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Spinraza

Spinraza

Manufacturer:

Biogen

Distributor:

Zuellig
Concise Prescribing Info
Contents
Nusinersen
Indications/Uses
Dosage/Direction for Use
12 mg (5 mL) per administration by intrathecal bolus over 1-3 min, using a spinal anaesth needle. Initiate as early as possible after diagnosis w/ 4 loading doses on day 0, 14, 28 & 63. Maintenance dose: Administer once every 4 mth thereafter.
Contraindications
Special Precautions
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 equiv to the vol of Spinraza to be injected. Sedation & ultrasound (or other 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, back pain, vomiting). Thrombocytopaenia & 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. Further evaluation should be considered for persistent elevated urinary protein. Reports of communicating 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 survival motor neuron (SMN) protein deficiency. Spinraza has not been studied in patients w/ renal or hepatic impairment. Avoid use during 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.
Adverse Reactions
Headache, vomiting & back pain associated w/ lumbar puncture.
MIMS Class
Other Drugs Acting on Musculo-Skeletal System
ATC Classification
M09AX07 - nusinersen ; Belongs to the class of other drugs for disorders of the musculo-skeletal system.
Presentation/Packing
Form
Spinraza soln for inj 12 mg/5 mL
Packing/Price
1's
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