Tividenofusp alfa-eknm Injection

Tividenofusp alfa-eknm injection may cause serious or life-threatening allergic or infusion-related reactions during or soon after the infusion. These reactions may also occur at any time during your treatment. You will be watched closely during and shortly after your infusion to be sure you are not having a serious reaction. Your doctor may give you certain medications before you receive tividenofusp alfa-eknm injection to help to prevent a reaction. If you experience any of the following symptoms, tell your doctor immediately or get emergency medical treatment: difficulty swallowing or breathing; shortness of breath; wheezing; hoarseness; swelling of the face, throat, tongue or lips; hives; flushing; redness of the skin; bumps on the skin; rash; itching; fainting; dizziness; fast heartbeat; tightness of the throat or chest; vomiting; stomach pain; diarrhea; cough; irritablity; headache; fever; chills. Your doctor may need to slow down your infusion or delay or permanently stop your treatment if you experience these side effects.

Tividenofusp alfa-eknm Injection is used to treat Hunter syndrome (MPS II; an inherited condition in which certain sugars build up in the body, resulting in brain and organ damage). Tividenofusp alfa-eknm is in a class of medications called enzymes. It works by replacing an enzyme that is normally produced by the body that helps prevent the build up of the sugars in the body.

Tividenofusp alfa-eknm comes as a powder to be mixed with liquid and injected intravenously (into a vein) by a doctor or a nurse. It is given once a week. Iti s given over at least 4 hours but after time, may be given over 3 hours, if tolerated.

You will receive tividenofusp alfa-eknm injection in a medical facility for at least the first 9 doses. If these doses are tolerated, your doctor may decide that this medication may be given at home under medical supervision.

Your doctor will probably start you on a low dose of tividenofusp alfa-eknm injection and gradually increase your dose, not more than once every 4 weeks.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving tividenofusp alfa-eknm injection,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you have or have ever had anemia or kidney problems.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving tividenofusp alfa-eknm injection, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

If you miss an appointment to receive a dose of tividenofusp alfa-eknm injection, call your doctor right away.

Tividenofusp alfa-eknm injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• stuffy or runny nose, cough, or sore throat
• ear pain or other signs of an ear infection
• constipation
• trouble falling asleep or staying asleep
• skin scrapes or cuts
• bruising
• pain, itching, redness, or swelling at the injection site
• falling

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• pale skin, unusual tiredness or weakness, shortness of breath, or feeling dizzy or faint
• foamy urine; swelling of arms, hands, face, stomach, ankles, feet, or lower legs; decreased appetite; or unexplained weight gain

Tividenofusp alfa-eknm injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to tividenofusp alfa-eknm injection.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

• Avlayah ^®