Itvisma (onasemnogene abeparvovec-brve)

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

Onasemnogene abeparvovec-brve is for single-dose intrathecal injection only. The drug should only be administered intrathecally using a lumbar puncture by healthcare professionals (e.g., interventional radiologist or neurologist) experienced in performing lumbar punctures.

*The recommended dose of onasemnogene abeparvovec-brve in adult and pediatric patients 2 years of age and older with confirmed mutation in SMN1 gene.is 1.2 x 1014 vector genomes (vg).

*Administer onasemnogene abeparvovec-brve as an intrathecal bolus injection over approximately 1 to 2 minutes.

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

*Starting one day prior to onasemnogene abeparvovec-brve injection, 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, 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 at any time patients do not respond adequately to the equivalent of 1 mg/kg/day oral prednisolone, based on the patient's clinical course, prompt consultation with a gastroenterologist or hepatologist and adjustment to the recommended corticosteroid regimen may be considered.

*See Full Prescribing Information for additional instructions on preparation and administration, and recommendations for patient monitoring.

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No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Myelosuppressives; Immunomodulators/Sodium Iodide I 131

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Sodium iodide I 131 can cause depression of the hematopoetic system. Myelosuppressives and immunomodulators also suppress the immune system.(1)

CLINICAL EFFECTS: Concurrent use of sodium iodide I 131 with agents that cause bone marrow depression, including myelosuppressives or immunomodulators, may result in an enhanced risk of hematologic disorders, including anemia, blood dyscrasias, bone marrow depression, leukopenia, and thrombocytopenia. Bone marrow depression may increase the risk of serious infections and bleeding.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The US manufacturer of sodium iodide I 131 states that concurrent use with bone marrow depressants may enhance the depression of the hematopoetic system caused by large doses of sodium iodide I 131.(1) Sodium iodide I 131 causes a dose-dependent bone marrow suppression, including neutropenia or thrombocytopenia, in the 3 to 5 weeks following administration. Patients may be at increased risk of infections or bleeding during this time. Monitor complete blood counts within one month of therapy. If results indicate leukopenia or thrombocytopenia, dosimetry should be used to determine a safe sodium iodide I 131 activity.(1)

DISCUSSION: Hematologic disorders including death have been reported with sodium iodide I 131. The most common hematologic disorders reported include anemia, blood dyscrasias, bone marrow depression, leukopenia, and thrombocytopenia.(1)

There are no moderate interactions for this drug.

None.

There are no contraindication contraindications for this drug.

• Disease of liver
• Infection
• Thrombocytopenic disorder

• Dehydration

The most common adverse reactions that occurred in at least 10% of patients were upper respiratory tract infection, upper gastrointestinal symptoms, pyrexia, and headache.

Less Frequent

• Abnormal hepatic function tests
• Head sensation disturbance
• Thrombocytopenic disorder

Rare or Very Rare

• Drug-induced hepatitis
• Hepatic failure
• Hepatocellular damage
• Thrombotic microangiography

More Frequent

• Acute abdominal pain
• Fever
• Headache disorder
• Upper respiratory infection

Less Frequent

• Dizziness
• Pain in extremities

Rare or Very Rare

• Increased troponin-I level
• Injection site sequelae

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The safety and efficacy of onasemnogene abeparvovec-brve have been established in pediatric patients 2 years of age and older. The use of onasemnogene abeparvovec-brve was supported by data from one clinical study which enrolled 126 pediatric patients 2 years of age and older.

The safety and effectiveness of onasemnogene abeparvovec-brve have not been established in pediatric patients younger than 2 years of age.

There are no clinical studies in pregnant women to inform a product-associated risk. There are no available data in animal embryo-fetal development studies with onasemnogene abeparvovec-brve. It is not known whether onasemnogene abeparvovec-brve has the potential to be transferred to the fetus. Therefore, women who are pregnant or desire to become pregnant should only be treated with onasemnogene abeparvovec-brve after a thorough benefit-risk evaluation.

In the United States 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-brve 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-brve and any potential adverse effects on the breastfed child from onasemnogene abeparvovec-brve or from the underlying maternal condition.

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