Roctavian Side Effects

Generic name: valoctocogene roxaparvovec

Medically reviewed by Drugs.com. Last updated on Aug 27, 2024.

Note: This document provides detailed information about Roctavian.

Applies to valoctocogene roxaparvovec: intravenous suspension 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.

Precautions

It is very important that your doctor check you closely and at regular visits to make sure this medicine is working properly. Blood tests will be needed to check for unwanted effects.

Do not drink alcohol during treatment and for at least 1 year after receiving this medicine.

Women should not use this medicine, especially women who are pregnant or able to become pregnant. This medicine can harm an unborn baby. It can also cause birth defects if the father is using it when his sexual partner becomes pregnant. Males with female partners who can become pregnant must use an effective birth control during treatment and for at least 6 months after the last dose. If a pregnancy occurs while you are using this medicine, tell your doctor right away.

This medicine may cause infusion-related reactions. Check with your doctor right away if you have back pain, chest tightness, chills, fever, flushing, headache, nausea and vomiting, trouble breathing, or weakness.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have blurred vision, chills, confusion, cough, diarrhea, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, fast, pounding, or irregular heartbeat or pulse, fever, hives, itching, skin rash, nausea, runny nose, shivering, sneezing, sweating, tingling of the throat, trouble breathing, unusual tiredness or weakness, or watery eyes after you receive the medicine.

Check with your doctor right away if you have clay-colored stool, dark urine, decreased appetite, fever, itching, loss of appetite, nausea and vomiting, skin rash, stomach pain, swelling of the feet or lower legs, unusual tiredness or weakness, or yellow eyes or skin. These may be symptoms of a serious liver problem.

This medicine may increase risk for blood clots. Check with your doctor right away if you have 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 trouble breathing for no apparent reason, sudden onset of slurred speech, or sudden vision changes.

While you are being treated with valoctocogene roxaparvovec-rvox injection, do not have any immunizations (vaccines) without your doctor's approval. Live virus vaccines should not be given with valoctocogene roxaparvovec-rvox.

Do not donate semen for at least 6 months after treatment.

Do not donate blood, organs, tissues or cells for transplant after treatment.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

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:

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]

See also:

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