Kalydeco

Before taking this medicine

The FDA label lists no contraindications for Kalydeco. However, the following precautions apply: Liver enzymes may rise during treatment. Liver blood tests are needed before starting, every 3 months during the first year, and annually thereafter. More frequent testing may be needed if liver enzymes have been elevated before. Treatment should be interrupted if ALT or AST exceeds 5 times the upper limit of normal. Restarting treatment requires an assessment of the benefits and risks after levels return to normal. Severe allergic reactions, including anaphylaxis, have been reported and require prompt medical treatment. Raised pressure inside the skull has been reported with medicines containing the same or similar active ingredients. An unusual headache or changes in vision require prompt medical evaluation; treatment should be interrupted if this condition is suspected. Serious mental health and sleep-related symptoms have been reported with Kalydeco or medicines containing the same or similar active ingredient. These include anxiety, depression, suicidal thoughts or behaviour, and sleep disturbances. Patients should be monitored closely for new or worsening symptoms. 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 can reduce ivacaftor exposure and effectiveness. Cataracts have been reported in children receiving Kalydeco. Eye examinations are recommended before treatment and during follow-up.