Tividenofusp alfa

Tividenofusp alfa is used to treat nerve and brain issues caused by Hunter syndrome in children before symptoms appear, or in children who have symptoms and weigh at least 11 pounds.

Tividenofusp alfa may also be used for reasons not mentioned in this medication guide.

Tividenofusp alfa is given through an infusion into a vein, usually once a week by a healthcare provider. You will receive tividenofusp alfa in a medical setting.

You will be closely monitored during and after the infusion to ensure you do not have serious side effects.

Doses are based on your weight. Your dose may change if you gain or lose weight.

You may receive other medications to help prevent serious side effects or allergic reactions. Continue 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 provide you with medicine or other support if anemia occurs.

Tividenofusp alfa can cause a severe allergic reaction. Tell your caregiver right away if you have wheezing, trouble breathing, hives, vomiting, a fast heartbeat, dizziness, or swelling of your lips or tongue.

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.

Get emergency medical help if you have signs of an allergic reaction: hives, trouble breathing, swelling of your face, lips, tongue, or throat.

Some side effects may happen during the infusion or within 24 hours after the infusion. Tell your caregiver immediately if you have vomiting, a fast heartbeat, dizziness, fever, chills, flushing, cough, diarrhea, headache, or stomach pain.

Common side effects of tividenofusp alfa 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.

Usual Pediatric Dose for Mucopolysaccharidosis Type II:

Weight at least 5 kg: -Week 1 to 4: 3 mg/kg via IV infusion once a week -Week 5 to 8: 7.5 mg/kg via IV infusion once a week-Week 9 and beyond: 15 mg/kg via IV infusion once a weekComments:-Administer each dosage level for at least 4 weeks before escalating to the next dosage level.-Do not escalate the dosage level if the current dosage level is not tolerated.-Limitations of Use: This drug not recommended for use in combination with other enzyme replacement therapies for the treatment of Hunter syndrome.Use: For the treatment of neurologic manifestations of Hunter syndrome (Mucopolysaccharidosis type II, MPS II) when initiated in presymptomatic or symptomatic pediatric patients weighing at least 5 kg prior to advanced neurologic impairment

Call your doctor for instructions if you miss an appointment for your tividenofusp alfa infusion.

In a medical setting, an overdose would be treated right away.

Follow your doctor's instructions about any limits on food, drinks, or activities.

Other drugs may affect tividenofusp alfa, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are using.