Spinraza
(Nusinersen)Dosage & Administration
SPINRAZA is administered intrathecally (
SPINRAZA is administered intrathecally by, or under the direction of, healthcare professionals experienced in performing lumbar punctures.
The recommended dosage is 12 mg (5 mL) per administration.
Initiate SPINRAZA treatment with 4 loading doses. The first three loading doses should be administered at 14-day intervals. The 4th loading dose should be administered 30 days after the 3rd dose. A maintenance dose should be administered once every 4 months thereafter.
If a loading dose (any of the 4 loading doses) is missed, administer the missed loading dose as soon as possible; adjust the date for the subsequent doses to maintain the recommended interval between doses.
Administer the missed maintenance dose as soon as possible; then administer the next maintenance dose per the originally scheduled date, as long as these two doses are administered at least 14 days apart.
Administer the missed maintenance dose as soon as possible, followed by one additional dose 14 days later, and then administer the next maintenance dose 4 months thereafter.
Administer the missed maintenance dose as soon as possible, followed by two additional doses 14 days apart, and then administer the next maintenance dose 4 months thereafter.
Restart dosing as described in Recommended Dosage.
SPINRAZA is administered intrathecally by, or under the direction of, healthcare professionals experienced in performing lumbar punctures.
The recommended dosage is 12 mg (5 mL) per administration.
Initiate SPINRAZA treatment with 4 loading doses. The first three loading doses should be administered at 14-day intervals. The 4th loading dose should be administered 30 days after the 3rd dose. A maintenance dose should be administered once every 4 months thereafter.
If a loading dose (any of the 4 loading doses) is missed, administer the missed loading dose as soon as possible; adjust the date for the subsequent doses to maintain the recommended interval between doses.
Administer the missed maintenance dose as soon as possible; then administer the next maintenance dose per the originally scheduled date, as long as these two doses are administered at least 14 days apart.
Administer the missed maintenance dose as soon as possible, followed by one additional dose 14 days later, and then administer the next maintenance dose 4 months thereafter.
Administer the missed maintenance dose as soon as possible, followed by two additional doses 14 days apart, and then administer the next maintenance dose 4 months thereafter.
Restart dosing as described in Recommended Dosage.
SPINRAZA is for intrathecal use only.
Prepare and use SPINRAZA according to the following steps using aseptic technique. Each vial is intended for single dose only.
Conduct the following laboratory tests at baseline and prior to each dose of SPINRAZA and as clinically needed
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Spinraza Prescribing Information
SPINRAZA is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.
SPINRAZA is administered intrathecally (
SPINRAZA is administered intrathecally by, or under the direction of, healthcare professionals experienced in performing lumbar punctures.
The recommended dosage is 12 mg (5 mL) per administration.
Initiate SPINRAZA treatment with 4 loading doses. The first three loading doses should be administered at 14-day intervals. The 4th loading dose should be administered 30 days after the 3rd dose. A maintenance dose should be administered once every 4 months thereafter.
If a loading dose (any of the 4 loading doses) is missed, administer the missed loading dose as soon as possible; adjust the date for the subsequent doses to maintain the recommended interval between doses.
Administer the missed maintenance dose as soon as possible; then administer the next maintenance dose per the originally scheduled date, as long as these two doses are administered at least 14 days apart.
Administer the missed maintenance dose as soon as possible, followed by one additional dose 14 days later, and then administer the next maintenance dose 4 months thereafter.
Administer the missed maintenance dose as soon as possible, followed by two additional doses 14 days apart, and then administer the next maintenance dose 4 months thereafter.
Restart dosing as described in Recommended Dosage.
SPINRAZA is administered intrathecally by, or under the direction of, healthcare professionals experienced in performing lumbar punctures.
The recommended dosage is 12 mg (5 mL) per administration.
Initiate SPINRAZA treatment with 4 loading doses. The first three loading doses should be administered at 14-day intervals. The 4th loading dose should be administered 30 days after the 3rd dose. A maintenance dose should be administered once every 4 months thereafter.
If a loading dose (any of the 4 loading doses) is missed, administer the missed loading dose as soon as possible; adjust the date for the subsequent doses to maintain the recommended interval between doses.
Administer the missed maintenance dose as soon as possible; then administer the next maintenance dose per the originally scheduled date, as long as these two doses are administered at least 14 days apart.
Administer the missed maintenance dose as soon as possible, followed by one additional dose 14 days later, and then administer the next maintenance dose 4 months thereafter.
Administer the missed maintenance dose as soon as possible, followed by two additional doses 14 days apart, and then administer the next maintenance dose 4 months thereafter.
Restart dosing as described in Recommended Dosage.
- The recommended dosage is 12 mg (5 mL) per administration
- Initiate SPINRAZA treatment with 4 loading doses: the first three loading doses should be administered at 14-day intervals; the 4th loading dose should be administered 30 days after the 3rd dose. A maintenance dose should be administered once every 4 months thereafter.
SPINRAZA is for intrathecal use only.
Prepare and use SPINRAZA according to the following steps using aseptic technique. Each vial is intended for single dose only.
- Store SPINRAZA in the carton in a refrigerator until time of use.
