Spironolactone bodies are eosinophilic, round, concentrically laminated cytoplasmic inclusions surrounded by clear halos in preparations stained with hematoxylin and eosin. Pregnancy and breastfeeding
In the United States, spironolactone is considered pregnancy category C meaning that it is unclear if it is safe for use during pregnancy. It is able to cross the placenta. Likewise, it has been found to be present in the breast milk of lactating mothers and, while the effects of spironolactone or its metabolites have not been extensively studied in breastfeeding infants, it is generally recommended that women also not take the medication while nursing. However, only very small amounts of spironolactone and its metabolite canrenone enter breast milk, and the amount received by an infant during breastfeeding (<0.5% of the mothers dose) is considered to be insignificant.A study found that spironolactone was not associated with teratogenicity in the offspring of rats. Because it is an antiandrogen, however, spironolactone could theoretically have the potential to cause feminization of male fetuses at sufficient doses. In accordance, a subsequent study found that partial feminization of the genitalia occurred in the male offspring of rats that received doses of spironolactone that were five times higher than those normally used in humans (200 mg/kg per day). Another study found permanent, dose-related reproductive tract abnormalities rat offspring of both sexes at lower doses (50 to 100 mg/kg per day).In practice however, although experience is limited, spironolactone has never been reported to cause observable feminization or any other congenital defects in humans.
Society and culture
Legal status
On 27 January 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Breyanzi, intended for the treatment of adults with relapsed or refractory diffuse large B cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), after at least two previous lines of treatments. The applicant for this medicinal product is Bristol-Myers Squibb Pharma EEIG. Lisocabtagene maraleucel was approved for medical use in the European Union in April 2022. Names
Lisocabtagene maraleucel is the international nonproprietary name (INN). References
External links
"Lisocabtagene maraleucel". NCI Drug Dictionary. National Cancer Institute. Clinical trial number NCT02631044 for "Study Evaluating the Safety and Pharmacokinetics of JCAR017 in B-cell Non-Hodgkin Lymphoma (TRANSCEND-NHL-001)" at ClinicalTrials.gov
Manali Kamdar, MD, MBBS, an Associate Professor at the University of Colorado Denver gives a video interview entitled Lisocabtagene Maraleucel FDA Approved For Large B-cell Lymphoma - https://oncologytube.com/video/41258