According to the FDA, zoledronic acid is now contraindicated for use in patients with significant renal impairment.14 This comes after they received 20 reports of acute renal failure leading to death, or requiring dialysis in patients with a creatinine clearance (CrCl) of less than 35 mLs/min or in patients that had evidence of acute renal failure. Clinicians need to screen patients for renal dysfunction before commencing zoledronic acid. Other risk factors that should be taken into consideration before prescribing this agent include advanced age, concomitant therapy with other potential nephrotoxins, dehydration secondary to fever, sepsis, or gastrointestinal losses, or diuretic therapy. In 2009, the zoledronic acid label was changed to recommend serum creatinine measurement prior to each dose, noting that renal failure was a risk with use of this agent. The patient’s actual body weight and the Cockcroft-Gault equation should be used to calculate the CrCl.
New Drug Approvals
Tapentadol extended-release tablets (Nucynta ER) have been approved by the FDA as a twice-daily continuous, around-the-clock opioid analgesic to treat moderate to severe chronic pain in adults when analgesia is needed for an extended period of time.15 A Risk Evaluation and Mitigation Strategy (REMS) is available for this medication. This REMS educates prescribers about the potential for abuse, misuse, overdose, and addiction from exposure to tapentadol extended release. Similar to the immediate-release tapentadol product, this product is classified as a Schedule II. It is available in 50-mg, 100-mg, 150-mg, 200-mg, and 250-mg strengths.
Tocilizumab (RoActemra) has been approved in the European Union (EU) to treat active systemic juvenile idiopathic arthritis (SJIA) in patients two years of age and older who have inadequately responded to previous therapy with NSAIDs and systemic corticosteroids.16 The agent can be used as monotherapy or as combination therapy along with methotrexate. The agent was already approved in the EU for adults with rheumatoid arthritis. In the United States, it was already approved for use in patients with SJIA age two years and older.
Pipeline
Canakinumab, an investigational IL-1-beta protein targeted monoclonal antibody, has met primary and secondary endpoints in a study of patients with SJIA.17 Eighty-four patients 2 to 19 years old with active SJIA were treated in a phase III trial and received either a single subcutaneous dose of canakinumab (ACZ885) or placebo. At Day 15, 84% of patients in the treatment arm achieved at least a 30% improvement in SJIA compared with 10% of placebo-treated patients. The studies are continuing in this patient population.