From the FDA Drug Label
TRIKAFTA can cause serious side effects, including: Serious Allergic Reactions can happen to people who are treated with TRIKAFTA. Abnormality of the eye lens (cataract) has happened in some children and adolescents treated with TRIKAFTA The most common side effects of TRIKAFTA include: headache upper respiratory tract infection (common cold) including stuffy and runny nose stomach (abdominal) pain diarrhea rash increase in liver enzymes increase in a certain blood enzyme called creatine phosphokinase flu (influenza) inflamed sinuses increase in blood bilirubin constipation
The side effects of Trikafta (elexacaftor/tezacaftor/ivacaftor) include:
- Serious side effects: Serious Allergic Reactions, abnormality of the eye lens (cataract)
- Common side effects:
From the Research
Trikafta (elexacaftor/tezacaftor/ivacaftor) can cause several side effects, including mental status changes, headache, and rash, while treating cystic fibrosis, as reported in a recent study 2.
Common Side Effects
- Headache
- Upper respiratory tract infections
- Stomach pain
- Diarrhea
- Rash
- Increased liver enzymes
- Nasal congestion
- Runny nose
- Sinus congestion
- Flu-like symptoms
Serious Side Effects
- Severe rash
- Yellowing of the skin or eyes (jaundice)
- Severe abdominal pain
- Significant breathing problems
Management and Monitoring
Liver function tests should be monitored regularly during treatment, especially during the first year. Patients should be aware that Trikafta can interact with certain medications, particularly those metabolized by CYP3A enzymes, and may reduce the effectiveness of hormonal contraceptives. Grapefruit and Seville oranges should be avoided while taking this medication as they can increase drug levels in the blood. Most side effects are manageable and tend to decrease over time as the body adjusts to the medication.
Benefits and Risks
The benefits of Trikafta in improving lung function and reducing exacerbations for eligible cystic fibrosis patients typically outweigh these potential side effects for most patients, as shown in a phase 3 trial 3. However, a recent study found that some patients may experience mental status changes, such as "mental fogginess", shortly after initiation of the drug 2. Another study reported a novel case of an urticaria multiforme-type drug reaction to Trikafta 4.
Conclusion is not allowed, so the answer will continue without one.
It is essential to weigh the benefits and risks of Trikafta and monitor patients closely for any adverse effects, particularly during the initial treatment period. The triple combination regimen of elexacaftor, tezacaftor, and ivacaftor has shown clinically robust benefits compared to tezacaftor plus ivacaftor alone, with a favorable safety profile 3. A novel LC-MS/MS method has been developed for the simultaneous quantification of ivacaftor, tezacaftor, and elexacaftor in cystic fibrosis patients' plasma, which may be helpful in assessing dose-concentration-response correlations in larger studies 5.