Details for: ALDURAZYME
Company: SANOFI GENZYME, A DIVISION OF SANOFI-AVENTIS CANADA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02254506 | ALDURAZYME | LARONIDASE | 0.58 MG / ML | SOLUTION | INTRAVENOUS |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Aldurazyme® (laronidase) is used to treat the non-central nervous system manifestations of Mucopolysaccharidosis I (MPS I; α-Liduronidase deficiency) in patients with a confirmed diagnosis of this disease
What it does
Patients with MPS I are deficient in the enzyme α -L-iduronidase. Laronidase is a form of α-L-iduronidase produced by recombinant DNA technology. Laronidase can help to treat some of the symptoms of MPS I by replacing the deficient enzyme
When it should not be used
Do not use Aldurazyme® if you are allergic to laronidase or to any ingredient of Aldurazyme® or component of the container.
What the medicinal ingredient is
Laronidase
What the non-medicinal ingredients are
Polysorbate 80, Sodium chloride, Sodium phosphate monobasic
monohydrate, Sodium phosphate dibasic heptahydrate, Water for
Injection
For a full listing of nonmedicinal ingredients see Part 1 of the
product monograph.
What dosage form it comes in
Aldurazyme® is supplied as a sterile concentrate for solution to be used as intravenous infusion.
Warnings and precautions
Do not use Aldurazyme® if you are severely allergic to any ingredients of Aldurazyme® or if you have experienced a severe allergic or anaphylactic reaction to laronidase.
If you are treated with Aldurazyme® you may experience an infusion related reaction. Infusion related reaction is defined as any related side effect occurring during the infusion or during the 3 hours following infusion. Life-threatening infusion related reactions including anaphylactic reactions have been observed in some patients during Aldurazyme® infusions. Reactions have included: inability to breath independently, difficulty breathing, noisy breathing, fast breathing, temporary narrowing of the airway, partial or complete blockage of the airway, low levels of oxygen in the blood, low blood pressure, slow heartrate, and hives. Interventions have included: life saving emergency medical treatment, the use of a machine to help with breathing,, emergency access to the patient’s windpipe, and hospitalization. Other treatment may include inhaled beta-adrenergic agonists to help with breathing, epinephrine as part of emergency care and intravenous corticosteroids to help fight inflammation. In clinical trials and post-marketing experience with Aldurazyme® ,approximately 1% of patients experienced severe or serious allergic reactions. In patients with MPS I, pre-existing upper airway obstruction may have contributed to the severity of some reactions. Because of the potential for severe infusion reactions, appropriate medical support should be readily available when Aldurazyme® is administered. Because of the potential for recurrent severe reactions, some patients may require additional observation.
Patients with an acute underlying illness (e.g. cold or flu, severe infections, bronchitis, wheezing/difficulty in breathing) at the time of Aldurazyme® infusion may be at risk for infusion-related reactions. Careful consideration should be given to your clinical status prior to administration of Aldurazyme®.
BEFORE you use Aldurazyme®, talk to your doctor or pharmacist if:
- If you have an acute underlying illness such as cold or flu
- If you have had a severe allergic or anaphylactic reaction to administration of Aldurazyme®
- Any allergies to this drug or its ingredients or components of the container
- If you are pregnant or plan to become pregnant or are breast-feeding
Interactions with this medication
Drugs that may interact with Aldurazyme® include:
No formal drug/drug interaction studies have been conducted. Please inform your doctor if you use medicinal products containing chloroquine or procaine due to the possible risk they may decrease the action of Aldurazyme®.
Proper use of this medication
Usual Dose
The recommended dosage regimen of Aldurazyme® is 0.58 mg/kg body weight administered once weekly as an intravenous infusion.
Aldurazyme® treatment should be supervised by a physician experienced in the management of patients with MPS I or other inherited metabolic diseases.
Administration of Aldurazyme® should be carried out in an appropriate clinical setting where resuscitation equipment to manage medical emergencies would be readily available.
Overdose
There is no experience with overdoses of Aldurazyme®.
Missed Dose
If you have missed an Aldurazyme® infusion, please contact your doctor.
Side effects and what to do about them
Like all medicines, Aldurazyme® can have side effects.
