scholarly journals Predictors of Subcutaneous Injection Site Reactions to Sustained-Release Buprenorphine in Rhesus Macaques (Macaca mulatta)

2021 ◽  
Author(s):  
Andrew J Haertel ◽  
Matthew A Schultz ◽  
Lois M Colgin ◽  
Amanda L Johnson
Keyword(s):  
Sustained Release ◽  
Injection Site ◽  
Macaca Mulatta ◽  
Subcutaneous Injection ◽  
Rhesus Macaques ◽  
Single Case ◽  
Subcutaneous Tissue ◽  
Injection Site Reaction ◽  
Reaction Rates ◽  
Injection Site Reactions

Subcutaneous injection site reactions to sustained-release buprenorphine hydrochloride (Buprenorphine SR) in macaqueshave been reported in only a single case report. In the current study, we evaluated the incidence rate and predictors ofbuprenorphine SR reactions in the subcutaneous tissue of rhesus macaques (Macaca mulatta) based on retrospective reviewof macaque buprenorphine SR injection records. Potentially predictive variables were identified with logistic regressionmodeling and were evaluated using model selection based on Akaike information criterion. Record review revealed subcutaneoustissue reactions occurred in 52 (3%) of 1559 injections and were noted between 4 and 311 d after injection. Modelselection showed that body weight and MHC allele Mamu-B*29 were the best predictors of subcutaneous reactions. Basedon these results, we recommend consideration of potential risk factors prior to the administration of buprenorphine SR toa rhesus macaque. In addition, the authors advise that using the highest concentration of buprenorphine SR available mayreduce injection site reaction rates due to the injection of less copolymer.

scholarly journals PMS36 INJECTION SITE REACTION QUESTIONNAIRE: AN ADEQUATE TOOL FOR MEASURING INJECTION SITE REACTIONS?

2010 ◽  
Vol 13 (3) ◽  
pp. A129
Author(s):  
EH Lee ◽  
E Jutkowitz ◽  
S Parasuraman ◽  
C Derk ◽  
LT Pizzi
Keyword(s):  
Injection Site ◽  
Injection Site Reaction ◽  
Site Reaction ◽  
Injection Site Reactions

Phase I, double-blind, placebo-controlled, ascending single subcutaneous dose, safety, tolerability, and pharmacokinetic study of sustained release granisetron (APF530).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e20587-e20587
Author(s):  
John Barr ◽  
Erin O'Boyle ◽  
Martin Johnson
Keyword(s):  
Sustained Release ◽  
Injection Site ◽  
Therapeutic Benefit ◽  
Absolute Bioavailability ◽  
Adult Males ◽  
Double Blind ◽  
Injection Site Reactions ◽  
Subcutaneous Dose ◽  
Upper Abdominal ◽  
Dose Proportional

e20587 Background: Although several 5-HT3antagonists are approved for chemotherapy-induced nausea and vomiting, agents with longer duration of therapeutic benefit are needed. APF530 incorporates a polymer that allows for controlled and sustained release of granisetron. Methods: Adult males were randomized to receive subcutaneous (SC) APF530 125 mg, 250 mg, 500 mg, or 1 g (groups A-D, respectively) and simultaneous placebo. Groups B-D subsequently received intravenous (IV) granisetron ≥ 7 days after APF530 dosing. Safety, tolerability, pharmacokinetics (PK), and absolute bioavailability of granisetron from APF530 were examined. Results: 26 subjects were randomized. All APF530 doses were well tolerated; most adverse events (AEs) were mild injection site reactions (pain on palpation, erythema); all resolved. Other AEs included headache (IV, SC), upper abdominal pain (SC), and constipation (SC). PK parameters were generally dose proportional (Table). APF530 elicited slow sustained absorption of granisetron; tmax was 8-10 h, and some subjects had secondary plasma peaks at 24-96 h. Systemic levels were reached within 30 min. Based on AUCall, granisetron was shown to be completely bioavailable from the SC dose formulation of APF530. Conclusions: APF530 safety profile was similar to that of granisetron, with the addition of mild injection site reactions. Granisetron was completely bioavailable at all APF530 doses. PK parameters were generally dose proportional. Absorption of granisetron from APF530 was prolonged compared with that from IV granisetron. Clinical trial information: NCT01416259. [Table: see text]

scholarly journals Evaluation of injection-site-related adverse events with galcanezumab: a post hoc analysis of Phase 3 studies in participants with migraine

