Safety & Side Effects
Safety was based on 41 patients treated with ZYNTEGLO® in 2 open-label, single-arm clinical studies and 1 long-term follow-up study.
What is the most important information I should know about ZYNTEGLO®?
- Increased heart rate
- Abdominal pain
- Low level of platelets, which may reduce the ability of blood to clot and may cause bleeding
- Low level of white blood cells, which may make you more susceptible to infection
- Pain in arms or legs
- Severe headache
- Abnormal bruising
- Nose bleed
- Blood in your urine, stool, or vomit
- Coughing up blood
- Unusual stomach or back pain
You may experience side effects associated with other medicines administered as part of the ZYNTEGLO treatment regimen. Talk to your physician regarding those possible side effects. Your healthcare providers may give you other medicines to treat your side effects
It is important for you to be monitored at least yearly for at least 15 years for any changes to your blood. There is a potential risk of blood cancer associated with this treatment; however, no cases have been seen in studies of ZYNTEGLO. If you are diagnosed with a cancer, have your treating physician contact bluebird bio at 1-833-999-NEST (6378).
What should I avoid after receiving ZYNTEGLO?
- Do not donate blood, organs, tissues, or cells.
What are additional possible or reasonably likely side effects of ZYNTEGLO?
ZYNTEGLO will not give you human immunodeficiency virus (HIV) infection. Treatment with ZYNTEGLO may cause a false-positive HIV test result by some commercial tests. If you need a HIV test, talk with your healthcare provider about the appropriate test to use.
These are not all the possible side effects of ZYNTEGLO. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.Explore Questions & Conversation Starters
What other information should I know about ZYNTEGLO?
Safety is important to think about, so it will help to have an open conversation with your doctor about the side effects that you could experience with ZYNTEGLO. You may want to ask about potential side effects related to specific parts of treatment (example: chemotherapy). This discussion could help you consider the benefits and risks of ZYNTEGLO. You may also ask about the post-treatment monitoring period and what may happen during that time.
- As of March 2021, all patients treated with ZYNTEGLO in clinical trials remain alive at last follow-up
- It is important for you to be monitored at least yearly for at least 15 years for any changes to your blood. There is a potential risk of blood cancer associated with this treatment. However, no cases have been seen in studies of ZYNTEGLO. If you are diagnosed with a cancer, have your treating physician contact bluebird bio at 1-833-999-NEST (6378)
Clinical trial patients in the long-term follow-up study and patients who enroll in the registry will be followed for a total of 15 years after receiving ZYNTEGLO
- As of March 2021, all of the people who completed a 2-year clinical trial of ZYNTEGLO have enrolled in the long-term study, allowing them to be assessed for safety and treatment effects for an additional 13 years
- Other people who are treated with ZYNTEGLO will be encouraged to enroll in a registry to evaluate safety and treatment effects for 15 years
General information about the safe and effective use of ZYNTEGLO
- It is important that you have regular check-ups with your healthcare provider, including at least annual blood tests, to detect any adverse effects and to confirm that ZYNTEGLO is still working
- Talk to your healthcare provider about any concerns