Prescription medicine
Ivacaftor and lumacaftor Brand names: Orkambi
Ivacaftor and lumacaftor (Orkambi) is a prescription medicine with an FDA approval on record since 2015. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the ivacaftor and lumacaftor FDA label on DailyMed (effective March 24, 2026, Vertex Pharmaceuticals Incorporated); the NDA 206038 record on Drugs@FDA; every ivacaftor and lumacaftor label on DailyMed.
Highlights of the record
FDA label of March 24, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageORKAMBI is indicated for the treatment of cystic fibrosis (CF) in patients aged 1 year and older who are homozygous for the F508del mutation in the CFTR gene.
Forms and strengths
- 75 mg / 94 mg
- 100 mg / 125 mg
- 150 mg / 188 mg
- 200 mg / 125 mg
Granule; film-coated tablet.
On the market
- Earliest approval on file
- July 2, 2015 Orkambi, Vertex Pharms Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- June 11, 2031 Orkambi granule; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 8,520 through July 30, 2026
What is ivacaftor and lumacaftor used for?
From the label: indications and usageORKAMBI is indicated for the treatment of cystic fibrosis (CF) in patients aged 1 year and older who are homozygous for the F508del mutation in the CFTR gene. If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of the F508del mutation on both alleles of the CFTR gene. ORKAMBI is a combination of ivacaftor, a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator, and lumacaftor, indicated for the treatment of cystic fibrosis (CF) in patients aged 1 year and older who are homozygous for the F508del mutation in the CFTR gene. […]
FDA pharmacologic class: Cystic Fibrosis Transmembrane Conductance Regulator Potentiator.
Source: FDA drug label (ORKAMBI), Vertex Pharmaceuticals Incorporated, effective March 24, 2026 (SPL set 3fc1c40e-cfac-47a1-9e1a-61ead3570600), via openFDA; the full label on DailyMed
What does the patient leaflet for ivacaftor and lumacaftor say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while taking ORKAMBI?Do not eat or drink grapefruit products during your first week of treatment with ORKAMBI. Eating or drinking grapefruit products can increase the amount of ORKAMBI in your blood.
From the patient leaflet: How should I store ORKAMBI?Store ORKAMBI at room temperature between 68°F to 77°F (20°C to 25°C). Keep ORKAMBI and all medicines out of the reach of children.
Source: FDA drug label (ORKAMBI), Vertex Pharmaceuticals Incorporated, effective March 24, 2026 (SPL set 3fc1c40e-cfac-47a1-9e1a-61ead3570600), via openFDA; the full label on DailyMed
Is there a generic for ivacaftor and lumacaftor (Orkambi)?
No generic ivacaftor and lumacaftor is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 21 patents for Orkambi granule: the compound patent runs to September 20, 2030 (pediatric exclusivity to March 20, 2031), and the last listed entry to June 11, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2015 earliest approval on file
- 2031 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the ivacaftor and lumacaftor label say about other medicines?
The ivacaftor and lumacaftor label names 49 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name ivacaftor and lumacaftor. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Azithromycin | drug interactions | No dosage adjustment of ORKAMBI or concomitant drug is recommended when ORKAMBI is given with the following: azithromycin, aztreonam, budesonide, ceftazidime, cetirizine, ciprofloxacin, colistimethate, colistin, dornase alfa, fluticasone, ipratropium, levofloxacin, pancreatin, pancrelipase, salbutamol, salmeterol … |
| Aztreonam | drug interactions | No dosage adjustment of ORKAMBI or concomitant drug is recommended when ORKAMBI is given with the following: azithromycin, aztreonam, budesonide, ceftazidime, cetirizine, ciprofloxacin, colistimethate, colistin, dornase alfa, fluticasone, ipratropium, levofloxacin, pancreatin, pancrelipase, salbutamol, salmeterol … |
| Budesonide | drug interactions | No dosage adjustment of ORKAMBI or concomitant drug is recommended when ORKAMBI is given with the following: azithromycin, aztreonam, budesonide, ceftazidime, cetirizine, ciprofloxacin, colistimethate, colistin, dornase alfa, fluticasone, ipratropium, levofloxacin, pancreatin, pancrelipase, salbutamol, salmeterol … |
| Calcium carbonate | drug interactions | No dose adjustment is recommended for calcium carbonate antacid. |
| Carbamazepine | drug interactions | Therefore, co-administration with strong CYP3A inducers, such as rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, and St. John's wort ( Hypericum perforatum ), is not recommended [see Warnings and Precautions (5.8) and Clinical Pharmacology (12.3) ]. |
