Posted from: Wednesday, August 02, 2017 - 12:56 PM - Present

Benlysta Subcutaneous Injection Approved

July 21, 2017 – The U.S. FDA has approved a new subcutaneous (SC) formulation of Benlysta® (belimumab), manufactured by GlaxoSmithKline, for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE). Benlysta, a biologic drug that inhibits the protein B-lymphocyte stimulator (BLyS), has been available as a one-hour intravenous infusion since 2011. The recommended dose of the original Benlysta IV formulation is 10mg/kg every four weeks following induction dosing. Recommended dosing for the new Benlysta SC formulation is 200mg once weekly. Once given proper training by a healthcare provider, patients are able to self-administer the SC formulation. GlaxoSmithKline plans to launch Benlysta SC in late August.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.


Last Updated Friday, November 15, 2019 - 10:41 AM.