Preparat: Daratumumab, Darzalex, DARZALEX
ATC kod: L01FC01
Inga skillnader mellan kvinnor och män i effekt eller säkerhet har beskrivits för daratumumab vid behandling av multipelt myelom.
Multiple myeloma is more common in men (incidence in the US: 7.7/100 000 men and 4.9/100 000 women, respectively) and two-fold more common in blacks than in whites in the US . A retrospective data analysis,patients with multiple myelomas who underwent autologous stem cell transplantation (ASCT) (110 men, 81 women) found no differences between men and women in baseline characteristics or five-year overall survival rate .A population-based study in Medicare beneficiaries (1089 men, 1330 women) in the US found male sex to be a risk factor for death together with older age, more co-morbidities, anemia, and hypercalcemia . This is in concordance with an analysis of the EUROCARE database which includes European adults (15-99 years of age, in all 35 086) diagnosed with multiple myeloma between 1995 and 1999. Women were found to have a higher survival rate compared to men, particularly in age groups over the age of 55 years . In this study, age at diagnosis was the main determinant of women’s good outcome. In elderly women, however, the advantage was negligible, suggesting sex hormone patterns to have a role in the prognosis .
Patient’s sex has been shown to have no clinically meaningful effect on pharmacokinetics of daratumumab (in monotherapy or as combination therapy) provided a body weight-based regimen was used [5-7].
In a randomized controlled trial in patients with newly diagnosed multiple myeloma (327 men, 379 women) a beneficial effect of adding daratumumab to bortezomib, melphalan, and prednisone was found in both men and women .An exploratory analysis of data from two randomized studies in patients with relapsed/refractory multiple myeloma (GEN501 and NMY2002, in all 82 men, 69 women) found no difference between men and women in overall response rate .
An exploratory analysis of data from two randomized studies in patients with relapsed/refractory multiple myeloma (GEN501 and NMY2002, in all 82 men, 69 women) found no difference between men and women in overall grade 3 or higher (serious) adverse events or infection of any grade .
As daratumumab is transferred across the placenta and may theoretically cause myeloid- or lymphoid-cell depletion it is recommended that women of reproductive potential should use effective contraception during treatment and for 3 months after cessation of daratumumab treatment [2, 9]. Regarding teratogenic aspects please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).
Läkemedel innehållande daratumumab (ATC-kod L01XC24) används huvudsakligen på sjukhus och därför saknas könsspecifika användningsdata .
Faktagranskat av: Mia von Euler
Godkänt av: Karin Schenck-Gustafsson