Kalydeco 150 mg/1
ivacaftor · TABLET, FILM COATED · Vertex Pharmaceuticals Incorporated
Kalydeco is a tablet, film coated containing ivacaftor at 150 mg/1, taken oral. Manufactured by Vertex Pharmaceuticals Incorporated.
Key Facts
- Brand Name
- Kalydeco
- Generic Name
- ivacaftor
- NDC Code (Product)
51167-200- Manufacturer
- Vertex Pharmaceuticals Incorporated
- Strength
- 150 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA203188
- Drug Class
- Cystic Fibrosis Transmembrane Conductance Regulator Potentiator [EPC]
- Marketing Start
- 01/31/2012
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 sequencing when recommended by the mutation test instructions for use. KALYDECO is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator 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 based on clinical and/or in vitro assay data. ( 12.1 , 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 sequencing when recommended by the mutation test instructions for use. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Age Weight Dosage Administration 1 month to less than 2 months 3 kg or greater One 5.8 mg packet every 12 hours Mixed with one teaspoon (5 mL) of soft food or liquid and administered orally with fat-containing food 2 months to less than 4 months 3 kg or greater One 13.4 mg packet every 12 hours 4 months to less than 6 months 5 kg or greater One 25 mg packet every 12 hours 6 months to less than 6 years 5 kg to less than 7 kg One 25 mg packet every 12 hours 7 kg to less than 14 kg One 50 mg packet every 12 hours 14 kg or greater One 75 mg packet every 12 hours 6 years and older - One 150 mg tablet every 12 hours Taken orally with fat-containing food See full prescribing information for the recommended dosage in patients aged 6 months and older with moderate or severe hepatic impairment. ( 2.3 , 8.6 ) See full prescribing information for dosage modifications due to drug interactions with KALYDECO. ( 2.4 , 7.1 ) Not recommended in pediatric patients less than 1 month of age. ( 2.2 , 8.4 ) Not recommended in patients 1 month to less than 6 months of age with any level of hepatic impairment and/or taking concomitant moderate or strong CYP3A inhibitors. ( 2.3 ,…
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
Drug Interactions
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 sensitive CYP3A substrate. Co-administration with ketoconazole, a strong CYP3A inhibitor, significantly increased ivacaftor exposure [measured as area under the curve (AUC)] by 8.5-fold. Based on simulations of these results, a reduction of the KALYDECO dosage is recommended for patients aged 6 months and older taking concomitant strong CYP3A inhibitors, such as ketoconazole, itraconazole, posaconazole, voriconazole, telithromycin, and clarithromycin. KALYDECO is not recommended for patients less than 6 months of age taking strong CYP3A inhibitors [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3) ] . Co-administration with fluconazole, a moderate inhibitor of CYP3A, increas…
Adverse Reactions
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 common adverse drug reactions to KALYDECO (≥8% of patients with CF who have a G551D mutation in the CFTR gene) were headache, oropharyngeal pain, upper respiratory tract infection, nasal congestion, abdominal pain, nasopharyngitis, diarrhea, rash, nausea, and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Vertex Pharmaceuticals Incorporated at 1-877-634-8789 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates …
Frequently Asked Questions
What is Kalydeco used for?
Kalydeco contains ivacaftor. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Kalydeco a controlled substance?
Kalydeco is not classified as a controlled substance by the DEA.
What is the generic name for Kalydeco?
The generic name for Kalydeco is ivacaftor. There are no other listed brand versions of ivacaftor.
What is the NDC code for Kalydeco 150 mg/1?
The NDC (National Drug Code) for Kalydeco 150 mg/1 is 51167-200, listed by Vertex Pharmaceuticals Incorporated.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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