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Trikafta
Elexacaftor/tezacaftor/ivacaftor (combination)
$37595.00
50mg/25mg/37.5mg · 84 tablets · 3 months supply
BrandBranded medicine· By Vertex Pharmaceuticals
$12531.67 per month
Strength
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Annual cost
$150380a year at this pack size
Prescription required
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50mg/25mg/37.5mg
100MG/50MG/75MG/150MG
100mg/50mg/75mg
80/40/602mg
FDA boxed warningDrug-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. 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.
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.
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.
TRIKAFTA can cause serious and potentially fatal drug-induced liver injury. Liver failure leading to transplantation and death has been reported.
Assess liver function tests (ALT, AST, alkaline phosphatase, bilirubin) in all patients prior to initiating TRIKAFTA.
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.
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.
Resume TRIKAFTA if abnormalities resolve and only if the benefit is expected to outweigh the risk.
About Trikafta
Overview
Trikafta contains elexacaftor, tezacaftor and ivacaftor, supplied as combination tablets co-packaged with separate ivacaftor tablets. It treats cystic fibrosis in adults and children aged 2 years and older who have a clinical diagnosis and at least one CFTR gene variant that responds to treatment or results in CFTR protein production. If the gene variant is unknown, an FDA-cleared cystic fibrosis genetic test is needed to confirm eligibility. It works by helping more CFTR protein reach the cell surface and helping its channels open, increasing chloride movement through them.
What it treats
Cystic fibrosis (CF) in adults and children aged 2 years and older with a clinical diagnosis of CF and at least one CFTR gene variant that is responsive to Trikafta based on clinical or laboratory data, or that results in production of CFTR protein.
Safety information
Side effects
Common side effects include headache, upper respiratory tract infections, stomach pain, diarrhea, constipation, rash, a blocked or runny nose, inflammation inside the nose, flu and sinus infections. Blood tests may show increased liver enzymes, bilirubin or creatine phosphokinase. Serious side effects that need medical attention include: • Liver injury and liver failure, which can be fatal. Liver blood tests are needed before and throughout treatment. • Severe allergic reactions, including swelling beneath the skin (angioedema) and anaphylaxis. Seek emergency medical help for a severe allergic reaction. • Increased pressure inside the skull. Contact a doctor promptly if you develop an unusual headache or changes in vision. • New or worsening anxiety, depression, sleep disturbances, or suicidal thoughts or behavior. Contact a doctor promptly for mental health changes; seek emergency help for suicidal thoughts or behavior. • Cataracts have been reported in children taking medicines containing ivacaftor. Eye examinations are recommended before and during treatment in children.
FDA boxed 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. 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.
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.
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.
TRIKAFTA can cause serious and potentially fatal drug-induced liver injury. Liver failure leading to transplantation and death has been reported.
Assess liver function tests (ALT, AST, alkaline phosphatase, bilirubin) in all patients prior to initiating TRIKAFTA.
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.
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.
Resume TRIKAFTA if abnormalities resolve and only if the benefit is expected to outweigh the risk.
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
The label lists no formal contraindications. However, Trikafta should not be used in people with severe liver impairment and is not recommended for those with moderate liver impairment. Trikafta can cause serious, potentially fatal liver injury. Liver blood tests are required before and throughout treatment. Treatment should be interrupted if significant liver test abnormalities or signs of liver injury occur. Other conditions requiring caution include: - Serious allergic reactions, including angioedema (swelling) and anaphylaxis, have been reported and require appropriate treatment. - Raised pressure inside the skull has been reported. An unusual headache or changes in vision require prompt medical assessment; treatment should be interrupted if this condition is suspected. - Serious mental health effects, including anxiety, depression, suicidal thoughts or behaviour, and sleep disturbances, have been reported with Trikafta or medicines containing the same or similar active ingredients. Close monitoring for new or worsening symptoms is needed. The prescriber should assess whether treatment needs to be interrupted. - Use with strong CYP3A inducers, such as rifampin or St. John’s wort, is not recommended because they may reduce Trikafta’s effectiveness. - Cataracts have been reported in children receiving ivacaftor-containing medicines. Eye examinations are recommended before and during treatment in children.
Interactions
Tell your doctor about other medicines or supplements you take. Trikafta should not be used with strong CYP3A inducers. Strong or moderate CYP3A inhibitors require your prescriber to reduce your Trikafta dose. Ask your doctor whether any of your medicines fall into these groups. Avoid food or drinks containing grapefruit.
Using Trikafta
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store below 25°C in a dry place, in the original pack, away from direct light and moisture. Do not keep it in a bathroom. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label TRIKAFTA (ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR) KIT [VERTEX PHARMACEUTICALS INCORPORATED] (DailyMed, retrieved 19 September 2026).
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