Roctavian Side Effects

Generic name: valoctocogene roxaparvovec

Medically reviewed by Drugs.com. Last updated on Jun 7, 2024.

Note: This document provides detailed information about Roctavian Side Effects associated with valoctocogene roxaparvovec. Some dosage forms listed on this page may not apply specifically 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 side effects

• 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 side effects

• 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 side effects

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

Less common side effects

• stomach pain

For healthcare professionals

Applies to valoctocogene roxaparvovec: intravenous suspension.

General adverse events

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]

Psychiatric

• Common (1% to 10%): Dizziness^[Ref]

Nervous system

• Common (1% to 10%): Headache^[Ref]

Further information

Roctavian side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer