Description
Fidanacogene elaparvovec-dzkt injection is used to treat moderate to severe hemophilia B (congenital Factor IX deficiency) in patients who are using Factor IX treatment, have current or history of life-threatening bleeding, have repeated serious bleeding episodes, or who do not have antibodies to adeno-associated virus serotype Rh74var (AAVRh74var) capsid.
This medicine is to be given only by or under the supervision of your doctor.
This product is available in the following dosage forms:
- Suspension
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of fidanacogene elaparvovec-dzkt injection in children. Safety and efficacy have not been established.
Geriatric
Appropriate studies on the relationship of age to the effects of fidanacogene elaparvovec-dzkt injection have not been performed in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Bacillus of Calmette and Guerin Vaccine, Live
- Cholera Vaccine, Live
- Dengue Tetravalent Vaccine, Live
- Ebola Zaire Vaccine, Live
- Influenza Virus Vaccine, Live
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Poliovirus Vaccine, Live
- Rotavirus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Monkeypox Vaccine, Live Non-Replicating
- Smallpox Vaccine
- Typhoid Vaccine, Live
- Varicella Virus Vaccine, Live
- Yellow Fever Vaccine
- Zoster Vaccine, Live
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Cancer or
- Liver disease (eg, hepatitis B or C, non-alcoholic fatty liver disease, chronic alcohol consumption, and non-alcoholic steatohepatitis)—Use with caution. May make these conditions worse.
Proper Use
A doctor or other trained health professional will give you this medicine. It is given through an IV catheter that is placed into one of your veins. It must be given slowly, so the IV will have to remain in place for at least 60 minutes.
Precautions
It is very important that your doctor check your progress 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.
Check with your doctor right away if you have clay-colored stools, 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 (eg, liver cancer).
This medicine may cause infusion reactions. Check with your doctor right away if you have dizziness, fever or chills, facial swelling, headache, nausea or vomiting, skin rash, 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 this medicine.
Male patients should not donate sperm and must use an effective form of birth control 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.
Side Effects
Along with its needed effects, a medicine 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:
Incidence not known
- Blurred vision
- chest tightness
- clay-colored stools
- confusion
- cough
- dark urine
- decreased or loss of appetite
- difficulty swallowing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast, irregular, pounding, or racing heartbeat or pulse
- fever or chills
- headache
- hives, itching, skin rash
- nausea or vomiting
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- stomach pain or tenderness
- sweating
- swelling of the feet or lower legs
- trouble breathing
- unusual tiredness or weakness
- yellow eyes or skin
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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