Acetavance (acetaminophen) / Mallinckrodt - LARVOL DELTA

M7824 and Topotecan or Temozolomide in Relapsed Small Cell Lung Cancers (clinicaltrials.gov) - P1/2 | N=37 | Completed | Sponsor: National Cancer Institute (NCI) | Active, not recruiting ➔ Completed | Trial completion date: Jan 2027 ➔ Mar 2025

Trial completion • Trial completion date • Tumor mutational burden • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Sunitinib or Cediranib for Alveolar Soft Part Sarcoma (clinicaltrials.gov) - P2 | N=34 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Mar 2025 ➔ Mar 2026

Monotherapy • Trial completion date • Alveolar Soft Tissue Sarcoma • Oncology • Sarcoma • Solid Tumor

IV vs Oral Acetaminophen in Spine Fusion Perioperative Care (clinicaltrials.gov) - P4 | N=166 | Enrolling by invitation | Sponsor: Hospital for Special Surgery, New York | Trial completion date: Mar 2025 ➔ Mar 2026 | Trial primary completion date: Mar 2025 ➔ Mar 2026

HEOR • Trial completion date • Trial primary completion date • Pain

PANDORA: Delirium Prevention After Cardiac Surgery Using IV Acetaminophen to Prevent Postoperative Delirium in Older Cardiac Surgical Patients (clinicaltrials.gov) - P3 | N=900 | Active, not recruiting | Sponsor: Beth Israel Deaconess Medical Center | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • CNS Disorders • Coronary Artery Disease

PANDORA: Delirium Prevention After Cardiac Surgery Using IV Acetaminophen to Prevent Postoperative Delirium in Older Cardiac Surgical Patients (clinicaltrials.gov) - P3 | N=900 | Recruiting | Sponsor: Beth Israel Deaconess Medical Center | Trial completion date: Oct 2024 ➔ Jan 2026 | Trial primary completion date: Oct 2024 ➔ Jan 2025

Trial completion date • Trial primary completion date • Cardiovascular • CNS Disorders • Coronary Artery Disease

A Comparative Efficacy Trial of IV Acetaminophen Versus IV Ketorolac for Emergency Department Treatment of Generalized Headache (clinicaltrials.gov) - P4 | N=0 | Withdrawn | Sponsor: Spectrum Health - Lakeland | N=500 ➔ 0 | Terminated ➔ Withdrawn

Enrollment change • Trial withdrawal • Migraine • Pain

Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery (clinicaltrials.gov) - P=N/A | N=58 | Recruiting | Sponsor: Boston Children's Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Head-to-Head • Surgery • Anesthesia • CNS Disorders • Infectious Disease • Otorhinolaryngology • Pain • Pediatrics

IV vs Oral Acetaminophen in Spine Fusion Perioperative Care (clinicaltrials.gov) - P4 | N=166 | Enrolling by invitation | Sponsor: Hospital for Special Surgery, New York | Trial completion date: Mar 2024 ➔ Mar 2025 | Trial primary completion date: Mar 2024 ➔ Mar 2025

HEOR • Trial completion date • Trial primary completion date • Pain

Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery (clinicaltrials.gov) - P=N/A | N=58 | Not yet recruiting | Sponsor: Boston Children's Hospital

Head-to-Head • New trial • Surgery • Anesthesia • CNS Disorders • Infectious Disease • Otorhinolaryngology • Pain • Pediatrics

POPCORN: Postoperative Pain Control & Relief in Neonates (clinicaltrials.gov) - P4 | N=11 | Terminated | Sponsor: St. Louis University | Active, not recruiting ➔ Terminated; Involved investigators no longer at the investigating center

Trial termination • Pain

A Phase II Study of Axicabtagene Ciloleucel, an Anti-CD19 Chimeric Antigen Receptor (CAR) Tcell Therapy, in Combination With Radiotherapy (RT) in Relapsed/Refractory Follicular Lymphoma (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

Medication Use Evaluation of Ofirmev (ASHP 2023) - No abstract available

A Phase II Study of Axicabtagene Ciloleucel, an Anti-CD19 Chimeric Antigen Receptor (CAR) Tcell Therapy, in Combination With Radiotherapy (RT) in Relapsed/Refractory Follicular Lymphoma (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: M.D. Anderson Cancer Center

Combination therapy • New P2 trial • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

Post-op Acetaminophen vs NSAID Use on Lumbar Spinal Fusion Outcomes (clinicaltrials.gov) - P=N/A | N=178 | Completed | Sponsor: Hospital for Special Surgery, New York | Active, not recruiting ➔ Completed | N=300 ➔ 178

Enrollment change • Trial completion • CNS Disorders • Immunology • Musculoskeletal Diseases • Orthopedics • Osteoarthritis • Pain • Rheumatology • CORIN

How troubles at a factory in India led to a U.S. cancer-drug shortage (The Washington Post) - "William Dahut...said patients can't simply wait for a chemotherapy drug to become available and risk having their cancer continue to grow. 'You may just continue on with other drugs that might not be as effective,' he said."

