Last reviewed 2026-05-13 · How we verify

Trikafta (Copackaged) (ELEXACAFTOR)

Trikafta works by correcting the faulty protein that causes cystic fibrosis, allowing the body to produce normal amounts of mucus.

At a glance

Mechanism of action

In people with cystic fibrosis, the protein that regulates mucus production is defective. This leads to thick, sticky mucus that clogs the lungs and digestive system. Trikafta helps to correct this defect, allowing the body to produce normal amounts of mucus that can be easily cleared from the lungs and digestive system.

Approved indications

• Cystic fibrosis

Boxed warnings

• WARNING: DRUG-INDUCED LIVER INJURY AND LIVER FAILURE TRIKAFTA can cause serious and potentially fatal drug-induced liver injury. Cases of liver failure leading to transplantation and death have been reported in patients with and without a history of liver disease taking TRIKAFTA, in both clinical trials and the postmarketing setting [see Adverse Reactions (6) ]. Liver injury has been reported within the first month of therapy and up to 15 months following initiation of TRIKAFTA . Assess liver function tests (ALT, AST, alkaline phosphatase, and bilirubin) in all patients prior to initiating TRIKAFTA. Assess 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 Dosage and Administration (2.1) , Warnings and Precautions (5.1) , Adverse Reactions (6) and Use in Specific Populations (8.7) ] . Interrupt TRIKAFTA 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. If abnormalities resolve, resume treatment only if the benefit is expected to outweigh the risk. Closer monitoring is advised after resuming TRIKAFTA [see Warnings and Precautions (5.1) ] . TRIKAFTA should not be used in patients with severe hepatic impairment (Child-Pugh Class C). TRIKAFTA is not recommended in patients with moderate hepatic impairment (Child-Pugh Class B). If used, use with caution at a reduced dosage and monitor patients closely [see Dosage and Administration (2.3) , Warnings and Precautions (5.1) , Adverse Reactions (6) , Use in Specific Populations (8.7) and Clinical Pharmacology (12.3) ] . WARNING: DRUG-INDUCED LIVER INJURY AND LIVER FAILURE See full prescribing information for complete boxed warning. TRIKAFTA can cause serious and potentially fatal drug-induced liver injury. Liver failure leading to transplantation and death has been reported. ( 5.1 , 6 ) Assess liver function tests (ALT, AST, alkaline phosphatase, bilirubin) in all patients prior to initiating TRIKAFTA. ( 2.1 , 5.1 ) Monitor liver function tests (ALT, AST, alkaline phosphatase, bilirubin) every month for the first 6 months of treatment, then every 3 months for the next 12 months, then at least annually. ( 2.1 , 5.1 ) Interrupt TRIKAFTA for significant elevations in liver function tests or signs or symptoms of liver injury. Follow patients closely with clinical and laboratory monitoring until abnormalities resolve. ( 5.1 ) Resume TRIKAFTA if abnormalities resolve and only if the benefit is expected to outweigh the risk. ( 5.1 ) TRIKAFTA should not be used in patients with severe hepatic impairment (Child-Pugh Class C). TRIKAFTA is not recommended in patients with moderate hepatic impairment (Child-Pugh Class B). ( 2.3 , 5.1 , 8.7 , 12.3 )

Common side effects

• Headache
• Upper respiratory tract infection
• Abdominal pain
• Diarrhea
• Rash
• Alanine aminotransferase increased
• Nasal congestion
• Blood creatine phosphokinase increased
• Aspartate aminotransferase increased
• Rhinorrhea
• Rhinitis
• Influenza

Serious adverse events

• Rash
• Influenza

Key clinical trials

• Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis (CF) Participants 2 Years and Older (PHASE3)
• Modulate-CF: Cystic Fibrosis Transmembrane Regulator (CFTR) Biomarker Study to Evaluate the Rescue of Mutant CFTR in Patients With Cystic Fibrosis Treated With CFTR-modulators
• Population Pharmacokinetics of Elexacaftor-tezacaftor-ivacaftor in a Paediatric Population
• Trikafta for Patients With Non-cystic Fibrosis Bronchiectasis (PHASE4)
• Impact of Elexacaftor-Tezacaftor-Ivacaftor Treatment on Metabolic, Epigenetic and Fecal Microbiota Profiles in People With Cystic Fibrosis.
• Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) Long-term Safety and Efficacy in Subjects Without F508del (PHASE3)
• Glucose Metabolism in Cystic Fibrosis Related Diabetes (CFRD)
• Prevalence of Exercise-induced Ventilatory Limitation and Associated Factors in Patients With Cystic Fibrosis Receiving Elexacaftor-Tezacaftor-Ivacaftor (NA)

Patents

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Trikafta (Copackaged) CI brief — competitive landscape report
• Trikafta (Copackaged) updates RSS · CI watch RSS
• Vertex Pharms Inc portfolio CI