10/18/2024

Janusmed sex and gender

Janusmed sex and gender – galcanezumab

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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Galcanezumab

Galcanezumab

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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.]