Transition from Intravenous to Subcutaneous Daratumumab Formulation in Clinical Practice.

INTRODUCTION: Daratumumab is an anti-CD38 monoclonal antibody widely used for treating patients with newly diagnosed or relapsed/refractory multiple myeloma. The subcutaneous formulation of daratumumab was developed with the purpose of minimizing the treatment burden (to patients and health care system) associated with intravenous daratumumab. Given its recent approval, there is a knowledge gap regarding the best practices that should be instituted for safe administration of subcutaneous daratumumab. METHODS: A retrospective chart review was performed from August 2020 until November 2020 to identify patients either switched to or treated upfront (daratumumab naive) with any subcutaneous daratumumab-based treatment regimen. All patients received appropriate premedications per institutional standards of care. The study end points were to report real-world data regarding administration-related reaction rates (at or following discharge from infusion center), as well as compare their incidence rates to those noted in the COLUMBA study (historical cohort). RESULTS: The study included 58 patients, of whom 38% (n = 22) were daratumumab naive. The majority (84%, n = 49) received subcutaneous daratumumab in combination with various antimyeloma regimens. There were no cases of administration-related reactions at infusion center or after discharge irrespective of previous exposure to intravenous daratumumab. None of the patients included herein required rescue home medications or visited the emergency department within 24 to 48 hours after subcutaneous daratumumab administration. These translated into a significant difference in incidence of administration-related reactions compared with historical cohort (0% vs. 13%, P = .003). CONCLUSION: Subcutaneous daratumumab was extremely well tolerated and could be safely administered without need for monitoring or rescue home medications.

Evolution of Diabetes Technology.

Technological innovations have fundamentally changed diabetes care. Insulin pump use and continuous glucose monitoring are associated with improved glycemic control along with a better quality of life; automated insulin-dosing advisors facilitate and improve decision making. Glucose-responsive automated insulin delivery enables the highest targets for time in range, lowest rate and duration of hypoglycemia, and favorable quality of life. Clear targets for time in ranges and a standard visualization of the data will help the diabetes technology to be used more efficiently. Decision support systems within and integrated cloud environment will further simplify, unify, and improve modern routine diabetes care.

Subcutaneous Immunoglobulin Therapy for Chronic Inflammatory Demyelinating Polyneuropathy: A Nursing Perspective.

Chronic inflammatory demyelinating polyneuropathy (CIDP), an immune-mediated peripheral neuropathy, is frequently treated with long-term maintenance intravenous immunoglobulin (IVIG). However, disadvantages of IVIG are the systemic adverse reactions, lengthy infusions, and need for vascular access. Subcutaneous immunoglobulin (SCIG) addresses many of the issues encountered by those unable, or unwilling, to tolerate the treatment burden of long-term IVIG. Subcutaneous immunoglobulin, a 20% solution stabilized with L-proline, is US Food and Drug Administration-approved for CIDP maintenance therapy in patients after being stabilized with IVIG. Approval was based on a randomized, double-blind, placebo-controlled trial where SCIG demonstrated superiority over placebo and was safe and efficacious in maintaining function. In addition to reviewing the primary efficacy results from the clinical trial, this article aims to update the neurology nursing community on a new option for long-term management of CIDP, including the practicalities of initiating and maintaining patients on SCIG therapy.

Knowledge and use of sterile water injections amongst midwives in the United Kingdom: A cross-sectional study.

BACKGROUND: The use of sterile water injections (SWI) for the relief of pain in labour is popular amongst midwives in countries such as Sweden and Australia. Anecdotal reports suggest the procedure is used less commonly in the United Kingdom (UK) and that a number of barriers to introducing the practice may exist. OBJECTIVE: The objective of this study was to explore the awareness and use of SWI amongst midwives in the UK. DESIGN: A cross-sectional study using an internet-based questionnaire. PARTICIPANTS: Midwives with Nursing and Midwifery Council Registration and currently practicing. SETTING: The questionnaire was distributed via the Royal College of Midwives Facebook page and Twitter account. Invitations to participate were also sent to Heads of Midwifery to distribute to staff. FINDINGS: Three hundred and ninety-eight midwives completed the survey. Eighty-two percent of midwives did not use SWI in practice although 69% would consider learning the procedure. There was considerable variation in techniques amongst midwives that did provide SWI. The lack of available practice guidelines and the advice from the National Institute for Health and Care Excellence to not use SWI were cited as the main barriers. KEY CONCLUSIONS: SWI use is uncommon in the UK although midwives are interested in incorporating the procedure into practice. IMPLICATIONS FOR PRACTICE: National guidance on SWI and the lack of information and training is restricting the use of the procedure in practice, despite SWI being widely used in other countries and being effective in the treatment of pain in labour.

Home care use of intravenous and subcutaneous immunoglobulin for primary immunodeficiency in the United States.

