Practice Information

Intravenous monoclonal antibodies


The Board has recently been asked to opine on whether or not intravenous monoclonal antibodies (MABs) such as Remicade/Infliximab, Rituxan/Rituximab and Tysabri/Natalizumab may be administered by a registered professional nurse (RN).

In examining the use of intravenous immunological agents such as monoclonal antibodies the Board reviewed both the black box warnings as well as manufacturers’ recommendations for use as included in package inserts. We noted that some of the black box warnings address the risk of infusion reactions, hypersensitivity and anaphylaxis, while others focus on serious complications that can develop over a prolonged period of time. All of these agents have potential drug interactions and numerous adverse reactions which require continuous nursing assessment and monitoring during the infusion, as well as detailed patient teaching regarding identification and reporting of side effects that may occur between treatments. Some MAB agents include specific monitoring and site-of-care recommendations as a result of the severity of side effects and adverse effects that can occur. For example, Tysabri is limited to patients enrolled in a risk minimization plan called the TOUCH prescribing Program, which limits administration of the drug to manufacturer-approved sites of care.

Given these conditions, it is the position of the State Board for Nursing that registered professional nurses (RNs) licensed by the New York State Education Department may administer intravenous monoclonal antibodies only under the following conditions:

  • A patient-specific order must be available from an authorized prescriber such as a physician or nurse practitioner that details the immunological therapy including dosage, route, rate, treatment monitoring requirements, premedication, if indicated, and a patient-specific order for management of an acute infusion reaction,
  • An authorized prescriber must be readily available by phone during each administration of the drug,
  • An anaphylaxis kit or emergency code cart must be immediately available during each infusion of the drug,
  • There must be a written patient consent,
  • The facility/employer must provide education and skill training that addresses proper technique and hazards including contraindications for such therapy and how to handle unexpected outcomes/emergencies,
  • The facility/employer must have a written institutional policy and procedure for such therapy describing the role of the RN,
  • The RN must be able to document the completion of appropriate education and clinical competence in the administration of intravenous biologic agents to safe guard the patient against risks or complications,
  • The RN must be designated by the facility/employer to carry out the procedure,
  • The facility/employer must provide competency assessment of each RN’s ability to provide therapy. Such assessment must be documented in the personnel file of each RN and updated annually,
  • A complete nursing assessment must be performed and documented prior to each treatment.

Failure to comply with these guidelines may place the nurse at increased risk for a charge of unprofessional conduct especially in a situation involving a bad patient outcome.

It is not within the scope of practice of a Licensed Practical Nurse to administer these agents in any clinical setting.

If you have additional questions, please contact Barbara Zittel, Executive Secretary to the State Board for Nursing - e-mail: nursebd@nysed.gov; phone: 518-474-3817 ext. 120; or fax: 518-474-3706.

January 2009; revised September 2009; revised December 2009
Last Updated: January 31, 2013