scholarly journals Recurrent injection‐site reactions after incorrect subcutaneous administration of a COVID‐19 vaccine

Author(s):  
M Gyldenløve ◽  
L Skov ◽  
CB Hansen ◽  
P Garred
Author(s):  
Sandra Kurtin, RN, MS, AOCN®, ANP-C ◽  
Carol S. Knop, RN, MS, AOCN® ◽  
Todd Milliron, RN, SCN I

Author(s):  
Leslie A Stewart ◽  
Denise M Imai ◽  
Laurel Beckett ◽  
Yueju Li ◽  
K C Lloyd ◽  
...  

An extended-release formulation of the NSAID meloxicam (MSR) is used to provide 72 h of continuous analgesia in many species, including rodents. Although standard formulations of meloxicam are frequently used in rats with no observable injection-site reactions, the potential adverse effects from MSR have not been characterized sufficiently nor has a prospective study of these effects been performed in rats. To address this deficiency, we evaluated injection-site reactions after a single subcutaneous administration of MSR (n = 16) or sterile saline (SC, n = 6) in the flank of age- and sex-matched Sprague–Dawley rats. Mass and erythema scores were measured daily for 2 wk, and injection sites were collected for histopathology after euthanasia. Rats were randomly selected for euthanasia at 7 d (n = 12) or 14 d (n = 10) after injection to capture the subacute and chronic phases of mass and erythematic lesion formation. No rats in the SC group developed lesions, whereas all 16 MSR-treated rats developed masses. The median time to first mass in the MSR treatment group was 3 d (95% CI, 2–3 d), and nearly 8 d for erythema (95% CI, 6.7–9.1 d). The trajectory of mass lesion severity showed rapid progression from score 1 at onset (day 2 or 3) to score 2 for almost all animals by day 5 or 6. Histopathology was characterized by localized inflammation with central necrosis and peripheral fibrosis, with some sections showing developing draining tracts. Given the high prevalence and severity of localized skin reactions, MSR analgesia should be considered carefully for Sprague–Dawley rats.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1783.1-1784
Author(s):  
F. Demir ◽  
E. Gürler ◽  
B. Çolak ◽  
B. Sözeri

