Do not inj in areas of the skin w/ signs of infection or inflammation. Prior to administration, it is recommended to remove vol of CSF equivalent to the vol of Spinraza to be injected. Sedation & imaging techniques may be required to aid administration, particularly in younger patients & in patients w/ scoliosis. Use aseptic technique when preparing & administering Spinraza. Lumbar puncture adverse reactions & complications (eg, headache, backpain, vomiting). Thrombocytopaenia & coagulation abnormalities &/or renal toxicity have been observed after administration of other SC or IV antisense oligonucleotides. Appropriate testing is recommended prior to administration if clinically indicated. Further evaluation should be considered for persistent elevated urinary protein. Reports of hydrocephalus not related to meningitis or bleeding. Consider evaluation for hydrocephalus in patients w/ decreased consciousness. Benefits & risk in patients w/ ventriculo-peritoneal shunt are unknown; maintenance of treatment needs to be carefully considered. Patients w/ profound hypotonia & resp failure at birth, where Spinraza has not been studied, may not experience a clinically meaningful benefit due to severe SMN protein deficiency. Spinraza has not been studied in patients w/ renal or hepatic impairment. Avoid use in pregnancy. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Spinraza therapy taking into account the benefit of breast-feeding for the child & the benefit of therapy for the woman.
Sign Out
