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News Updates for Diclofenac Sodium, Denosumab & Sarilumab

Michele B. Kaufman, PharmD, BCGP  |  June 20, 2017

When taking sarilumab, there is an increased risk of the development of serious infections that may lead to hospitalization or death. In clinical trials, the most common adverse reactions were neutropenia (7–10%), increased alanine aminotransferase levels (5%), injection-site erythema (4–5%), upper respiratory infections (3–4%) and urinary tract infections (3%). The manufacturer claims that the U.S. Wholesale Acquisition Cost (WAC) of sarilumab is $39,000/year for the 200 mg and 150 mg doses, which is approximately 30% lower than the WAC price for the two most commonly used TNF-alpha inhibitors.


Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

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References

  1. U.S. Food and Drug Administration. Drugs@FDA: FDA approved drug products—diclofenac sodium 2% topical solution. 2017 May 15.
  2. U.S. Food and Drug Administration. Drugs@FDA: FDA approved drug products—Pennsaid (diclofenac sodium 2% topical solution). 2014 Jan 16.
  3. Kocjan T, Rajic AS, Sever MJ et al. The effect of denosumab or bisphosphonates in women with severe postmenopausal osteoporosis after completion of teriparatide treatment. Endocrine Abstracts. 2017:49[abstract OC10.4] DOI: 10.1530/endoabs.49.OC10.4
  4. Berrie C. Denosumab more effective than bisphosphonates in treating severe, post-menopausal osteoporosis post-teriparatide: Presented At ECE. First Word: Pharma. 2017 May 26.
  5. Regeneron Pharmaceuticals Inc. Regeneron and Sanofi announce FDA approval of Kevzara (sarilumab) for the treatment of moderately to severely active rheumatoid arthritis in adult patients. 2017 May 22.

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Filed under:Biologics/DMARDsConditionsDrug UpdatesOsteoarthritis and Bone Disorders Tagged with:denosumabdiclofenac sodiumFDAFood and Drug Administrationgeneric drugsKnee Osteoarthritis (OA)OsteoporosisRheumatoid Arthritis (RA)sarilumab

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