VALOCTOCOGENE ROXAPARVOVEC-RVOX

Other

Brand names: ROCTAVIAN

Intravenous

Mechanism of Action

12.1 Mechanism of Action Valoctocogene roxaparvovec-rvox is an adeno-associated virus serotype 5 (AAV5) based gene therapy vector, designed to introduce a functional copy of a transgene encoding the B-domain deleted SQ form of human coagulation factor VIII (hFVIII-SQ). Transcription of this transgene occurs within the liver, using a liver-specific promoter, which results in the expression of hFVIII-SQ. The expressed hFVIII-SQ replaces the missing coagulation factor VIII needed for effective hemostasis.

Indications

See full prescribing information

Contraindications

• 4 CONTRAINDICATIONS Administration of ROCTAVIAN is contraindicated in: patients with active infections
• or cirrhosis [see Dosage and Administration (2) ]. patients with known hypersensitivity to mannitol. Active infections
• either acute or uncontrolled chronic. ( 4 ) Known significant hepatic fibrosis (stage 3 or 4)
• or cirrhosis. ( 4 ) Known hypersensitivity to mannitol. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Infusion-related reactions: Infusion reactions, including hypersensitivity reactions and anaphylaxis, have occurred
Evaluate for risk factors for thrombosis including cardiovascular risk factors prior to and after ROCTAVIAN use and advise patients accordingly
4 ) Malignancy: Monitor for hepatocellular malignancy in patients with risk factors for hepatocellular carcinoma (e
An increase in factor VIII activity may increase the risk for venous and arterial thromboembolic events

Known Side Effects

3 documented side effects by frequency

Headache

1-10%

Nausea

1-10%

Fatigue

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Intravenous