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‘Healthy Gut from the Start’ campaign sheds light on GI tract function, digestive diseases (Healio) - "'Anecdotally we had several patients in rapid succession with acetaminophen overdose - in the setting of taking over-the-counter flu/cold medications - requiring liver transplantation, and we wanted to understand FDA limits around dosing,' Jayme E. Locke, MD, MPH, FACS, FAST..."

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FDA limit on acetaminophen dosage linked to fewer hospitalizations, cases of liver failure (Healio) - "'Anecdotally we had several patients in rapid succession with acetaminophen overdose - in the setting of taking over-the-counter flu/cold medications - requiring liver transplantation, and we wanted to understand FDA limits around dosing,' Jayme E. Locke, MD, MPH, FACS, FAST...told Healio....'The FDA mandate resulted in fewer ALF cases and hospitalizations related to combination acetaminophen and opioid products,' Locke said."

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IV vs Oral Acetaminophen in Spine Fusion Perioperative Care (clinicaltrials.gov) - P4 | N=166 | Enrolling by invitation | Sponsor: Hospital for Special Surgery, New York | Trial completion date: Jun 2023 ➔ Mar 2024 | Trial primary completion date: Apr 2023 ➔ Mar 2024

HEOR • Trial completion date • Trial primary completion date • Pain

POPCORN: Postoperative Pain Control & Relief in Neonates (clinicaltrials.gov) - P4 | N=11 | Active, not recruiting | Sponsor: St. Louis University | Trial completion date: Apr 2023 ➔ Apr 2024 | Trial primary completion date: Apr 2023 ➔ Apr 2024

Trial completion date • Trial primary completion date • Pain

3 ways you may be able to boost your vaccine response - "'Get a vaccine when it is most convenient to you. Immune cells circulate around the body 24/7. But if you can prioritize getting it in the morning, you may get a small advantage,' said Chin-Hong....'Both Tylenol and NSAIDs like ibuprofen may prevent inflammation and theoretically reduce the ability of the immune system to respond to a vaccine,' said Chin-Hong."

Media quote • Novel Coronavirus Disease

A Comparative Efficacy Trial of IV Acetaminophen Versus IV Ketorolac for Emergency Department Treatment of Generalized Headache (clinicaltrials.gov) - P4 | N=500 | Terminated | Sponsor: Spectrum Health - Lakeland | Unknown status ➔ Terminated; no longer recruiting or studying

Trial termination • Migraine • Pain

Enhanced Recovery After Surgery (eras) Protocol For Cleft Palate Repair Resulting In Decrease In Opioid Medication Consumption (ASA 2022) - "Patients receive oral Versed or intranasal Precedex in pre-op. We also give oral gabapentin 5mg/kg to max 300mg, and oral Celecoxib: 50mg for children 10-25kg, or 100mg for those >25kg. In OR, we use intravenous Ofirmev 15mg/kg and TXA 10mg/kg up to 1g over 15min every 2-3h; and Zofran, Decadron, and antibiotic prophylaxis...Postop, we give intravenous Toradol 0.5mg/kg and continue Ofirmev if >6h from first dose. None of our first 12 patients have required opioids after discharge."

Clinical

"Why do so many hospitals not have Ofirmev on the formulary?" (@EdoajoEric)

Clinical

Concomitant Medications May Affect the Response to Immune Checkpoint Inhibitor Therapy (ASCO Daily News) - "'The main objective was to assess the potential impact of acetaminophen on efficacy of immunotherapy in patients [with cancer],' Dr. Italiano said in an interview...'This is the first study looking at the effects of acetaminophen on ICIs'....Diwakar Davar, MD...noted that the finding about how acetaminophen can negatively impact the outcomes of patients treated with ICI therapy is provocative, and aligns with reports of reduced immunogenicity following vaccination, including SARS-CoV-2, but that it needs confirmation in additional studies."

Checkpoint inhibition • Interview

Acetaminophen may reduce immunotherapy efficacy in patients with cancer (Healio) - "'This is the first comprehensive picture of the immunomodulatory effects of acetaminophen, which showed the drug is associated with decreased efficacy of immune checkpoint inhibitors in patients with advanced cancer,' Italiano said. 'Future research will examine the direct or indirect effect of the association of acetaminophen on [regulatory T cells].'...This study does a great job of highlighting something that could dramatically change the way we manage our patients who are on immunotherapy, and it is concerning because acetaminophen is so commonly used for patients with cancer....And yet, it is definitely a wake-up call and another variable to consider when managing our patients treated with immune checkpoint inhibitors."

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