Please wait while the formulary information is being retrieved.
ORKAMBI (lumacaftor/ivacaftor)
- Cystic fibrosis with homozyg f508del mutation in CFTR
100 mg-125 mg tablet
- Dosage information is not available
200 mg-125 mg tablet
- 2 tablets by oral route every 12 hours with fat-containing food
100 mg-125 mg oral granules in packet
- Dosage information is not available
150 mg-188 mg oral granules in packet
- Dosage information is not available
Cystic fibrosis with homozyg f508del mutation in CFTR
- 2 tablets by oral route every 12 hours with fat-containing food
- Adalat Cc
- Afeditab Cr
- artemether-lumefantrine
- boceprevir
- Coartem
- Complera
- Edurant
- emtricitab-rilpivirine-tenofov
- Incivek
- Korlym
- Latuda
- lurasidone
- Mifeprex
- mifepristone
- Nifedical Xl
- nifedipine
- Procardia
- Procardia Xl
- rilpivirine
- telaprevir
- Vfend
- Vfend Iv
- Victrelis
- voriconazole
Contraindicated
- Afinitor
- Afinitor Disperz
- aprepitant
- Astagraf Xl
- axitinib
- B cplx-C-St.Johnwrt-K.&S.ginsg
- bedaquiline
- Belladonna-phenobarbital
- bortezomib
- Bosulif
- bosutinib
- Brilinta
- cabozantinib
- calcium-mag-B complex-D3-hrb61
- Caprelsa
- carbamazepine
- Carbatrol
- Cerebyx
- Cold & Flu Fighter
- Cometriq
- crizotinib
- cyclosporine
- cyclosporine modified
- dabrafenib
- dasatinib
- dextromethorphan-quinidine
- Dilantin
- Dilantin Extended
- Dilantin Infatabs
- Dilantin Kapseal
- Dilantin-125
- Donnatal
- elvitegr-cobicist-emtric-tenof
- Emend
- enzalutamide
- Epitol
- Equetro
- erlotinib
- everolimus
- Fareston
- Fatigue Relief Complex
- fosaprepitant
- fosphenytoin
- Gengraf
- Gleevec
- guanfacine
- Hecoria
- ibrutinib
- imatinib
- Imbruvica
- Inlyta
- Intuniv Er
- isoniazid-rifamp-pyrazinamide
- Istodax
- ivacaftor
- Jentadueto
- Kalydeco
- lapatinib
- linagliptin
- linagliptin-metformin
- Luminal
- mefloquine
- Mycobutin
- Mysoline
- Neoral
- Nexavar
- nilotinib
- Nuedexta
- Olysio
- pazopanib
- phenobarb-hyoscy-atropine-scop
- phenobarbital
- phenobarbital sodium
- Phenytek
- phenytoin
- phenytoin sodium
- phenytoin sodium extended
- pomalidomide
- Pomalyst
- primidone
- Prograf
- Qualaquin
- quetiapine
- quinidine gluconate
- quinidine sulfate
- quinine sulfate
- Rapamune
- rifabutin
- Rifadin
- Rifamate
- rifampin
- rifampin-isoniazid
- Rifater
- romidepsin
- Samsca
- Sandimmune
- Seroquel Xr
- simeprevir
- sirolimus
- Sirturo
- Soltamox
- sorafenib
- Sprycel
- St. John's wort
- Stribild
- sunitinib
- Sutent
- tacrolimus
- Tafinlar
- tamoxifen
- Tarceva
- Tasigna
- Tegretol
- Tegretol Xr
- temsirolimus
- Tenex
- ticagrelor
- tolvaptan
- toremifene
- Torisel
- Tradjenta
- Tykerb
- vandetanib
- Velcade
- vit C-St. John wort-elder-hb30
- Votrient
- Women's Complex
- Xalkori
- Xtandi
- Zortress
Severe
Moderate
- Abilify
- Abilify Discmelt
- Abilify Maintena
- Adoxa
- alprazolam
- Alprazolam Intensol
- aripiprazole
- Aromasin
- Astramorph-pf
- Ativan
- Avidoxy
- Avinza
- bosentan
- Buprenex
- buprenorphine
- buprenorphine-naloxone
- Butrans
- Daliresp
- Depodur (pf)
- Diastat
- Diastat Acudial
- diazepam
- Diazepam Intensol
- Diskets
- Dolophine
- Doryx
- Doxy-100
- doxycycline calcium
- doxycycline hyclate
- doxycycline monohydrate
- Duramorph (pf)
- exemestane
- Haldol
- Haldol Decanoate
- haloperidol
- haloperidol decanoate
