Key facts about Fidanacogene Elaparvovec-DZKT
What dosages is Fidanacogene Elaparvovec-DZKT available in?
Fidanacogene Elaparvovec-DZKT is available as a 1 × 10^13 vg/mL suspension for IV infusion.
What is Fidanacogene Elaparvovec-DZKT used for?
Fidanacogene Elaparvovec-DZKT is type of gene therapy used to treat adults with moderate to severe hemophilia B (congenital factor IX deficiency) who: Currently use factor IX prophylaxis therapy, or Have current or historical life-threatening hemorrhage, or Have repeated, serious spontaneous bleeding episodes, and, Do not have neutralizing antibodies to adeno-associated virus serotype Rh74var (AAVRh74var) capsid.
How does Fidanacogene Elaparvovec-DZKT work?
Fidanacogene Elaparvovec-DZKT is designed to give your body the healthy (working or functioning) FIX gene it lacks. It uses a vector to carry the working gene to your liver. After Fidanacogene Elaparvovec-DZKT gets to your liver, it helps your body make more clotting FIX proteins. In hemophilia B, your FIX gene is changed or mutated.
How do I take Fidanacogene Elaparvovec-DZKT?
Fidanacogene Elaparvovec-DZKT is dosed based on your weight and then given over a 60 minute IV infusion.
Is it safe for me to take Fidanacogene Elaparvovec-DZKT?
Fidanacogene Elaparvovec-DZKT is a safe and effective treatment when used for FDA approved indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.
Fidanacogene Elaparvovec-DZKT Common Side Effects
Common side effects of Fidanacogene Elaparvovec-DZKT: Elevated liver enzymes
Fidanacogene Elaparvovec-DZKT Serious Side Effects
Serious side effects are rare with Fidanacogene Elaparvovec-DZKT. Contact your healthcare provider immediately if you experience any of the following: Liver damage: nausea/vomiting that doesn’t stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine Serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing Infusion reactions: fever, heart palpitations, nausea, vomiting, chills, headache, or signs of low blood pressure (such as dizziness on standing) Increased risk of liver cancer
Effects of other drugs, drug classes and over-the-counter products on Fidanacogene Elaparvovec-DZKT
No interaction studies have been performed with Fidanacogene Elaparvovec-DZKT.
Who makes Fidanacogene Elaparvovec-DZKT?
Various FDA-approved generic manufacturers
Is Fidanacogene Elaparvovec-DZKT safe in pregnancy?
Fidanacogene Elaparvovec-DZKT is not intended for use in women. There are no data from the use of Fidanacogene Elaparvovec-DZKT in pregnant women and no animal studies have been conducted with this medication.
