20 mg / ml solution for injection
plerixafor
What Mozobil is and what it is used for
Mozobil contains the active substance plerixafor, which blocks a protein on the surface of blood stem cells. This protein “binds” the blood stem cells to the bone marrow. Plerixafor improves the release of stem cells into the bloodstream (mobilization). The stem cells can then be collected by a machine that separates the blood components (apheresis machine) and frozen and stored until it is time for your transplant.
For patients who have difficulty mobilizing, Mozobil is used to facilitate the collection of blood stem cells from the patient, for collection, storage, and reintroduction (transplantation)
- For adults with lymphoma (cancer of the white blood cells ) or multiple myeloma (cancer affecting plasma cells in the bone marrow ).
- In children 1 year to younger than 18 years with lymphoma or solid tumor er.
What you need to know before using Mozobil
Do not use Mozobil
- if you are allergic to plerixafor or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor before using Mozobil:
Inform your doctor:
- if you have or have had heart problems.
- if you have kidney problems. Your doctor may adjust dose one.
- if you have a high number of white blood cells .
- if you have low platelet counts .
- if you have previously felt weak or dizzy while standing or sitting, or have previously fainted in connection with the injection .
Your doctor may take regular blood tests to check the number of blood cells.
Mozobil should not be used for stem cell mobilization if you have leukemia (cancer of the blood or bone marrow ).
Other medicines and Mozobil
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
You should not use Mozobil if you are pregnant, as there is no experience with Mozobil in pregnant women. It is important that you inform your doctor if you are, think you may be or are planning to become pregnant. You should use contraception if you are of childbearing age.
You should not breastfeed if you are using Mozobil, as it is not known if Mozobil is excreted in human milk.
Driving and using machines
Mozobil can cause dizziness and fatigue. You should therefore avoid driving if you feel dizzy, tired, or unwell.
Mozobil contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’. is next to “sodium-free”.
How to use Mozobil
The medicine is injected by a doctor or nurse.
You first receive G-CSF and then Mozobil The
mobilization starts by first receiving another medicine called G-CSF ( granulocyte colony-stimulating factor). G-CSF helps Mozobil work properly in your body. You can find out more about G-CSF by asking your doctor and reading the accompanying leaflet.
How large a dose of Mozobil is given?
The recommended dose for adults is either 20 mg (fixed-dose ) or 0.24 mg / kg body weight / day. Your dose depends on your body weight. You will be weighed the week before you receive your first dose. If you have moderate or severe kidney problems, your doctor will lower your dose.
The recommended dose for children 1 year to younger than 18 years is 0.24 mg/kg body weight/day.
How is Mozobil given?
Mozobil is given by subcutaneous injection (under the skin).
When is Mozobil first given?
You will receive your first dose 6 to 11 hours before apheresis (collection of blood stem cells).
How long will Mozobil be given?
The treatment lasts for 2-4 consecutive days (in some cases up to 7 days) until enough stem cells have been collected for your transplant. In some cases, it is not possible to collect enough stem cells and the collection attempt will then be stopped.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately
- shortly after you receive Mozobil you get a rash, swelling around the eyes, shortness of breath or lack of oxygen, feel dizzy when standing or sitting, feel weak or faint
- you have pain in the upper left part of the abdomen (stomach) or in the left shoulder.
Very common side effects (may affect more than 1 user in 10)
- diarrhea, nausea, flushing or irritation at the injection site
- low number of red blood cells from laboratory tests ( anemia in children)
Common side effects (may affect up to 1 in 10 people)
- headache
- dizziness, feeling tired or unwell
- sleeping problems
- flatulence, constipation, indigestion, vomiting
- stomach symptoms such as pain, swelling or discomfort
- dry mouth , numbness around the mouth
- sweating, general redness of the skin, joint pain, muscle and leg pain.
Uncommon side effects (may affect up to 1 in 100 people)
- allergic reactions such as skin rash, swelling around the eyes, shortness of breath
- anaphylactic reactions, including anaphylactic shock
- abnormal dreams, nightmares
In rare cases, side effects in the gastrointestinal tract can be serious (diarrhea, vomiting, abdominal pain, and nausea).
Heart attack
In clinical trials, patients with risk factors for heart attack have, in less common cases, suffered a heart attack after receiving Mozobil and G-CSF. Tell your doctor immediately if you feel any discomfort in your chest.
Ants crawling and numbness
Ants crawling and numbness are common in patients being treated for cancer. About one in five patients experience these discomforts. But these effects do not seem to occur more often when using Mozobil.
Your blood tests may show that you also have an increase in the number of white blood cells ( leukocytosis ).
How to store Mozobil
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and vial.
No special storage instructions.
After opening the vial, use Mozobil immediately.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is plerixafor. Each ml of solution for injection contains 20 mg of plerixafor. Each vial contains 24 mg plerixafor in 1.2 ml solution.
- The other ingredients are sodium chloride, hydrochloric acid (concentrated) and sodium hydroxide for pH adjustment and water for injections.
What the medicine looks like and contents of the pack
Mozobil is supplied as a clear, colorless, or pale yellow solution for injection in a glass vial with a latex-free rubber stopper. Each vial contains 1.2 ml of solution.
Each pack contains 1 vial.
Marketing Authorisation Holder
Genzyme Europe BV
Paasheuvelweg 25
1105 BP Amsterdam
Netherlands.
Manufacturer
Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Contact the representative of the marketing authorization holder if you want to know more about this medicine:
Sanofi AB
Tel: +46 (0) 8 634 50 00