Must not be administered in areas of the skin w/ signs of infection or inflammation. Use aseptic technique when preparing soln for intrathecal administration. Remove CSF vol, equiv to Spinraza vol to be injected, prior to administration. Sedation may be required to administer Spinraza. Ultrasound (or other imaging techniques) may be considered to guide intrathecal administration, particularly in younger patients & in patients w/ scoliosis. Risk of adverse reactions occurring as part of the lumbar puncture procedure. Thrombocytopenia & coagulation abnormalities &/or renal toxicity have been observed after administration of other SC or IV antisense oligonucleotides. Platelet & coagulation lab testing &/or urine protein testing (preferably 1st morning urine specimen) is recommended prior to administration if clinically indicated. Consider further evaluation for persistent elevated urinary protein. Post-marketing reports of communicating hydrocephalus not related to meningitis or bleeding. Consider evaluation for hydrocephalus in patients w/ decreased consciousness. Benefits & risks of treatment in patients w/ ventriculo-peritoneal shunt are unknown at present, & maintenance of treatment needs to be carefully considered. Has not been studied in patients w/ profound hypotonia & resp failure at birth who may not experience a clinically meaningful benefit due to severe survival motor neuron (SMN) protein deficiency. Has not been studied in patients w/ renal or hepatic impairment. Preferable to avoid use during pregnancy. Discontinue breast-feeding or discontinue/abstain from nusinersen therapy.
Sign Out
Continue with Google
Sign Up With Email
Already a member?
Sign In
