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KALYDECO (IVACAFTOR)
- Cystic fibrosis with heterozyg f508del mutation in CFTR
- Cystic fibrosis with homozyg f508del mutation in CFTR
- Cystic fibrosis with class III CFTR mutation
- Cystic fibrosis with r117H mutation in CFTR gene
150 mg tablet
- 1 tablet (150 mg) by oral route every 12 hours with fat-containing food
25 mg oral granules in packet
- Dosage information is not available
50 mg oral granules in packet
- Dosage information is not available
75 mg oral granules in packet
- 2 packets (150 mg) by oral route every 12 hours with fat-containing food mix with 1 teaspoonful of soft food or liquid
Cystic fibrosis with class III CFTR mutation
- 2 packets (150 mg) by oral route every 12 hours with fat-containing food mix with 1 teaspoonful of soft food or liquid
- 2 packets (150 mg) by oral route every 12 hours with fat-containing food mix with 1 teaspoonful of soft food or liquid and within1 hour
- 1 tablet (150 mg) by oral route every 12 hours with fat-containing food
Cystic fibrosis with heterozyg f508del mutation in CFTR
- 2 packets (150 mg) by oral route every 12 hours with fat-containing food mix with 1 teaspoonful of soft food or liquid
- 2 packets (150 mg) by oral route every 12 hours with fat-containing food mix with 1 teaspoonful of soft food or liquid and within1 hour
- 1 tablet (150 mg) by oral route every 12 hours with fat-containing food
Cystic fibrosis with homozyg f508del mutation in CFTR
- 2 packets (150 mg) by oral route every 12 hours with fat-containing food mix with 1 teaspoonful of soft food or liquid
- 2 packets (150 mg) by oral route every 12 hours with fat-containing food mix with 1 teaspoonful of soft food or liquid and within1 hour
- 1 tablet (150 mg) by oral route every 12 hours with fat-containing food
Cystic fibrosis with r117H mutation in CFTR gene
- 2 packets (150 mg) by oral route every 12 hours with fat-containing food mix with 1 teaspoonful of soft food or liquid
- 2 packets (150 mg) by oral route every 12 hours with fat-containing food mix with 1 teaspoonful of soft food or liquid and within1 hour
- 1 tablet (150 mg) by oral route every 12 hours with fat-containing food
- Korlym
- Mifeprex
- mifepristone
Contraindicated
- B cplx-C-St.Johnwrt-K.&S.ginsg
- Belladonna-phenobarbital
- calcium-mag-B complex-D3-hrb61
- carbamazepine
- Carbatrol
- Cerebyx
- Cold & Flu Fighter
- Dilantin
- Dilantin Extended
- Dilantin Infatabs
- Dilantin Kapseal
- Dilantin-125
- Donnatal
- enzalutamide
- Epitol
- Equetro
- Fatigue Relief Complex
- fosphenytoin
- Hycamtin
- isoniazid-rifamp-pyrazinamide
- Luminal
- Mycobutin
- Mysoline
- phenobarb-hyoscy-atropine-scop
- phenobarbital
- phenobarbital sodium
- Phenytek
- phenytoin
- phenytoin sodium
- phenytoin sodium extended
- primidone
- rifabutin
- Rifadin
- Rifamate
- rifampin
- rifampin-isoniazid
- Rifater
- St. John's wort
- Tegretol
- Tegretol Xr
- topotecan
- vit C-St. John wort-elder-hb30
- Women's Complex
- Xtandi
Severe
Moderate
- afatinib
- Afinitor
- Afinitor Disperz
- amoxicil-clarithromy-lansopraz
- Anti-diarrhea
- Anti-diarrheal (lope)-anti-gas
- Anti-diarrheal (loperamide)
- aprepitant
- atazanavir
- Biaxin
- Biaxin Xl
- Biaxin Xl Pak
- boceprevir
- Cardizem
- Cardizem Cd
- Cardizem La
- Cartia Xt
- Cipro
- Cipro In D5W
- Cipro Xr
- ciprofloxacin
- ciprofloxacin (mixture)
- ciprofloxacin in D5W
- clarithromycin
- conivaptan in 5 % dextrose
- Crixivan
- crizotinib
- darunavir
- Diamode
- Diflucan
- Dilacor Xr
- Dilt-xr
- diltiazem HCl
- elvitegr-cobicist-emtric-tenof
- Emend
- Erythrocin
- erythromycin
- erythromycin-sulfisoxazole
- Etopophos
- etoposide
- etoposide phosphate
- everolimus
- fluconazole
- fluconazole in dextrose(iso-o)
- fluconazole in NaCl (iso-osm)
- fosamprenavir
- fosaprepitant
- Gilotrif
- Gleevec
- imatinib
- Imodium Multi-symptom Relief
- Incivek
- indinavir
- Invirase
- itraconazole
- Juxtapid
- Kaletra
- Ketek
- ketoconazole
- Lexiva
- Lo-peramide
- lomitapide
- loperamide
- loperamide-simethicone
- lopinavir-ritonavir
- Matzim La
- nefazodone
- nelfinavir
- Norvir
- Norvir Soft Gelatin
- Noxafil
- Omeclamox-pak
- omeprazole-clarith-amoxicillin
- Onmel
- posaconazole
- Prevpac
- Prezista
- Reyataz
- ritonavir
- rivaroxaban
- saquinavir mesylate
- Sporanox
- Sporanox Pulsepak
