Tividenofusp Alfa (Intravenous)
Tividenofusp alfa is used to treat the nerve and brain problems of Hunter syndrome in children before symptoms start, or in children with symptoms who weigh at least 11 pounds.
Tividenofusp alfa may also be used for purposes not listed in this medication guide.
warnings
What is the most important information I should know about Tividenofusp Alfa (Intravenous)?
Tell your doctor if you have or have ever had:
- a severe allergic reaction;
- anemia;
- heart or lung problems;
- any other enzyme replacement therapy for Hunter syndrome; or
- kidney problems.
It is not known if tividenofusp alfa will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Tell your doctor if you are breastfeeding or plan to breastfeed.
Side Effects
What are the side effects of Tividenofusp Alfa (Intravenous)?
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Some side effects may occur during the infusion or within 24 hours after the infusion. Tell your caregiver right away if you have vomiting, a fast heartbeat, dizziness, fever, chills, flushing, cough, diarrhea, headache, or stomach pain.
Common side effects may include:
- infusion-related reactions such as rash or hives;
- headache;
- infections--symptoms may include fever, runny or stuffy nose, ear pain;
- COVID-19;
- vomiting or diarrhea;
- cough;
- low red blood cells;
- falls; or
- skin scrapes.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Pregnancy & Breastfeeding
Can I take Tividenofusp Alfa (Intravenous) if I’m pregnant or breastfeeding?
It is not known if tividenofusp alfa will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Tell your doctor if you are breastfeeding or plan to breastfeed.
Interactions
What drugs and food should I avoid while taking Tividenofusp Alfa (Intravenous)?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Dosage Guidelines & Tips
How to take Tividenofusp Alfa (Intravenous)?
Use Tividenofusp Alfa (Intravenous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Tividenofusp alfa is given as an infusion into a vein, usually once each week by a healthcare provider. You will receive this medicine in a medical setting.
You will be watched closely during and after the infusion to make sure you do not have serious side effects.
Doses are based on weight. Your dose may change if you gain or lose weight.
You may be given other medications to help prevent serious side effects or allergic reaction. Keep taking these medicines for as long as your doctor has prescribed.
You will need blood tests to check your hemoglobin levels before and during treatment. Your doctor may give you medicine or other support measures if anemia occurs.
Call your doctor for instructions if you miss an appointment for your tividenofusp alfa infusion.
Overdose Signs
What happens if I overdose on Tividenofusp Alfa (Intravenous)?
In a medical setting an overdose would be treated quickly.