Elexacaftor, Tezacaftor, and Ivacaftor
Elexacaftor, tezacaftor, and ivacaftor (Trikafta) is a three-drug combination used to treat cystic fibrosis in patients aged 2 years and older who have at least one qualifying CFTR gene variant.
🧬 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 →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Trikafta can cause serious and potentially fatal liver injury, including liver failure leading to transplant or death. This has happened in people with and without a history of liver disease, sometimes within the first month of treatment and up to 15 months after starting. Before beginning Trikafta, your doctor will check your liver function with blood tests. Those tests must be repeated every month for the first 6 months, every 3 months for the next year, and at least once a year after that. If your liver tests show significant problems, or if you develop symptoms like yellowing of the skin or eyes, stomach pain, or confusion, Trikafta should be stopped immediately. Trikafta must not be used in patients with severe liver impairment, and is not recommended in those with moderate liver impairment unless absolutely necessary and at a reduced dose with close monitoring.
📖 Elexacaftor, Tezacaftor, and Ivacaftor: Patient Information Guide
A plain-language walkthrough of Elexacaftor, Tezacaftor, and Ivacaftor — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Trikafta (elexacaftor, tezacaftor, and ivacaftor) is approved to treat cystic fibrosis (CF) across a broad age range and range of CFTR gene variants.
- Treats CF in adults and children aged 2 years and older who have a clinical diagnosis of CF and at least one CFTR gene variant that is responsive based on clinical or laboratory data, or that results in production of CFTR protein
- Approved for patients with at least one F508del variant (the most common CF mutation), as well as a wide range of other qualifying CFTR variants listed in the prescribing information
- If a patient's specific CFTR variant is unknown, an FDA-cleared genetic test should be used to confirm eligibility before starting treatment
- Should only be used in patients with a confirmed clinical diagnosis of CF — a qualifying gene variant alone is not sufficient justification for use
⚙️How it works▾
In cystic fibrosis, a faulty gene causes the CFTR protein — which normally acts as a chloride channel in cells — to be misfolded, misrouted, or unable to open properly. Elexacaftor and tezacaftor each bind to different locations on the defective CFTR protein and work together to help more of it fold correctly and reach the cell surface. Ivacaftor then acts as a "potentiator," helping the channel actually open and function. The combined result is more working CFTR protein at the cell surface, leading to improved chloride transport — which in patients with CF translates to measurable reductions in sweat chloride, a marker of CFTR function.
💊How it's taken▾
Trikafta is taken by mouth twice daily — a larger morning dose and a smaller evening dose, roughly 12 hours apart. The exact number of tablets or packets, and the strengths used, depend on the patient's age and weight, so always follow the prescriber's specific instructions. All doses must be taken with fat-containing food to ensure proper absorption.
- Tablets (used in patients aged 6 years and older): swallow whole with a fatty meal or snack
- Oral granules (used in patients aged 2 to less than 6 years): mix each packet with a small amount of soft food or liquid and consume within one hour; give with fat-containing food
- If a dose is missed, take it as soon as remembered — but follow your prescriber's guidance on missed doses
🤒Side effects — in detail▾
The most common side effects reported with Trikafta include:
- Headache
- Upper respiratory tract infection
- Abdominal pain
- Diarrhea
- Rash (more common in females and in those taking hormonal contraceptives)
- Elevated liver enzymes (ALT, AST) on blood tests
- Nasal congestion, runny nose, or rhinitis
- Constipation
- Elevated creatine phosphokinase (a muscle enzyme) on blood tests
More serious reactions — including significant liver injury, severe allergic reactions, increased pressure in the skull, and new or worsening mental health symptoms — require prompt medical attention and may mean stopping the medication.
⚠️Warnings & precautions▾
- Liver injury and liver failure: Trikafta can cause serious, potentially fatal liver damage. Liver function tests must be monitored before starting and regularly throughout treatment. Stop the medication and contact a doctor immediately if signs of liver injury appear (jaundice, right-sided abdominal pain, dark urine, confusion).
- Neuropsychiatric events: Anxiety, depression, insomnia, and suicidal thoughts or behaviors have been reported, including in children, sometimes within the first three months. Monitor closely for any new or worsening mental health symptoms.
