Before Initiation of Therapy
- CBC,creatinine, TSH, liver enzymes, HIV, VZV, HBsAg, anti-HBc, anti-HBs,hepatitis C, Pap test for HPV, urine analysis, urine albumine/creatinine ratio
- Pregnancy test
- Chest Xray and/or Quantiferon
- Immunization should be brought up to date and vaccination for pneumococcus and haemophilus influenza type B and HPV for unvaccinated patients less than 25 years old be done preferably >6 weeks prior to receiving Alemtuzumab
- Brain MRI unless recently (<3 months) done
- When switching from Gilenya a normalized lymphocyte count is recommended
- When switching from Aubagio, cholestyramine 8 gms Q8H PO X 11 days or until serum levels are less than 0.02mg/L is recommended
- When switching from Tysabri a less than 2 month washout period, serum JCV index and baseline brain MRI with CSF PCR for JCV is recommended
Monitoring Until 48 Months Post Last Therapy
- Monthly CBC, creatinine, urine analysis
- Q3months TSH
- Annual PAP test for HPV positive patients
- If the urine analysis is abnormal repeat the urine albumine/creatinine ratio and if the latter is abnormal then a 24hrs urine collection and referral to a nephrologist are recommended
Patients with: TB, PML,HIV, carriers of HBV and/or HCV, active malignancies, severe active infection, receiving immunosuppressive medication,patients not immunized against varicella virus.
Infusion Reactions :
82% of patients treated with Lemtrada in controlled clinical trials in MS experienced mild to moderate infusion associated reactions (IARs) during and/or up to 24 hours after Lemtrada and 9% of patients experienced severe IARs. IARs included:
- headache (43.7%)
- rash (43.1%)
- pyrexia (25.2%)
- nausea (15.9%)
- urticaria (14.7%)
- pruritus (12.7%)
- insomnia (11.1%)
- chills (9.5%)
- flushing (9.5%)
- fatigue (8.4%)
- dyspnea (7.2%)
- dysgeusia (7.0%)
- chest discomfort (6.6%)
- generalized rash (6.5%)
- tachycardia (6.4%)
- dyspepsia (6.2%)
- dizziness (5.7%)
- and pain (5.2%)
Serious reactions occurred in 3% (26/919) of patients and included cases of cardiac ararrhythmias (tachycardia, bradycardia and atrial fibrillation), pyrexia, urticaria, nausea, chest discomfort, and hypotension. Anaphylaxis has been reported rarely.
Adverse Events :
- Treatment with LEMTRADA may result in the formation of autoantibodies and increase the risk of autoimmune mediated conditions including immune thrombocytopenic purpura (ITP) 1 %, thyroid disorders (30%) or, rarely, nephropathies (0.3%) (e.g., anti-glomerular basement membrane disease).
- Suspected autoimmune cytopenias such as neutropenia, hemolytic anemia, and pancytopenia have been reported in patients in clinical trials in MS.
- There was an increased incidence of infections in Lemtrada treated patients during the clinical trials. Infections included; TB, HSV reactivation, VZV reactivation, HPV infection and cervical dysplasia, listeria meningitis and superficial fungal infections.
- Lymphopenia: lowest observed values occurred by 1 month after each course of treatment. The mean lymphocyte count at 1 month after treatment was 0.25 (range 0.02-2.30 ) and 0.32 (0.02-1.81 ) for treatment courses 1 and 2, respectively. Total lymphocyte counts increased to reach the lower limit of normal in approximately 40% of patients by 6 months after each treatment course and approximately 80% of patients by 12 months after each course.
Ceiling Effect :
It is unknown how many cylces of alemtuzumab can be safely administered over the disease duration of any given patient. It is also unknown how repeated cycles influence the risk of autoimmune and infectious adverse events.