What is it?

What is Herozyme^®?

Laronidase, as the active ingredient of this drug, is a synthetic enzyme that can replace the body's natural enzyme in patients with mucopolysaccharidosis type 1 (MPS 1). One mL of the concentrated solution in the vial contains 100 units (U) of laronidase for Intravenous (IV) infusion. Each vial of 5 mL contains 500 U of laronidase.

How does Herozyme^® work?

Laronidase is a recombinant form of alpha-L-iduronidase. A deficiency or lack of alpha-L-iduronidase leads to an accumulation of Glycosaminoglycans (GAGs), causing cellular, tissue, and organ dysfunction. Replacing this enzyme with laronidase leads to the improvement of pulmonary function and walking capacity.

Indications

What Herozyme^®  is used for?

Mucopolysaccharidosis type 1 (MPS 1): Herozyme® is used to treat the non-neurological manifestations of patients with MPS 1 disease.People with MPS I disease have either a low level or no level of an enzyme called α-L-iduronidase which breaks down Glycosaminoglycans (GAGs) in the body. As a result, these substances are not broken down and processed by the body as they should. They accumulate in many tissues in the body, which causes the symptoms of MPS 1.

Contraindications

You should not be given Herozyme®

if you are allergic (hypersensitive) to laronidase or any of the other ingredients of this medicine (sodium chloride, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, polysorbate 80, water for injections).

Important information

What you need to know before you are given Herozyme®

• Talk to your doctor about concomitant disease and other medications you are taking.
• If you experience any infusion-associated reactions, you should contact your doctor immediately. Severe systemic allergic reaction (anaphylactic reaction) has been observed in patients during or up to after the end of the infusion day. Some of the symptoms of such a severe allergic reaction are life-threatening and include extreme difficulty breathing, swelling of the throat, low blood pressure, and low oxygen level in the body. When you experience such a reaction, you should immediately contact your doctor. In this case, Herozyme® infusion should be stopped immediately, and appropriate treatment will be started by your doctor. You may be given additional medication to help prevent allergic-type reactions.

What you need to know when you are taking Herozyme®

This medicine contains 23 mg (1.29 mmol) sodium per vial. To be taken into consideration by patients on a controlled sodium diet. Other medicines and Herozyme®

Inform your doctor if you are using medicines containing chloroquine or procaine, due to a possible risk of decreasing the action of Herozyme®.Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including over the counter medications, herbal medications etc.

Pregnancy and breast-feeding

• There is not enough experience of the use of Herozyme® in pregnant women. You should not be given Aldurazyme during pregnancy unless clearly necessary by your doctor.
• It is not known whether Herozyme®appears in breast milk. It is recommended to stop breast-feeding during treatment with Herozyme®.
• No information is available on the effects of Herozyme® on fertility
• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

The effects on the ability to drive and use machines have not been studied.

If you miss an infusion of Herozyme®

If you have missed a Herozyme® infusion, please contact your doctor.

How to Use?

How Herozyme^® is given

Herozyme® is for IV infusion and the concentrate for solution for infusion has to be diluted with sodium chloride 9 mg/mL (0.9%) solution for infusion before use. Administration of Herozyme® should be carried out in an appropriate clinical setting where resuscitation equipment to manage medical emergencies would be readily available.

Side Effects

What are the side effects of Herozyme®

• Like all medicines, this medicine can cause side effects, although not everybody gets them.

• Important side effects may be mainly seen while patients were being given the medicine or shortly after (infusion-associated reactions), include severe systemic allergic reaction (anaphylactic reaction), bronchospasm (airway constriction), respiratory arrest, and swelling of the face.
• common symptoms which were not serious include headache, nausea, abdominal pain, rash, joint disease, joint pain, back pain, pain in arms or legs, flushing, fever, chills, increased heart rate, increased blood pressure, and reaction at the infusion site such as swelling, redness, build-up of fluid, discomfort, itchy rash, pale colour of the skin, discoloured skin, or sensation of being warm.
• Other less common side effects include: increased body temperature, tingling, dizziness, cough, difficulty in breathing, vomiting, diarrhoea, rapid swelling under the skin in areas such as the face, throat, arms and legs which can be life-threatening if throat swelling blocks the airway, hives, itching, hair loss, cold sweat, heavy sweating, muscle pain, paleness, cold hands or feet, feeling hot, feeling cold, fatigue, influenza like illness, restlessness and pain at injection site.

A few patients who had a prior history of severe mucopolysaccharidosis I (MPS I) related to upper airway and pulmonary involvement experienced severe reactions, including bronchospasm (airway constriction), respiratory arrest, and swelling of the face. The frequency of bronchospasm and respiratory arrest is unknown.

• To get more information about side effects, refer to the product leaflet.

Storage

How to store Herozyme^®

• Keep this medicine out of the sight and reach of children.

• The diluted solution should be used immediately.

• Each vial is for single use only.

• Do not store any unused portion of the infusion solution for reuse

• Store Unopened vials in a refrigerator (2-8°C).Do not Freeze.

• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw

away medicines you no longer use. These measures will help protect the environment.

• You should not be given this medicine after the expiration date which is stated on the label after the letter EXP.

FAQs