- Intracranial hypertension (increased pressure in the skull): Unusual headaches or vision changes (blurred vision, double vision) should prompt immediate medical evaluation and possible interruption of the drug.
- Severe allergic reactions: Anaphylaxis and angioedema (severe swelling) have been reported. Seek emergency care if these occur.
- Cataracts in children: Lens opacities (early cataracts) have been reported in pediatric patients on ivacaftor-containing regimens. Eye exams are recommended at baseline and during treatment for children.
- Elevated blood pressure and creatine phosphokinase: Small increases in blood pressure and muscle enzyme levels have been observed; muscle breakdown (rhabdomyolysis) has been reported rarely, particularly after intense exercise.
🔀What it interacts with▾
Trikafta interacts with several medications and foods that affect how it is broken down in the body — mostly through an enzyme system called CYP3A.
- Strong CYP3A inducers (rifampin, rifabutin, carbamazepine, phenobarbital, phenytoin, St. John's wort): Avoid — these significantly lower Trikafta levels and can make it ineffective
- Strong CYP3A inhibitors (ketoconazole, itraconazole, posaconazole, voriconazole, clarithromycin, telithromycin): Require a Trikafta dose reduction — they markedly raise Trikafta levels
- Moderate CYP3A inhibitors (fluconazole, erythromycin): Also require a Trikafta dose reduction
- Grapefruit or grapefruit juice: Avoid entirely — it raises Trikafta drug levels
- Warfarin: Trikafta may increase warfarin's blood-thinning effect; INR monitoring is recommended
- Digoxin and other narrow therapeutic index P-gp substrates (cyclosporine, tacrolimus, sirolimus, everolimus): Trikafta may raise their levels; use with caution and monitor
- Statins and certain diabetes medications (glimepiride, glipizide, glyburide, nateglinide, repaglinide): Trikafta may increase exposure to these drugs; use with caution
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Tell your doctor about any history of liver disease or abnormal liver tests — more frequent monitoring will be needed throughout treatment
- Trikafta should not be used in patients with severe liver impairment; it is not recommended in moderate liver impairment unless the benefit clearly outweighs the risk
- Pregnant patients should discuss risks and benefits with their doctor — human safety data in pregnancy are limited; animal studies did not show harm at most tested doses
- It is not known whether Trikafta passes into human breast milk; breastfeeding patients should discuss this with their doctor
- Children starting Trikafta should have a baseline eye exam before treatment and follow-up exams during treatment due to the risk of lens opacities (early cataracts)
- Patients with elevated vitamin A levels may be at higher risk for intracranial hypertension
- Women taking hormonal contraceptives should be aware that hormonal contraceptives may increase the risk of rash with Trikafta
- Tell your prescriber about all medications, supplements, and herbal products — especially antifungals, antibiotics, anti-seizure medications, and St. John's wort
🚑If you take too much▾
There is no specific antidote for a Trikafta overdose. If too much is taken, treatment is supportive — monitoring vital signs and the patient's clinical condition. If you suspect an overdose, contact a poison control center or seek emergency medical care right away.
📡Pharmacodynamics — effects in the body▾
In clinical trials, Trikafta produced meaningful reductions in sweat chloride — a direct measure of CFTR function — beginning as early as week 4 of treatment and sustained through 24 weeks across all age groups studied. In patients aged 6 to less than 12 years, the average reduction in sweat chloride was about 61 mmol/L compared to baseline. In patients aged 2 to less than 6 years, the average reduction was about 58 mmol/L. In older patients with non-F508del qualifying variants, sweat chloride fell by about 28 mmol/L compared to placebo. At up to twice the recommended dose, Trikafta did not prolong the heart's QT interval to any clinically meaningful extent.
🔬Pharmacokinetics — how your body processes it▾
All three components of Trikafta — elexacaftor, tezacaftor, and ivacaftor — are absorbed through the gastrointestinal tract and reach steady levels in the body within about one week. Food with fat significantly increases absorption, particularly for elexacaftor and ivacaftor, which is why all doses must be taken with a fatty meal or snack. All three drugs are broken down primarily by a liver enzyme called CYP3A4/5, so medications that affect this enzyme can significantly alter Trikafta levels. They are excreted mainly through the feces, with only a small fraction leaving the body through urine. The effective half-lives (how long each drug stays active in the body) are roughly 27 hours for elexacaftor, 25 hours for tezacaftor, and 15 hours for ivacaftor.
