Chemical Structure (Kalydeco 01)
Kalydeco Granule
Product Images NDC 51167-300
View Photos of Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Kalydeco (NDC 51167-300). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Vertex Pharmaceuticals Incorporated, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.
Product Images & Figures Index
Figure 1 (Kalydeco 02)
This is a drug interaction warning indicating the effects of co-administered drugs: Midazolam, Rosiglitazone, and Desipramine. It suggests monitoring for benzodiazepine-related side effects when using Midazolam, and appropriate monitoring for other CYP3A substrates such as cyclosporine and tacrolimus. There is no adjustment recommended for oral contraceptives or CYP2C9 substrates in rosiglitazone, and CYP2D6 substrate desipramine. The warning advises monitoring for serum digoxin concentrations and use of other P-gp substrates with caution and with monitoring.*
Figure 2 (Kalydeco 03)
This is a drug interaction table which provides recommendations for dosage adjustments of KALYDECO when co-administered with different drugs. The table includes information on CYP3A inhibitors, CYP3A inducers, and CYP3A substrates. The PK values, AUC, fold change and 90% CI are used to recommend a reduced dose of KALYDECO. The table recommends a reduction in the KALYDECO dose when used with certain drugs such as ketoconazole, fluconazole, and erythromycin. The use of certain drugs such as phenobarbital, carbamazepine and St John's wort is not recommended when using KALYDECO.*
Figure 3 (Kalydeco 04)
Figure 4 (Kalydeco 05)
KALYDECO is a prescription medicine that comes in tablets containing 150mg of ivacaftor. It's manufactured by Vertex Pharmaceuticals and used for treating cystic fibrosis in patients who have specific mutations in their cystic fibrosis transmembrane conductance regulator (CFTR) gene. Patients are required to follow the instructions given by their doctors while taking this medication. The tablets should be stored at a controlled room temperature, and each tablet must be taken with food that contains fat. The package insert provides detailed information regarding the dosage, precautions, and side effects of KALYDECO.*
Principal Display Panel (150 mg Tablet Blister Card Carton)
Principal Display Panel (150 mg Tablet Bottle Carton)
KALYDECO (ivacaftor) oral granules are to be taken every 12 hours or as directed by your healthcare provider. Each packet contains 50 mg acaftor, and the usual dosage is mentioned in the Prescribing Information. It is recommended to keep the medicine at a controlled temperature of 20-25°C (68-77°F), with excursions allowed to 15-30°C (59-86°F). It is important to contact the pharmacy 7 to 10 days before the last dose to ensure the next supply of medicine arrives on time. The Patient Package Insert should be followed for directions for use. The NDC number for KALYDECO is 1167-300:01.*
Principal Display Panel (50 mg Granule Packet Carton)
Kalydeco (ivacaftor) oral granules are medication used to treat cystic fibrosis. Each packet of Kalydeco contains 75mg of the active ingredient (ivacaftor) and should be taken every 12 hours, as directed by your healthcare provider. The patient package insert contains directions for use. It is important to ensure timely delivery of medication. The medication should be stored at a controlled temperature range of 20-25°C (68-77°F), with a permitted temperature excursion of 15-30°C (59-86°F). Kalydeco is a prescription drug and should only be taken as prescribed by a healthcare provider. The product is manufactured by Vertex Pharmaceuticals Incorporated and its National Drug Code (NDC) is 51167-400-01.*
Principal Display Panel (75 mg Granule Packet Carton)
This appears to be a mix of text, some of which is illegible, and fragmented information about a medication called KALYDECO, which is an oral granule medication consisting of 25mg of acor that is typically taken every 12 hours. The text provides prescribing information, dosage instructions and an image of the medication carton containing 4 individual wallets. However, due to illegible, incomplete and scattered text, it is difficult to determine more specific details about the medication or its uses.*
* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.
