Zolgensma (onasemnogene abeparvovec-xioi)

It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Onasemnogene abeparvovec-xioi is for single-dose IV infusion only.

*The recommended dose of onasemnogene abeparvovec-xioi in pediatric patients younger than 2 years of age with spinal muscular atrophy (SMA) is 1.1 x 1014 vector genomes (vg) per kg of body weight. Administration of onasemnogene abeparvovec-xioi to premature neonates before reaching full-term gestational age is not recommended.

*Administer onasemnogene abeparvovec-xioi as an IV infusion over 60 minutes. DO NOT INFUSE AS AN IV PUSH OR BOLUS. Flush line with saline following completion of infusion.

*Postpone onasemnogene abeparvovec-xioi in patients with infections until the infection has resolved and the patient is clinically stable.

*Starting one day prior to onasemnogene abeparvovec-xioi infusion, administer systemic corticosteroids equivalent to oral prednisolone at 1 mg/kg of body weight per day for a total of 30 days.

*At the end of the 30-day period of systemic corticosteroid treatment, check liver function by clinical examination and by laboratory testing. For patients with unremarkable findings, taper the corticosteroid dose gradually over the next 28 days. If liver function abnormalities persist, continue systemic corticosteroids (equivalent to oral prednisolone at 1 mg/kg/day) until findings become unremarkable, and then taper the corticosteroid dose gradually over the next 28 days or longer if needed. Do not stop systemic corticosteroids abruptly.

*If liver function abnormalities continue to persist >= 2 x ULN after the 30-day period of systemic corticosteroids, promptly consult a pediatric gastroenterologist or hepatologist.

*See Full Prescribing Information for additional instructions on preparation and administration.

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No dosing information is available for this tab.

No dosing information is available for this tab.

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There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

None.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

The most common adverse reactions (incidence >= 5%) were elevated aminotransferases and vomiting.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

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Administration of onasemnogene abeparvovec-xioi to premature neonates before reaching full-term gestational age is not recommended, because concomitant treatment with corticosteroids may adversely affect neurological development. Delay onasemnogene abeparvovec-xioi infusion until the corresponding full-term gestational age is reached.

The safety of onasemnogene abeparvovec-xioi was studied in pediatric patients who received onasemnogene abeparvovec-xioi infusion at age 0.3 to 7.9 months (weight range, 3.0 kg to 8.4 kg). Safety was also studied in Study 3 (post-authorization study) in patients weighing 9.5 kg to 20.2 kg.

The efficacy of onasemnogene abeparvovec-xioi was studied in pediatric patients who received onasemnogene abeparvovec-xioi infusion at age 0.5 to 7.9 months (weight range, 3.6 kg to 8.4 kg).

There are no available data regarding onasemnogene abeparvovec-xioi use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with onasemnogene abeparvovec-xioi.

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.

There is no information available on the presence of onasemnogene abeparvovec-xioi in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for onasemnogene abeparvovec-xioi and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.

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