Vimizim 5 mg/5 mL (1 mg/mL) intravenous solution

Generic name:
Elosulfase alfa - injection

Pronunciation
(EL-oh-SUL-fase AL-fa)

Brand name(s)
Vimizim

Elosulfase alfa may rarely cause serious (sometimes fatal) allergic reactions during the infusion of this drug. A health care professional will monitor you closely during and after your infusion. Your doctor may prescribe other medications (such as antihistamines) to help prevent these side effects. Get medical help right away if you have any symptoms of a serious allergic reaction such as cough, chest pain, bluish fingers/toes/lips, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, or shortness of breath. Your doctor may give you other medications to help with these side effects or may slow down or stop your treatment for some time.

Before you start your infusion, tell your doctor if you have breathing problems or a fever. Breathing problems may get worse during the infusion. Your doctor may delay your infusion or monitor you for longer periods after your infusion.

Elosulfase alfa is used to treat a certain inherited condition (mucopolysaccharidosis type IVA-Morquio A syndrome) that causes a buildup of certain substances (glycosaminoglycans-GAGs) in the body. Elosulfase alfa works by breaking down GAGs in the body.

Read the Patient Information Leaflet if available from your pharmacist before you start using elosulfase alfa and each time you get an infusion. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into a vein by a health care professional. It is given as directed by your doctor, usually once a week. The dosage and treatment schedule are based on your medical condition, weight, and response to treatment.

Infusion reactions may happen during the infusion of this drug. Your doctor may prescribe other medications before each treatment to help prevent these side effects. Tell your doctor right away if you have any symptoms of infusion reactions such as headache, abdominal pain, flushing, fever, chills, tiredness, nausea, or vomiting. Your doctor may give you other medications to help with these side effects or may slow down or stop your treatment for some time. See also Warning section.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

Tell your doctor if your condition gets worse.

See also Warning and How to Use sections.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before using elosulfase alfa, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Keep all medical and lab appointments.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a hospital or clinic or doctor's office and will not be stored at home.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.