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Details for: MOZOBIL

Company: SANOFI-AVENTIS CANADA INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02377225MOZOBILPLERIXAFOR20 MG / MLSOLUTIONSUBCUTANEOUS
Search Reported Side Effects Report a Side Effect

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

MOZOBIL in combination with granulocyte-colony stimulating factor (G-CSF) is used to help collect blood stem cells for transplantation in

  • Adults with non-Hodgkin’s lymphoma (a cancer of the white blood cells) and multiple myeloma (a cancer that affects plasma cells in the bone marrow).
  • Children and adolescents (1 to less than 18 years of age) with lymphoma or solid cancerous tumors, where following G-CSF treatment:
    • Blood stem cell count is low on the predicted date of collection, or
    • Previous collection has failed to yield enough stem cells
What it does

MOZOBIL contains the active substance plerixafor which blocks a protein on the surface of blood stem cells. This protein “ties” blood stem cells to the bone marrow. Plerixafor improves the release of stem cells into the blood stream (mobilization). The stem cells can then be collected by an apheresis machine, and subsequently frozen and stored until your transplant.

When it should not be used

If you or your child are allergic (hypersensitive) to plerixafor or any of the other ingredients of MOZOBIL (see below for a list of important non-medicinal ingredients).

What the medicinal ingredient is

Plerixafor

What the non-medicinal ingredients are

Sodium chloride (typically less than 6 mg per dose). Other ingredients are hydrochloric acid (concentrated) and sodium hydroxide for pH adjustment and water for injections.

What dosage form it comes in

MOZOBIL is supplied as a clear colorless or pale yellow solution for injection in a glass vial with a non-latex rubber stopper. Each vial contains 1.2 mL solution.

Warnings and precautions

Serious Warnings and Precautions

MOZOBIL will be prescribed and managed by a healthcare professional experienced in oncology and/or hematology.

BEFORE you or your child are given MOZOBIL talk to your doctor or pharmacist if:

  • you or your child have or have had any heart problems.
  • you or your child have kidney problems.
  • you or your child have high white blood cell counts.
  • you or your child have low platelet counts.
  • you or your child have a history of feeling faint or lightheaded on standing or sitting or have fainted following injections.
  • you are pregnant or are planning to become pregnant. Female patients who can get pregnant should use an effective birth control while having treatment with MOZOBIL.
  • you are breast feeding.

Your doctor may perform regular blood tests to monitor your blood cell count.

It is not recommended to use MOZOBIL for stem cell mobilization if you have leukemia (a cancer of the blood or bone marrow).

Driving and using machines
MOZOBIL may cause dizziness and fatigue. Therefore, you should avoid driving if you feel dizzy, tired or unwell.

Interactions with this medication

Before and during treatment with MOZOBIL tell your doctor or pharmacist about your other medicines, including medicines that you bought without a prescription.

Proper use of this medication

You or your child will first receive a treatment with G-CSF once daily for 4 days.

Then MOZOBIL will be given 10 to 11 hours for adults and 8 to 12 hours for children and adolescents before each session of apheresis (a collection of stem cells).

The usual dose of MOZOBIL is 0.24 mg/kg body weight/day given to you as an injection under the skin (subcutaneous injection). For adults who weigh 83 kg or less, your doctor may prescribe a fixed dose of 20 mg of MOZOBIL.

MOZOBIL can be used for up to

  • 4 consecutive days in adults
  • 3 consecutive days in children and adolescents (1 to less than 18 years of age).

Overdose

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.
Side effects and what to do about them

Like all medicines, MOZOBIL can cause side effects. The following are potential side effects with the use of MOZOBIL:

  • Injection site reactions, such as swelling, pain, irritation, bruising
  • feeling tired
  • stuffy and runny nose
  • abnormal dreams, nightmares.

Please tell your doctor immediately if

  • shortly after receiving MOZOBIL, you experience rash, swelling around the eyes, shortness of breath or lack of oxygen, feeling lightheaded on standing or sitting, feeling faint or fainting
  • you have pain in the upper left abdomen (belly) or at the tip of your shoulder.
  • Heart attacks
    In clinical trials, 0.9% of patients with risk factors for a heart attack suffered heart attacks after being given MOZOBIL and G-CSF. Please inform your doctor immediately if you experience chest discomfort.

    Serious side effects, how often they happen and what to do about them
    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 call your doctor or pharmacist
    Very Common
    Diarrhea, nausea (feeling sick), injection site redness or irritation    
    Fever (pyrexia)    
    Decreased level of protein in blood (hypoproteinemia)    
    Decreased red blood cells (anemia) – fatigue, loss of energy, weakness, shortness of breath    
    Decreased white blood cells (neutropenia or leukopenia) – infections, fatigue, fever, aches, pains and flu-like symptoms    
    Decreased platelets (thrombocytopenia)– bruising, bleeding, fatigue and weakness    
    Common
    Headache    
    Dizziness, feeling tired or unwell    
    Difficulty in sleeping, anxiety    
    Flatulence, constipation, indigestion, vomiting    
    Stomach symptoms such as pain, swelling or discomfort    
    Numbness around the mouth, pins and needles and numbness    
    Sweating, generalized redness of the skin    
    Joint pains, pains in muscles and bones.    
    Uncommon
    Systemic reactions such as skin rash, swelling around the eyes, shortness of breath    
    Feeling faint, sudden drop in pulse and/or blood pressure, fainting    
    Heart attack, chest discomfort    
    Fever with low white blood cell count (febrile neutropenia) – fever, signs of low white blood cell count and/or infection    
    Decreased red and white blood cells and platelets (pancytopenia) –bruising, bleeding (gums), nose bleed, weakness, paleness of skin, fatigue, shortness of breath, rapid heart rate, and/or symptoms of infection    
    Rare
    Severe diarrhea, vomiting, stomach pain and/or nausea.    
    Unknown frequency
    Spleen enlargement and/or rupture: pain in the upper left abdomen (belly) or at the tip of your shoulder    

    This is not a complete list of side effects. For any unexpected effects while taking MOZOBIL contact your doctor or pharmacist.

    How to store

    You will not be given MOZOBIL to store. It will only be administered by a doctor or nurse.

    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.sanofi.ca or by contacting the sponsor, sanofi-aventis Canada Inc., at: 1-800-265-7927

    This leaflet was prepared by sanofi-aventis Canada Inc.

    Date of Revision: January 9, 2019

    Date modified: