OLUMIANT Film-coated tablets (2018)
Active ingredients: Baricitinib
Product Name and Form
Olumiant 2 mg film-coated tablets.
Olumiant 4 mg film-coated tablets.
Film-coated tablet (tablet).
Olumiant 2 mg film-coated tablets: Light pink, 9.0 × 7.5 mm oblong tablets, debossed with “Lilly” on one side and “2” on the other.
Olumiant 4 mg film-coated tablets: Medium pink, 8.5 mm round tablets, debossed with “Lilly” on one side and “4” on the other.
The tablets contain a recessed area on each side.
Qualitative and Quantitative Composition
Olumiant 2 mg film-coated tablets: Each film-coated tablet contains 2 mg baricitinib.
Olumiant 4 mg film-coated tablets: Each film-coated tablet contains 4 mg baricitinib.
For the full list of excipients, see section 6.1.
Baricitinib is a selective and reversible inhibitor of Janus kinase (JAK)1 and JAK2. In isolated enzyme assays, baricitinib inhibited the activities of JAK1, JAK2, Tyrosine Kinase 2 and JAK3 with IC50 values of 5.9, 5.7, 53 and >400 nM, respectively. Janus kinases (JAKs) are enzymes that transduce intracellular signals from cell surface receptors for a number of cytokines and growth factors involved in haematopoiesis, inflammation and immune function.
- cellulose, microcrystalline
- croscarmellose sodium
- magnesium stearate
- iron oxide red (E172)
- lecithin (soya) (E322)
- poly (vinyl alcohol)
- titanium dioxide (E171)
Pack sizes and Marketing
Polyvinylchloride/polyethylene/polychlorotrifluoroethylene – aluminium blisters in cartons of 14, 28, 35, 56, 84 or 98 film-coated tablets.
Polyvinylchloride/aluminium/oriented polyamide – aluminium perforated unit dose blisters in cartons of 28 × 1 or 84 × 1 film-coated tablets.
Not all pack sizes may be marketed.
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, The Netherlands
Date of first Authorisation: 13 February 2017
Olumiant 2 mg film-coated tablets:
Olumiant 4 mg film-coated tablets: