What is it and what is it used for?
Mozobil contains the active substance Plerixafor which blocks a protein on the surface of stem cells in the blood. This protein "ties" blood stem cells to the bone marrow. Plerixafor improves the release of stem cells into the bloodstream (mobilization). The stem cells can then be removed with an apheresis machine, and subsequently frozen and stored until your transplant.
If the mobilization is insufficient, plerixafor is intended to help in the recovery of stem cells from the blood for transplantation in patients with lymphoma (a cancer that affects the white blood cells) and multiple myeloma (a cancer that plasma cells in the bone marrow attacks) suffer ,
What you need to consider before using it?
Mozobil MUST NOT be applied,
- if you are allergic (hypersensitive) to plerixafor or any of the other ingredients of plerixafor (listed in section 6, "What Mozobil contains').
Take special care when taking plerixafor is required
Tell your doctor:
- if you suffer from heart problems or have suffered.
- if you suffer from kidney problems. Your doctor adjusts the dose.
- when there are high white blood cell numbers with you.
- when there are low Bluttplättchenzahlen yours.
- if you are filled close in the past, when rising or setting of impotence
have you felt dizzy or have fallen in injections fainted.
if you are under 18 years. The effects of Mozobil on children and adolescents have not been studied.
Your doctor performs regular blood tests by to monitor your blood cell count.
It is not recommended to use plerixafor for stem cell mobilization if you suffer from leukemia (a cancer that affects the blood or bone marrow).
In Mozobil with other medicinal products
Please inform your doctor or pharmacist if you are taking other medicines / or have recently taken / used, even if it is not prescribed.
pregnancy and breast feeding period
You should not use Mozobil if you are pregnant, there is no experience with Mozobil in pregnant women are present. It is important that you tell your doctor if you are pregnant or might be or are planning a pregnancy. Contraception is recommended if you are of childbearing age.
You should not breastfeed if you are taking Mozobil, since it is not known if Mozobil is excreted in human milk.
Driving and using machines
Mozobil may cause dizziness and fatigue. That's why you should not get behind the wheel of a vehicle, if you feel dizzy, tired or unwell.
Important information about some of the ingredients of Mozobil
Mozobil is essentially sodium-free. It contains less than 1 mmol sodium (23 mg) per dose.
How is it used?
The medicine will be injected by a doctor or a nurse.
You will not receive G-CSF, then you will be given Mozobil
The mobilization is started by first another agent called G-CSF (granulocyte-colony stimulating factor) is given to you. G-CSF will help plerixafor that properly acts in your body. If you want to know more about G-CSF ask your doctor or read the corresponding package leaflet.
How much Mozobil is used?
The usual dose is 0.24 mg / kg body weight / day. Your Mozobil dose depends on your body weight, which should be in the week before you receive your first dose determined. If you suffer from moderate or severe kidney problems, your doctor will reduce the dose.
How is Mozobil given?
plerixafor is given by subcutaneous injection (under the skin).
When is Mozobil given for the first time?
You will receive your first dose of Mozobil 6 to 11 hours before apheresis (collection of stem cells from your blood).
How long Mozobil used?
Treatment with plerixafor lasts 2 to 4 consecutive days (in some cases up to 7 days), were until enough stem cells obtained for your transplant. In some cases, can not enough stem cells are obtained. Then the attempt to obtain stem cells, is aborted.
What are possible side effects?
Like all medicines, Mozobil can cause side effects, although not everybody gets them.
Inform your doctor immediately if
- happens to you shortly after Mozobil rash, swelling around the eyes, shortness of breath or lack of oxygen, dizziness when standing or sitting, the feeling of being close to fainting, or fainting.
- You have pain in the left upper abdomen or at the tip of your shoulder.
Side effects may occur with certain frequencies, which are defined below:
- very common: affects more than 1 user in 10
- common: affects 1 to 10 users in 100
- uncommon: affects 1 to 10 of 1,000 users
- rare: affects 1 to 10 of 10,000 users
- very rare: affects less than 1 in 10,000
- not known: frequency can not be estimated from the available data.
Very common side effects
- Diarrhea, nausea (feeling sick), redness or irritation at the injection site
Common side effects
- a headache
- Dizziness, fatigue or discomfort
- sleep disorders
- Flatulence, constipation, indigestion, vomiting
- Gastrointestinal symptoms such as pain, swelling or discomfort
- Dry mouth, numbness around the mouth
- Increased sweating, general redness of the skin, pain in joints, muscles and bones
Uncommon side effects
- Allergic reactions such as rash, swelling around the eyes, shortness of breath
In rare cases, severe effects on the gastrointestinal tract may occur (diarrhea, vomiting, abdominal pain and nausea).
In clinical trials, patients suffered with relevant risk factors occasionally heart attacks after their Mozobil and G-CSF were added. Please tell your doctor immediately if you have chest discomfort.
Tingling and numbness
Tingling and numbness are common in patients who are being treated for cancer, often. Approximately one in five patients suffering from these symptoms. However, they do not appear to occur in greater frequency if you use Mozobil.
If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
How should it be stored?
Store drug out of reach of children.
You may Mozobil after the expiry date stated on the carton and vial no longer apply.
This medicinal product does not require special storage conditions.