FDA Approves Injectable NSAID Dyloject for Mild to Severe Pain
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Updated January 12, 2015.
On December 30, 2014, it was announced that the U.S. Food and Drug Administration (the FDA) had approved Dyloject (diclofenac sodium) for the management of mild to moderate pain in adults and for the management of moderate to severe pain with or without opioid analgesics. Dyloject, developed by Hospira, Inc., is an injectable form of diclofenac sodium. Oral and topical formulations of diclofenac sodium already exist.
Dyloject is classified as an injectable nonsteroidal anti-inflammatory drug (NSAID), as well as a non-opioid analgesic drug. Dyloject provides another injectable pain relief option which can be administered conveniently in a small intravenous bolus over 15 seconds. Dyloject is not intended to replace other non-opioid analgesics which are formulated in large volumes or require dilution before they can be infused over a period of 15-30 minutes. Dyloject is simply another weapon in the arsenal against pain.
The approval of Dyloject was based on two double-blind, placebo and active controlled, multiple-dose studies involving adults with postoperative pain. One study involved 245 patients who had elective abdominal or pelvic surgery. The patients were treated with Dyloject, ketorolac tromethamine (a positive control), or placebo every 6 hours starting within 6 hours following surgery for up to 5 days. Effectiveness was determined by the reduction of pain intensity (the sum of pain intensity differences from 0 to 48 hours), comparing Dyloject to placebo.
The second clinical trial was a controlled, multiple-dose study of adults with post-op pain who had an elective orthopedic procedure. In the study, 277 patients were treated with Dyloject., ketorolac tromethamine, or placebo every 6 hours beginning 6 hours after surgery for up to 5 days. Effectiveness was determined by reduction in pain intensity (the sum of pain intensity differences from 0 to 48 hours), comparing Dyloject to placebo.
Common Side Effects
In clinical trials, the most common side effects associated with Dyloject included nausea, constipation, headache, pain at the infusion site, dizziness, flatulence, vomiting, and insomnia.
Black Box Warning
Dyloject also carries a black box warning about the risk of cardiovascular and gastrointestinal events associated with its use. The entire class of NSAID drugs carries the risk and warnings.
NSAIDs may increase the risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. The risk may increase with greater duration of use. Patients with existing cardiovascular disease or risk factors for cardiovascular disease may be at even greater risk.
NSAIDs increase the risk of gastrointestinal events including bleeding, ulcers, and perforation of the stomach and intestines, which can be fatal. Such events can occur without any warning. Elderly patients have greater risk of developing gastrointestinal adverse events associated with NSAID use.
Other Warnings and Precautions
Because of the black box warnings, Dyloject should be used for the shortest duration possible. In addition to the cardiovascular and gastrointestinal warnings, long-term use of NSAIDs may cause renal injury or renal capillary necrosis. NSAIDs should be used with caution in patients with heart, kidney or liver impairments and in patients who take diuretics or ACE inhibitors. Patients should be monitored for elevated liver function tests, worsening hypertension, fluid retention or edema, serious skin reactions, or anaphylactic reactions. With serious adverse events, discontinuation of the drug would be necessary.
Who Should Not Use Dyloject?
Dyloject should not be used by patients with a known hypersensitivity to diclofenac or by those with a history of asthma, urticaria (hives), or allergic reactions after taking aspirin or any NSAID. Dyloject should not be used for perioperative pain (i.e., pain occurring during a surgical procedure) in patients having coronary artery bypass graft surgery or in patients having moderate to severe renal insufficiency in the perioperative phase who are at risk for volume depletion.
Dyloject. Full Prescribing Information. Hospira, Inc. 12/2014.