology (12.3) ] . Examples of strong CYP3A inducers include: rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin and St. John's wort ( Hypericum perforatum ) Strong or Moderate CYP3A Inhibitors The dosage of TRIKAFTA should be reduced when used concomitantly with strong CYP3A inhibitors [see Dosage and Administration (2.4) and Warnings and Precautions (5.6) ] . Concomitant use with itraconazole, a strong CYP3A inhibitor, increased elexacaftor AUC by 2.8-fold and tezacaftor AUC by 4.0- to 4.5-fold. When used concomitantly with itraconazole and ketoconazole, ivacaftor AUC increased by 15.6-fold and 8.5-fold, respectively [see Clinical Pharmacology (12.3) ] . Examples of strong CYP3A inhibitors include: ketoconazole, itraconazole, posaconazole and voriconazole telithromycin and clarithromycin The dosage of TRIKAFTA should be reduced when used concomitantly with moderate CYP3A inhibitors [see Dosage and Administration (2.4) and Warnings and Precautions (5.6) ].

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿138 supplements and herbs with documented Elexacaftor, Tezacaftor, and Ivacaftor interactions, ranked by severity Check Elexacaftor, Tezacaftor, and Ivacaftor against a supplement or herb →

Before taking Elexacaftor, Tezacaftor, and Ivacaftor

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  • Tell your doctor about any history of liver disease — more frequent monitoring will be needed, and Trikafta is not recommended (and must not be used) in moderate-to-severe liver impairment without careful risk-benefit assessment
  • Inform your doctor of all medications, supplements, and herbal products — especially antifungals, antibiotics, seizure medicines, and tuberculosis drugs like rifampin
  • Pregnancy: Human safety data are limited. Animal studies did not show fetal harm at relevant doses, but discuss the risks and benefits with your doctor before starting or continuing Trikafta during pregnancy
  • Breastfeeding: It is unknown whether Trikafta passes into human breast milk. The components do pass into rat milk. Discuss the benefits and risks with your doctor
  • Children aged 2 and older: Safety and effectiveness have been established in clinical trials. Children starting Trikafta should have baseline and follow-up eye exams due to the risk of lens clouding
  • Patients with elevated vitamin A levels may be at increased risk of intracranial hypertension — inform your doctor
  • There are no formal contraindications; however, use in severe liver impairment (Child-Pugh Class C) is prohibited

Elexacaftor, Tezacaftor, and Ivacaftor overdose

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There is limited specific information about what happens in a Trikafta overdose. If too much is taken, the recommended approach is general supportive care — monitoring vital signs and watching the patient's clinical condition closely. If an overdose is suspected, contact a poison control center or seek emergency medical attention immediately.

What Elexacaftor, Tezacaftor, and Ivacaftor does in the body

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Trikafta's effect on the body can be measured by looking at sweat chloride levels — a standard marker of CFTR function in CF patients. In clinical trials, patients showed meaningful reductions in sweat chloride starting at week 4 of treatment, and these reductions were sustained throughout the study periods. Younger children (ages 2 to under 12) and patients with non-F508del variants also showed significant sweat chloride reductions. At doses up to twice the recommended amount, Trikafta did not cause any clinically meaningful effects on heart rhythm (QT interval).

How your body processes Elexacaftor, Tezacaftor, and Ivacaftor

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All three components of Trikafta — elexacaftor, tezacaftor, and ivacaftor — are well absorbed when taken by mouth with fatty food, which significantly increases their absorption (elexacaftor and ivacaftor exposure roughly doubles or more with food). They are all primarily broken down by a liver enzyme called CYP3A4/5 and are highly protein-bound in the bloodstream. Elexacaftor and tezacaftor reach steady levels in the body within about 7–8 days; ivacaftor within 3–5 days. The medicines are cleared mainly through the stool (feces), with very little exiting through the urine. Drug exposures in children aged 2 to under 12 are comparable to those seen in adults and older adolescents.

How to store Elexacaftor, Tezacaftor, and Ivacaftor

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Store at 20 ºC – 25 ºC (68 ºF – 77 ºF); excursions permitted to 15 ºC – 30 ºC (59 ºF – 86 ºF) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

138

Supplements & herbs that interact with Elexacaftor, Tezacaftor, and Ivacaftor

138 supplements and herbal products have documented interactions with Elexacaftor, Tezacaftor, and Ivacaftor in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 3
  • Moderate · 94
  • Minor · 41
ACTIVATED CHARCOAL Major GRAPEFRUIT Major ST. JOHN'S WORT Major ACACIA RIGIDULA Moderate ADRAFINIL Moderate AFRICAN WILD POTATO Moderate AMERICAN ELDER Moderate ASTAXANTHIN Moderate +130 more
Every supplement checked against Elexacaftor, Tezacaftor, and Ivacaftor — ranked by severity The full interaction hub: 3 major · 94 moderate · 41 minor · every one linked to its full report. Check Elexacaftor, Tezacaftor, and Ivacaftor against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Elexacaftor, Tezacaftor, and Ivacaftor: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Elexacaftor, Tezacaftor, and Ivacaftor — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly does Trikafta do — does it cure cystic fibrosis?