2020 ◽  
Author(s):  
Virginia L. Stauffer ◽  
Shufang Wang ◽  
Jo Bonner ◽  
ByungKun Kim ◽  
Rohit Bhandari ◽  
...  
Keyword(s):  
Injection Site ◽  
Injection Site Reaction ◽  
Treatment Phase ◽  
Site Reaction ◽  
Open Label ◽  
Double Blind ◽  
Exposure Analysis ◽  
Injection Site Reactions ◽  
Post Hoc ◽  
Site Pain

Abstract Background: Injection-site reactions have been reported with biologicals. In this post hoc analysis of Phase 3 studies in participants with migraine, we provide a comprehensive overview and detailed summary of injection-site reaction with galcanezumab. Methods: Data were obtained from two randomised clinical studies in participants with episodic migraine (EVOLVE-1 and EVOLVE-2), one randomised study in participants with chronic migraine (REGAIN) and one open-label study (Study CGAJ) in participants with episodic or chronic migraine. The injection-site reactions were measured for two different cohorts: 1) six-month double-blind treatment phase in the EVOLVE-1 and EVOLVE-2 studies and three-month double-blind treatment phase in the REGAIN study, where participants received placebo and galcanezumab (placebo-controlled analysis set); 2) three month double-blind (Month 0 to Month 3; 1:1:placebo:galcanezumab) + nine months open-label extension phase (Month 3 to Month 12) of REGAIN and twelve month open-label phase of Study CGAJ, where participants received only galcanezumab (galcanezumab exposure analysis set).Results: A total of 477 participants in the placebo-controlled analysis set (galcanezumab 240 mg, 166/730 [22.7%]; galcanezumab 120 mg, 128/705 [18.2%]; placebo, 183/1451 [12.6%]) reported at least one injection-site reaction. Most of the injection-site reactions were reported as injection-site pain, unspecified injection-site reaction, injection-site erythema, and injection-site pruritus. The incidence of injection-site pain was highest among all reported Injection-site reactions and were reported with similar frequency by participants receiving galcanezumab (galcanezumab 120mg, 10.1%; galcanezumab 240 mg, 11.6%) and placebo (9.5%) and was the most common injection-site reaction reported within 60 minutes of injection (~86% of participants). The frequency of unspecified injection-site reaction, injection-site erythema and injection-site pruritus was significantly (P<0.001) higher in participant receiving galcanezumab versus placebo. In the galcanezumab exposure analysis set participants received up to 12 doses and the frequency of injection-site reactions reported for both doses combined was 21.8%. The reporting of injection-site reactions did not increase with the number of doses received. No ISR-related serious adverse events were reported in both the placebo-controlled and galcanezumab exposure analysis sets.Conclusions: The most common adverse event of galcanezumab is injection-site reactions. However, these events were generally mild-to-moderate in severity, non-serious, resolved spontaneously, and discontinuations due to injection-site reactions were low (1%).

scholarly journals Paliperidone Palmitate Associated with Necrotizing Deep Tissue Infection and Sepsis Requiring Surgical Intervention

2015 ◽  
Vol 2015 ◽  
pp. 1-3 ◽  
Author(s):  
Jonathan G. Leung ◽  
Kirstin J. Kooda ◽  
Erin N. Frazee ◽  
Sarah Nelson ◽  
Katherine M. Moore
Keyword(s):  
Injection Site ◽  
Injection Site Reaction ◽  
Extended Period ◽  
Repeated Administration ◽  
Oral Formulation ◽  
Paliperidone Palmitate ◽  
Deep Tissue ◽  
Injection Site Reactions ◽  
First Case ◽  
Long Acting

