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Alemtuzumab Infusion-associated Reactions and Management in Multiple Sclerosis Lori Mayer,1 Lise Casady,2 Gail Clayton,3 Pedro Oyuela,4 David H. Margolin4

1Central Texas Neurology Consultants, MS Clinic of Central Texas, Round Rock, TX, USA; 2University of South Florida, Tampa, FL, USA; 3Helen Durham Centre, University Hospital of Wales, Cardiff, UK; 4Genzyme, a Sanofi company, Cambridge, MA, USA

Presented at the Infusion Nurses Society 2014 Annual Convention and Industrial Exhibition, May 3–8, 2014, Phoenix, AZ

Figure 1. IAR Management Strategies During Alemtuzumab Clinical Trials

Urticarial rash

Non-selective antihistamine (IV for rapid onset; some administered IM)

Bronchospasm/anaphylactoid reactions

Epinephrine (0.3 mg IV or IM) Beta-adrenergic agonist inhaler for

bronchospasm Non-selective antihistamine for anaphylactoid

reaction (IV for rapid onset; some administered IM)

Oxygen

Hypotension/bradycardia

IV fluid (normal saline) bolus (500 cc) + oral hydration

Epinephrine (0.3 mg IV or IM) Atropine for bradycardia

Headache, myalgia, rigors

Analgesic (eg, acetaminophen) Narcotic analgesia Triptan (for more persistent or migrainous

headache)

Patient education

• Risks and benefits of alemtuzumab

• Detailed description of potential AEs, including short-term (IARs, infections) and long-term effects (autoimmune events)

• Counseled that IARs are mostly mild-to-moderate in severity, transient, and manageable

• Educated about the duration of infusion and what to expect on each infusion day

Premedication

• All patients were pre-treated with methylprednisolone 1 g IV immediately prior to infusion on each of the first 3 days of any treatment course

• Pre-treatment with antihistamines, antipyretics, and/or anti-emetics was also permitted

• Mild or moderate IARs occurred in most patients despite pre-treatment

Before Infusion During Infusion After Infusion

Monitoring

• Continued monitoring for 2 hours post-infusion for potential IARs

Prescriptions

• Medications were prescribed in some cases for symptoms occurring after patients left the clinic:- Antihistamine and antipyretics for rash,

headache, or fever- Anti-emetics for nausea- Analgesics for pain- Sleep aids

Patient observation

• Hourly vital signs

• Body language indicative of possible AEs (eg, urge to void; reaching for blanket may indicate chills)

• Infusion site was regularly inspected for possible IV complications

• Adequate hydration

Infusion rate adjustment or interruption

• Infusions were typically administered over a period of 4 hours

• Infusions were interrupted and resumed at a lower rate, or discontinued, in a minority of patients

• Maximum infusion period was 8 hours

Symptomatic treatment

AE=adverse event; IAR=infusion-associated reaction; IM=intramuscular; IV=intravenous

Presented at the Infusion Nurses Society 2014 Annual Convention and Industrial Exhibition, May 3–8, 2014, Phoenix, AZ

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