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Trikafta doesn't cure CF, but it works differently from most CF treatments. Instead of just managing symptoms, it targets the defective CFTR protein at the root of the disease — helping it work better so your cells can move chloride (salt) more normally. Most patients see meaningful improvements in lung function and quality of life, but they still have CF and still need to continue their other CF care routines as directed by their care team.

Why do I have to take it with food — can't I just take it with water?

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The fat in food is actually essential for this medication to be absorbed properly. Without fat in your stomach, your body won't take up enough of the medicine, and it won't work as well. Good options include eggs, peanut butter, cheese, nuts, whole milk, or anything made with butter or oil. This isn't just a suggestion — it's an important part of how the medication works, so try to make it a habit with every dose.

Why do I need so many liver blood tests while I'm on this medication?

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Trikafta can, in rare cases, cause serious liver damage — including cases that required liver transplants. The good news is that regular blood tests can catch problems early, before they become serious. You'll need tests every month for the first 6 months, then every 3 months for the next year, and at least once a year after that. If you notice yellowing of your skin or eyes, severe belly pain, nausea or vomiting, or confusion at any point, contact your doctor right away — don't wait for your next scheduled test.

Are there any medications or foods I need to completely avoid while taking Trikafta?

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Yes — grapefruit and grapefruit juice should be avoided entirely during treatment, because they can raise Trikafta levels in your body to potentially unsafe amounts. Certain medications are also a concern: drugs like rifampin, St. John's wort, carbamazepine, and phenytoin can make Trikafta much less effective, while antifungals like ketoconazole or itraconazole, and some antibiotics like clarithromycin, can make Trikafta levels too high and require a dose reduction. Always tell every prescriber and pharmacist you see that you're on Trikafta before starting any new medication.

I've been feeling more anxious and not sleeping well since starting Trikafta — could that be from the medication?

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It's possible. Anxiety, depression, sleep problems, and even suicidal thoughts have been reported in people taking Trikafta — in both adults and children, and in people who had no previous mental health history. These symptoms can appear within the first few months of treatment. Please don't dismiss what you're feeling — tell your doctor about it. They can help you weigh the benefits and risks and decide whether any changes to your treatment are needed. If you're having thoughts of harming yourself, seek help immediately.

Can my child take Trikafta, and are there any special concerns for kids?

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Yes — Trikafta is approved for children as young as 2 years old. For younger children (under 6), it comes in a granule form that can be mixed into soft food or liquid; older children and teens take tablets. One thing to know specifically for kids: there have been reports of lens clouding (early cataracts) in children taking ivacaftor-containing medicines like Trikafta. Because of this, your child should have an eye exam before starting treatment and follow-up exams during treatment. The liver monitoring requirements are the same for children as for adults.

Is Elexacaftor, Tezacaftor, and Ivacaftor available over the counter?

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No. Elexacaftor, Tezacaftor, and Ivacaftor is a prescription medicine: every Elexacaftor, Tezacaftor, and Ivacaftor product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Elexacaftor, Tezacaftor, and Ivacaftor first available?

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The earliest FDA record we hold for Elexacaftor, Tezacaftor, and Ivacaftor is from 2019: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Elexacaftor, Tezacaftor, and Ivacaftor was first used.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Elexacaftor, Tezacaftor, and Ivacaftor on HelloPharmacist

📊Elexacaftor, Tezacaftor, and Ivacaftor supplement interactions138 checked — ranked by severity 🌿Drug & Supplement CheckerElexacaftor, Tezacaftor, and Ivacaftor vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Elexacaftor, Tezacaftor, and Ivacaftor NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Elexacaftor, Tezacaftor, and Ivacaftor Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Elexacaftor, Tezacaftor, and Ivacaftor forms and strengths (how it comes)

Elexacaftor, Tezacaftor, and Ivacaftor is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Elexacaftor, Tezacaftor, and Ivacaftor inactive ingredients by manufacturer.

Tablet

By mouth
How this form is used
What it may be used for
  • Treats cystic fibrosis in patients aged 6 years and older who have at least one eligible CFTR gene variant
  • Used in children aged 6 to less than 12 years at weight-based doses, as part of a morning and evening tablet regimen
  • Used in patients aged 12 years and older as a standard morning and evening tablet regimen
Important instructions
  • Swallow tablets whole — do not crush or chew
  • Take both the morning dose and the evening dose with fat-containing food (such as eggs, peanut butter, cheese, nuts, whole milk, or food cooked in butter or oil)
  • Take the morning and evening doses approximately 12 hours apart
  • Follow your prescriber's instructions exactly for your age and weight — do not adjust the number of tablets on your own
Available strengths 2 strengths
25 mg / 50 mg / 37.5 mg 50 mg / 100 mg / 75 mg
2 FDA-listed product records ⓘ

Elexacaftor, Tezacaftor, and Ivacaftor on the U.S. market: products, makers and brands

How Elexacaftor, Tezacaftor, and Ivacaftor appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1 company lists 4 Elexacaftor, Tezacaftor, and Ivacaftor product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2019. Brand names on the directory include Trikafta; the rest are generics.

