Details for: VIMIZIM
Company: BIOMARIN INTERNATIONAL LIMITED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02427184 | VIMIZIM | ELOSULFASE ALFA | 1 MG / ML | SOLUTION | INTRAVENOUS |
Summary Reports
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
Vimizim is used to treat patients with MPS IVA (Mucopolysaccharidosis Type IVA, Morquio A Syndrome).
People with MPS IVA do not have enough of an enzyme called N-acetylgalactosamine-6-sulfatase, which breaks down specific substances in the body (for example keratan sulfate). As a result, these substances build-up in many tissues in the body which causes the symptoms of MPS IVA.
What it does
This medicine is an enzyme called elosulfase alfa. It can replace the missing enzyme in MPS IVA patients. Treatment with Vimizim in MPS IVA patients has shown improvement in walking ability and reduction in levels of keratan sulfate in the body.
What the medicinal ingredient is
elosulfase alfa
What the non-medicinal ingredients are
L-arginine hydrochloride, polysorbate 20, sodium acetate trihydrate, sodium phosphate monobasic monohydrate, sorbitol, and water for injection.
What dosage form it comes in
Vimizim is supplied as a concentrated solution for intravenous infusion. One mL of Vimizim contains 1 mg elosulfase alfa. A 5 mL vial contains 5 mg elosulfase alfa.
Warnings and precautions
Serious Warnings and Precautions
- Vimizim may cause severe or life-threatening allergic reactions.
- Tell your doctor or nurse immediately if you experience any of the following symptoms: shortness of breath, coughing, wheezing or trouble breathing, swelling of the face, lips, tongue or other parts of the body, tightness in the throat, chest pain, bluish skin, flushing, rash, itching, or hives.
- Tell your doctor if you have a fever, cough, or cold. These conditions may worsen the symptoms of an allergic reaction.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Vimizim. Talk about any health conditions or problems you may have, including if you:
- Have ever had an allergic reaction to elosulfase alfa or any other ingredients of Vimizim.
- Have a fever, cough, or cold
- Are pregnant or planning to become pregnant.
- Are breast-feeding or planning to breast-feed
Other warnings you should know about:
- Tell your doctor immediately if you have neck or back pain, numb or weak arms or legs, or any bowel or bladder problems. These symptoms may be caused by pressure on your spinal cord, which is a medical emergency.
- Vimizim given to test animals passes into their unborn babies. Vimizim has not been studied in pregnant patients. Vimizim should not be given during pregnancy unless clearly necessary. Female patients who could become pregnant while taking Vimizim should use two forms of effective birth control.
- Vimizim given to test animals passes into their breast milk. It is not known if Vimizim passes into human breast milk. You and your doctor should discuss the risks and benefits of taking Vimizim while breastfeeding.
- In animal studies, Vimizim had no effects on their sperm quality, but it is not known if Vimizim affects human sperm.
Tell your health professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines. Studies to test how Vimizim interacts with other medicines have not been done.
Proper use of this medication
Vimizim is given through a drip into a vein (intravenous infusion). Each infusion takes approximately 4 hours and is supervised by a health professional in case you have a reaction to Vimizim.
Before treating you with Vimizim, your doctor will give you medicine to help prevent allergic reactions. If you have an allergic reaction during your Vimizim treatment, your doctor may slow down or stop the infusion and may give you additional medicines to treat the reaction. You and your doctor will decide whether to continue treatment with Vimizim.
Usual dose
The dose you receive is based on your body weight. The recommended dose regimen is 2 mg/kg body weight given once every week.
Overdose
Vimizim is administered under the supervision of a health professional, who will check that the correct dose has been given and treat any overdose.
Missed Dose
If you have missed a Vimizim treatment, contact your health professional. If you have any other questions about this medicine, ask your health professional or pharmacist.
Side effects and what to do about them
These are not all the possible side effects you may feel when using Vimizim. If you experience any side effects not listed here, contact your health care professional.
Like all medicines, this medicine can cause side effects. Most side effects are mild to moderate and generally are associated with the infusion; however some side effects may be serious and may need treatment. Most side effects happened during the treatment or up to one day later, but some happen up to 6 days later. Side effects may include:
- Headache
- Nausea
- Vomiting (throwing up)
- Fever
- Chills
- Stomach ache
- Diarrhea
- Mouth and throat pain
- Dizziness
- Muscle pain
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Severe allergic reactions (signs and symptoms may include wheezing, shortness of breath, coughing, throat tightness, chest pain, hives, turning red or blue and feeling hot) | ✔ | ✔ | |
| Shortness of breath | ✔ | ||
| Enlarged tonsils (difficulty swallowing or sore throat) | ✔ | ||
| Pressure or swelling on the spinal cord (neck or back pain, numbness in your arms or legs, or any bowel or bladder problems) | ✔ | ✔ | |
| Serious skin infection that may spread to the bloodstream (redness, pain, swelling or blistering of the skin or high fever) | ✔ | ✔ | |
| Weakness or looseness in joints | ✔ |
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
Unopened vials: Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Store in the original package in order to protect from light.
Do not take this medicine after the expiry date which is stated on the vial after EXP. The expiry date refers to the last day of that month.
Keep out of the sight and reach of children
Reporting side effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffect;
- By calling 1-866-234-2345 (toll-free);
- By completing a Patient Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
Health Canada, Postal Locator 0701E
Ottawa, ON
K1A 0K9
Postage paid labels and the Patient Side Effect Reporting Form are available at 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
- Talk to your healthcare professional
- Find the full product monograph that is prepared for health professionals and includes this Patient Medication Information by visiting the Health Canada website; or by calling BioMarin Pharmaceutical (Canada) Inc, at 1-877-597-6744
This leaflet was prepared by BioMarin Pharmaceutical (Canada) Inc.
Last Revised: April 29, 2016