- Allow the SPINRAZA vial to warm to room temperature (25oC/77oF) prior to administration. Do not use external heat sources.
- Inspect the SPINRAZA vial for particulate matter and discoloration prior to administration. Do not administer SPINRAZA if visible particulates are observed or if the liquid in the vial is discolored. The use of external filters is not required.
- Withdraw 12 mg (5 mL) of SPINRAZA from the single-dose vial into a syringe and discard unused contents of the vial.
- Administer SPINRAZA within 4 hours of removal from vial.
- Consider sedation as indicated by the clinical condition of the patient.
- Consider ultrasound or other imaging techniques to guide intrathecal administration of SPINRAZA, particularly in younger patients.
- Prior to administration, remove 5 mL of cerebrospinal fluid.
- Administer SPINRAZA as an intrathecal bolus injection over 1 to 3 minutes using a spinal anesthesia needle[see Dosage and Administration ].Do not administer SPINRAZA in areas of the skin where there are signs of infection or inflammation[see Adverse Reactions ].
- Allow to warm to room temperature prior to administration
- Administer within 4 hours of removal from vial
- Prior to administration, remove 5 mL of cerebrospinal fluid
- Administer as intrathecal bolus injection over 1 to 3 minutes
Conduct the following laboratory tests at baseline and prior to each dose of SPINRAZA and as clinically needed
- Platelet count
- Prothrombin time; activated partial thromboplastin time
- Quantitative spot urine protein testing
- At baseline and prior to each dose, obtain a platelet count, coagulation laboratory testing, and quantitative spot urine protein testing
Injection: 12 mg/5 mL (2.4 mg/mL) nusinersen as a clear and colorless solution in a single-dose vial.
Pregnancy: Based on animal data, may cause fetal harm (
There are no adequate data on the developmental risk associated with the use of SPINRAZA in pregnant women. When nusinersen was administered by subcutaneous injection to mice throughout pregnancy and lactation, developmental toxicity (long-term neurobehavioral impairment) was observed at all doses tested
When nusinersen (0, 3, 10, or 25 mg/kg) was administered subcutaneously to male and female mice every other day prior to and during mating and continuing in females throughout organogenesis, no adverse effects on embryofetal development were observed. Subcutaneous administration of nusinersen (0, 6, 12.6, or 25 mg/kg) to pregnant rabbits every other day throughout organogenesis produced no evidence of embryofetal developmental toxicity.
When nusinersen (1.4, 5.8, or 17.2 mg/kg) was administered to pregnant female mice by subcutaneous injection every other day throughout organogenesis and continuing once every six days throughout the lactation period, adverse neurobehavioral effects (alterations in locomotor activity, learning and memory deficits) were observed when offspring were tested after weaning or as adults. A no-effect level for neurobehavioral impairment was not established.
None.
- Thrombocytopenia and Coagulation Abnormalities:Increased risk for bleeding complications; testing required at baseline and before each dose and as clinically needed (,
5.1 Thrombocytopenia and Coagulation AbnormalitiesCoagulation abnormalities and thrombocytopenia, including acute severe thrombocytopenia, have been observed after administration of some antisense oligonucleotides.
In the sham-controlled studies for patients with infantile-onset and later-onset SMA, 24 of 146 (16%) SPINRAZA-treated patients with high, normal, or unknown platelet count at baseline developed a platelet level below the lower limit of normal, compared to 10 of 72 (14%) sham-controlled patients.
In the sham-controlled study in patients with later-onset SMA (Study 2), two SPINRAZA-treated patients developed platelet counts less than 50,000 cells per microliter, with a lowest level of 10,000 cells per microliter recorded on study day 28.
Because of the risk of thrombocytopenia and coagulation abnormalities from SPINRAZA, patients may be at increased risk of bleeding complications.
Perform a platelet count and coagulation laboratory testing at baseline and prior to each administration of SPINRAZA and as clinically needed.
)2.3 Laboratory Testing and Monitoring to Assess SafetyConduct the following laboratory tests at baseline and prior to each dose of SPINRAZA and as clinically needed
[see Warnings and Precautions ]:- Platelet count
- Prothrombin time; activated partial thromboplastin time
- Quantitative spot urine protein testing
- Renal Toxicity:Quantitative spot urine protein testing required at baseline and prior to each dose (,
5.2 Renal ToxicityRenal toxicity, including potentially fatal glomerulonephritis, has been observed after administration of some antisense oligonucleotides.
SPINRAZA is present in and excreted by the kidney
[see Clinical Pharmacology ]. In the sham-controlled studies for patients with infantile-onset and later-onset SMA, 71 of 123 (58%) of SPINRAZA-treated patients had elevated urine protein, compared to 22 of 65 (34%) sham-controlled patients. Conduct quantitative spot urine protein testing (preferably using a first morning urine specimen) at baseline and prior to each dose of SPINRAZA. For urinary protein concentration greater than 0.2 g/L, consider repeat testing and further evaluation.)2.3 Laboratory Testing and Monitoring to Assess SafetyConduct the following laboratory tests at baseline and prior to each dose of SPINRAZA and as clinically needed
[see Warnings and Precautions ]:- Platelet count
- Prothrombin time; activated partial thromboplastin time
- Quantitative spot urine protein testing