Kalydeco Tablet, Film Coated
Product Images NDC 51167-200

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Kalydeco (NDC 51167-200). 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.

FDA Label Image

Chemical Structure (Kalydeco 01)

Chemical structure of ivacaftor, the active ingredient in Kalydeco. The diagram shows the molecular arrangement of atoms and bonds characteristic of ivacaftor's chemical formula.*

FDA Label Image

Figure 1 (Kalydeco 02)

A graphical figure showing fold changes with 90% confidence intervals in pharmacokinetic parameters (Cmax and AUC) for various co-administered drugs interacting with the main drug. The chart includes CYP3A substrate Midazolam, oral contraceptives, CYP2C substrate Rosiglitazone, CYP2D6 substrate Desipramine, and P-gp substrate Digoxin, along with corresponding interaction recommendations such as dose adjustment guidance and monitoring advice.*

FDA Label Image

Figure 2 (Kalydeco 03)

A pharmacokinetic chart showing fold changes in Cmax and AUC of Kalydeco (ivacaftor) when coadministered with various CYP3A inhibitors, inducers, substrates, and other drugs. The chart includes recommendations for dose adjustments based on these interactions on a log scale change relative to reference.*

FDA Label Image

Figure 3 (Kalydeco 04)

Two line graphs labeled Trial 1 and Trial 2 showing absolute change in percent predicted FEV1 (mean ± SEM) over 48 weeks. The graphs compare placebo and ivacaftor treatment groups, with ivacaftor showing higher positive changes compared to placebo in both trials.*

FDA Label Image

Figure 4 (Kalydeco 05)

Kalydeco (ivacaftor) tablets 150 mg per tablet packaging label by Vertex Pharmaceuticals Incorporated. The carton contains 56 tablets, arranged in 4 blister cards of 14 tablets each. The label includes storage instructions, dosage form, and patient usage guidance illustrating a twice-daily dosing schedule with food containing fat.*

FDA Label Image

Principal Display Panel (150 mg Tablet Blister Card Carton)

Packaging label for Kalydeco (ivacaftor) tablets, 150 mg strength. The label indicates the product contains 60 tablets and is manufactured for Vertex Pharmaceuticals Incorporated. Storage instructions and barcode are present, along with trademark and manufacturing information. The label design features teal and purple colors with the Vertex logo.*

FDA Label Image

Principal Display Panel (150 mg Tablet Bottle Carton)

Kalydeco 50 mg oral granules carton label by Vertex Pharmaceuticals Incorporated. The label indicates 56 packets per carton, each containing 50 mg ivacaftor. Packaging instructions note 4 individual wallets with 14 packets each. The label includes storage information and dosage guidance highlighting use every 12 hours or as directed by a healthcare provider.*

FDA Label Image

Principal Display Panel (50 mg Granule Packet Carton)

Packaging label for Kalydeco 75 mg oral granules, containing ivacaftor. The carton indicates 56 packets total, divided into 4 individual wallets with 14 packets each. The labeler is Vertex Pharmaceuticals Incorporated. Storage instructions and a reminder to contact the pharmacy 7 to 10 days before running out are included. Directions mention taking one packet every 12 hours or as directed by a healthcare provider.*

FDA Label Image

Principal Display Panel (75 mg Granule Packet Carton)

The image shows the flattened carton label for Kalydeco 25 mg (ivacaftor) oral granules by Vertex Pharmaceuticals Incorporated. The label states that the carton contains 56 packets, each with 25 mg ivacaftor, organized in 4 individual wallets of 14 packets each. Instructions for use and storage information are also visible.*

* 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.