Can Daratumumab (daratumumab) be administered orally?

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Last updated: May 26, 2025View editorial policy

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From the Guidelines

No, Daratumumab cannot be given orally. Daratumumab is a monoclonal antibody medication that must be administered intravenously (IV) or subcutaneously (under the skin) [ 1 ]. The medication is a large protein molecule that would be broken down by digestive enzymes if taken by mouth, preventing it from reaching the bloodstream intact and rendering it ineffective.

Administration Routes

  • Intravenous (IV) infusion: typically takes several hours, especially for initial doses
  • Subcutaneous injection: takes about 3-5 minutes Daratumumab works by targeting the CD38 protein found on multiple myeloma cells, helping the immune system identify and destroy these cancer cells [ 1 ]. The dosing schedule varies depending on the specific treatment protocol and whether it's being used alone or in combination with other medications. Patients receiving Daratumumab should be monitored for infusion-related reactions, which are most common during the first infusion but can occur with subsequent treatments as well [ 1 ]. According to the most recent guidelines, daratumumab intravenous infusion or daratumumab and hyaluronidase-fihj, subcutaneous injection may be used in all daratumumab-containing regimens [ 1 ].

From the FDA Drug Label

DARZALEX ®(daratumumab) injection, for intravenous use Dilute and administer as an intravenous infusion. Injection: 100 mg/5 mL (20 mg/mL) solution in a single-dose vial Injection: 400 mg/20 mL (20 mg/mL) solution in a single-dose vial For Intravenous Infusion Only

Daratumumab administration: Daratumumab is administered as an intravenous infusion.

  • The recommended dose is 16 mg/kg actual body weight.
  • It is not intended for oral use. The FDA drug label does not support oral administration of Daratumumab 2, 2.

From the Research

Administration of Daratumumab

  • Daratumumab is typically administered via intravenous infusion 3, 4 or subcutaneous formulation 5.
  • There is no evidence to suggest that daratumumab can be given orally.

Routes of Administration

  • Intravenous daratumumab has been shown to be effective in treating multiple myeloma 3, 4.
  • Subcutaneous daratumumab has been approved for use in both the United States and European Union, offering shorter infusion times and decreased rate of infusion reactions while maintaining non-inferior efficacy 5.

Pharmacokinetics and Pharmacodynamics

  • The pharmacokinetics and pharmacodynamics of daratumumab have been studied in various clinical trials 5, 6, 7.
  • However, none of these studies mention oral administration as a viable option for daratumumab.

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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