Tuesday, December 4, 2012

Dec 2012 – Pain Product Announcements & Warnings

AnnouncementsFeatured Items: tofacitinib citrate (Xeljanz) approved for RA; tocilizumab (Actemra) expanded approval for RA; linaclotide (Constella) approved in Europe for IBS; adalimumab (Humira) approved for pediatric Crohn's disease; lidocaine/tetracaine cream (Pliaglis) FDA approved; SENSUS pain management system FDA cleared. — All brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.

Tofacitinib Citrate (Xeljanz®) – FDA Approved for RA
The U.S. Food and Drug Administration approved Pfizer's Xeljanz in November 2012 for the treatment of moderately to severely active rheumatoid arthritis (RA) in adult patients who had an inadequate response to methotrexate. Xeljanz is a twice-daily oral therapy and works by blocking Janus kinase molecules which are key to the body's autoimmune response of joint inflammation. The product may be used as monotherapy or in combination with methotrexate or a nonbiologic DMARD, but should not be combined with biologic DMARDs or potent immunosuppressant agents like azathioprine or cyclosporine. The approval was based on the efficacy and safety results of 7 clinical trials in adult patients with active, moderate-to-severe RA. Healthcare providers are advised to be aware that serious infections have occurred in patients receiving Xeljanz and patients should be screened for latent tuberculosis before beginning treatment. In addition, Xeljanz has been associated with increased cholesterol and liver enzyme test results as well as decreases in blood counts. Common adverse effects reported in clinical trials were upper respiratory tract infections, diarrhea, headache, and nasopharyngeal inflammation. See the Xeljanz Prescribing Information and Medication Guide for complete administration and safety instructions.

Tocilizumab (ACTEMRA®) Injection – Expanded Approval for RA
According to an October 2012 announcement by Genentech, the FDA expanded their approved indication for Actemra in the adult treatment of moderate-to-severe rheumatoid arthritis (RA). The interleukin-6 (IL-6) receptor inhibitor can be used in patients who have previously had inadequate results with one or more disease-modifying antirheumatic drugs (DMARDs). This approval is broader than the original one in 2010, which limited its use to patients who did not respond to tumor necrosis factor (TNF) inhibitors. Actemra can be administered as monotherapy or in combination with methotrexate or other DMARDs. Serious and occasionally fatal infections due to bacterial, fungal, and viral pathogens have occurred in patients receiving tocilizumab. It is recommended that healthcare providers screen for latent tuberculosis prior to treatment initiation. For full administration and safety data, consult the Actemra prescribing information and medication guide.

Linaclotide (Constella®) – Approved in Europe for IBS with Constipation in Adults
Allmirall and Ironwood Pharmaceuticals announced a November 2012 European Commission approval of Constella for the adult treatment of symptomatic moderate-to-severe irritable bowel syndrome with constipation (IBS-C). The active ingredient in linaclotide is a guanylate cyclase-C agonist (GCCA) which acts on the intestine by decreasing pain-fiber activity and increasing fluid secretion and, therefore, has negligible systemic exposure. The approval was based on 2 randomized, double-blind, placebo-controlled studies of more than 1600 patients with IBS-C who took linaclotide 290 micrograms or placebo once daily for 12 or 26 weeks. Results showed significant improvements in relief from abdominal pain and discomfort. The FDA granted an August 2012 approval of this product under the name Linzess for U.S. adult patients with chronic idiopathic constipation or IBS-C. Linzess is available in 145 mcg and 290 mcg strengths; see Linzess prescribing information for full safety and administration instructions. See Constella product information for administration and safety instructions.

Adalimumab (HUMIRA®) – European Approval for Severely Active Pediatric Crohn's Disease
Abbott Laboratories announced a November 2012 European Commission approval of Humira for pediatric treatment of severely active Crohn's disease in patients who experienced an inadequate response to or were found to be intolerant to conventional therapy. Humira was approved in Europe in April 2012 for the adult treatment of moderately-to-severely active ulcerative colitis, but this is the first biologic treatment approved for European patients aged 6 to 17 years in more than 5 years. See the Abbott Laboratories press release on this pediatric approval; healthcare providers should be aware that prescribing information varies between countries.

Lidocaine/Tetracaine Cream (Pliaglis®) – FDA Approved
In October 2012, the FDA granted a supplemental NDA to Nuvo Research and Galderma for Pliaglis, a fast-acting topical local anesthetic cream often used for superficial aesthetic procedures in adults. The combination lidocaine/tetracaine cream provides dermal analgesia as the active ingredients are released into the skin from a pliable peel which forms when applied to the skin and exposed to air. Minor transient local adverse effects like erythema, skin discoloration, and edema have been reported in clinical trials. Systemic adverse events occurred in less than 1% of users, with headache, vomiting, dizziness, and fever reported most frequently. The product, originally FDA approved in 2006, was voluntarily removed from the U.S. market in 2008 due to manufacturing issues. The product label provides full safety and administration information.

SENSUS® Pain Management System – FDA 510(k) Clearance Received
In November 2012, NeuroMetrix reported receiving FDA 510(k) clearance for the disposable electrode used in their SENSUS Pain Management System. The device is a non-invasive transcutaneous electrical nerve stimulator designed to provide relief of chronic intractable leg and foot pain in patients suffering from diabetic neuropathy. It is easy to apply, activated by a single button, and worn on the upper calf under clothing. Once programmed for the individual user, it delivers a therapeutic dose of electricity that activates nerves under the skin, thereby reducing local pain signals to the brain. The SENSUS product information website provides a description and supporting literature.

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