Indications for LEMTRADA:
Relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease in adults who have had an inadequate response to ≥2 MS drugs.
Limitations of Use:
Not recommended for use in patients with clinically isolated syndrome.
Premedicate with high-dose corticosteroids (eg, methylprednisolone 1000mg or equivalent) immediately prior to infusion and for the first 3 days of each treatment course; may consider antihistamines and/or antipyretics. Administer antivirals for herpetic prophylaxis on 1st day of each treatment course and for ≥2 months following treatment or until CD4+ lymphocyte count ≥200cells/μL, whichever occurs later. Give by IV infusion over 4 hours. ≥17yrs: First course: 12mg daily for 5 consecutive days; Second course: 12mg daily for 3 consecutive days given 12 months after first course. May administer subsequent courses as needed (12mg daily for 3 consecutive days given ≥12 months after last dose of any prior courses).
<17yrs: not recommended.
Autoimmunity. Infusion reactions. Stroke. Malignancies.
Risk of serious autoimmune conditions (eg, immune thrombocytopenia, anti-glomerular basement membrane disease); treat promptly if occur. Obtain CBCs (w. differential), serum creatinine, urinalysis with urine cell counts prior to initiation and at monthly intervals, urine protein to creatinine ratio (at baseline), thyroid function tests (at baseline then every 3 months), and serum transaminases, total bilirubin (at baseline then periodically) for 48 months after last dose. Monitor for infusion reactions during and for ≥2 hours after each dose; discontinue immediately if severe reactions occur. Have equipment and personnel available to manage anaphylaxis. Stroke and cervicocephalic arterial dissection: monitor. Increased risk of malignancies (eg, thyroid cancer, melanoma, lymphoproliferative disorders); monitor. Perform baseline and yearly skin exams. Preexisting or ongoing malignancies; monitor. Cardiovascular or pulmonary function compromised: monitor more frequently. Glomerular nephropathies. Thyroid disorders. Risk of autoimmune hepatitis; promptly obtain LFTs if signs/symptoms of hepatic dysfunction develop; interrupt or discontinue therapy as appropriate. Hemophagocytic lymphohistiocytosis. Active infection: consider delaying treatment until controlled. Perform annual HPV screening in female patients. Screen for TB and treat if positive prior to initiation. Avoid potential sources of Listeria monocytogenes (eg, deli or undercooked meat, soft cheeses, unpasteurized milk); monitor for symptoms. HBV/HCV carriers. Monitor for progressive multifocal leukoencephalopathy (PML); withhold and evaluate at the first sign suggestive of PML. Increased risk of acute acalculous cholecystitis; if suspected, evaluate and treat promptly. Monitor for other autoimmune cytopenias. Complete necessary immunizations ≥6 weeks prior to treatment initiation. Pregnancy. Advise females of reproductive potential to use effective contraception during and for 4 months after the last dose. Nursing mothers.
Monoclonal antibody, CD52 (recombinant, humanized).
Avoid live virus vaccines (after recent alemtuzumab therapy). Delay therapy for 6 weeks after varicella zoster vaccination. Increased risk of immunosuppression with concomitant antineoplastics or immunosuppressants. Additive effects following other previously received alemtuzumab-containing therapy (eg, Campath); caution.
Rash, headache, pyrexia, nasopharyngitis, nausea, UTI, fatigue, insomnia, URTI, herpes viral infection, urticaria, pruritus, thyroid gland disorders, fungal infection, arthralgia, pain in extremity, back pain, diarrhea, sinusitis, oropharyngeal pain, paresthesia, dizziness, abdominal pain, flushing, vomiting; autoimmune disorders, infusion reactions, stroke (may be serious), cytopenias, pneumonitis (monitor).