- haloperidol lactate
- Iclusig
- Kadian
- lorazepam
- Lorazepam Intensol
- macitentan
- methadone
- Methadone Intensol
- Methadose
- midazolam
- midazolam (PF)
- Monodox
- Morgidox
- morphine
- morphine (PF)
- morphine concentrate
- morphine liposomal (PF)
- Ms Contin
- Niravam
- Opsumit
- Oracea
- ponatinib
- regorafenib
- Risperdal
- Risperdal Consta
- Risperdal M-tab
- risperidone
- risperidone microspheres
- roflumilast
- Seroquel
- Stivarga
- Suboxone
- Tracleer
- triazolam
- Valium
- Vibramycin
- Xanax
- Xanax Xr
- Zubsolv
- None
Contraindicated
- Disease of liver
Severe
Moderate
- Cataracts
- Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
ORKAMBI (lumacaftor/ivacaftor)
- Cystic fibrosis with homozyg f508del mutation in CFTR
- None
- Diarrhea
- Dyspnea
- Fatigue
- Flatulence
- Increased creatine kinase level
- Influenza
- Nasal congestion
- Nausea
- Pharyngitis
- Rhinorrhea
- Skin rash
- Sore throat
- Upper respiratory infection
More Frequent
Severe
Less Severe
- Increased alanine transaminase
- Increased aspartate transaminase
- Acute respiratory insufficiency
- Headache disorder
- Hyperglycemia
- Hypertension
- Increased sputum
- Menstrual disorder
- Non-cardiac chest pain
- Upper abdominal pain
- Wheezing
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Cataracts
- Hepatic encephalopathy
- Hepatic failure
- Hyperbilirubinemia
Less Severe
- Chest discomfort
- Respiration changes
Contraindicated
None
Severe Precaution
Lumacaftor, Ivacaftor
Potential risk of developing lens opacity. No safety and efficacy established age < 2 years.
- 1 Day – 2 Years
- Potential risk of developing lens opacity. No safety and efficacy established age < 2 years.
Management or Monitoring Precaution
Lumacaftor, Ivacaftor
Potential risk of developing lens opacity. Maintain ophthalmological examinations during treatment.
- 2 Years – 18 Years
- Potential risk of developing lens opacity. Maintain ophthalmological examinations during treatment.
Ivacaftor-lumacaftor
- Severity Level:
2
- Additional Notes: Insuff human data; animal data do not sug dev tox at doses <10 times mrhd
Contraindicated
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Precaution Exists
Ivacaftor-lumacaftor
Insuff human data available
| General | Excretion Potential | Effect on Infant | Notes |
| Evaluate use carefully | Unknown | Not known; no or inclusive data | Insuff human data available |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
None
No Known Risk
None
- None
| Cystic fibrosis with homozyg f508del mutation in CFTR | |
| E84 | Cystic fibrosis |
| E84.0 | Cystic fibrosis with pulmonary manifestations |
| E84.1 | Cystic fibrosis with intestinal manifestations |
| E84.11 | Meconium ileus in cystic fibrosis |
| E84.19 | Cystic fibrosis with other intestinal manifestations |
| E84.8 | Cystic fibrosis with other manifestations |
| E84.9 | Cystic fibrosis, unspecified |
| 0-9 | A-Z |
|---|---|
| E84 | Cystic fibrosis |
| E84.0 | Cystic fibrosis with pulmonary manifestations |
| E84.1 | Cystic fibrosis with intestinal manifestations |
| E84.11 | Meconium ileus in cystic fibrosis |
| E84.19 | Cystic fibrosis with other intestinal manifestations |
| E84.8 | Cystic fibrosis with other manifestations |
| E84.9 | Cystic fibrosis, unspecified |
Formulary Reference Tool