Prevention of Infusion Reactions with Lemtrada

Patient Expert

Infusion nurses can be an MS patients’ best friend with the common uses of intravenous steroids, such as Solumedrol (methylprednisolone), to treat acute relapses and a number of disease-modifying therapies that are delivered by IV, such as natalizumab (Tysabri) and alemtuzumab (Lemtrada), or experimental medications rituxumab (Rituxan) and ocrelizumab.

Each of these medications are monoclonal antibody therapies which deplete specific types of cells, such as T-cells or B-cells, or modulate the immune system. The rapid cell death (lysis) and release of histamines caused by monoclonal antibody (MAB) therapy can result in mild to moderate infusion-associated reactions (IAR).

Alemtuzumab and infusion reactions

Lemtrada (alemtuzumab 12 mg) is a humanized monoclonal antibody, targeting CD52+ T and B cells, delivered by IV infusion on five consecutive days (course 1) followed by another three consecutive days one year later (course 2). Lemtrada has been approved in several countries for treatment of relapsing-remitting multiple sclerosis (RRMS) and is generally reserved for people with MS who have failed other treatments.

In clinical trials, infusion-associated reactions (IARs) affected 90.1 percent of patients receiving alemtuzumab. The most common IARs were headache, rash, fever (pyrexia), nausea, and flushing; most were mild to moderate in severity. The two main types of IARs are allergic (hypersensitivity) and nonallergic (cytokine release) reactions.

IARs were more frequent during course 1 than during course 2 of treatment; IARs occurred in 84.7-96.3 percent of patients during course 1 compared with 68.6-81.9 percent of patients during course 2. In each treatment course, the greatest numbers of IARs occurred with the first infusion and decreased with each infusion thereafter.

Management of IARs

Nurses play an important role in the detection and management of IARs. Best practices for management of IARs associated with Lemtrada include patient and caregiver education, prophylactic medication—particularly corticosteroids, antihistamines, and antipyretics—to reduce IAR severity, infusion monitoring, and discharge planning.

Severe IARs can generally be managed by slowing the infusion rate or by temporarily stopping the infusion, allowing time for recovery of symptoms, and then restarting at a slower rate.

Premedication and Patient Guidance

  • Antipyretic drugs, such as ibuprofen and acetaminophen, are commonly used to treat or prevent fever, headache, and body aches.
  • Antihistamines, such as diphenhydramine, cetirizine, fexofenadine, hydroxyzine, and loratadine, are used to counteract rash, hives, and itching.
  • H2 receptor antagonists, including ranitidine, cimetidine, and famotidine, are administered to maximize the effect of antihistamines and to prevent or manage gastric side-effects caused by some of the other medications.
  • Antiemetic agents, including ondansetron and prochlorperazine, help to treat nausea.
  • Intravenous methylpredisolone (1 gram) is administered before the first three infusions in both course 1 and course 2 to mitigate the phenomenon of a recurrence of previous MS relapse symptoms, typically lasting a few hours, reportedly associated with alemtuzumab infusion.
  • During clinical trials, a low-sodium diet was emphasized to prevent corticosteroid-induced hypertension, avoidance of high-sugar foods was highlighted to prevent corticosteroid-induced hyperglycemia, and prophylactic use of insomnia medications was offered.

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Caon C, Namey M, Meyer C, et al. Prevention and Management of Infusion-Associated Reactions in the Comparison of Alemtuzumab and Rebif(®) Efficacy in Multiple Sclerosis (CARE-MS) Program. Int J MS Care. 2015 Jul-Aug;17(4):191-8. doi: 10.7224/1537-2073.2014-030.

McEwan L, Caon C, Chieffe C, et al. Best Practices in Alemtuzumab Administration: Practical Recommendations for Infusion in Patients With Multiple Sclerosis. J Infus Nurs. 2015 Sep 3. [Epub ahead of print]