When can daratumumab (Darzalex) be restarted after surgery?

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Last updated: April 17, 2025View editorial policy

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From the Guidelines

Daratumumab can be restarted approximately 14 days after surgery, once the wound shows evidence of healing, any sutures/staples are out, there is no significant swelling, erythema, or drainage, and there is no ongoing nonsurgical site infection. This recommendation is based on the general guidelines for restarting antirheumatic therapy after surgery, as outlined in the 2022 American College of Rheumatology/American Association of Hip and Knee Surgeons guideline for the perioperative management of antirheumatic medication in patients with rheumatic diseases undergoing elective total hip or total knee arthroplasty 1. Although this guideline does not specifically mention daratumumab, it provides a framework for managing biologics and other immunomodulatory agents in the perioperative period.

When considering the restart of daratumumab, several factors should be taken into account, including:

  • The type of surgery performed and its complexity
  • The patient's overall health status and risk factors for complications
  • The presence of any signs of infection or delayed wound healing
  • Laboratory parameters to ensure acceptable blood counts and organ function

It is crucial to individualize the decision to restart daratumumab based on these factors, as the medication's immunomodulatory effects can potentially impact wound healing and infection risk. The guideline conditionally recommends restarting antirheumatic therapy, including biologics, once the wound is healed and there are no signs of infection, typically around 14 days post-surgery 1. However, the exact timing may vary depending on the specific clinical scenario and the patient's recovery progress.

In clinical practice, it is essential to balance the risks and benefits of restarting daratumumab, considering the potential for improved disease control against the possible increased risk of complications in the post-surgical period. Therefore, a thorough assessment of the patient's condition and close monitoring after restarting the medication are necessary to ensure the best possible outcomes in terms of morbidity, mortality, and quality of life.

From the FDA Drug Label

When DARZALEX dosing was interrupted in the setting of ASCT (CASSIOPEIA) for a median of 3.75 months (range: 2.4 to 6. 9 months), upon re-initiation of DARZALEX, the incidence of infusion-related reactions was 11% for the first infusion following ASCT.

The FDA drug label does not provide information on when daratumumab can be started back up after surgery. The information provided is related to the interruption of daratumumab dosing in the setting of autologous stem cell transplantation (ASCT), but it does not specifically address surgery. Therefore, no conclusion can be drawn regarding the timing of restarting daratumumab after surgery 2.

From the Research

Daratumumab Treatment After Surgery

  • There is no direct information available in the provided studies regarding when daratumumab can be started back up after surgery.
  • The studies primarily focus on the efficacy, safety, and cost-effectiveness of daratumumab in combination with other treatments for relapsed or refractory multiple myeloma, as well as its use in newly diagnosed multiple myeloma patients who are ineligible for stem cell transplantation 3, 4, 5, 6, 7.
  • None of the studies provide specific guidance on the timing of daratumumab treatment resumption after surgery.

General Information on Daratumumab Treatment

  • Daratumumab is a human CD38-directed monoclonal antibody indicated for the treatment of relapsed and refractory multiple myeloma (MM) 3.
  • It has been shown to improve outcomes in transplant-ineligible patients with newly diagnosed multiple myeloma when added to bortezomib, melphalan, and prednisone (D-VMP) 4.
  • The treatment-emergent adverse events associated with daratumumab include neutropenia, thrombocytopenia, and anemia, among others 3, 4, 6.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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