Elosulfase Alfa, Injection

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KEY POINTS

• This medicine is given by IV to treat the symptoms of MPS IV.
• You may get infections more easily when you are taking this medicine.
• Keep all appointments for tests to see how this medicine affects you.
• Some people have had a life-threatening allergic reaction while receiving the medicine or several hours or days later. This medicine may cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: enzyme replacement therapy

Generic and brand names: elosulfase alfa, injection; Vimizim

What is this medicine used for?

This medicine is given by IV infusion (slow drip through a needle into a large vein) to treat the symptoms of Mucopolysaccharidosis type IVA (MPS IV). This treatment is called long-term enzyme replacement therapy.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Lung or breathing problems such as asthma, COPD, or sleep apnea

Also, tell your healthcare provider if you currently have a cold, fever, or infection of any kind.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

This medicine is given by a healthcare provider in a clinic or hospital where you will be monitored closely. It is given as an IV infusion, usually once a week. Keep all your appointments. If you miss an appointment for an infusion, contact your healthcare provider right away to reschedule.

You may be given other medicines before this medicine to help prevent allergic reactions.

What should I watch out for?

Some people have had a life-threatening allergic reaction while receiving the medicine or several hours or days later. Symptoms may include trouble breathing; cough; hives; itching; swelling of your lips, tongue, and throat; throat tightness; flushing or skin color changes; rash; chest pain; fainting or lightheadedness; nausea, stomach pain, and vomiting. Contact your healthcare provider or get medical help right away if you have these symptoms during or after infusions of this medicine.

This medicine will not cure your disease but will help control it. You may need to take this medicine for the rest of your life.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you have received this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); cough; throat tightness; flushing or skin color changes; fainting or lightheadedness; seizures.

Serious (Report these to your healthcare provider right away.): Fast or irregular heartbeat; chest pain; severe nausea, vomiting, or stomach pain; fever, sore throat or any other signs of infection.

Other: Discomfort, burning, and swelling at the spot where infusions are given; slight fever; headache; mild nausea, vomiting, or stomach pain; tiredness.

What products might interact with this medicine?

No significant interactions have been reported.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.