Side effects were mainly seen while patients were being given the medicine or shortly after (infusion-related reactions). The number of these reactions decreased the longer the patients were on Aldurazyme® . Most side effects seen in the clinical studies were thought to be not related to Aldurazyme. The majority of these reactions were of mild to moderate intensity.
In clinical trials, the most common infusion associated reactions in patients 6 years and older were flushing, headache, rash, fever, stomach pain, and problems where the catheter was placed to give the drug. One life threatening allergic reaction occurred resulting in swelling and blockage of the trachea (breathing airway) which required treatment with a breathing tube placed through the neck. One event of an abnormal heart rhythm thought to be unrelated to Aldurazyme resulted in a patient death. The most common infusion associated reactions in patients less than 5 years of age were fever and chills. In an early clinical study, three patients had episodes of swelling of their mouth and breathing passage (see table below).
In post-marketing experience with Aldurazyme® , severe and serious infusion-related reactions have been reported, some of which were life threatening. The most frequently reported side effects included chills, vomiting, nausea, joint pain, diarrhea, fast heart rate, abdominal pain, blood pressure increased, and oxygen saturation decreased. Additional adverse reactions identified in the post marketing setting also include difficulty breathing, bluish color of the skin (due to lower levels of oxygen in blood), feeling cold, redness of skin, swelling of larynx (voice box), and feeling tingling. There have been a small number of reports of leakage of IV drug from the injection site into the surrounding area under the skin. However, there have been no reports that this leakage has caused severe damage to this area under the skin near the injection site.
If you exhibit such a reaction following the administration of Aldurazyme®, you should immediately contact your doctor. You may be given additional medication such as antihistamines and paracetamol to help prevent allergic-type reactions.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist | ||
|---|---|---|---|
| 45 Patients 6 years and older treated for up to 12 months | |||
| 45 Patients 6 years and older treated for up to 12 months | Flushing, joint disease, infusion reactions | ✔ | |
| Common (occurred in <10% of patients) | Back pain, headache, joint pain, rash, feeling hot or feeling cold, abdominal pain, severe allergic reaction with airway obstruction, swelling of the mouth and breathing passage | ✔ | |
| 45 patients 6 years and older treated up to 208 weeks (48 months) | |||
| Very Common (occurred in ≥ to 10%) | Fever, flushing, rash, infusion reactions | ✔ | |
| Common (occurred in <10% of patients) | Diarrhea, difficulty breathing, feeling a change in temperature, headache, hernia, low blood pressure, nausea, problems where the catheter was placed to give the drug, problems with lungs, problems with a vein, severe allergic reaction, stomach pain, vomiting, back pain, sleep apnea, problems accessing a vein | ✔ | |
| Uncommon | Anaphylaxis (lifethreatening allergic reaction). abnormal heart rhythm resulting in death | ✔ | |
| 20 Patients younger than 5 years treated for up to 12 months | |||
| Very Common (occurred in > 10% of patients) | Fever, chills, fast heart rate, increased blood pressure, decreased oxygen in the blood, infusion reactions | ✔ | |
| Common (occurred in <10% of patients) | Heart rate increased, respiratory distress, wheezing, itching, rash | ✔ | |
This is not a complete list of side effects. For any unexpected effects while taking Aldurazyme®, contact your doctor or pharmacist.
How to store
Keep out of reach and sight of children. Store under refrigeration at 2°C to 8°C (36°F to 46°F). Do not use after the expiration date on the vial. This product contains no preservatives.
MPS I Registry:
A registry for MPS I patients has been established in order to better understand the variability and progression of MPS I disease, and to continue to monitor and evaluate treatments. You are encouraged to participate. Your participation, or your child’s participation, may involve long-term follow-up. Information regarding the registry program may be found at www.MPSIregistry.com or by calling (800) 745-4447. If you are interested in participating, please contact your doctor. You can only participate in the Registry through your doctor
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for health professionals can be found at:
www.genzyme.ca
or by contacting the sponsor, Genzyme Canada, a division of sanofi-aventis Canada Inc., at: 1-877-220-8918
This leaflet was prepared by Genzyme Canada, a division of sanofi-aventis Canada Inc.
Date of Revision: August 2014
Aldurazyme® is a registered trademark of BioMarin/Genzyme LLC.