There is no known treatment, prevention, or cure for PML. Your risk of getting PML is higher if you: Your risk of getting PML is greatest if you have all 3 risk factors listed above. There may be other risk factors that have not yet been identified.
Monitor complete blood counts with differential, serum creatinine levels, and urinalysis with urine cell counts at periodic intervals for 48 months after the last dose of LEMTRADA.
LEMTRADA must be administered in a setting with appropriate equipment and personnel to manage anaphylaxis or serious infusion reactions.
Monitor patients for two hours after each infusion. Make patients aware that serious infusion reactions can also occur after the 2-hour monitoring period.
Perform baseline and yearly skin exams. Treatment with LEMTRADA can result in the formation of autoantibodies and increase the risk of serious autoimmune mediated conditions, and may increase the risk of other autoimmune conditions because of the broad range of autoantibody formation. Obtain complete blood counts CBC with differential, serum creatinine levels, and urinalysis with cell counts before starting treatment and then at monthly intervals until 48 months after the last dose of LEMTRADA, or longer, if clinically indicated.
Infusion reactions may occur despite pretreatment. Monitor for symptoms of thyroid cancer.
Healthcare facilities must have on-site access to equipment and personnel trained to manage infusion reactions including anaphylaxis and cardiac and respiratory emergencies.
If ITP is confirmed, promptly initiate medical intervention. Glomerular nephropathies occurred in 0. Anti-glomerular basement membrane anti-GBM disease can lead to renal failure requiring dialysis and transplantation and has in post-marketing cases of MS patients treated with alemtuzumab.
Anti-GBM disease can be life-threatening if untreated; early detection and treatment may decrease the risk of poor outcomes. Newly diagnosed thyroid disorders occurred throughout the uncontrolled clinical study follow-up period, more than 7 years after the first LEMTRADA dose. Obtain thyroid function tests prior to initiation of treatment and every 3 months until 48 months after the last infusion, or longer, if clinically indicated.
Thyroid disease poses special risks in women who are pregnant. Prompt medical intervention is indicated if a cytopenia is confirmed. Concomitant use of antineoplastic or immunosuppressive therapies could increase the risk of immunosuppression.
Annual screening is recommended for female patients. Active and latent tuberculosis cases occurred in 0. Advise patients to watch for symptoms of Listeria infection and seek prompt medical help if symptoms occur.
Acute acalculous cholecystitis AAC: Post-marketing cases of AAC have also been reported. Typical risk or predisposing factors such as concurrent critical illness were often not reported. AAC is associated with high morbidity and mortality if not diagnosed early and treated.Regulatory filings with the Securities and Exchange Commission show Biogen Idec paid the school $35 million, and Genzyme paid $25 million in royalties for use of the patent.
Dr Defer received personal compensation for participation in a scientific advisory board from Biogen Idec, Novartis, sanofi-aventis, Genzyme, and Teva Pharmaceuticals and received funding for travel or speaker honoraria from Merck Serono, Biogen Idec, Guerbet, sanofi-aventis, Novartis, Genzyme, and Teva Pharmaceuticals.
Wuerfel has received research support from Biogen Idec and Novartis.
Dr. Thangavelu has received personal compensation for activities with Genzyme as an employee.
Biogen Idec asked Charles River Associates (CRA) to examine how access to innovative treatments for multiple sclerosis (MS) varies across European countries, the .
Genzyme, which is ranked on the Fortune , a list of America's largest companies. The top companies on the Fortune -- Fortune magazine's annual ranking of America's largest. Amit Bar-Or reports personal compensation for consulting for Biogen, Celgene/Receptos, EMD Serono, Genzyme, MedImmune, Novartis, and Roche.
Douglas L. Arnold reports personal fees for consulting from Acorda, Biogen, MedImmune, Mitsubishi Pharma, Novartis, Receptos, Roche, and.