Roctavian Side Effects

Generic name: valoctocogene roxaparvovec

Medically reviewed by Drugs.com. Last updated on Feb 6, 2024.

Note: This document contains side effect information about valoctocogene roxaparvovec. Some dosage forms listed on this page may not apply to the brand name Roctavian.

Applies to valoctocogene roxaparvovec: intravenous suspension.

Serious side effects of Roctavian

Along with its needed effects, valoctocogene roxaparvovec (the active ingredient contained in Roctavian) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking valoctocogene roxaparvovec:

More common

Back pain
blurred vision
chest tightness
chills
confusion
cough
diarrhea
difficulty swallowing
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
fast heartbeat
fever
flushing
headache
hives, itching, skin rash
nausea and vomiting
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
runny nose
shivering
sweating
tingling of the throat
trouble breathing
unusual tiredness or weakness
watery eyes

Less common

Loss of appetite
stomach pain

Incidence not known

Dark urine
pains in the chest, groin, or legs, especially the calves of the legs
severe headaches of sudden onset
sudden loss of coordination
sudden onset of slurred speech
sudden vision changes
yellow eyes or skin

Other side effects of Roctavian

Some side effects of valoctocogene roxaparvovec may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

General feeling of discomfort or illness
headache
unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness

Less common

Stomach pain

For Healthcare Professionals

Applies to valoctocogene roxaparvovec: intravenous suspension.

General

The most common adverse reactions with a frequency of 5% or greater were nausea, fatigue, headache, infusion-related reactions, vomiting, and abdominal pain.

The most common laboratory abnormalities with a frequency of 10% or greater were increased alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactate dehydrogenase (LDH), creatine phosphokinase (CPK), factor VIII activity levels, gamma-glutamyl transferase (GGT), and bilirubin greater than ULN.^[Ref]

Dermatologic

Uncommon (0.1% to 1%): Rash

Frequency not reported: Maculopapular rash^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (31%)

Common (1% to 10%): Vomiting, abdominal pain (includes abdominal discomfort, abdominal distension, abdominal tenderness, upper abdominal pain), diarrhea

Uncommon (0.1% to 1%): Gastroenteritis^[Ref]

Hepatic

Very common (10% or more): Hepatotoxicity (96%), increased ALT (81%), increased AST (69%), increased GGT (18%), increased bilirubin (13%)^[Ref]

Hypersensitivity

Common (1% to 10%): Infusion related reactions, hypersensitivity reactions, anaphylaxis

Frequency not reported: Presyncope^[Ref]

Other

Very common (10% or more): Fatigue (includes fatigue, lethargy, and malaise;16%), increased LDH (57%), increased CPK (45%), increased factor VIII activity levels (28%)^[Ref]