- Stribild
- Taztia Xt
- telaprevir
- telithromycin
- Tiazac
- Toposar
- Ultra A-d
- Vaprisol
- Vfend
- Vfend Iv
- Victrelis
- Viracept
- voriconazole
- Xalkori
- Xarelto
- Zortress
- None
Contraindicated
- Abnormal hepatic function tests
Severe
Moderate
- Cataracts
- Kidney disease with reduction in GFR
KALYDECO (IVACAFTOR)
- Cystic fibrosis with heterozyg f508del mutation in CFTR
- Cystic fibrosis with homozyg f508del mutation in CFTR
- Cystic fibrosis with class III CFTR mutation
- Cystic fibrosis with r117H mutation in CFTR gene
- None
- Acute abdominal pain
- Diarrhea
- Dizziness
- Headache disorder
- Nasal congestion
- Nausea
- Pain in oropharynx
- Pharyngitis
- Skin rash
- Sore throat
- Upper respiratory infection
More Frequent
Severe
Less Severe
- Hypoglycemic disorder
- Increased alanine transaminase
- Increased aspartate transaminase
- Acne vulgaris
- Arthralgias
- Hyperglycemia
- Myalgias
- Non-cardiac chest pain
- Rhinitis
- Wheezing
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Cataracts
Less Severe
- None
Contraindicated
None
Severe Precaution
Ivacaftor
Use not recommended per manufacturer. Safety and efficacy not established for age < 6 months.
- 1 Day – 179 Days
- Use not recommended per manufacturer. Safety and efficacy not established for age < 6 months.
Management or Monitoring Precaution
Ivacaftor
Baseline and follow-up eye exams recommended for all pediatric patients due to risk of cataracts. Consider more frequent monitoring of liver function when liver transaminase are increased at baseline.
Baseline and follow-up eye exams recommended for all pediatric patients due to risk of cataracts.
- 180 Days – 6 Years
- Baseline and follow-up eye exams recommended for all pediatric patients due to risk of cataracts. Consider more frequent monitoring of liver function when liver transaminase are increased at baseline.
- Baseline and follow-up eye exams recommended for all pediatric patients due to risk of cataracts.
- 6 Years – 18 Years
- Baseline and follow-up eye exams recommended for all pediatric patients due to risk of cataracts. Consider more frequent monitoring of liver function when liver transaminase are increased at baseline.
- Baseline and follow-up eye exams recommended for all pediatric patients due to risk of cataracts.
Ivacaftor
- Severity Level:
2
- Additional Notes: Insufficient human data; not teratogenic in animals at 5-11 times mrhd
Contraindicated
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Precaution Exists
Ivacaftor
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 class III CFTR mutation | |
| 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 |
| Cystic fibrosis with heterozyg 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 |
| 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 |
| Cystic fibrosis with r117H mutation in CFTR gene | |
| 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 | Cystic fibrosis |
| E84 | Cystic fibrosis |
| E84 | Cystic fibrosis |
| E84.0 | Cystic fibrosis with pulmonary manifestations |
| E84.0 | Cystic fibrosis with pulmonary manifestations |
| E84.0 | Cystic fibrosis with pulmonary manifestations |
| E84.0 | Cystic fibrosis with pulmonary manifestations |
| E84.1 | Cystic fibrosis with intestinal manifestations |
| E84.1 | Cystic fibrosis with intestinal manifestations |
| E84.1 | Cystic fibrosis with intestinal manifestations |
| E84.1 | Cystic fibrosis with intestinal manifestations |
| E84.11 | Meconium ileus in cystic fibrosis |
| E84.11 | Meconium ileus in cystic fibrosis |
| E84.11 | Meconium ileus in cystic fibrosis |
| E84.11 | Meconium ileus in cystic fibrosis |
| E84.19 | Cystic fibrosis with other intestinal manifestations |
| E84.19 | Cystic fibrosis with other intestinal manifestations |
| E84.19 | Cystic fibrosis with other intestinal manifestations |
| E84.19 | Cystic fibrosis with other intestinal manifestations |
| E84.8 | Cystic fibrosis with other manifestations |
| E84.8 | Cystic fibrosis with other manifestations |
| E84.8 | Cystic fibrosis with other manifestations |
| E84.8 | Cystic fibrosis with other manifestations |
| E84.9 | Cystic fibrosis, unspecified |
| E84.9 | Cystic fibrosis, unspecified |
| E84.9 | Cystic fibrosis, unspecified |
| E84.9 | Cystic fibrosis, unspecified |
Formulary Reference Tool