(macitentan)
This information is intended for US healthcare professionals to access current scientific information about Janssen products. It is prepared by Janssen Medical Information and is not intended for promotional purposes, nor to provide medical advice.
Last Updated: 04/09/2024
The OPSUMIT tablet is not scored nor has been evaluated for splitting.1 Physical characteristics, such as size, shape, and tablet score, can impact the uniformity of split tablets.2 The decision to administer reformulated OPSUMIT (eg, orally or via nasogastric tube) is at the discretion of the prescribing physician.
NIOSH published a guide to manage hazardous drug exposure in healthcare facilities, including hospitals, long-term care facilities, outpatient clinics, and nontraditional settings such as home health.3 OPSUMIT was listed in the 2020 NIOSH Hazardous Drugs list as a developmental and/or reproductive hazard. It met the NIOSH criteria, but it does not have the manufacturer’s special handling information or is classified by the National Toxicology Program as “known to be a human carcinogen” or classified by the International Agency for Research on Cancer as “carcinogenic” or “probably carcinogenic”.4
A study evaluated the stability of crushed OPSUMIT film-coated tablets and crushed OPSUMIT film-coated tablets with either lactose or maize starch mixed in a 1:1 ratio, following storage for 4 weeks at 30°C-75% humidity. Study results showed no change in the appearance, macitentan content, or degradation products of crushed OPSUMIT tablets with/without lactose or maize starch after storage for 4 weeks at 30°C-75% humidity. Furthermore, the tablets were photostable after exposure to ultraviolet (UV) and visible light for 5 days.5
During in vitro testing of the OPSUMIT film-coated tablet, >50% of the active ingredient was dissolved after 5 minutes and >90% after 45 minutes in 1000 mL of 50 mM sodium phosphate buffer (pH 6.8) with 0.1% (w/v) of CTAB.6
A literature search of MEDLINE®
1 | NDA 204410 Opsumit (macitentan) PM Overview. 2024-04-01. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204410Orig1s000OtherR.pdf |
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