"Nevro Corp has received an "approvable" letter from the US Food and Drug Administration (FDA) for its spinal cord stimulation (SCS) system for treatment of chronic pain.
The Senza SCS system delivers Nevro's proprietary HF10"...
For demographics, see Clinical Trials section.
The following table of incidence of reactions is based upon controlled clinical studies in which OXILAN® (ioxilan (ioxilan (ioxilan) ) ) was compared with a nonionic contrast agent (iohexol) in 531 patients. It includes all reported adverse events, regardless of attribution.
Adverse reactions are listed by body system and in decreasing order of occurrence greater than 0.5% in the OXILAN® (ioxilan (ioxilan (ioxilan) ) ) group.
|Body System||Adverse Event|| Ioxilan
(n = 531)
(n = 542)
|Body as a Whole||Headache||19 (3.6%)||15 (2.8%)|
|Fever||9 (1.7%)||11 (2.0%)|
|Hematoma at Injection Site||4 (0.8%)||0 (0%)|
|Chills||3 (0.6%)||0 (0%)|
|Cardiovascular||Angina Pectoris||7(1.3%)||11 (2.0%)|
|Hypotension||5 (0.9%)||3 (0.6%)|
|Digestive||Nausea||8 (1.5%)||7 (1.3%)|
|Nausea with Vomiting||5 (0.9%)||5 (0.9%)|
One or more adverse reactions were reported in 76 of 531 (14.3%) of patients in the clinical trials, coincidental with the administration of OXILAN® (ioxilan (ioxilan (ioxilan) ) ) or within the study follow-up period of 24 to 72 hours. The incidence and type of adverse reactions were similar to those associated with the nonionic comparator (iohexol) used in the clinical trials. OXILAN® (ioxilan (ioxilan (ioxilan) ) ) , as do other iodinated contrast agents, often causes warmth and/or pain on injection. The rates are similar to that of the iohexol comparator.
Serious, life threatening and fatal reactions have been associated with the administration of iodine-containing contrast media. In all clinical trials 3/835 (0.3%) patients given OXILAN® (ioxilan (ioxilan (ioxilan) ) ) and 3/542 (0.6%) given iohexol died 4 days or later after drug administration. In the controlled trials 8/531 (1.5%) patients given OXILAN® (ioxilan (ioxilan (ioxilan) ) ) and 6/542 (1.1%) given iohexol had serious adverse events.
The following adverse reactions were observed ≤ 0.5% of patients receiving OXILAN® (ioxilan (ioxilan (ioxilan) ) ) Injection: BODY: allergic reaction, asthenia, chest and back pain, edema of the neck, facial edema, pain, peripheral edema; CARDIOVASCULAR: atrial fibrillation, syncope, tachycardia, vasodilation, ventricular extra systole; DIGESTIVE: anorexia, constipation, dyspepsia, dysphagia, Gl hemorrhage, ileus, liver failure; NERVOUS: hypotonia, nystagmus, paresthesia, somnolence, vertigo; RESPIRATORY: dyspnea, pharyngitis, rhinitis; SKIN: pruritus, sweating; SPECIAL SENSES: amblyopia, conjunctivitis, taste perversion, vision abnormality; UROGENITAL: anuria, dysuria, hematuria, infection of urinary tract, impairment of urination, kidney failure.
Additional adverse events reported in postmarketing surveillance with the use of OXILAN® (ioxilan (ioxilan (ioxilan) ) ) Injection include: bronchospasm.
Read the Oxilan (ioxilan) Side Effects Center for a complete guide to possible side effects
Renal toxicity has been reported in a few patients with liver dysfunction who were given an oral cholecystographic agent followed by intravascular contrast agents. Administration of any intravascular contrast agent should therefore be postponed in any patient with a known or suspected hepatic or biliary disorder who has recently received a cholecystographic contrast agent. Other drugs should not be admixed with OXILAN® (Ioxilan (ioxilan (ioxilan) ) Injection).
Drug/Laboratory Test Interactions
The results of protein bound iodine and radioactive iodine uptake studies. which depend on iodine estimations, '.-.ill not accurately reflect thyroid function for at least 16 days following administration of iodinated contrast media However thyroid function tests which do not depend on iodine estimations, e.g., T3 resin uptake and total or free thyroxine (T4) assays are not affected.
Laboratory Test Findings
In vitro assays were performed with human blood to assess the effects of ioxilan (ioxilan (ioxilan) ) , iohexol and iopamidol on red blood cell morphology and platelet aggregation. Ioxilan (ioxilan (ioxilan) ) , at a concentration of 35 mgl/mL, did not affect red blood cell morphology. Ioxilan (ioxilan (ioxilan) ) , iohexol and iopamidol all inhibited ADP-induced platelet aggregation in a concentration-dependent manner.
In vitro assays with human blood and serum were performed to determine the effects of ioxilan (ioxilan (ioxilan) ) , iohexol, and iopamidol at a dose of 35 mgl/mL on the following coagulation factors; thrombin time, prothrombin time and partial thromboplastin time. Data on reversibility are not available. The thrombin time increased from an average baseline value of 8.0 seconds to average values of 36.9 seconds for ioxilan (ioxilan (ioxilan) ) , (comparable to iohexol and iopamidol.) Prothrombin time increased from an average baseline value of 12.3 seconds to an average value of 17.6 seconds for ioxilan (ioxilan (ioxilan) ) , 18.8 seconds for iopamidol, and 27.8 seconds for iohexol. Partial thromboplastin time increased from an average baseline value of 55.8 seconds to an average value of 77.4 seconds for ioxilan (ioxilan (ioxilan) ) , 89.4 seconds for iohexol, and 70.9 seconds for iopamidol. The duration of these effects was not studied and the clinical impact is unknown.
In vitro assays with human serum were performed to determine the effects of ioxilan (ioxilan (ioxilan) ) and iohexol on complement levels. Total complement consumption (CH50 was not significantly affected by either ioxilan (ioxilan (ioxilan) ) or iohexol. However, the C3 and C3c components of complement decreased by 14% and 19%, respectively, with ioxilan (ioxilan (ioxilan) ) and by 18% and 23% with iohexol. C3c was not detected for either agent.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 2/25/2009
Additional Oxilan Information
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