Details for: MOZOBIL
Company: SANOFI-AVENTIS CANADA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02377225 | MOZOBIL | PLERIXAFOR | 20 MG / ML | SOLUTION | SUBCUTANEOUS |
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
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
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
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.
| 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