Drug delivery improvements to enable a flexible care setting for monoclonal antibody medications in oncology - Analogue-based decision framework.

INTRODUCTION: The substantial acceleration in healthcare spending together with the expenditures to manage the COVID19 pandemic demand drug delivery solutions that enable a flexible care setting for high-dose monoclonal antibodies (mAbs) in oncology. AREAS COVERED: This expert opinion introduces an analogue-based framework applied to guide decision-making for associated product improvements for mAb medications that are either already authorized or in late-stage clinical development. The four pillars of this framework comprise (1) the drug delivery profile of current and emerging treatments in the market, (2) the needs and preferences of people treated with mAbs, (3) existing healthcare infrastructures, and (4) country-dependent reimbursement and procurement models. The following product optimization examples for mAb-based treatments are evaluated based on original research and review articles in the field: subcutaneous formulations, an established drug delivery modality to reduce parenteral dosing complexity, fixed-dose combinations, an emerging concept to complement combination therapy, and (connected) on-body delivery systems, an identified future opportunity to support dosing outside of a controlled healthcare institutional environment. EXPERT OPINION: Leveraging existing synergies and learnings from other disease areas is a measure to reduce associated development and commercialization costs and thus to provide sustainable product offerings already at the initial launch of a medication.

Implications of obesity for drug administration and absorption from subcutaneous and intramuscular injections: A primer.

PURPOSE: To discuss the potential implications of obesity for drug administration and absorption from subcutaneous (SC) and intramuscular (IM) injection sites. SUMMARY: The SC and IM routes are useful for the parenteral administration of medications to optimize pharmacokinetic properties such as time to onset and duration of effect, for cost considerations, or for ease of administration, such as when intravenous access is unavailable. The choice of SC or IM injection depends on the specific medication, with SC administration preferred for products such as insulin where a slower and more sustained response is desirable, while IM administration is usually preferred for products such as vaccines where more rapid absorption leads to a more rapid antibody response. Obesity has the potential to influence the rate and extent of absorption, as well as adverse effects, of medications administered by the SC or IM route through changes in SC tissue composition and depth or by inadvertent administration of IM medications into SC tissue because of improper needle length. Potential adverse effects associated with IM or SC injections in addition to pain, bruising, and hematoma formation include sciatic nerve injury, particularly with IM injection in the upper outer quadrant of the buttock; bone contusion or rarely osteonecrosis if the IM injection is excessively deep; and granulomas, fat necrosis, and calcification with SC injection. CONCLUSION: Issues related to medication absorption in obese patients are likely to become more prominent in the future with increasing approvals of a wide range of biotherapeutic agents administered by SC injection. Studies should be directed toward these and other agents to assist with dosing decisions in this challenging population.

COVID-19 mRNA Vaccination-Induced Lymphadenopathy Mimics Lymphoma Progression on FDG PET/CT.

ABSTRACT: We present here a 72-year-old man with mantle cell lymphoma who has completed chemotherapy and achieved complete metabolic response to the therapy 10 months ago. Series follow-up FDG PET/CT scans have been negative for lymphoma. Current FDG PET/CT scan showed a new cluster of subcentimeter left axillary lymphadenopathy with avid FDG uptake. There was also focal FDG uptake in the left upper arm deltoid muscle and adjacent subcutaneous soft tissue, with no other abnormal FDG-avid lesion or suspicious CT image findings. The medical history revealed that the patient received COVID-19 mRNA vaccine 2 days before the FDG PET/CT examination.