Velaglucerase alfa

Velaglucerase alfa is a prescription medication used to treat type 1 Gaucher disease. Gaucher disease is a condition in which people do not have enough of an enzyme called glucocerebrosidase, which helps break down certain kinds of fats. Velaglucerase belongs to a group of drugs called enzyme replacement therapy (ERT) agents. Velaglucerase alfa works by replacing the enzyme glucocerebrosidase.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects of velaglucerase alfa include a reaction at the site of injection, headache, and fever.

Velaglucerase alfa can also cause dizziness. Do not drive or operate heavy machinery until you know how velaglucerase alfa affects you.

Velaglucerase alfa is a prescription medication used to treat type 1 Gaucher disease. Gaucher disease is a condition in which people do not have enough of an enzyme called glucocerebrosidase, which helps break down certain kinds of fats. Velaglucerase alfa belongs to a group of drugs called enzyme replacement therapy (ERT) agents. Velaglucerase alfa works by replacing the enzyme glucocerebrosidase.

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

Velaglucerase alfa may be found in some form under the following brand names:

• Vpriv

Serious side effects have been reported with velaglucerase alfa. See the “Velaglucerase alfa Precautions” section.

Common side effects of velaglucerase alfa include the following:

• reaction at site of injection
• headache
• fever
• dizzines
• stomach pain
• upper airway infection
• back pain
• joint pain

This is not a complete list of velaglucerase alfa side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

No drug interactions have been reported by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with velaglucerase alfa including the following:

• hypersensitivity reactions, including anaphylaxis

Do not take velaglucerase alfa if you:

• are allergic to velaglucerase alfa or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of velaglucerase alfa, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking velaglucerase alfa, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to velaglucerase alfa or to any of its ingredients
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Velaglucerase alfa falls into category B. There are no well-done studies that have been done in humans with Vpriv. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if velaglucerase alfa crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using velaglucerase alfa.

Take velaglucerase alfa exactly as prescribed.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take 2 doses of velaglucerase alfa at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• your weight
• how you respond to this medication

The recommended dose of velaglucerase alfa is 60 units/kg every other week. It is administered as an infusion over 60 minutes.

If you take too much velaglucerase alfa, call your healthcare provider or local Poison Control Center or seek emergency medical attention right away.

If velaglucerase alfa is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Keep this and all medications out of the reach of children.