| Ceftazidime | drug interactions | No dosage adjustment of ORKAMBI or concomitant drug is recommended when ORKAMBI is given with the following: azithromycin, aztreonam, budesonide, ceftazidime, cetirizine, ciprofloxacin, colistimethate, colistin, dornase alfa, fluticasone, ipratropium, levofloxacin, pancreatin, pancrelipase, salbutamol, salmeterol … |
| Cetirizine | drug interactions | No dosage adjustment of ORKAMBI or concomitant drug is recommended when ORKAMBI is given with the following: azithromycin, aztreonam, budesonide, ceftazidime, cetirizine, ciprofloxacin, colistimethate, colistin, dornase alfa, fluticasone, ipratropium, levofloxacin, pancreatin, pancrelipase, salbutamol, salmeterol … |
| Ciprofloxacin | drug interactions | No dosage adjustment of ORKAMBI or concomitant drug is recommended when ORKAMBI is given with the following: azithromycin, aztreonam, budesonide, ceftazidime, cetirizine, ciprofloxacin, colistimethate, colistin, dornase alfa, fluticasone, ipratropium, levofloxacin, pancreatin, pancrelipase, salbutamol, salmeterol … |
| Citalopram | drug interactions | Concomitant use of ORKAMBI may reduce the exposure and effectiveness of citalopram, escitalopram, and sertraline. |
| Clarithromycin | drug interactions | Following this period, continue with the recommended daily dose [see Dosage and Administration (2.3) ]. Examples of strong CYP3A inhibitors include: ketoconazole, itraconazole, posaconazole, and voriconazole. telithromycin, clarithromycin. |
| Colistimethate | drug interactions | No dosage adjustment of ORKAMBI or concomitant drug is recommended when ORKAMBI is given with the following: azithromycin, aztreonam, budesonide, ceftazidime, cetirizine, ciprofloxacin, colistimethate, colistin, dornase alfa, fluticasone, ipratropium, levofloxacin, pancreatin, pancrelipase, salbutamol, salmeterol … |
| Cyclosporine | drug interactions | Immunosuppressants: cyclosporine, everolimus, sirolimus, and tacrolimus (avoid the use of ORKAMBI). |
| Digoxin | drug interactions | Monitor the serum concentration of digoxin and titrate the digoxin dose to obtain the desired clinical effect. |
| Dornase alfa | drug interactions | No dosage adjustment of ORKAMBI or concomitant drug is recommended when ORKAMBI is given with the following: azithromycin, aztreonam, budesonide, ceftazidime, cetirizine, ciprofloxacin, colistimethate, colistin, dornase alfa, fluticasone, ipratropium, levofloxacin, pancreatin, pancrelipase, salbutamol, salmeterol … |
Every other medicine the ivacaftor and lumacaftor label names
| Medicine named | Section | What the label says |
|---|---|---|
| Erythromycin | drug interactions | Concomitant use of ORKAMBI may decrease the exposure of clarithromycin, erythromycin, and telithromycin, which may reduce the effectiveness of these antibiotics. |
| Escitalopram | drug interactions | Concomitant use of ORKAMBI may reduce the exposure and effectiveness of citalopram, escitalopram, and sertraline. |
| Esomeprazole | drug interactions | Proton Pump Inhibitors, H 2 Blockers, Antacids ORKAMBI may reduce the exposure and effectiveness of proton pump inhibitors such as omeprazole, esomeprazole, and lansoprazole, and may alter the … |
| Everolimus | drug interactions | Immunosuppressants: cyclosporine, everolimus, sirolimus, and tacrolimus (avoid the use of ORKAMBI). |
| Fluconazole | drug interactions | Consider an alternative such as fluconazole. |
| Fluticasone | drug interactions | … cetirizine, ciprofloxacin, colistimethate, colistin, dornase alfa, fluticasone, ipratropium, levofloxacin, pancreatin, pancrelipase, salbutamol, salmeterol, sulfamethoxazole, trimethoprim … |
| Ibuprofen | drug interactions | Concomitant use of ORKAMBI may reduce the exposure and effectiveness of ibuprofen. |
| Ipratropium | drug interactions | … ciprofloxacin, colistimethate, colistin, dornase alfa, fluticasone, ipratropium, levofloxacin, pancreatin, pancrelipase, salbutamol, salmeterol, sulfamethoxazole, trimethoprim, tiotropium, and … |
| Itraconazole | drug interactions | Inhibitors of CYP3A Co-administration of lumacaftor/ivacaftor with itraconazole, a strong CYP3A inhibitor, did not impact the exposure of lumacaftor, but increased ivacaftor exposure by 4.3-fold. |
| Ketoconazole | drug interactions | … Administration (2.3) ]. Examples of strong CYP3A inhibitors include: ketoconazole, itraconazole, posaconazole, and voriconazole. telithromycin, clarithromycin. |
| Lansoprazole | drug interactions | … effectiveness of proton pump inhibitors such as omeprazole, esomeprazole, and lansoprazole, and may alter the exposure of ranitidine. |