Long-acting injectable antipsychotics provide the delivery of medication over an extended period of time requiring administration typically only every 2 to 4 weeks. The side effect profile of a long-acting injectable antipsychotic is predictable and similar to the oral formulation. However, injection site reactions may occur with this novel delivery system. The risk of an injection site reaction may be greater with the repeated administration of a lipophilic decanoate formulation and include pain, development of indurations, and fibrosis. Severe complications from injection site reactions have rarely been described in the literature with newer agents. We report the first case of a patient prescribed paliperidone palmitate every 3 weeks that developed severe sepsis requiring vasopressors and intubation due to delayed relayed recognition of a necrotizing infection at an injection site. Clinicians should be alerted to screen for injection site reactions when there is an unknown source infection in a patient receiving a long-acting injectable antipsychotic.

scholarly journals Injection Reactions after Administration of Sustained-release Meloxicam to BALB/cJ, C57BL/6J, and Crl:CD1(ICR) Mice

2021 ◽  
Author(s):  
Stephanie R Fuetsch ◽  
Leslie A Stewart ◽  
Denise M Imai ◽  
Laurel A Beckett ◽  
Yueju Li ◽  
...  
Keyword(s):  
Sustained Release ◽  
Injection Site ◽  
Treated Group ◽  
Saline Control ◽  
Point System ◽  
Release Formulation ◽  
Skin Reactions ◽  
Sustained Release Formulation ◽  
Injection Site Reactions ◽  
Severity Scores

The sustained-release formulation of meloxicam (MSR) is a compounded NSAID that may provide pain relief for as longas 72 h after administration. MSR injection-site skin reactions have occurred in several species but have not previously been observed in mice. We investigated the development and progression of localized skin reactions after a single injection of MSR in Crl:CD1(ICR), C57BL/6J, and BALB/cJ mice. Each mouse received a subcutaneous injection of MSR (n = 60), standardformulation meloxicam (MEL; n = 24) or saline (control; SC; n = 24) and was scored daily according to a 5-point system for erythema and mass characteristics. Mice were euthanized at either 7 or 14 d after injection and underwent postmortem analysis.MSR-treated mice had more erythematous and mass reactions than did MEL and SC mice. Mass lesions developed in 49 MSRmice (82%; 95% CI, 70% to 90%), 5 MEL animals (21%; 95% CI, 7% to 42%), and 1 SC mouse. MSR-treated BALB/cJ developed erythematous lesions less frequently than similarly treated Crl:CD1(ICR) or C57BL/6J. Lesions often were ventrolateral to the injection site. The median times to the appearance of mass and erythematous lesions were 2 d and 3 d, respectively. Histologically, the erythematous and mass reactions correlated with necrotizing to pyogranulomatous injection-site panniculitis.Inflammation severity scores at 7 and 14 d after injection were greater in the MSR-treated group than the other 2 groups. No strain- or sex-associated differences emerged except that inflammation severity scores at day 14 were higher in Crl:CD1(ICR) females than males. The character of the inflammatory response in MSR-treated mice did not differ between 7 and 14 d after injection, indicating that MSR-induced inflammation is slow to resolve. The ventral migration and delayed onset of MSR injection-site reactions could result in their being attributed to another cause or not being identified. Researchers and clinicians should be aware of the potential for slowly resolving injection-site reactions with MSR.

scholarly journals Evaluation of injection-site-related adverse events with galcanezumab: a post hoc analysis of Phase 3 studies in participants with migraine

2020 ◽  
Author(s):  
Virginia Stauffer ◽  
Shufang Wang ◽  
Jo Bonner ◽  
ByungKun Kim ◽  
Rohit Bhandari ◽  
...  
Keyword(s):  
Injection Site ◽  
Injection Site Reaction ◽  
Treatment Phase ◽  
Site Reaction ◽  
Open Label ◽  
Double Blind ◽  
Exposure Analysis ◽  
Injection Site Reactions ◽  
Post Hoc ◽  
Site Pain

