2/9/2026

Janusmed sex and gender

Janusmed sex and gender – ivacaftor

Janusmed Sex and Gender is a knowledge database providing information on sex and gender aspects of drug treatment. The knowledge database is primarily intended to be used by physicians and healthcare professionals. The texts are general and should not be considered as treatment guidelines. The individual patient’s physician is responsible for the patient’s drug treatment.

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Ivacaftor

Ivacaftor

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  1. EMA. Kalydeco. CHMP Assessment report; 2012 http://goo.gl/vIoApt

  2. Socialstyrelsen. Sällsynta hälsotillstånd - cystisk fribros. Socialstyrelsen [www]. [updated 2022-01-21, cited 2025-12-19].

  3. Olesen HV, Pressler T, Hjelte L, Mared L, Lindblad A, Knudsen PK et al. Gender differences in the Scandinavian cystic fibrosis population. Pediatr Pulmonol. 2010;45(10):959-65.

  4. Holtrop M, Cosmich S, Lee M, Keller A, Jain R. Sex Differences After Treatment With Ivacaftor in People With Cystic Fibrosis. Chest. 2024;166(5):951-962.

  5. Harness-Brumley CL, Elliott AC, Rosenbluth DB, Raghavan D, Jain R. Gender differences in outcomes of patients with cystic fibrosis. J Womens Health (Larchmt). 2014;23(12):1012-20.

  6. Lam GY, Goodwin J, Wilcox PG, Quon BS. Sex disparities in cystic fibrosis: review on the effect of female sex hormones on lung pathophysiology and outcomes. ERJ Open Res. 2021;7(1):.

  7. EMA Assessment report. Orkambi (lumacaftor/ivacaftor). Published 01/12/2015.

  8. Kaftrio Assessment report. EMA [www]. [updated 2021-03-25, cited 2022-07-21].

  9. Wang A, Lee M, Keller A, Jian S, Lowe K, Finklea JD et al. Sex differences in outcomes of people with cystic fibrosis treated with elexacaftor/tezacaftor/ivacaftor. J Cyst Fibros. 2024;23(1):91-98.

  10. Middleton PG, Mall MA, Dřevínek P, Lands LC, McKone EF, Polineni D et al. Elexacaftor-Tezacaftor-Ivacaftor for Cystic Fibrosis with a Single Phe508del Allele. N Engl J Med. 2019;381(19):1809-1819.

  11. Terlizzi V, Fevola C, Presti S, Castaldo A, Daccò V, Claut L et al. Reported Adverse Events in a Multicenter Cohort of Patients Ages 6-18 Years with Cystic Fibrosis and at Least One F508del Allele Receiving Elexacaftor/Tezacaftor/Ivacaftor. J Pediatr. 2024;274:114176.

  12. Jennings MT, Dezube R, Paranjape S, West NE, Hong G, Braun A et al. An Observational Study of Outcomes and Tolerances in Patients with Cystic Fibrosis Initiated on Lumacaftor/Ivacaftor. Ann Am Thorac Soc. 2017;14(11):1662-1666.

  13. Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2024 [cited 2025-04-23.]

  1. EMA. Kalydeco. CHMP Assessment report; 2012 http://goo.gl/vIoApt
  2. Socialstyrelsen. Sällsynta hälsotillstånd - cystisk fribros. Socialstyrelsen [www]. [updated 2022-01-21, cited 2025-12-19].
  3. Olesen HV, Pressler T, Hjelte L, Mared L, Lindblad A, Knudsen PK et al. Gender differences in the Scandinavian cystic fibrosis population. Pediatr Pulmonol. 2010;45(10):959-65.
  4. Holtrop M, Cosmich S, Lee M, Keller A, Jain R. Sex Differences After Treatment With Ivacaftor in People With Cystic Fibrosis. Chest. 2024;166(5):951-962.
  5. Harness-Brumley CL, Elliott AC, Rosenbluth DB, Raghavan D, Jain R. Gender differences in outcomes of patients with cystic fibrosis. J Womens Health (Larchmt). 2014;23(12):1012-20.
  6. Lam GY, Goodwin J, Wilcox PG, Quon BS. Sex disparities in cystic fibrosis: review on the effect of female sex hormones on lung pathophysiology and outcomes. ERJ Open Res. 2021;7(1):.
  7. EMA Assessment report. Orkambi (lumacaftor/ivacaftor). Published 01/12/2015.
  8. Kaftrio Assessment report. EMA [www]. [updated 2021-03-25, cited 2022-07-21].
  9. Wang A, Lee M, Keller A, Jian S, Lowe K, Finklea JD et al. Sex differences in outcomes of people with cystic fibrosis treated with elexacaftor/tezacaftor/ivacaftor. J Cyst Fibros. 2024;23(1):91-98.
  10. Middleton PG, Mall MA, Dřevínek P, Lands LC, McKone EF, Polineni D et al. Elexacaftor-Tezacaftor-Ivacaftor for Cystic Fibrosis with a Single Phe508del Allele. N Engl J Med. 2019;381(19):1809-1819.
  11. Terlizzi V, Fevola C, Presti S, Castaldo A, Daccò V, Claut L et al. Reported Adverse Events in a Multicenter Cohort of Patients Ages 6-18 Years with Cystic Fibrosis and at Least One F508del Allele Receiving Elexacaftor/Tezacaftor/Ivacaftor. J Pediatr. 2024;274:114176.
  12. Jennings MT, Dezube R, Paranjape S, West NE, Hong G, Braun A et al. An Observational Study of Outcomes and Tolerances in Patients with Cystic Fibrosis Initiated on Lumacaftor/Ivacaftor. Ann Am Thorac Soc. 2017;14(11):1662-1666.
  13. Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2024 [cited 2025-04-23.]