Kebilidi (eladocagene exuparvovec-tneq)

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

*For single-dose intraputaminal infusion only.

*Prior to treatment, confirm that patient has AADC deficiency due to biallelic mutations in the DDC gene.

*Administer in a medical center which specializes in stereotactic neurosurgery.

*Brain imaging for stereotactic planning and intraoperative navigation should be done prior to the procedure.

*After stereotactic registration is complete, mark the entry point on the skull. Surgical access through the skull bone and dura should be performed.

*Administer a total recommended dose of 1.8x1011 vg (0.32 mL total volume) delivered as four 0.08 mL (0.45x1011 vg) infusions (2 in anterior putamen and 2 in posterior putamen) at a rate of 0.003 mL/minute (0.18 mL/hour) at each target point for a total of 27 minutes per site; administer in a single stereotactic surgery using a cannula that is FDA-authorized for intraparenchymal infusion.

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

No dosing information is available for this tab.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Patients who have not achieved skull maturity assessed by neuroimaging.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• No disease contraindications

Most common adverse reactions (incidence >=15%) were dyskinesia, pyrexia, hypotension, anemia, salivary hypersecretion, hypokalemia, hypophosphatemia, insomnia, hypomagnesemia, and procedural complications.

More Frequent

• Anemia
• Hypokalemia
• Hypomagnesemia
• Hypophosphatemia
• Hypotension

Less Frequent

• Oculogyric crisis

More Frequent

• Dyskinesia
• Fever
• Insomnia
• Sialorrhea

No enhanced messaging available.

The safety and effectiveness of eladocagene exuparvovec-tneq have been established in pediatric patients. The use of eladocagene exuparvovec-tneq was evaluated in a single-arm, open-label study that enrolled 13 pediatric patients 16 months to 10 years of age who had achieved skull maturity.

The safety and effectiveness of eladocagene exuparvovec-tneq have not been studied in pediatric patients younger than 16 months of age.

There are no clinical data from the use of eladocagene exuparvovec-tneq in pregnant women. Animal reproductive and developmental toxicity studies have not been conducted with eladocagene exuparvovec-tneq.

In the US 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 data on the presence of eladocagene exuparvovec-tneq in human milk, the effects on the breastfed infant, or the effects on milk production.

Eladocagene exuparvovec-tneq has not been studied in patients 65 years of age and older.