Naglazyme

Naglazyme is a prescription medication used to treat Maroteaux-Lamy syndrome (or MPS VI), a rare condition in which patients do not have a certain enzyme that is responsible for getting rid of a waste product in the body called GAG. 

Naglazyme belongs to a group of drugs called enzymes. It works by replacing an enzyme in the body that patients with Maroteaux-Lamy syndrome do not have enough of that helps to break down GAG.

This medication comes in an injectable form to be given directly into a vein (IV) by a healthcare provider. It is given once weekly with infusion time lasting no less than 4 hours.

Common side effects include pain, rash, trouble breathing, and eye infection.

Naglazyme is a prescription medication used to improve walking and stair-climbing ability in patients with Maroteaux-Lamy syndrome (or MPS VI), a rare condition in which patients do not have a certain enzyme that is responsible for getting rid of a waste product in the body called GAG. When GAG builds up in cells, it is harmful and can damage many organs. 

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

• Biomarin Pharmaceutical. Inc.

Serious side effects have been reported with Naglazyme. See the “Naglazyme Precautions” section.

Common side effects of Naglazyme including the following:

• rash
• hives
• fever
• itching
• chills
• headache
• nausea
• vomiting
• stomach pain
• ear pain
• joint pain
• chest pain
• difficulty breathing
• eye infection
• nasal congestion
• high blood pressure

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

No drug interactions have been evaluated 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 Naglazyme including the following:

Anaphylaxis and allergic reactions. Severe allergic reactions can occur during Naglazyme infusions and up to 24 hours after infusion. Your doctor may give you certain medications before receiving Naglazyme to help prevent these reactions. Tell your healthcare provider about any signs or symptoms of hypersensitivity, which include the following:

• chest pain
• swelling of the face, eyes, lips, tongue, arms, or legs
• difficulty breathing or swallowing
• rash

Immune-mediated reactions. Serious reactions can occur based on how your immune system responds to Naglazyme. Your doctor should monitor you for any reactions.

Acute cardiorespiratory failure. Patients with underlying heart or lung/breathing problems may have an acute worsening of their condition when they receive Naglazyme. Tell your doctor about any conditions you have that affect your heart, lung,s or make it difficult for you to breathe, or if you are currently sick.

Infusion reactions. Infusion reactions can occur with this medication. Tell your doctor or get medical help right away if you get any of these symptoms during or after an infusion this medication:

• hives (red itchy welts) or rash
• itching
• swelling of your lips, tongue, throat or face
• sudden cough
• shortness of breath, difficulty breathing, or wheezing
• weakness
• dizziness or feel faint
• palpitations (feel like your heart is racing or fluttering)

Spinal or cervical cord compression. Spinal cord damage may occur due to the natural disease process of MPS VI. Some patients experienced worsening or new onset spinal cord compression while taking Naglazyme. Tell your doctor immediately if you experience any of the following symptoms:

• back pain
• loss of bladder control
• loss of bowel control
• numbness
• paralysis

Do not take Naglazyme if you are allergic to Naglazyme 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 Naglazyme, there are no specific foods that you must exclude from your diet when receiving this medication.

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

• are allergic to Nagalazyme or to any of its ingredients
• have heart problems
• have lung problems
• have breathing problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

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.

Naglazyme falls into category B. There are no well-done studies that have been done in humans with Naglazyme. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication. Naglazyme should be used during pregnancy only if clearly needed.

A program has been created to monitor the long-term effects of Naglazyme, as well as the effects in pregnant and breast-feeding women. For more information, contact your doctor or call the MPS VI Clinical Surveillance Program at 800-983-4587.

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

Naglazyme comes as an injectable form to be given directly into a vein (IV) by a healthcare professional. It is given once a week as an intravenous (IV) infusion.

Your doctor may give you certain medications 30-60 minutes before the infusion to help prevent any reactions.

The infusion is given over a minimum of 4 hours, but may be given over a period of up to 20 hours if you have experienced an infusion reaction.

If you miss an appointment to receive a dose of Naglazyme, contact your healthcare provider to make plans to receive your next infusion.

The dose your doctor recommends is based on your weight.

The recommended dose of Naglazyme is 1 mg per kg of body weight given once weekly as an intravenous (IV) infusion.

If Naglazyme 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 all appointments with your doctor and laboratory.

• A program has been created to monitor the long-term effects of Naglazyme, as well as the effects in pregnant and breast-feeding women. For more information, contact your doctor or call the MPS VI Clinical Surveillance Program at 800-983-4587.