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Search results for: denosumab

Biosimilars to Denosumab Approved with an Interchangeable Designation

Michele B. Kaufman, PharmD, BCGP  |  April 18, 2024

The FDA has approved the first interchangeable biosimilars for denosumab.

Filed under:Biologics/DMARDsConditionsDrug UpdatesOsteoarthritis and Bone Disorders Tagged with:denosumabdenosumab-bbdzJubbontiProliaWyostXgeva

FDA Issues Boxed Warning for Denosumab & Approves a Generic NSAID

Michele B. Kaufman, PharmD, BCGP  |  February 27, 2024

In January, the U.S. Food & Drug Administration approved indomethacin in an oral suspension, a generic version of Indocin Oral Suspension. The agency also issued a boxed warning and updated label for denosumab, warning of the risks of severe hypocalcemia in patients with chronic kidney disease.

Filed under:AnalgesicsBiologics/DMARDsConditionsDrug UpdatesOsteoarthritis and Bone Disorders Tagged with:denosumabDrug SafetyFDA approvalOsteoporosisU.S. Food and Drug Administration (FDA)

Patients on Dialysis Taking Denosumab May Be at Risk of Severe Hypocalcemia

Michele B. Kaufman, PharmD, BCGP  |  December 12, 2022

The FDA is investigating the risk of severe hypocalcemia with serious outcomes, such as hospitalization and death, in patients on dialysis taking denosumab.

Filed under:Drug Updates Tagged with:denosumabdialysisDrug SafetyFDAhypocalcemiaRenal diseaseU.S. Food and Drug Administration (FDA)

Denosumab vs. Zoledronate: An Analysis of Treatments for Low Bone Mineral Density in Patients with HIV

Michele B. Kaufman, PharmD, BCGP  |  May 9, 2022

In a small study of men with low bone mineral density (BDM) living with HIV and taking anti-retroviral therapy, both zoledronate or denosumab were well tolerated and effective for bone mineral density of the lumbar spine and femoral neck.

Filed under:ConditionsDrug UpdatesOsteoarthritis and Bone Disorders Tagged with:bone mineral density (BMD)denosumabHIVOsteoporosisosteoporosis treatmentszoledronate

Improving Bone Mineral Density: Risedronate vs. Denosumab

Michele B. Kaufman, PharmD, BCGP  |  March 2, 2022

Treatment with denosumab for patients with RA and glucocorticoid-induced osteoporosis led to greater increases in bone mineral density of the lumbar spine and hips of patients than treatment with risedronate.

Filed under:ACR ConvergenceConditionsDrug UpdatesMeeting ReportsOsteoarthritis and Bone Disorders Tagged with:ACR Convergence 2021bone mineral density (BMD)denosumabGlucocorticoidsOsteoporosisrisedronate

The Race Is On: Clinical Trials Begin for Agents Biosimilar to Denosumab

Michele B. Kaufman, PharmD, BCGP  |  May 24, 2021

As the U.S. and other patents for branded denosumab products get closer to expiring, drug manufacturers are initiating clinical trials for more affordable, biosimilar versions of the treatment.

Filed under:Biologics/DMARDsDrug Updates Tagged with:BiosimilarsdenosumabEB1001monoclonal antibody

New Clinical Trials for Ustekinumab & Denosumab Biosimilars Begin Recruitment

Michele B. Kaufman, PharmD, BCGP  |  March 17, 2021

Clinical trials of biosimilar treatments, including a phase 1 study of SB17, which is biosimilar to ustekinumab, and two phase 3 studies investigating of SB16, which is biosimilar to denosumab, are currently recruiting.

Filed under:Biologics/DMARDsDrug Updates Tagged with:Biosimilarsclinical trialsdenosumabSB17ustekinumab

Denosumab Has Edge on Alendronate for Steroid-Induced Bone Loss

Matthew Phelan  |  March 10, 2021

NEW YORK (Reuters Health)—Long-term glucocorticoid users see greater gains in spine bone-mineral density when treated with the monoclonal antibody denosumab vs. oral alendronate, a small clinical trial shows. The drug also proved superior at lowering bone-turnover markers at 12 months, researchers in Hong Kong report in Bone.1 “Denosumab may be considered as an alternative first-line…

Filed under:Drug Updates Tagged with:alendronatebone lossbone mineral density (BMD)denosumabGlucocorticoids

Denosumab Promising for Osteolysis after Total Hip Replacement

Marilynn Larkin  |  January 25, 2021

NEW YORK (Reuters Health)—Denosumab showed biological efficacy against osteolysis after total hip replacement in a proof-of-concept trial. “Denosumab is already a well-established licensed drug for the indications of osteoporosis and metastatic bone lesions in cancer, and has been shown to be effective in reducing erosions in inflammatory arthritis,” Dr. Mark J.M. Wilkinson of the University…

Filed under:Drug Updates Tagged with:denosumabtotal hip arthroplastytotal hip replacement

New Findings on Hydroxychloroquine, Denosumab

Ruth Jessen Hickman, MD  |  November 12, 2020

ACR Convergence 2020—At two plenary sessions, speakers highlighted key findings, including results on the QTc interval in patients on hydroxychloroquine, and data from a study on denosumab vs. alendronate for glucocorticoid-induced osteoporosis. The QTc Interval & Hydroxychloroquine The safety profile and optimal dosing of hydroxychloroquine has been a topic for decades because it is known…

Filed under:ACR ConvergenceConditionsDrug UpdatesMeeting ReportsOsteoarthritis and Bone DisordersRheumatoid Arthritis Tagged with:ACR Convergence 2020bone mineral density (BMD)COVID-19denosumabFracturesHydroxychloroquine (HCQ)Osteoporosis

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