1
Dose forms ⓘ
1
Labelers (makers, repackagers, distributors)
1
Brand names
4
FDA-listed product records ⓘ
2019
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Kit (14) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

How widely Elexacaftor, Tezacaftor, and Ivacaftor is used (Medicaid data)

A general measure of how commonly Elexacaftor, Tezacaftor, and Ivacaftor is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Elexacaftor, Tezacaftor, and Ivacaftor is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

51,835
Medicaid prescriptions filled (Q1–Q4 2025)
$1.39B gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Elexacaftor, Tezacaftor, and Ivacaftor prescribed? Of the 1,601 medications we measure, Elexacaftor, Tezacaftor, and Ivacaftor ranks #628 by Medicaid prescriptions — more than 61% of them.

Where Elexacaftor, Tezacaftor, and Ivacaftor ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #628 of 1,601
#623 Cefepime Injection 52,968 Rx #624 Sulindac 52,720 Rx #625 Leucovorin Injection 52,618 Rx #626 Cefprozil 52,006 Rx #627 Mometasone Nasal Spray 51,854 Rx #628 Elexacaftor, Tezacafto... 51,835 Rx #629 Naratriptan 51,801 Rx #630 Abacavir, Dolutegravir... 51,277 Rx #631 Pembrolizumab Injectio... 51,156 Rx #632 Eslicarbazepine 50,618 Rx #633 Pegfilgrastim Injectio... 50,322 Rx

Utilization by Elexacaftor, Tezacaftor, and Ivacaftor product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

Other Elexacaftor, Tezacaftor, and Ivacaftor products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

51,835 Medicaid prescriptions (Q1–Q4 2025) 100% of Elexacaftor, Tezacaftor, and Ivacaftor prescriptions shown $1.39B gross reimbursement (before rebates) ≈ $26,849 per prescription (gross)

Summed across the 4 of 5 listed NDC products with Medicaid activity.

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Elexacaftor, Tezacaftor, and Ivacaftor, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 4 of 5 listed Elexacaftor, Tezacaftor, and Ivacaftor NDCs with Medicaid activity.

Compare Elexacaftor, Tezacaftor, and Ivacaftor products

A representative set of FDA-listed product records for Elexacaftor, Tezacaftor, and Ivacaftor — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Manufacturer / Labeler Category ⓘ Details
💊Kits
Vertex Pharmaceuticals Incorporated × 4 listings NDA View NDC →

Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Elexacaftor, Tezacaftor, and Ivacaftor NDCs →

Elexacaftor, Tezacaftor, and Ivacaftor recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Elexacaftor, Tezacaftor, and Ivacaftor recalls since July 2021.

✅No Elexacaftor, Tezacaftor, and Ivacaftor recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.

Multiple ingredients (MIN) Elexacaftor, Tezacaftor, and Ivacaftor RxCUI 2257010 2 dose forms · 4 strengths

Look up RxCUI 2257010 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Elexacaftor, Tezacaftor, and Ivacaftor brand names

Elexacaftor, Tezacaftor, and Ivacaftor is sold under one brand name in the FDA directory — Trikafta. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Trikafta

Who makes Elexacaftor, Tezacaftor, and Ivacaftor: manufacturers and labelers

One company lists Elexacaftor, Tezacaftor, and Ivacaftor products with the FDA. By number of product records, the largest are Vertex Pharmaceuticals Incorporated. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Vertex Pharmaceuticals Incorporated 4

Elexacaftor, Tezacaftor, and Ivacaftor drug class (RxNorm)

Elexacaftor, Tezacaftor, and Ivacaftor belongs to the Cystic Fibrosis Transmembrane Conductance Regulator Potentiator class.

Pharmacologic class Cystic Fibrosis Transmembrane Conductance Regulator Potentiator
Drug family (ATC) Other respiratory system products
How it works Chloride Channel Activation Potentiators, P-Glycoprotein Inhibitors, Cytochrome P450 2C9 Inhibitors, Cytochrome P450 3A Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Elexacaftor, Tezacaftor, and Ivacaftor page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jun 22, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Elexacaftor, Tezacaftor, and Ivacaftor.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Elexacaftor, Tezacaftor, and Ivacaftor after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
Finished products in the current FDA directory
4
Companies listing them (makers, repackagers, distributors)
1
FDA labeler codes behind them ⓘ
1
Linked representative label ⓘ
Vertex Pharmaceuticals Incorporated
Linked label effective
Jun 22, 2026
Composite sections available
24
Linked SPL Set ID
f354423a-85c2-41c3-a9db-0f3aee135d8d
Linked SPL Document ID
b63ac090-8d8b-43a0-82d1-558127f2d598
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Vertex Pharmaceuticals Incorporated is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →