What is Kalydeco used for?

1 INDICATIONS AND USAGE KALYDECO is indicated for the treatment of cystic fibrosis (CF) in patients aged 1 month and older who have at least one mutation in the CFTR gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data [see Clinical Pharmacology (12.1) and Clinical Studies (14) ] . If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of a CFTR mutation followed by verification with bi-directional seq

How does Kalydeco work?

11 DESCRIPTION The active ingredient in KALYDECO tablets and oral granules is ivacaftor, a cystic fibrosis transmembrane conductance regulator potentiator, which has the following chemical name: N -(2,4-di-tert-butyl-5-hydroxyphenyl)-1,4-dihydro-4-oxoquinoline-3-carboxamide.

What is the active ingredient in Kalydeco?

Tezacaftorum + Ivacaftorum (Ivacaftorum, Tezacaftorum)

What pharmaceutical form is Kalydeco available in?

Kalydeco: Tabletki powlekane 100 mg + 150 mg (doustna)

Is Kalydeco OTC or prescription only?

Kalydeco requires a doctor's prescription.

What are the side effects of Kalydeco?

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Transaminase Elevations [ see Warnings and Precautions (5.1) ] Hypersensitivity Reactions, Including Anaphylaxis [see Warnings and Precautions (5.2) ] Intracranial Hypertension [see Warnings and Precautions (5.3) ] Neuropsychiatric Events, Including Suicidal Thoughts and Behaviors [see Warnings and Precautions (5.4) ] Cataracts [see Warnings and Precautions (5.6) ] The most comm

Who should NOT take Kalydeco?

4 CONTRAINDICATIONS None. None ( 4 )

Does Kalydeco interact with other medications?

7 DRUG INTERACTIONS Potential for other drugs to affect ivacaftor CYP3A inhibitors: Reduce KALYDECO dosage in patients aged 6 months and older when co-administered with strong CYP3A inhibitors (e.g., ketoconazole) or moderate CYP3A inhibitors (e.g., fluconazole). KALYDECO is not recommended in patients aged 1 month to less than 6 months when co-administered with strong or moderate CYP3A inhibitors. Avoid food or drink containing grapefruit. ( 2.4 , 7.1 ) 7.1 Inhibitors of CYP3A Ivacaftor is a se

Can Kalydeco be used during pregnancy?

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are limited and incomplete human data from clinical trials and postmarketing reports on use of KALYDECO in pregnant women. In animal reproduction studies, oral administration of ivacaftor to pregnant rats and rabbits during organogenesis demonstrated no teratogenicity or adverse effects on fetal development at doses that produced maternal exposures up to approximately 5 (rats) and 11 (rabbits) times the exposure at the maximum recomm

What precautions should be taken with Kalydeco?

• Caution should be exercised in patients with history of liver or kidney problems, who are taking other medications, any allergy, during pregnancy and breastfeeding. • Avoid drinking grapefruit juice, or eat grapefruit or Seville oranges while taking this medication. • Always take it with fatty food. • It may cause dizziness, do not drive a car or operate machinery while taking this medication.

Who manufactures Kalydeco?

Vertex Pharmaceuticals (Ireland) Ltd. (Irlandia)

What ATC class does Kalydeco belong to?

Kalydeco: ATC R07AX31. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

Kalydeco

100 mg + 150 mg, Tabletki powlekane

INN: Tezacaftorum + Ivacaftorum

Data updated: 2026-04-13

Available in:

🇨🇿🇩🇪🇬🇧🇵🇱🇵🇹🇸🇰

Form

Tabletki powlekane

Dosage

100 mg + 150 mg

Route

doustna

Storage

Store at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].

About This Product

User Reviews

Reviews reflect personal experiences and are not medical advice. Always consult your doctor.