For hemophilia (bleeding disorder).
Brand Name(s): Roctavian
Generic Name: Valoctocogene Roxaparvovec-rvox
Instructions
This medicine is given as an IV injection into a vein.
This medicine is given gradually through the IV line.
This medicine should be given by a trained health care provider.
You must be monitored by a health care professional for at least 3 hours after each dose is given.
Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.
Keep all appointments for medical exams and tests while on this medicine.
Cautions
This medicine is not approved for use by women.
Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.
Tell your doctor or nurse right away if fever, chills, skin rash, or shortness of breath develop while the medicine is being given. The medicine may need to be stopped or given at a slower rate.
Avoid alcohol for at least 1 year after treatment with this medicine.
Men with a female partner who is of childbearing age must use reliable birth control during sexual activity while taking this medicine and for 6 months after stopping to prevent pregnancy.
Always carry an ID card or wear a medical alert bracelet indicating your medical condition.
Do not donate blood, organs, tissues, or cells after using this medicine.
Do not donate sperm for 6 months after using this medicine.
Side Effects
The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.
- headaches
- nausea and vomiting
Call your doctor or get medical help right away if you notice any of these more serious side effects:
- chest or jaw pain
- dizziness
- fainting
- sudden leg pain, swelling, warmth or redness
- signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
- shortness of breath
- symptoms of stroke (such as one-sided weakness, slurred speech, confusion)
- excessive or unusual sweating
A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.
Please speak with your doctor, nurse, or pharmacist if you have any questions about this medicine.
IMPORTANT NOTE: This document tells you briefly how to take your medicine, but it does not tell you all there is to know about it. Your doctor or pharmacist may give you other documents about your medicine. Please talk to them if you have any questions. Always follow their advice.
There is a more complete description of this medicine available in English. Scan this code on your smartphone or tablet or use the web address below. You can also ask your pharmacist for a printout. If you have any questions, please ask your pharmacist.
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More information about VALOCTOCOGENE ROXAPARVOVEC - INJECTION
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