SPINRAZA- nusinersen injection, solution

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

Nusinersen (UNII: 5Z9SP3X666) (Nusinersen - UNII:5Z9SP3X666)

Sẵn có từ:

Biogen

INN (Tên quốc tế):

Nusinersen

Thành phần:

Nusinersen 2.4 mg in 1 mL

Tuyến hành chính:

INTRATHECAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

SPINRAZA is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. None. Risk Summary 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 (see Data). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data 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. Risk Summary There are no data on the presence of nusinersen in human milk, the effects on the breastfed infant, or the effects of the drug on milk production.Nusinersen was detected in the milk of lactating mice when administered by subcutaneous injection. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for SPINRAZA and any potential adverse effects on the breastfed infant from SPINRAZA or from the underlying maternal condition. The safety and effectiveness of SPINRAZA in pediatric patients from newborn to 17 years have been established [see Clinical Studies (14.1)]. Juvenile Animal Toxicity Data In intrathecal toxicity studies in juvenile monkeys, administration of nusinersen (0, 0.3, 1, or 3 mg/dose for 14 weeks and 0, 0.3, 1, or 4 mg/dose for 53 weeks) resulted in brain histopathology (neuronal vacuolation and necrosis/cellular debris in the hippocampus) at the mid and high doses and acute, transient deficits in lower spinal reflexes at the high dose in each study. In addition, possible neurobehavioral deficits were observed on a learning and memory test at the high dose in the 53-week monkey study. The no-effect dose for neurohistopathology in monkeys (0.3 mg/dose) is approximately equivalent to the human dose when calculated on a yearly basis and corrected for the species difference in CSF volume. Clinical studies of SPINRAZA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Tóm tắt sản phẩm:

SPINRAZA injection is a sterile, clear and colorless solution supplied as a 12 mg/5 mL (2.4 mg/mL) solution in a single-dose glass vial free of preservatives. The NDC is 64406-058-01. Store in a refrigerator between 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. SPINRAZA should be protected from light and kept in the original carton until time of use. If no refrigeration is available, SPINRAZA may be stored in its original carton, protected from light at or below 30o C (86o F) for up to 14 days. Prior to administration, unopened vials of SPINRAZA can be removed from and returned to the refrigerator, if necessary. If removed from the original carton, the total combined time out of refrigeration should not exceed 30 hours at a temperature that does not exceed 25o C (77o F).

Tình trạng ủy quyền:

New Drug Application

Đặc tính sản phẩm

SPINRAZA- NUSINERSEN INJECTION, SOLUTION
BIOGEN
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SPINRAZA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
SPINRAZA.
SPINRAZA (NUSINERSEN) INJECTION, FOR INTRATHECAL USE
INITIAL U.S. APPROVAL: 2016
INDICATIONS AND USAGE
SPINRAZA is a survival motor neuron-2 (SMN2)-directed antisense
oligonucleotide indicated for the
treatment of spinal muscular atrophy (SMA) in pediatric and adult
patients (1)
DOSAGE AND ADMINISTRATION
SPINRAZA is administered intrathecally (2.1)
Dosing Information (2.1)
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 4 loading dose should be administered 30 days
after the 3 dose. A
maintenance dose should be administered once every 4 months
thereafter.
Important Preparation and Administration Instructions (2.2)
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
Laboratory Testing and Monitoring to Assess Safety (2.3)
At baseline and prior to each dose, obtain a platelet count,
coagulation laboratory testing, and
quantitative spot urine protein testing
DOSAGE FORMS AND STRENGTHS
Injection: 12 mg/5 mL (2.4 mg/mL) in a single-dose vial (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
_Thrombocytopenia and Coagulation Abnormalities:_ Increased risk for
bleeding complications; testing
required at baseline and before each dose and as clinically needed
(5.1, 2.3)
_Renal Toxicity:_ Quantitative spot urine protein testing required at
baseline and prior to each dose (5.2,
2.3)
ADVERSE REACTIONS
The most common adverse reactions that occurred in at least 20% of
SPINRAZA-treated patients and
occurred at least 5% more frequently than in control patients were:
lower res