4/25/2024

Janusmed kön och genus

Janusmed kön och genus – galkanezumab

Janusmed kön och genus är ett kunskapsstöd som tillhandahåller information om köns- och genusaspekter på läkemedelsbehandling. Kunskapsstödet är avsedd främst för hälso- och sjukvårdspersonal. Texterna är generella och ska inte ses som behandlingsriktlinjer. Det är alltid behandlande läkare som ansvarar för patientens medicinering.

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Galkanezumab

Galkanezumab

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  1. Smitherman TA, Burch R, Sheikh H, Loder E. The prevalence, impact, and treatment of migraine and severe headaches in the United States: a review of statistics from national surveillance studies. Headache. 2013;53(3):427-36.

  2. Stovner LJ, Andree C. Prevalence of headache in Europe: a review for the Eurolight project. J Headache Pain. 2010;11(4):289-99.

  3. Lipton RB, Bigal ME, Diamond M, Freitag F, Reed ML, Stewart WF et al. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007;68(5):343-9.

  4. Dahlöf C, Linde M. One-year prevalence of migraine in Sweden: a population-based study in adults. Cephalalgia. 2001;21:664-71.

  5. Lipton RB, Munjal S, Alam A, Buse DC, Fanning KM, Reed ML, Schwedt TJ, Dodick DW. Migraine in America Symptoms and Treatment (MAST) Study: Baseline Study Methods, Treatment Patterns, and Gender Differences. Headache. 2018;58(9):1408-1426.

  6. Kurth T, Slomke MA, Kase CS, Cook NR, Lee IM, Gaziano JM, et al. Migraine, headache, and the risk of stroke in women: a prospective study. Neurology. 2005;64(6):1020-1026.

  7. Milhaud D, Bogousslavsky J, van Melle G, Liot P. Ischemic stroke and active migraine. Neurology. 2001;57(10):1805-11.

  8. Kielbasa W, Quinlan T. Population Pharmacokinetics of Galcanezumab, an Anti-CGRP Antibody, Following Subcutaneous Dosing to Healthy Individuals and Patients With Migraine. J Clin Pharmacol. 2020;60(2):229-239.

  9. Emgality (galcanezumab). Summary of Product Characteristics. European Medicines Agency (EMA) [updated 2021-07-21, cited 2021-12-13]

  10. Food and Drug Administration (FDA). Prescribing information - Emgality (galcanezumab). Drugs@FDA [www]. [updated 2019-12-05, cited 2021-12-13].

  11. Food and Drug Administration (FDA). Drug Trials Snapshot: Emgality (galcanezumab). Drug Trials Snapshot [www]. [updated 2018-10-23, cited 2021-12-13].

  12. EMA. Emgality. CHMP assessment report 2018-09-20.

  13. Dodick DW, Goadsby PJ, Lucas C, Jensen R, Bardos JN, Martinez JM et al. Phase 3 randomized, placebo-controlled study of galcanezumab in patients with chronic cluster headache: Results from 3-month double-blind treatment. Cephalalgia. 2020;40(9):935-948.

  14. European Medicines Agency (EMA). Refusal of a change to the marketing authorisation for Emgality (galcanezumab. European Medicines Agency (EMA) [www]. [updated 2020-02-28, cited 2021-12-13].

  15. Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2020 [cited 2021-03-10.]

  1. Smitherman TA, Burch R, Sheikh H, Loder E. The prevalence, impact, and treatment of migraine and severe headaches in the United States: a review of statistics from national surveillance studies. Headache. 2013;53(3):427-36.
  2. Stovner LJ, Andree C. Prevalence of headache in Europe: a review for the Eurolight project. J Headache Pain. 2010;11(4):289-99.
  3. Lipton RB, Bigal ME, Diamond M, Freitag F, Reed ML, Stewart WF et al. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007;68(5):343-9.
  4. Dahlöf C, Linde M. One-year prevalence of migraine in Sweden: a population-based study in adults. Cephalalgia. 2001;21:664-71.
  5. Lipton RB, Munjal S, Alam A, Buse DC, Fanning KM, Reed ML, Schwedt TJ, Dodick DW. Migraine in America Symptoms and Treatment (MAST) Study: Baseline Study Methods, Treatment Patterns, and Gender Differences. Headache. 2018;58(9):1408-1426.
  6. Kurth T, Slomke MA, Kase CS, Cook NR, Lee IM, Gaziano JM, et al. Migraine, headache, and the risk of stroke in women: a prospective study. Neurology. 2005;64(6):1020-1026.
  7. Milhaud D, Bogousslavsky J, van Melle G, Liot P. Ischemic stroke and active migraine. Neurology. 2001;57(10):1805-11.
  8. Kielbasa W, Quinlan T. Population Pharmacokinetics of Galcanezumab, an Anti-CGRP Antibody, Following Subcutaneous Dosing to Healthy Individuals and Patients With Migraine. J Clin Pharmacol. 2020;60(2):229-239.
  9. Emgality (galcanezumab). Summary of Product Characteristics. European Medicines Agency (EMA) [updated 2021-07-21, cited 2021-12-13]
  10. Food and Drug Administration (FDA). Prescribing information - Emgality (galcanezumab). Drugs@FDA [www]. [updated 2019-12-05, cited 2021-12-13].
  11. Food and Drug Administration (FDA). Drug Trials Snapshot: Emgality (galcanezumab). Drug Trials Snapshot [www]. [updated 2018-10-23, cited 2021-12-13].
  12. EMA. Emgality. CHMP assessment report 2018-09-20.
  13. Dodick DW, Goadsby PJ, Lucas C, Jensen R, Bardos JN, Martinez JM et al. Phase 3 randomized, placebo-controlled study of galcanezumab in patients with chronic cluster headache: Results from 3-month double-blind treatment. Cephalalgia. 2020;40(9):935-948.
  14. European Medicines Agency (EMA). Refusal of a change to the marketing authorisation for Emgality (galcanezumab. European Medicines Agency (EMA) [www]. [updated 2020-02-28, cited 2021-12-13].
  15. Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2020 [cited 2021-03-10.]