PURPOSE: Utilization reports on immunoglobulin (Ig) use for immunodeficiency in the United States (U.S.) have focused on prescribing practices in hospitals. There have been no large-scale reports on Ig use for immune deficiency in the home. We investigated the use of Ig in 3,187 subjects diagnosed with primary immunodeficiency. METHODS: Cross-sectional data on 4,580 subjects in the U.S. receiving Ig in 2011 was obtained from a major home care provider. Demographics, route, dose, and frequency of Ig use by subjects with ICD-9 coded primary immunodeficiencies were analyzed. RESULTS: Of 4,580 subjects, 3,187 had ICD-9 codes suggesting primary immunodeficiencies; 1,939 (60.8 %) were females and 1,248 (39.2 %) were males, with age ranging from 0 to 95 years. The predominant diagnoses were: common variable immunodeficiency (279.06; n=1,764; 55.3 %), hypogammaglobulinemia (279.00; n=635; 19.9 %), unspecified immunity deficiency (279.3; n=286; 9 %), other selective Ig deficiencies (279.03; n=171; 5.4 %), and agammaglobulinemia (279.04; n=127; 4 %). 54 % of subjects received Ig by the subcutaneous (SC) route, and 46 % by intravenous (IV) route, with more SC use by older subjects. The mean dose prescribed was 483 mg/kg/month, but less Ig was ordered for subjects on SCIg (409 mg/kg/month), as compared to subjects on IVIg (568 mg/kg/month). A highly significant inverse correlation between increasing age and dosage of Ig ordered was found (P= <.0001). CONCLUSION: Analysis of home care use of Ig in primary immune deficiency revealed that the SC route was prescribed more than the IV route, especially for older patients. By either method of administration, less immunoglobulin was prescribed for older subjects.

Parafinoma peneano tras inyección de parafina subcutánea. Tratamiento con plastia cutánea de diáfisis peneana con piel de escroto en dos tiempos / Penile paraffinoma after subcutaneous injection of paraffin. Treatment with a two step cutaneous plasty of the penile shaft with scrotal skin

OBJETIVO: Presentar un caso infrecuente de parafinoma peneano. Este es el resultado de la inyección subcutánea o intrauretral de sustancias que contienen hidrocarburos saturados de cadena larga que generan una reacción inflamatoria crónica granulomatosa. Se trata de una práctica poco común en nuestro entorno. MÉTODO: Descripción de un caso clínico y revisión de lo publicado. Varón de 32 años que consultó por aumento doloroso del tamaño y consistencia del pene a raíz de la inyección subcutánea de parafina líquida dos años antes. RESULTADO: Se realizó escisión y reconstrucción peneana en dos tiempos, con buen resultado estético y funcional. Macroscópicamente se genera inflamación, necrosis, cicatrices deformantes, ulceraciones, abscesos estériles, erección dolorosa e incluso imposibilidad para mantener relaciones sexuales. Aunque se han ensayado diversos tratamientos con esteroides intralesionales y sistémicos, el único recurso terapéutico efectivo es la extirpación quirúrgica del material inyectado seguida de cirugía reconstructiva en caso necesario. CONCLUSIÓN: La inyección subcutánea de parafina en el pene es una práctica no justificable cuyo tratamiento es la escisión quirúrgica del tejido afectado(AU)

OBJECTIVE: To report a rare case of penile paraffinoma caused by the subcutaneous or intra-urethral injection of foreign substances containing long-chain saturated hydrocarbons. These were injected in order to increase the penis size which generated a chronic granulomatous inflammatory reaction. This is a rare practice in the western world. METHODS: We present the case of a 32-year-old Bulgarian male who presented with a two-year history of elastic, slightly painful penis swelling after subcutaneous liquid paraffin injection. The proposed treatment was excision of the affected tissue and penile reconstruction in a two-stage procedure. RESULTS: The operative procedure was successful and the patient had good aesthetic and functional results. Paraffin and other materials injected into the penis can produce many complications. Foreign body granuloma, skin necrosis, penile deformity, chronic and unhealed ulcer, painful erection, and the inability to achieve a satisfactory sexual relationship are some of the resulting complications. Intralesional or systemic steroids have been used in primary sclerosing lipogranuloma resulting in the disappearance of the granuloma, but in our opinion the treatment of choice should be radical excision, and, if necessary, secondary reconstruction of the penis. CONCLUSION: The injection of foreign substances to enhance penis size is currently an unjustifiable practice. However, it is still carried out, especially in Eastern Europe and Asia. In most cases surgical treatment is needed to treat the complications and the best modality seems to be radical excision together with follow-up(AU)

Utilización de la vía subcutánea en Atención Primaria / Use of the subcutaneous route in primary care

La vía subcutánea se presenta como una alternativa a la vía oral cuando ésta no es posible. En el manejo de los pacientes paliativos está extendido el uso de esta vía, pero no es así en el resto de pacientes. Existen distintas situaciones en Atención Primaria donde nuestros enfermos se pueden beneficiar en numerosas ocasiones del uso de esta forma de administración de fármacos. Revisamos varios artículos, capítulos de libros y guías clínicas donde se precisan las ventajas e inconvenientes de esta vía, las principales indicaciones, las técnicas de administración subcutánea de fármacos en bolo o en infusión continua y los fármacos más empleados. En definitiva, intentamos hacer una revisión del uso de la vía subcutánea útil para el médico de familia y para los diplomados en enfermería que trabajan en atención primaria, tanto en la consulta diaria como en la atención continuada (AU)

The subcutaneous route may be used as an alternative when the oral route is not possible This route is commonly used in the management of palliative care patients, but not in other kinds of patients. Patients could benefit from this type of drug administration in several Primary Care situations. We reviewed several articles, book chapters and clinical guidelines which point out the advantages and disadvantages of this route, its main indications for use, subcutaneous bolus or continuous subcutaneous infusion administration techniques and the most commonly used drugs. In short, we attempted to provide a review of the use of the subcutaneous route that will be useful for the Primary Care Physicians and Nurses, not only in daily practice but also in continued care (AU)