Kommersiellt obunden läkemedelsinformation riktad till läkare och sjukvårdspersonal

Denosumab

Klassificering: B

Preparat: Prolia, XGEVA

ATC kod: M05BX04

Substanser: denosumab

Sammanfattning

Det saknas kontrollerade studier om skillnader mellan könen avseende effekt och säkerhet för denosumab. Resultat från studier på enbart män respektive enbart kvinnor visar att effekten på benmineraltätheten (BMD) är likartad för båda könen.
 

Additional information

Pharmacokinetics and dosing

According to the original manufacturer, denosumab pharmacokinetics is similar in men and women [1]. No studies with a clinically relevant sex analysis regarding the dosing of denosumab have been found.

Effects

Well-powered trials evaluating clinical fracture risk reduction in male osteoporosis are lacking. To estimate the anti-fracture efficacy of denosumab in men, trials have used assumptions concerning drug efficacy derived from trials in postmenopausal women [2]. For instance, percentage change from baseline to month 12 in lumbar spine BMD in women in the FREEDOM trial (placebo 0.7 vs. denosumab 4.8) was comparable to men in the ADAMO trial (placebo 1.0 vs. denosumab 4.8) [2-4]. According to one reference [5] there is a small ongoing not yet published study of the effect of treatment with denosumab in men with primary osteoporosis.

Dose exposure-response relationship for denosumab was determined in patients with bone metastases from solid tumors. Patients (92 men, 281 women) received denosumab as single or multiple subcutaneous doses ranging from 30-180 mg administrated every 4 or 12 weeks for up to 3 years. Denosumab efficacy and potency did not differ between men and women [6].

Adverse effects

No studies with a clinical relevant sex analysis regarding adverse effects of denosumab have been found.

Reproductive health issues

Denosumab may cause fetal harm when a man treated with denosumab has unprotected sexual intercourse with a pregnant partner [7]. Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).

Försäljning på recept

Fler kvinnor än män hämtade ut injektionsvätska innehållande denosumab (ATC-kod M05BX04) på recept i Sverige år 2015, totalt 6 441 kvinnor och 1 216 män. Det motsvarar 1,3 respektive 0,3 personer per tusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgruppen 75 år och äldre hos båda könen. Totalt sett var injektionsvätska innehållande denosumab 5,3 gånger vanligare hos kvinnor [8]. Detta speglar könsskillnaden i prevalensen av osteoporos.

Uppdaterat: 2017-03-27

Litteratursökningsdatum: 2014-08-07

Referenser

  1. PROLIA (denosumab). Summary of Product Characteristics. European Medicines Agency (EMA); 2014.
  2. Parthan A, Kruse M, Agodoa I, Silverman S, Orwoll E. Denosumab: a cost-effective alternative for older men with osteoporosis from a Swedish payer perspective. Bone. 2014;59:105-13. PubMed
  3. Cummings SR, San Martin J, McClung MR, Siris ES, Eastell R, Reid IR et al. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med. 2009;361:756-65. PubMed
  4. Orwoll E, Teglbjærg CS, Langdahl BL, Chapurlat R, Czerwinski E, Kendler DL et al. A randomized, placebo-controlled study of the effects of denosumab for the treatment of men with low bone mineral density. J Clin Endocrinol Metab. 2012;97:3161-9. PubMed
  5. Adler RA, Gill RS. Clinical utility of denosumab for treatment of bone loss in men and women. Clin Interv Aging. 2011;6:119-24. PubMed
  6. Doshi S, Sutjandra L, Zheng J, Sohn W, Peterson M, Jang G et al. Denosumab dose selection for patients with bone metastases from solid tumors. Clin Cancer Res. 2012;18:2648-57. PubMed
  7. Prolia (denosumab). DailyMed [www]. US National Library of Medicine. [updated 2014-06-01, cited 2014-08-07]. länk
  8. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-04-05.] länk

Författare: Linnéa Karlsson Lind, Desirée Loikas

Faktagranskat av: Mia von Euler

Godkänt av: Karin Schenck-Gustafsson