ETRANACOGENE DEZAPARVOVEC

Other

Brand names: HEMGENIX

Oral

Mechanism of Action

12.1 Mechanism of Action HEMGENIX is an adeno-associated virus serotype 5 (AAV5) based gene therapy designed to deliver a copy of a gene encoding the Padua variant of human coagulation Factor IX (hFIX-Padua). Single intravenous infusion of HEMGENIX results in cell transduction and increase in circulating Factor IX activity in patients with Hemophilia B.

Indications

or Have current or historical life-threatening hemorrhage

or Have repeated

or Have current or historical life-threatening hemorrhage

or Have repeated

serious spontaneous bleeding episodes.

Contraindications

• 4 CONTRAINDICATIONS None. None. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Infusion reactions: Monitor during administration and for at least 3 hours after end of infusion
1 ) Hepatotoxicity: Closely monitor transaminase levels once per week for 3 months after HEMGENIX administration to mitigate the risk of potential hepatotoxicity
2 ) Hepatocellular carcinogenicity: For patients with preexisting risk factors (e
Closely monitor transaminase levels once per week for 3 months after HEMGENIX administration to mitigate the risk of potential hepatotoxicity

Known Side Effects

7 documented side effects by frequency

Headache

>10%

Fatigue

>10%

Nausea

1-10%

Back Pain

0.1-1%

General Unwellness

0.1-1%

Fever

0.1-1%

Rash

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral