elosulfase alfa

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Pronunciation: EE loe SUL face AL fa

Brand: Vimizim

What is the most important information I should know about elosulfase alfa?

A serious allergic reaction may occur during the elosulfase alfa infusion, or up to several days afterward. Tell your caregiver right away if you feel dizzy, itchy, nauseated, light-headed, or if you have chest pain, tightness in your throat, pale skin, blue lips, diarrhea, or vomiting.

You may be more likely to have a reaction to elosulfase alfa if you have a breathing disorder, or if you are sick with a fever at the time of your infusion.

Your breathing, blood pressure, and other vital signs will be watched closely during and after the infusion, so your caregivers can quickly treat any serious side effects that occur.

What is elosulfase alfa?

Elosulfase alfa contains an enzyme that occurs naturally in the body in healthy people. Some people lack this enzyme because of a genetic disorder. Elosulfase alfa helps replace this missing enzyme in such people.

Elosulfase alfa is used to treat some of the symptoms of a genetic condition called mucopolysaccharidosis (MYOO-koe-pol-ee-SAK-a-rye-DOE-sis) IV (4) type A, or MPS IV A, also called Morquio A syndrome.

MPS IVA is a metabolic disorder in which the body lacks the enzyme needed to break down certain natural substances. These substances can build up in the body, causing enlarged organs, abnormal bone structure, changes in facial features, breathing problems, heart problems, vision or hearing loss, and changes in mental or physical abilities.

Elosulfase alfa may improve walking and stair-climbing ability in people with this condition. However, this medication is not a cure for MPS IVA.

Elosulfase alfa may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving elosulfase alfa?

You should not receive this medicine if you are allergic to elosulfase alfa.

To make sure this medicine is safe for you, tell your doctor if you have:

  • asthma or any other lung problems;
  • sleep apnea (breathing stops during sleep); or
  • any current illness, especially if you have a fever.

Your name may need to be listed on a Morquio A Registry while you are using this medicine. The purpose of this registry is to track the progression of this disorder and the effects that elosulfase alfa has on long-term treatment of Morquio A syndrome.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether elosulfase alfa passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How is elosulfase alfa given?

Elosulfase alfa is injected into a vein through an IV. You will most likely receive this injection in a clinic or hospital setting.

Elosulfase alfa must be given slowly through an IV infusion, and can take up to 4 hours or longer to complete.

Elosulfase alfa is usually given once per week. Follow your doctor's instructions.

If a child is using this medicine, tell your doctor if the child has any changes in weight. Elosulfase alfa doses are based on body weight.

About 30 to 60 minutes before each injection, you will be given other medications to help prevent a serious allergic reaction.

Your doctor will need to check your progress while you are using elosulfase alfa.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your elosulfase alfa injection.

What happens if I overdose?

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving elosulfase alfa?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of elosulfase alfa?

Some side effects may occur during the elosulfase alfa infusion, or up to several days afterward. Tell your caregiver right away if you feel dizzy, itchy, nauseated, light-headed, or if you have chest pain, tightness in your throat, pale skin, blue lips, diarrhea, or vomiting.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; cough, difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

It may still be possible for you to receive elosulfase alfa even after you have had a reaction to it. There are other medications that can be given to you before your elosulfase alfa infusion to help prevent symptoms of a reaction.

Common side effects of elosulfase alfa may include:

  • nausea, vomiting, stomach pain;
  • headache;
  • fever, chills;
  • tired feeling.

Even though it may not be a side effect of elosulfase alfa, increased pressure on the spinal cord is a complication of MPS IVA that may occur while you are using this medicine. Tell your doctor right away if you have any symptoms of spinal cord compression:

  • back pain;
  • loss of movement in any part of your body; or
  • loss of bowel or bladder control.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect elosulfase alfa?

Other drugs may interact with elosulfase alfa, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

Your doctor or pharmacist can provide more information about elosulfase alfa.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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