Spinraza Disease Interactions

Coagulation abnormalities and thrombocytopenia, including acute severe thrombocytopenia, have been reported after administration of some antisense oligonucleotides. In one clinical study, platelet levels below the lower limit of normal were observed in 6 of 56 (11%) nusinersen-treated patients compared to 0 of 28 sham-procedure control patients who had normal or above normal platelet levels at baseline. No patient had a platelet count less than 50,000 cells/microliter, however, and no patient developed a sustained low platelet count despite continued drug exposure. Given the potential for increased risk of bleeding complications, therapy with nusinersen should be administered cautiously in patients with active bleeding or coagulation abnormalities. Platelet counts and coagulation laboratory testing should be performed at baseline and prior to each administration of nusinersen and as clinically needed.

Renal toxicity, including potentially fatal glomerulonephritis, has been observed after administration of some antisense oligonucleotides. Caution is advised if used in patients with renal impairment. The manufacturers recommend to conduct quantitative spot urine protein- testing (preferable using a first morning urine specimen) at baseline and prior to each dose of nusinersen. A urine protein concentration greater than 0.2 g/L merits retesting and further evaluation.