Velmanase alfa

Velmanase alfa has been associated with hypersensitivity (severe allergic) reactions, including anaphylaxis, during and after infusions. Your doctor or nurse will monitor you very closely during your infusion. If you experience any of the following symptoms after receiving velmanase alfa, you should seek emergency medical care: bluish coloring of the skin, vomiting, itching, redness, swelling of the face, fever, tremor, chills, cough, rash, or eye irritation. Your doctor may given you medicines prior to each infusion to reduce the chance of these events occurring.

Velmanase alfa is used to treat certain symptoms associated with alpha-mannosidosis (a genetic condition where the body is unable to break down complex sugars). Velmanase alfa is in a class of medications called recombinant lysosomal enzymes. It works by breaking down mannose-containing oligosaccharides, a complex sugar, that can build up in people with alpha-mannosidosis and cause toxicity to many of the body's tissues.

Velmanase alfa comes as a powder to be mixed with water and administered intravenously (into the vein) by a doctor or a nurse at a healthcare facility. It is usually given every week.

Velmanase alfa controls symptoms associated with alpha-mannosidosis but does not cure it. Continue to show up for your scheduled infusion appointments unless your doctor tells you not to.

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 velmanase alfa,

• tell your doctor and pharmacist if you are allergic to velmanase alfa, any other medications, or any of the ingredients in velmanase alfa injection. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking velmanase alfa. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you are pregnant or plan to become pregnant. You will need to have a negative pregnancy test before you start receiving velmanase alfa. If you are a female, you should not become pregnant while you are receiving velmanase alfa and for 14 days after your final dose. Talk to your doctor about birth control methods that will work for you. If you become pregnant while receiving velmanase alfa, call your doctor immediately. Velmanase alfa may harm the fetus. Talk to your doctor before breastfeeding while receiving velmanase alfa.

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

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

• runny nose, congestion, sneezing
• fever
• headache
• joint pain

Velmanase alfa 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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

If you miss an infusion appointment for velmanase alfa, call and reschedule right away. If it is within 3 days of the next scheduled dose, just restart with that dose.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Lamzede^®