Prescription medicine
Deutivacaftor and tezacaftor and vanzacaftor Brand names: Alyftrek
Deutivacaftor and tezacaftor and vanzacaftor (Alyftrek) is a prescription medicine with an FDA approval on record since 2024. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the deutivacaftor and tezacaftor and vanzacaftor FDA label on DailyMed (effective August 26, 2026, Vertex Pharmaceuticals Incorporated); the NDA 218730 record on Drugs@FDA; every deutivacaftor and tezacaftor and vanzacaftor label on DailyMed.
Highlights of the record
FDA label of August 26, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
DRUG-INDUCED LIVER INJURY AND LIVER FAILURE.
Elevated transaminases have been observed in patients treated with ALYFTREK. Cases of serious and potentially fatal drug-induced liver injury and liver failure were reported in patients who were taking a fixed-dose combination drug containing elexacaftor, tezacaftor, and ivacaftor, which contains the same or similar active ingredients as ALYFTREK. Liver injury has been reported within the first month of therapy and up to 15 months following initiation of elexacaftor/tezacaftor/ivacaftor [see Warnings and Precautions (5.1) and Adverse Reactions (6) ]. Assess liver function tests (ALT, AST, alkaline phosphatase, and bilirubin) in all patients prior to initiating ALYFTREK, 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 elevated liver function tests at baseline [see Dosage and Administration (2.1), Warnings and Precautions (5.1), Adverse Reactions (6), and Use in Specific Populations (8.7) ]. Interrupt ALYFTREK for significant elevations in liver function tests or in the event of signs or symptoms of liver injury. Consider referral to a hepatologist. Follow patients closely with clinical and laboratory monitoring until abnormalities resolve. […]
Used for
From the label: indications and usageALYFTREK is indicated for the treatment of cystic fibrosis (CF) in adult and pediatric patients 6 years of age and older who have a clinical diagnosis of CF and who have at least one variant in the cystic fibrosis transmembrane conductance regulator ( CFTR ) gene that is either responsive based on clinical and/or in vitro data (see Table 5 ) or results in production of CFTR protein [see Clinical Pharmacology (12.1) ]
Forms and strengths
- 4 mg / 20 mg / 50 mg
- 10 mg / 50 mg / 125 mg
Film-coated tablet.
On the market
- Earliest approval on file
- December 20, 2024 Alyftrek, Vertex Pharms Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- January 10, 2043 Alyftrek tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 666 through July 30, 2026
What is deutivacaftor and tezacaftor and vanzacaftor used for?
From the label: indications and usageALYFTREK is indicated for the treatment of cystic fibrosis (CF) in adult and pediatric patients 6 years of age and older who have a clinical diagnosis of CF and who have at least one variant in the cystic fibrosis transmembrane conductance regulator ( CFTR ) gene that is either responsive based on clinical and/or in vitro data (see Table 5 ) or results in production of CFTR protein [see Clinical Pharmacology (12.1) ]. If the patient's genotype is unknown, an FDA-cleared CF genetic test should be used to confirm the presence of at least one variant in the CFTR gene that is either responsive based on clinical and/or in vitro data or results in production of CFTR protein. […]
FDA pharmacologic class: Cystic Fibrosis Transmembrane Conductance Regulator Potentiator.
Source: FDA drug label (ALYFTREK), Vertex Pharmaceuticals Incorporated, effective August 26, 2026 (SPL set 7e635909-c6fd-4f0d-ae77-cdff03653a20), via openFDA; the full label on DailyMed
What does the patient leaflet for deutivacaftor and tezacaftor and vanzacaftor say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ALYFTREK?Elevated liver enzymes have been observed in patients taking ALYFTREK . Cases of serious liver damage and liver failure leading to transplantation and death have been seen in some people with or without a history of liver problems taking elexacaftor/tezacaftor/ivacaftor (TRIKAFTA), a medicine which has the same or similar active ingredients as ALYFTREK. Your healthcare provider will do blood tests to check your liver: before you start ALYFTREK every month during your first 6 months of taking ALYFTREK then every 3 months during the next 12 months of taking ALYFTREK then at least every year while you are taking ALYFTREK 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 ALYFTREK 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 have fluid in your stomach area (ascites)
From the patient leaflet: What should I avoid while taking ALYFTREK?Avoid food or drink that contains grapefruit while you are taking ALYFTREK.
From the patient leaflet: How should I store ALYFTREK?Store ALYFTREK at room temperature between 68°F to 77°F (20°C to 25°C). Keep ALYFTREK and all medicines out of the reach of children.
Source: FDA drug label (ALYFTREK), Vertex Pharmaceuticals Incorporated, effective August 26, 2026 (SPL set 7e635909-c6fd-4f0d-ae77-cdff03653a20), via openFDA; the full label on DailyMed
Is there a generic for deutivacaftor and tezacaftor and vanzacaftor (Alyftrek)?
No generic deutivacaftor and tezacaftor and vanzacaftor is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 33 patents for Alyftrek tablets: the compound patent runs to August 13, 2040, and the last listed entry to January 10, 2043. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2024 earliest approval on file
- 2043 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the deutivacaftor and tezacaftor and vanzacaftor label say about other medicines?
The deutivacaftor and tezacaftor and vanzacaftor label names 4 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Ciprofloxacin | drug interactions | Interactions with ALYFTREK Ciprofloxacin No clinically relevant effect on the exposure of tezacaftor was observed when tezacaftor/ivacaftor was used concomitantly with ciprofloxacin [see Clinical Pharmacology (12.3) ]. |
| Estradiol and norethindrone | drug interactions | Hormonal Contraceptives No clinically significant differences in the pharmacokinetics of ethinyl estradiol/norethindrone containing hormonal contraceptives were observed when used concomitantly with tezacaftor in combination with ivacaftor and ivacaftor alone [see Clinical Pharmacology (12.3) ]. |
| Ivacaftor | boxed warning | Cases of serious and potentially fatal drug-induced liver injury and liver failure were reported in patients who were taking a fixed-dose combination drug containing elexacaftor, tezacaftor, and ivacaftor, which contains the same or similar active ingredients as ALYFTREK. |
| Warfarin | drug interactions | Monitor the international normalized ratio (INR) more frequently with concomitant use of ALYFTREK with warfarin. |
Check deutivacaftor and tezacaftor and vanzacaftor against other medicines
Source: FDA drug label (ALYFTREK), Vertex Pharmaceuticals Incorporated, effective August 26, 2026 (SPL set 7e635909-c6fd-4f0d-ae77-cdff03653a20), via openFDA; the full label on DailyMed
What do FAERS reports show for deutivacaftor and tezacaftor and vanzacaftor?
The FDA Adverse Event Reporting System holds 666 reports that list deutivacaftor and tezacaftor and vanzacaftor among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6 are coded as a death and 162 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other cystic fibrosis transmembrane conductance regulator potentiators
- the pharmacologic class, with prices and generics
- Deutivacaftor and tezacaftor and vanzacaftor side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other