📦How to store it▾
Store at 20 ºC – 25 ºC (68 ºF – 77 ºF); excursions permitted to 15 ºC – 30 ºC (59 ºF – 86 ºF) .
📄 Written from Elexacaftor, Tezacaftor, and Ivacaftor’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
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.
- Major · 3
- Moderate · 94
- Minor · 41
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.
🩺 Pharmacist Counseling Corner
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? ▾
Does it matter what I eat when I take Trikafta? ▾
My doctor wants to check my liver regularly — is that really necessary? ▾
Are there medications I shouldn't take while on Trikafta? ▾
What side effects should I just watch, versus which ones mean I should call my doctor? ▾
My child is starting Trikafta — is there anything specific I should watch for? ▾
Is Elexacaftor, Tezacaftor, and Ivacaftor available over the counter? ▾
When was Elexacaftor, Tezacaftor, and Ivacaftor first available? ▾
Who makes Elexacaftor, Tezacaftor, and Ivacaftor? ▾
💬 Answers drafted from Elexacaftor, Tezacaftor, and Ivacaftor’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Elexacaftor, Tezacaftor, and Ivacaftor 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.
Tablet
How this form is used
- Treats cystic fibrosis in patients aged 6 years and older who have a qualifying CFTR gene variant
- Used as a morning dose (two tablets of the elexacaftor/tezacaftor/ivacaftor combination) plus a separate evening ivacaftor tablet, with the specific strength based on age and weight
- Swallow tablets whole — do not crush or chew
- Take with fat-containing food (such as eggs, peanut butter, cheese, nuts, whole milk, or food cooked with butter or oils)
- Take the morning dose and evening dose approximately 12 hours apart
- Follow your prescriber's exact dosing schedule, as the number of tablets and strengths differ by age and weight
📊 Elexacaftor, Tezacaftor, and Ivacaftor across the U.S. market
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.
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.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Elexacaftor, Tezacaftor, and Ivacaftor is used
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.
How commonly is Elexacaftor, Tezacaftor, and Ivacaftor prescribed? Of the 1,594 medications we measure, Elexacaftor, Tezacaftor, and Ivacaftor ranks #628 by Medicaid prescriptions — more than 61% of them.
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)
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.)
| Strength | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|
| 💊Tablet | |||
| TEZACAFTOR 25 mg/1; ELEXACAFTOR 50 mg/1; IVACAFTOR 37.5 mg | Patheon Pharmaceuticals Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| TEZACAFTOR 50 mg/1; ELEXACAFTOR 100 mg/1; IVACAFTOR 75 mg | Patheon Pharmaceuticals Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 💊Kits | |||
| — | Vertex Pharmaceuticals Incorporated × 14 listings | NDA | View NDC → |
Showing 16 of 16 products — FDA National Drug Code Directory. See every product, package size and price: browse all 16 Elexacaftor, Tezacaftor, and Ivacaftor NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Elexacaftor, Tezacaftor, and Ivacaftor — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Elexacaftor, Tezacaftor, and Ivacaftor in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Elexacaftor, Tezacaftor, and Ivacaftor went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 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.
Source: openFDA drug enforcement (recall) reports.
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.
RxCUI 2257010 2 dose forms · 4 strengths
-
Dose form (SCDF) Oral Granules RxCUI 2635012No current FDA listingClinical drug / strength (SCD) elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MGRxCUI 2635024elexacaftor 80 MG / ivacaftor 60 MG / tezacaftor 40 MGRxCUI 2635013 -
Dose form (SCDF) Oral Tablet RxCUI 2257009In current FDA listingsClinical drug / strength (SCD) elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MGRxCUI 2257011elexacaftor 50 MG / ivacaftor 37.5 MG / tezacaftor 25 MGRxCUI 2557214
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.
📦 Supply & shortage status
Whether Elexacaftor, Tezacaftor, and Ivacaftor is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Elexacaftor, Tezacaftor, and Ivacaftor belongs to the Cystic Fibrosis Transmembrane Conductance Regulator Potentiator class.
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.
🔬 Where this comes from
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.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Vertex Pharmaceuticals Incorporated is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.