Background:Anakinra, a recombinant IL-1 receptorantagonist, is a treatment option that acts byblocking the biological activity of IL-1 in autoinflammatory conditions. The diseases that the IL-1 was over expressed are the potential conditions for this treatment. Such as familial Mediterranean fever (FMF), cryopyrin-associated periodic syndrome (CAPS), and hyperimmunglobulin D syndrome (HIDS) with monogenic inheritance, and systemic juvenile idiopathic arthritis (SoJIA) or idiopathic recurrent pericarditis as non-Mendelian polygenic diseases, can be listed as examples of these diseases.Objectives:The aim of this study was to review the efficacy of anakinra treatment in children with rheumatic disease followed in our center.Methods:The study group consisted of children with pediatric rheumatic diseases followed up in the Pediatric Rheumatology Department of University of Health Sciences and treated with anakinra (anti-IL 1) for at least one month, between 1 July 2016 and 1 January 2020. The data of these patients were collected retrospectively. The disease activity of the patients at 3rd month and 12th month after the treatment were assessed. We aim to report our experiences of pediatric rheumatic diseases treated with anakinra.Results:There were 28 patients treated with anakinra for the different pediatric rheumatic diseases. The diagnoses of these patients were as follows; eight were macrophage activation syndrome (MAS) complicating SoJIA, six were HIDS, four were CAPS, four were FMF, four were idiopathic recurrent pericarditis, one was deficiency of interleukin-36 receptor antagonist (DITRA), and one was undefined systemic autoinflammatory disease. 46.4% of the patients were male and 53.6% were female. The median age of diagnosis of the patients was 6.5 ((interquartile range (IQR): 4-12.7) years. The median follow-up duration of the patients was 14 (IQR: 3.7-28) months. The patients median anakinra treatment duration was 3 (IQR: 1-4) months. Fever reduced and C-reactive protein normalized within median 2 (IQR: 1-3) and 5 (IQR: 5-7) days, respectively. In the 3rd month after treatment; It was observed that 53.6% of patients achieved a complete remission (no attack was seen or MAS was improved). The frequency of attacks were decreased more than 50% in 35.7% of patients and less than 50% in 7.1%. 3.6% of patients were unresponsive to treatment. In the 12th month assessment after the initiation of treatment, it was observed that 28.6% of patients were still under anakinra treatment and in remission, 10.7% of them were in remission without anakinra treatment. In 60.7% of patients, anakinra was switch to other biological treatments for different reasons (35.7% partial response or unresponsiveness, 17.8% injection site reactions and 7.1% daily-injection difficulty). Biologic drug switch to canakinumab and tocilizumab was observed in 88.2% and 11.8% of patients, respectively. One patient developed recurrent MAS episodes when the anakinra dose was tapered, and one another patient was unresponsive to the anakinra and dead due to secondary to MAS.Conclusion:Anakinra seems to be a successful treatment to achieve inactive disease in a significant portion of patients in the early period. The recurrence of disease attacks while drug tapering and injection site reactions were appears the main causes of treatment switch or discontinuation.References:[1]Ben-Zvi I, Kukuy O, Giat E, Pras E, Feld O, Kivity Set al. Anakinra for Colchicine-Resistant Familial Mediterranean Fever: A Randomized, Double-Blind, Placebo-Controlled Trial. Arthritis Rheumatol. 2017;69:854-862.Acknowledgments:We thank our patients and their familiesDisclosure of Interests:None declared


2008 ◽  
Vol 27 (8) ◽  
pp. 757-759 ◽  
Author(s):  
Emmanuel B. Walter ◽  
Martha A. Snyder ◽  
Dennis A. Clements ◽  
Samuel L. Katz

2018 ◽  
Vol 178 (5) ◽  
pp. 491-499 ◽  
Author(s):  
Gudmundur Johannsson ◽  
Ulla Feldt-Rasmussen ◽  
Ida Holme Håkonsson ◽  
Henrik Biering ◽  
Patrice Rodien ◽  
...  

Objective Somapacitan is a reversible albumin-binding growth hormone (GH) derivative, developed for once-weekly administration. This study aimed to evaluate the safety of once-weekly somapacitan vs once-daily Norditropin®. Local tolerability and treatment satisfaction were also assessed. Design 26-week randomized, controlled phase 3 safety and tolerability trial in six countries (Nbib2382939). Methods Male or female patients aged 18–79 years with adult GH deficiency (AGHD), treated with once-daily GH for ≥6 months, were randomized to once-weekly somapacitan (n = 61) or once-daily Norditropin (n = 31) administered subcutaneously by pen. Both treatments were dose titrated for 8 weeks to achieve insulin-like growth factor I (IGF-I) standard deviation score (SDS) levels within the normal range, and then administered at a fixed dose. Outcome measures were adverse events (AEs), including injection site reactions; occurrence of anti-somapacitan/anti-GH antibodies and change in treatment satisfaction, assessed using the Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9). Results Mean IGF-I SDS remained between 0 and 2 SDS throughout the trial in both groups. AEs were mostly mild or moderate and transient in nature. The most common AEs were nasopharyngitis, headache and fatigue in both groups. More than 1500 somapacitan injections were administered and no clinically significant injection site reactions were reported. No anti-somapacitan or anti-GH antibodies were detected. The TSQM-9 score for convenience increased significantly more with somapacitan vs Norditropin (P = 0.0171). Conclusions In this 26-week trial in patients with AGHD, somapacitan was well tolerated and no safety issues were identified. Once-weekly somapacitan was reported to be more convenient than once-daily Norditropin.


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