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Hormones and Cardiovascular Disease
Published in Stephen T. Sinatra, Mark C. Houston, Nutritional and Integrative Strategies in Cardiovascular Medicine, 2022
Side effects may include injection site reactions or skin reactions if using a topical preparation. Gynecomastia may develop in men who have an increase in estradiol. Some men may notice acne or feeling more aggressive, though these symptoms are found mainly in men being treated with doses that are higher than therapeutic level.
Can Recurrent Pregnancy Loss Be Prevented by Antithrombotic Agents?
Published in Howard J.A. Carp, Recurrent Pregnancy Loss, 2020
Audrey A. Merriam, Michael J. Paidas
However, the question is whether anticoagulants are warranted in patients with RPL and a thrombophilia. The editor performed a meta-analysis of the figures in Skeith et al.'s [18] meta-analysis for patients with RPL [19–22] and a trial by Aynioglu [23]. The figures are shown in Figure 9.2 of Chapter 9. There was a statistically significant increase in the live birth rate (odds ratio [OR] 4.88; CI 2.82–8.47). However, the OR is dependent on Aynioglu's [23] trial, which is at variance with the other three trials. Hence the need for the use of treatment with prophylactic anticoagulation, either heparin or LMWH, in women with a history of thrombophilia and RPL or second trimester fetal demise, is an open question. It is inappropriate to recommend treatment on the basis of one randomized controlled trial [23], as benefit, defined as successful pregnancy, has not been consistently demonstrated. In addition, anticoagulant medication does carry risk to the patient, even at prophylactic doses. Heparin-induced thrombocytopenia and major bleeding episodes are rare but can occur. More commonly, aversion to daily injections, cost, and potential injection site reactions can be seen. These potential serious and non-serious side effects question the use of anticoagulant medications solely for improved pregnancy outcomes if benefit is not consistent.
Enfuvirtide
Published in M. Lindsay Grayson, Sara E. Cosgrove, Suzanne M. Crowe, M. Lindsay Grayson, William Hope, James S. McCarthy, John Mills, Johan W. Mouton, David L. Paterson, Kucers’ The Use of Antibiotics, 2017
Juan Ambrosioni, Jose M. Gatell
Enfuvirtide is administered by injection via the subcutaneous route and must be previously reconstituted with sterile water before it can be injected. Patients generally learn to self-inject. The process of reconstitution may take 30–45 minutes, so it is important to train the patients before the first enfuvirtide dose to achieve correct drug administration and, subsequently, an optimal virologic response. Injection is usually into the thighs, abdomen, or upper arms. Use of gentle massage of the injection site or application or either ice or a warm water bottle may minimize injection site reactions.
Autoinjectors for large-volume subcutaneous drug delivery: a review of current research and future directions
Published in Expert Opinion on Drug Delivery, 2023
Andreas Schneider, Reto Jost, Christoph Jordi, Jakob Lange
No study reported any injection-related AEs except for injection-site reactions. In two cases, drug-related AEs were reported [31,88]. The occurrence of injection-site reactions varied greatly, ranging from 2.5% up to 100.0% of injections, highlighting how drug product-specific attributes may mask the effects of injection parameters [53,74,81,95]. Reactions typically observed at the injection site were redness, itching, and swelling; in some cases, hematomas or bleeding occurred. Bruising, which has been reported in other work on the tolerability of subcutaneous drug delivery using autoinjectors [102–104], was mentioned in only few of the studies [31,61,84,86,95]. While most injection-site reactions were mild, one study reported moderate injection-site reactions [78] and another study reported severe injection-site reactions [79]. The authors of the latter study attributed the severe injection-site reactions to the use of a novel injection patch rather than injection volume or rate. This study therefore highlights that the injection device technology can have a significant impact on AEs.
The global landscape on interchangeability of biosimilars
Published in Expert Opinion on Biological Therapy, 2022
Anurag S. Rathore, James G. Stevenson, Hemlata Chhabra, Chinmoyee Maharana
A total of 18 publications were identified in a literature search of etanercept switching to its biosimilar (Supplementary Figure 1b). Table 4 summarizes the results of these studies. Five were randomized controlled trials, with the remainder being either open-label extension or observational studies. The randomized control study reported with biosimilars SB4, LBEC0101, and YLB113 having single switch did not demonstrate any safety and efficacy issues in patients with rheumatoid arthritis [97–99]. Two studies were reported with GP-2015 for indications of psoriasis and rheumatoid arthritis with single and multiple switches, respectively [100,101]. Single switch study did not demonstrate any significant impact on efficacy and safety upto 48 week study period [100]. In the EGALITY study, researchers assessed the effect of multiple switching between etanercept reference biologic and the biosimilar in a multicentre study [101]. The study evaluated the effect of three treatment switches at 6-week intervals on efficacy, safety, and immunogenicity, and found no significant impact from switching measured by psoriasis area and severity index (PASI) scores. Adverse events like injection site reaction were observed but were comparable between groups.
Safety of a single intra-articular injection of LBSA0103 hyaluronic acid in patients with osteoarthritis of the knee: a multicenter, single-arm, prospective, cohort study
Published in Current Medical Research and Opinion, 2021
Ki-Mo Jang, Yong-Geun Park, Won Kee Choi, Young Yool Chung, Kwang Kyoun Kim, Jang Woo Lee, Soong Joon Lee, Yunae Eom, Jae-Hyuk Yang
Safety was assessed by adverse events following HA injection. Adverse events were defined as any undesired or unintended symptom, sign, or disease regardless of the relationship with the injection that occurred in enrolled patients during the study period. Previous studies reported that the onset of most adverse events occurred at several hours to a few days following HA injection25,50,60–62. Therefore, in this study, any adverse events including injection-site reactions were monitored for two weeks after intra-articular injection of HA. Injection-site reactions were collected and recorded as solicited adverse events, focusing on the degrees of pain, warmth, redness, and swelling experienced. Adverse events were classified according to the Medical Dictionary for Regulatory Activities (version 22.1). The disease incidence, disease severity (i.e. mild, moderate, or severe), relationship to the study drug, and outcome of adverse events were evaluated by the study investigators.