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The following information outlines important safety precautions and potential risks associated with the use of Kalydeco (ivacaftor). Please review these details carefully and discuss any concerns with your healthcare provider.

• Liver Health Monitoring: Kalydeco (ivacaftor) may cause elevated liver function tests. It is crucial to monitor liver health regularly. Your healthcare provider will perform liver tests before starting treatment, every three months during the first year, and annually thereafter. Patients with a history of liver issues may require more frequent monitoring. Seek immediate medical attention if you notice symptoms such as stomach pain, dark urine, pale stools, or yellowing of the skin or eyes.

• Drug Interactions: The effectiveness and safety of Kalydeco (ivacaftor) can be influenced by interactions with other medications. It is important to inform your healthcare provider about all the medicines you are taking to manage potential interactions and side effects.

• Risk of Cataracts in Children: There is a risk of cataract development in children taking Kalydeco (ivacaftor). Regular eye examinations are recommended before and during treatment. The risk may be increased if the child is also using corticosteroid medications or has been exposed to radiation.

Please ensure that you follow these guidelines and consult your healthcare provider for personalized advice and further information on managing your treatment with Kalydeco (ivacaftor).

When taking this medication, you may experience some common side effects that are usually mild and tend to resolve on their own. These include headaches, sore throat, upper respiratory tract infections like coughs and colds, stuffy nose, stomach pain, common colds, diarrhea, rashes, nausea, and dizziness. It's important to note that while these effects are common, they are generally not severe. However, if they persist or become bothersome, it is advisable to consult your healthcare provider.

In addition to these, some individuals have reported other side effects such as high blood sugar, joint pain, chest pain, muscle pain, wheezing, and acne. While these are less common, you should still be aware of them and seek guidance from a healthcare professional if they occur.

There are also rare but serious side effects that require immediate medical attention. These include signs of liver damage, such as persistent nausea or vomiting, loss of appetite, dark urine, stomach or abdominal pain, and yellowing of the skin or eyes. Severe allergic reactions, though rare, are also possible, with symptoms like rash, itching or swelling especially on the face, tongue, or throat, severe dizziness, and trouble breathing.

If you develop a rash, even though it is common and usually not serious, it is important to inform your doctor immediately as it could sometimes indicate a severe reaction. Always stay vigilant and report any unusual or severe symptoms to your healthcare provider promptly.