Abstract Background: Injection-site reactions have been reported with biologicals. In this post hoc analysis of Phase 3 studies in participants with migraine, we provide a comprehensive overview and detailed summary of injection-site reaction with galcanezumab.Methods: Data were obtained from two randomised clinical studies in participants with episodic migraine (EVOLVE-1 and EVOLVE-2), one randomised study in participants with chronic migraine (REGAIN) and one open-label study (Study CGAJ) in participants with episodic or chronic migraine. The injection-site reactions were measured for two different cohorts: 1) six-month double-blind treatment phase in the EVOLVE-1 and EVOLVE-2 studies and three-month double-blind treatment phase in the REGAIN study, where participants received placebo and galcanezumab (placebo-controlled analysis set); 2) three month double-blind (Month 0 to Month 3; 1:1:placebo:galcanezumab) + nine months open-label extension phase (Month 3 to Month 12) of REGAIN and twelve month open-label phase of Study CGAJ, where participants received only galcanezumab (galcanezumab exposure analysis set).Results: A total of 477 participants in the placebo-controlled analysis set (galcanezumab 240 mg, 166/730 [22.7%]; galcanezumab 120 mg, 128/705 [18.2%]; placebo, 183/1451 [12.6%]) reported at least one injection-site reaction. Most of the injection-site reactions were reported as injection-site pain, unspecified injection-site reaction, injection-site erythema, and injection-site pruritus. The incidence of injection-site pain was highest among all reported Injection-site reactions and were reported with similar frequency by participants receiving galcanezumab (galcanezumab 120mg, 10.1%; galcanezumab 240 mg, 11.6%) and placebo (9.5%) and was the most common injection-site reaction reported within 60 minutes of injection (~86% of participants). The frequency of unspecified injection-site reaction, injection-site erythema and injection-site pruritus was significantly (P<0.001) higher in participant receiving galcanezumab versus placebo. In the galcanezumab exposure analysis set participants received up to 12 doses and the frequency of injection-site reactions reported for both doses combined was 21.8%. The reporting of injection-site reactions did not increase with the number of doses received. No ISR-related serious adverse events were reported in both the placebo-controlled and galcanezumab exposure analysis sets.Conclusions: The most common adverse event of galcanezumab is injection-site reactions. However, these events were generally mild-to-moderate in severity, non-serious, resolved spontaneously, and discontinuations due to injection-site reactions were low (1%).Trial registration: Clinicaltrials.gov identifier: NCT02614183, NCT02614196, NCT02614261, NCT02614287.

scholarly journals Subcutaneous Injection of Trastuzumab – Analysis of Administration Time and Injection Site Reactions

2012 ◽  
Vol 23 ◽  
pp. ix103 ◽  
Author(s):  
X. Pivot ◽  
V. Semiglazov ◽  
S. Chen ◽  
S.D. Moodley ◽  
A. Manihkas ◽  
...  
Keyword(s):  
Injection Site ◽  
Subcutaneous Injection ◽  
Injection Site Reactions ◽  
Administration Time

scholarly journals Embolia Cutis Medicamentosa after Subcutaneous Injection with Glatiramer Acetate

2021 ◽  
pp. 114-120
Author(s):  
Lyubomira Vlahova ◽  
Lutz Kretschmer ◽  
Michael P. Schön ◽  
Rotraut Mössner
Keyword(s):  
Multiple Sclerosis ◽  
Injection Site ◽  
Glatiramer Acetate ◽  
Subcutaneous Injection ◽  
Rare Case ◽  
Injection Site Reaction ◽  
Disease Course ◽  
Site Reaction ◽  
Photo Documentation ◽  
Embolia Cutis Medicamentosa

Embolia cutis medicamentosa (ECM) is a rare and unpredictable injection site reaction, occurring after intramuscular, subcutaneous, and even after intraarticular injection of various drugs. We report a very rare case of necrotizing ECM after injection of glatiramer acetate for multiple sclerosis, include a photo documentation over the entire disease course, and discuss hypotheses as to etiology and treatment.

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