Overview
Indications
F508del CFTR F508del CFTR ORKAMBI is indicated for the treatment of cystic fibrosis (CF) in patients aged 1 year and older who are homozygous for themutation in thegene. If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of themutation on both alleles of thegene.
Contraindications
When this intervention should not be used
None.
Indications & Related Conditions
Conditions associated via SNOMED clinical relationships
Administration & Protocol
Dosing, route, and treatment protocol
Detailed dosage and administration information is available in the full FDA drug label.
View full prescribing information on DailyMedMonitoring & Follow-Up
Biomarkers relevant to this intervention via related conditions
No monitoring biomarkers have been mapped yet. Biomarker-intervention linkages are derived through related conditions and will expand as the knowledge graph grows.
Clinical Trials
75 trials linked to this intervention
Recent Trials
Role of Genetic Factors in the Development of Lung Disease
Study of Alendronate to Prevent and Treat Osteoporosis in Cystic Fibrosis Patients
Cystic Fibrosis and Totally Implantable Vascular Access Devices
Genetic Disorders of Mucociliary Clearance in Nontuberculous Mycobacterial Lung Disease
Scandinavian Cystic Fibrosis Azithromycin Study
Research Evidence
Published studies and systematic reviews
Research data from MEDLINE/PubMed
Benefits & Expected Outcomes
Benefits, expected outcomes, efficacy data, and NNT (Number Needed to Treat) are pending physician authorship and evidence review.
Risks & Side Effects
Adverse reaction and safety data for this drug is sourced from the FDA-approved label.
View adverse reactions & drug interactions on DailyMedRelated Symptoms
Symptoms associated with conditions this intervention addresses
No related symptoms have been mapped yet. Symptom linkages are derived through associated conditions.
Alternatives & Comparisons
Alternative treatments, comparison data, and clinical decision support are pending physician authorship.
This information is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider regarding any medical condition or treatment plan.
Do not start, stop, or change any treatment without consulting your healthcare provider.
Quick Facts
- Type
- Substance / Medication
- Fully Specified Name
- Lumacaftor (substance)
- SNOMED CT
- 716073005
- UMLS CUI
- C3852684
- RxNorm CUI
- 1655922
- Labeler
- Vertex Pharmaceuticals Incorporated
Clinical Data
This intervention maps to 1 entities in the Healos knowledge graph.
Data is sourced from SNOMED CT, UMLS, and the Healos clinical knowledge graph. Content sections marked as pending require physician authorship. Consult a healthcare provider before starting any treatment.