| Levofloxacin | drug interactions | … colistimethate, colistin, dornase alfa, fluticasone, ipratropium, levofloxacin, pancreatin, pancrelipase, salbutamol, salmeterol, sulfamethoxazole, trimethoprim, tiotropium, and tobramycin. |
| Metformin | drug interactions | No dosage adjustment is recommended for metformin. |
| Methylprednisolone | drug interactions | Concomitant use of ORKAMBI may reduce the exposure and effectiveness of prednisone and methylprednisolone. |
| Midazolam | drug interactions | Benzodiazepines: midazolam, triazolam (consider an alternative to these benzodiazepines). |
| Montelukast | drug interactions | Anti-allergics and Systemic Corticosteroids ORKAMBI may decrease the exposure of montelukast, which may reduce its efficacy. No dosage adjustment for montelukast is recommended. … |
| Omeprazole | drug interactions | Proton Pump Inhibitors, H 2 Blockers, Antacids ORKAMBI may reduce the exposure and effectiveness of proton pump inhibitors such as omeprazole, esomeprazole, and lansoprazole, and may alter the … |
| Phenobarbital | drug interactions | Therefore, co-administration with strong CYP3A inducers, such as rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, and St. … |
| Phenytoin | drug interactions | Therefore, co-administration with strong CYP3A inducers, such as rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, and St. … |
| Posaconazole | drug interactions | … Examples of strong CYP3A inhibitors include: ketoconazole, itraconazole, posaconazole, and voriconazole. telithromycin, clarithromycin. |
| Prednisone | drug interactions | Concomitant use of ORKAMBI may reduce the exposure and effectiveness of prednisone and methylprednisolone. |
| Ranitidine | drug interactions | … omeprazole, esomeprazole, and lansoprazole, and may alter the exposure of ranitidine. |
| Repaglinide | drug interactions | Concomitant use of ORKAMBI may reduce the exposure and effectiveness of repaglinide and may alter the exposure of sulfonylurea. |
| Rifabutin | drug interactions | Therefore, co-administration with strong CYP3A inducers, such as rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, and St. … |
| Rifampin | drug interactions | Use of ORKAMBI with strong CYP3A inducers, such as rifampin, significantly reduces ivacaftor exposure, which may reduce the therapeutic effectiveness of ORKAMBI. |
| Salmeterol | drug interactions | … fluticasone, ipratropium, levofloxacin, pancreatin, pancrelipase, salbutamol, salmeterol, sulfamethoxazole, trimethoprim, tiotropium, and tobramycin. |
| Sertraline | drug interactions | Concomitant use of ORKAMBI may reduce the exposure and effectiveness of citalopram, escitalopram, and sertraline. |
| Sirolimus | drug interactions | Immunosuppressants: cyclosporine, everolimus, sirolimus, and tacrolimus (avoid the use of ORKAMBI). |
| Tacrolimus | drug interactions | Immunosuppressants: cyclosporine, everolimus, sirolimus, and tacrolimus (avoid the use of ORKAMBI). |
| Tiotropium | drug interactions | … pancrelipase, salbutamol, salmeterol, sulfamethoxazole, trimethoprim, tiotropium, and tobramycin. |
| Tobramycin | drug interactions | … salbutamol, salmeterol, sulfamethoxazole, trimethoprim, tiotropium, and tobramycin. |
| Triazolam | drug interactions | Benzodiazepines: midazolam, triazolam (consider an alternative to these benzodiazepines). |
| Trimethoprim | drug interactions | … pancreatin, pancrelipase, salbutamol, salmeterol, sulfamethoxazole, trimethoprim, tiotropium, and tobramycin. |
| Voriconazole | drug interactions | … inhibitors include: ketoconazole, itraconazole, posaconazole, and voriconazole. telithromycin, clarithromycin. |
| Warfarin | drug interactions | Warfarin ORKAMBI may alter the exposure of warfarin. |
Other labels that name ivacaftor and lumacaftor
Source: FDA drug label (ORKAMBI), Vertex Pharmaceuticals Incorporated, effective March 24, 2026 (SPL set 3fc1c40e-cfac-47a1-9e1a-61ead3570600), via openFDA; the full label on DailyMed
What do FAERS reports show for ivacaftor and lumacaftor?
The FDA Adverse Event Reporting System holds 8,520 reports that list ivacaftor and lumacaftor among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 158 are coded as a death and 4,457 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2019 (1,989, against a median of 169 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other cystic fibrosis transmembrane conductance regulator potentiators
- the pharmacologic class, with prices and generics
- Ivacaftor and lumacaftor side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other