Fidanacogene elaparvovec: Patient drug information
What is this drug used for?
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No
It is used to treat certain people who have hemophilia B.
What do I need to tell my doctor BEFORE I take this drug?
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No
If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
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No
If you have or have ever had factor IX inhibitor.
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If you have any of the following conditions: HIV, hepatitis, other liver problems, abnormal liver enzyme levels, low albumin levels, or enlarged spleen.
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This is not a list of all drugs or health problems that interact with this drug.
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Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
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Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
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Have your blood work and other lab tests checked as you have been told by your doctor.
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This drug may not work for all people who use it. Talk with the doctor.
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If possible, make sure all vaccines are up to date before treatment with this drug.
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No
Talk with your doctor before you drink alcohol. You will need to limit drinking alcohol for a year after getting this drug.
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This drug may be passed to others through body fluids for up to 6 months after your infusion. This happens mostly through urine and stools, but sometimes through saliva, mucus, and semen. Talk with your doctor about how to avoid spreading this drug to others. Be sure to wash your hands well and dispose of anything that comes into contact with body fluids as you have been told.
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Male
No
Do not donate sperm for 6 months after you get this drug.
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Male
No
Use a condom during sex or do not have sex for 6 months after you get this drug.
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No
There is a chance this drug may cause liver cancer. No cases of liver cancer have been seen with this drug. Talk with your doctor if you have liver problems or you have been told you have a risk for liver cancer. Talk with your doctor if you are an older adult or you drink alcohol on a regular basis.
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Female
No
This drug is not approved for use in females. If you are a female using this drug, talk with your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding.
What are some side effects that I need to call my doctor about right away?
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WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
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Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
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No
Signs of liver problems like dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
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Infusion reactions have happened. You will be watched while you get this drug and for at least 3 hours after you get it. Tell your doctor right away if you have fever, chills, headache, abnormal heartbeat, upset stomach, throwing up, signs of low blood pressure like dizziness or passing out, or other effects.
What are some other side effects of this drug?
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All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.
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These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
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You may report side effects to your national health agency.
How is this drug best taken?
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Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
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It is given as an infusion into a vein over a period of time.
What do I do if I miss a dose?
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Call your doctor to find out what to do.
How do I store and/or throw out this drug?
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This injection will be given to you in a healthcare setting. You will not store it at home.
General drug facts
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If your symptoms or health problems do not get better or if they become worse, call your doctor.
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Do not share your drugs with others and do not take anyone else's drugs.
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Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
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Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
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US
No
Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
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If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Last Reviewed Date2024-05-03
Consumer Information Use and Disclaimer
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This generalized information is a limited summary of diagnosis, treatment, and/or medication information. It is not meant to be comprehensive and should be used as a tool to help the user understand and/or assess potential diagnostic and treatment options. It does NOT include all information about conditions, treatments, medications, side effects, or risks that may apply to a specific patient. It is not intended to be medical advice or a substitute for the medical advice, diagnosis, or treatment of a health care provider based on the health care provider's examination and assessment of a patient's specific and unique circumstances. Patients must speak with a health care provider for complete information about their health, medical questions, and treatment options, including any risks or benefits regarding use of medications. This information does not endorse any treatments or medications as safe, effective, or approved for treating a specific patient. UpToDate, Inc. and its affiliates disclaim any warranty or liability relating to this information or the use thereof. The use of this information is governed by the Terms of Use, available at https://www.wolterskluwer.com/en/know/clinical-effectiveness-terms.
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Topic 144948 Version 5.0