Why is this medication prescribed?

Kalydeco (generic name: ivacaftor) is prescribed as a medication for the treatment of cystic fibrosis (CF) in patients who have specific mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. CF is a genetic disorder that primarily affects the lungs and digestive system, leading to the production of thick, sticky mucus in these organs.

Kalydeco is specifically approved for use in individuals with CF who have certain mutations in the CFTR gene, including G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H. These mutations result in a defective CFTR protein, which is responsible for regulating the movement of salt and water in and out of cells. Kalydeco works by improving the function of the defective CFTR protein, which helps to reduce the production of thick mucus and improve lung function in CF patients.

How should this medicine be used?

Kalydeco (ivacaftor) is available in the form of oral tablets and should be taken as prescribed by a healthcare professional. Here are some general guidelines for using Kalydeco:

• Dosage: The recommended dosage of Kalydeco varies depending on the individual’s age, weight, and specific CFTR gene mutation. It is important to follow the prescribed dosage instructions provided by the healthcare professional.
• Timing: Kalydeco is typically taken with fat-containing food or a nutritional supplement that contains fat. This helps the body absorb the medication properly. It is important to take Kalydeco as instructed by the healthcare professional, usually once daily or as directed.
• Swallowing: The Kalydeco tablet should be swallowed whole with water. Do not crush, chew, or break the tablet unless specifically advised by a healthcare professional.
• Missed Dose: If a dose of Kalydeco is missed, it should be taken as soon as possible. However, if it is close to the time for the next scheduled dose, it is advisable to skip the missed dose and continue with the regular dosing schedule. It is important not to double the dose to make up for a missed one.
• Other Medications: It is crucial to inform the healthcare professional about all other medications, supplements, or treatments being taken, as they may interact with Kalydeco. Certain medications, such as strong CYP3A inhibitors or inducers, may affect the effectiveness or safety of Kalydeco.

Remember, these are general guidelines, and it is essential to follow the specific instructions provided by the prescribing healthcare professional. If there are any questions or concerns about the usage of Kalydeco, it is always best to consult with a healthcare professional or pharmacist for clarification.

Other uses for this medicine

Kalydeco (ivacaftor) is primarily used for the treatment of cystic fibrosis (CF) in individuals who have specific mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. However, it is important to note that Kalydeco is not approved or recommended for use in conditions other than CF. Its efficacy and safety profile have been specifically studied and established in CF patients with certain CFTR gene mutations.

What special precautions should I follow?

As for special precautions associated with Kalydeco, here are some important considerations:

• Allergies: Individuals with a known allergy or hypersensitivity to ivacaftor or any of the inactive ingredients in Kalydeco should not take this medication.
• Drug Interactions: Kalydeco may interact with other medications, including strong CYP3A inhibitors or inducers. These interactions can affect the effectiveness or safety of Kalydeco. It is crucial to inform the healthcare professional about all other medications, including prescription drugs, over-the-counter medications, and supplements, being taken to avoid potential interactions.
• Liver Function: Kalydeco can cause elevated liver enzymes, so regular monitoring of liver function is recommended during treatment. If significant liver enzyme elevations occur, the healthcare professional may adjust the dose or discontinue the medication.
• Pregnancy and Breastfeeding: The safety of Kalydeco during pregnancy or breastfeeding has not been well established. It is important to discuss the potential risks and benefits with a healthcare professional if pregnancy or breastfeeding is planned.
• Side Effects: Like any medication, Kalydeco can have side effects. Common side effects may include headache, upper respiratory tract infection, stomach pain, diarrhea, rash, nausea, and dizziness. It is important to report any concerning or persistent side effects to a healthcare professional.

These are just some of the precautions associated with Kalydeco. It is crucial to consult with a healthcare professional or refer to the medication’s prescribing information for a comprehensive list of precautions, warnings, and potential adverse effects specific to individual circumstances.

What special dietary instructions should I follow?

Special dietary instructions for Kalydeco (ivacaftor) include taking the medication with fat-containing food or a nutritional supplement that contains fat. This helps improve the absorption of the medication. It is generally recommended to take Kalydeco with a meal or a snack that includes fat. However, it is important to follow the specific instructions provided by the healthcare professional or pharmacist regarding the timing and composition of meals while taking Kalydeco.

What should I do if I forget a dose?

If you forget to take a dose of Kalydeco, here’s what you should do:

• Timing: If you realize that you missed a dose close to the time for your next scheduled dose, it is best to skip the missed dose and continue with your regular dosing schedule.
• Missed Dose: If there is a significant time gap between the missed dose and the next scheduled dose, you can take the missed dose as soon as you remember. However, it is important not to double the dose to make up for the missed one. Taking more than the prescribed amount can increase the risk of side effects.

What side effects can this medication cause?

Kalydeco (ivacaftor) may cause side effects in some individuals. While not everyone experiences these side effects, it is important to be aware of them. Common side effects associated with Kalydeco can include:

• Headache
• Upper respiratory tract infection (such as the common cold)
• Stomach pain
• Diarrhea
• Nausea
• Rash
• Dizziness

These side effects are generally mild and may not require medical attention unless they are persistent, bothersome, or worsen over time. It is important to inform your healthcare professional about any side effects you experience while taking Kalydeco.

In some cases, Kalydeco may cause more serious side effects. While these are less common, they should be reported to a healthcare professional immediately. These serious side effects can include:

• Liver problems: Kalydeco may cause elevated liver enzymes. Symptoms can include yellowing of the skin or eyes (jaundice), dark urine, abdominal pain, or unexplained itching. Regular liver function tests are usually conducted during treatment with Kalydeco to monitor for any liver-related issues.
• Breathing problems: If you experience new or worsened shortness of breath or wheezing while taking Kalydeco, it should be reported to a healthcare professional.
• Allergic reactions: While rare, severe allergic reactions to Kalydeco can occur. Symptoms can include rash, itching, swelling, severe dizziness, or difficulty breathing. If you experience any signs of an allergic reaction, seek immediate medical attention.

It is important to consult with your healthcare professional for a complete list of potential side effects, as well as any specific concerns you may have. They can provide you with personalized information and guidance based on your individual health condition and medical history.

What should I know about storage and disposal of this medication?

• Storage: Kalydeco tablets should be stored at room temperature, away from excessive heat, moisture, and direct light. It is important to follow the recommended storage conditions mentioned on the packaging or as advised by the pharmacist.
• Keep out of reach of children and pets: Store Kalydeco in a secure location to prevent accidental ingestion by children or pets. If accidental ingestion occurs, seek medical assistance immediately.
• Disposal: It is important to properly dispose of unused or expired medication to prevent potential harm. Follow the disposal instructions provided by your healthcare professional or pharmacist. Do not flush Kalydeco down the toilet or pour it down the drain unless specifically instructed to do so.

In case of emergency/overdose

In case of emergency or overdose, promptly seek medical attention or contact a poison control center. Overdose symptoms may include dizziness, nausea, vomiting, stomach pain, and headache. It is helpful to provide healthcare professionals with as much information as possible, including the medication name (Kalydeco), dosage, and the circumstances surrounding the overdose.

What other information should I know?

It is essential to keep regular follow-up appointments with your healthcare professional to monitor your response to Kalydeco and adjust the treatment plan if necessary. Additionally, inform all healthcare providers involved in your care that you are taking Kalydeco, as it may interact with other medications or treatments.

If you have any further questions or concerns about Kalydeco, its storage, usage, or any other related information, it is recommended to consult your healthcare professional or pharmacist for personalized guidance. They can provide you with specific instructions based on your individual circumstances and medical history.