Hemgenix (etranacogene dezaparvovec-drlb)

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

For single-use IV infusion only. Administer as an IV infusion through a peripheral venous catheter; do not administer as an IV push or bolus.

*Perform baseline testing to select patients, including testing for Factor IX inhibitor presence and liver health tests.

*The recommended dose of etranacogene dezaparvovec-drlb is 2 x 1013 genome copies (gc) per kg of body weight (or 2 mL/kg body weight). See Full Prescribing Information for instructions on calculating dose and number of vials required.

*Administer etranacogene dezaparvovec-drlb as an IV infusion after dilution with 0.9% sodium chloride (normal saline) at a constant infusion rate of 500 mL/hour (8 mL/minute).

*If an infusion-related reaction occurs during administration, decrease the infusion rate or stop the infusion. Administer treatment as needed to manage infusion reaction. If the infusion is stopped, restart the infusion at a slower rate when the infusion reaction is resolved. If the infusion rate needs to be reduced, or stopped and restarted, etranacogene dezaparvovec-drlb should be infused within 24 hours after the dose is prepared.

*See Full Prescribing Information for additional instructions on preparation and administration of etranacogene dezaparvovec-drlb, and for monitoring recommendations.

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.

*None.

There are no contraindication contraindications for this drug.

• Pregnancy

There are no moderate contraindications for this drug.

The most common adverse reactions (incidence >=5%) were elevated ALT, headache, blood creatine kinase elevations, flu-like symptoms, infusion-related reactions, fatigue, malaise, and elevated AST.

More Frequent

• Increased alanine transaminase
• Increased aspartate transaminase

Less Frequent

• Hypersensitivity drug reaction

More Frequent

• Fatigue
• Flu-like symptoms
• Headache disorder
• Increased creatine kinase level

Less Frequent

• Malaise
• Nausea

No enhanced messaging available.

The safety and efficacy of etranacogene dezaparvovec-drlb in pediatric patients have not been established.

Etranacogene dezaparvovec is not intended for administration in women. No adverse effects on mating rate and fertility indices or fetal weights were observed in healthy naive female mice mated with healthy male mice that were IV administered a predecessor of etranacogene dezaparvovec-drlb product 6 days prior to mating. Vector DNA was not detected in the uterus, placenta, or fetus.

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.

Etranacogene dezaparvovec-drlb is not intended for administration in women.

The clinical studies included a total of 6 geriatric subjects 68 to 75 years of age with hemophilia B at the time of enrollment. No meaningful differences in the safety and efficacy profile were observed in these subjects compared to subjects 18 to 65 years of age, and no dose adjustment was made.