Tocilizumab (Actemra), which targets the IL-6 receptor, has been FDA approved as a SubQ formulation for adults with RA who have not fully responded to treatment with conventional disease-modifying antirheumatic drugs (DMARDs).4 Approval was based on two randomized trials. The SUMMACTA trial (n=1,262) was six months in duration and compared the intravenous (IV) formulation of tocilizumab to the SubQ formulation in patients with moderate to severe RA. This noninferiority trial compared the ACR20 response at Month 6 between 8 mg/kg of IV tocilizumab every month and 162 mg of weekly SubQ tocilizumab. Patients were also receiving conventional DMARDs. Comparable efficacy was obtained with a 69% response in the SubQ-treated group and a 73% response in the IV-treated group. The BREVACTA trial (n=656) compared SubQ tocilizumab every two weeks to placebo. Tocilizumab-treated patients had a 61% response rate compared with placebo-treated patients (32%), as well as significantly less joint damage. Injection-site reactions were more common with the SubQ formulation, otherwise the safety profiles of the two formulations were similar.
Drug Safety
The FDA is to phasing out prescription opioid products that are combined with more than 325 mg of acetaminophen, in an attempt to decrease the amount of hepatotoxicity associated with their use. This phaseout begins January 14, 2014.5 Prior to this date, any combination product with more than 325 mg of acetaminophen could exist. Some of these products included generic hydrocodone/acetaminophen combinations (or their brands, Zydone, Vicodin, Vicodin ES, Vicodin HP, Lortab); generic oxycodone/acetaminophen combinations (or their brands, Percocet, Roxicet 5/500, Tylox); and butalbital combinations. After January 14, 2014, the maximum amount of acetaminophen allowable in these products will be 325 mg. Rather than reformulating all products to 325 mg of acetaminophen, the Vicodin-brand products were already reformulated to contain less than 325 mg of acetaminophen. Since most combination products will have 325 mg of acetaminophen, having these products with 300 mg acetaminophen will likely be confusing for many. For patients requiring a combination of acetaminophen and hydrocodone, write prescriptions for generic products with 325 mg as the amount of acetaminophen. This will cause less confusion and will give the pharmacist a number of options with which to choose to fill the prescription.
Dr. Kaufman is a freelance medical writer based in New York City, a pharmacist at New York Presbyterian–Lower Manhattan Hospital, and adjunct faculty at Touro College of Pharmacy.
References
- Cimzia (certolizumab pegol) approved by FDA for treatment of adults with active ankylosing spondylitis. Published October 18, 2013. Available at www.firstwordpharma.com/print/1147509?tsid=17. Accessed November 26, 2013.
- Dearment A. Sanofi and Regeneron report positive results with sarilumab in first phase 3 rheumatoid arthritis registration trial. Published October 14, 2013. Available at http:// http://newsroom.regeneron.com/releasedetail.cfm?ReleaseID=809088. Accessed December 9, 2013.
- FDA approves easy-to-use injectable methotrexate for RA, psoriasis, juvenile arthritis Published November 22, 2013 http://www.drugstorenews.com/article/fda-approves-easy-use-injectable-methotrexate-ra-psoriasis-juvenile-arthritis Accessed November 26, 2013.
- Walsh N. FDA greenlights sub Q Actemra. Published October 22, 2013. Available at www.medpagetoday.com/Rheumatology/Arthritis/42414. Accessed November 25, 2013.
- Opioids. Pharmacist’s Letter: 2013;29(12).
