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Details for: ELELYSO

Company: PFIZER CANADA ULC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02425637ELELYSOTALIGLUCERASE ALFA200 UNIT / VIALPOWDER FOR SOLUTIONINTRAVENOUS
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Summary Reports

Summary Basis of Decision

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

ELELYSO is an enzyme replacement therapy for pediatric and adult patients with Gaucher disease.

What it does

Gaucher disease is a genetic disorder caused by a missing or defective enzyme name glucocerebrosidase. When this enzyme is missing or does not work properly, a substance called glucocerebroside builds up inside cells in the body. The build-up of this substance causes the signs and symptoms found in Gaucher disease.

Signs of the disease are one or more of the following:

  • Spleen or liver enlargement
  • A low number of red blood cells (anaemia)
  • A tendency to bleed easily caused by a low blood platelet count
  • Bone disease
When it should not be used

Do not use ELELYSO if you are allergic to taliglucerase alfa or to any ingredient in the formulation or component of the container.

What the medicinal ingredient is

Taliglucerase alfa

What the non-medicinal ingredients are

Citric acid anhydrous, Mannitol, Polysorbate 80, Sodium citrate.

What dosage form it comes in

ELELYSO 200 units is presented as a powder for solution for infusion. ELELYSO is supplied in a 13.5mL vial.

Warnings and precautions

BEFORE you use ELELYSO talk to your doctor or pharmacist if:

  • You have previously experienced an adverse reaction related to the infusion or allergic reaction with another enzyme replacement therapy for Gaucher disease
  • You have allergies to this drug or its ingredients or components of the container; or if you are allergic to carrots
  • You are pregnant or plan to become pregnant or are breast-feeding
Interactions with this medication

No interaction studies have been performed. Please inform your doctor if you are using any other medicinal products.

Proper use of this medication

Usual Dose

Dosage is individualized for each patient. ELELYSO is only used under the supervision of a health care professional. If you are tolerating your infusions well in the clinic, your doctor may suggest that the infusion be administered at home by a health care professional.

The initial doses of ELELYSO range from 30 units/kg to 60 units/kg of body weight.

ELELYSO is given once every two weeks.

Overdose

There is no experience with overdose of taliglucerase alfa with doses over 78 units/kg.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

If you have missed an ELELYSO infusion, please contact your doctor.

Side effects and what to do about them

Like all medicines, ELELYSO can cause side effects, although not everybody gets them.

Most side effects are mild to moderate and generally are associated with the infusion however side effects may be serious and may need treatment.

Very common side effect (these are likely to affect more than 10 in every 100 people):

  • Headache
  • Abdominal pain
  • Pain in extremity, Joint pain
  • Fatigue
  • Vomiting
  • Back pain
  • Itching

Common side effects (these are likely to affect between 1 and 10 in every 100 people):

  • Allergic reactions
  • Dizziness
  • Flushing
  • Throat irritation
  • Nausea
  • Redness
  • Rash
  • Bone pain
  • Infusion related reaction
  • Infusion site pain
  • Swelling
  • Weight increase
    If you experience any of these symptoms, please tell your doctor immediately.

The most serious adverse reactions seen were allergic reactions. If you have an allergic reaction following administration of ELELYSO, contact your doctor immediately. If a severe allergic reaction occurs, immediately discontinue ELELYSO. If you experience an allergic reaction your doctor or nurse may continue treatment by slowing the infusion rate and/or giving you medicines such as antihistamines, antipyretics or corticosteroids. Pretreatment with antihistamines and/or corticosteroids may prevent subsequent reactions.

How to store

Keep out of reach and sight of children.

Unopened vial: store under refrigeration (2°-8°C). Keep the vial in the outer carton in order to protect from light. Do not use after the expiry date printed on the label.

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 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • By completing a Consumer Side Effect Reporting Form and sending it by:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
      Health Canada, Postal Locator 1908C
      Ottawa, ON
      K1A 0K9
      • Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect..

NOTE: Contact your health professional if you need information about how to manage your side effects. 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: http://www.Pfizer.ca or by contacting the sponsor, Pfizer Canada Inc., at: 1-800-463-6001

This leaflet was prepared by Pfizer Canada Inc.

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