SUMMARY CMI
Mozobil®
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.
1. Why am I using Mozobil?
Mozobil contains the active ingredient plerixafor. Mozobil is used to improve the release or "mobilisation" of blood stem cells into your blood stream; allowing their collection by apheresis, following which they will be frozen and stored until they are transplanted back to you when you need them to regenerate your bone marrow and blood.
For more information, see Section 1. Why am I using Mozobil? in the full CMI.
2. What should I know before I use Mozobil?
Do not use if you have ever had an allergic reaction to Mozobil or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Mozobil? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with Mozobil and affect how it works.
See Section 3. What if I am taking other medicines? in the full CMI.
4. How do I use Mozobil?
- Your medicine will be given to you by a doctor or a nurse in a hospital.
- The dose you will be given will depend on your weight. The usual dose of Mozobil is 240 microgram/kg body weight by subcutaneous injection (under your skin).
- Mozobil should be administered 6 to 11 hours before it is planned to start collecting blood stem cells by apheresis.
More instructions can be found in Section 4. How do I use Mozobil? in the full CMI.
5. What should I know while using Mozobil?
| Things you should do |
|
| Driving or using machines |
|
| Looking after your medicine |
|
For more information, see Section 5. What should I know while using Mozobil? in the full CMI.
6. Are there any side effects?
Very common side effects include diarrhoea, feeling sick, and injection site redness or irritation. Common side effects include headache, dizziness, feeling tired or unwell, difficulty sleeping, flatulence, constipation, indigestion, vomiting, stomach symptoms such as pain, swelling or discomfort, dry mouth, numbness around the mouth, sweating, generalised redness of the skin, joint pains, pains in the muscles and bones. Serious side effects include swelling of the face, lips, mouth or throat, which may cause difficultly in swallowing or breathing, hives, fainting, yellowing of the skin and eyes (jaundice), and a pain in the upper left abdomen (belly) or at the tip of your shoulder. If you experience any of these serious side effects, call your doctor straight away, or go straight to the Emergency Department at your nearest hospital. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
FULL CMI
Mozobil®
Active ingredient: plerixafor
Consumer Medicine Information (CMI)
This leaflet provides important information about using Mozobil. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Mozobil.
Where to find information in this leaflet:
1. Why am I using Mozobil?
2. What should I know before I use Mozobil?
3. What if I am taking other medicines?
4. How do I use Mozobil?
5. What should I know while using Mozobil?
6. Are there any side effects?
7. Product details
1. Why am I using Mozobil?
Mozobil contains the active ingredient plerixafor.
Mozobil is in a class of medicines called haematopoietic stem cell mobilisers.
Mozobil is a targeted and reversible blocker of a receptor which is present on many cells in the body, but particularly blood stem cells. Blood stem cells are the cells which give rise to all the cells in your blood - red cells which carry oxygen from the lungs to the tissues; white cells which fight infections, and platelets which stop bleeding. In the case of blood stem cells, this receptor "ties" the blood stem cells to the bone marrow. If this "tie" is broken, the stem cells will float out into the blood flowing in your blood vessels (arteries and veins) where they can then be collected by a process called apheresis. Apheresis involves the insertion of a tube into a vein. Blood is then sucked out into a machine which collects the cells wanted (in your case the stem cells) and the unneeded cells are returned back into your veins.
Mozobil is used to improve the release or "mobilisation" of blood stem cells into your blood stream; allowing their collection by apheresis, following which they will be frozen and stored until they are transplanted back to you when you need them to regenerate your bone marrow and blood.
In studies which have been carried out with Mozobil, it was used with G-CSF (granulocyte-colony stimulating factor), another medicine which is used to mobilise stem cells into the bloodstream.
2. What should I know before I use Mozobil?
Warnings
Do not use Mozobil if:
- you are allergic to plerixafor, or any of the ingredients listed at the end of this leaflet.
- Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
- have any other medical conditions, including:
- heart problems
- kidney problems
- high platelet counts - have a history of feeling faint or lightheaded on standing or sitting or have fainted before upon injections.
- are under 18 years of age. The effects of Mozobil on children and adolescents have not been studied.
- take any medicines for any other condition.
During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?
Pregnancy and breastfeeding
You should not use Mozobil if you are pregnant. There are no adequate clinical trials with Mozobil in pregnant women. Tell your doctor if you are, think you may be, or are planning to become pregnant.
It is recommended that you use contraception if you are of child-bearing age during Mozobil use and for one week after cessation of treatment.
Men treated with Mozobil should use effective contraception during treatment and for one week after cessation of treatment.
You should not breastfeed if you are using Mozobil. It is not known if Mozobil is excreted in human milk.
Use in children
- There is limited experience with Mozobil in children. Your doctor will discuss the risks and benefits of using Mozobil in children. If you have any questions about using Mozobil ask your doctor.
3. What if I am taking other medicines?
Tell your doctor, nurse or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may interfere with Mozobil and affect how it works.
Check with your doctor, nurse or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Mozobil.
4. How do I use Mozobil?
How to use Mozobil
- The decision to treat you with Mozobil should be made by a doctor experienced in cancers or blood diseases.
- Your medicine will be given to you by a doctor or a nurse in a hospital.
- Mobilisation (release of blood stem cells into your blood stream) will be started by first giving you G-CSF per your doctor's recommendation. If you want to know more about G-CSF, please ask your doctor.
How much to use
- The dose you will be given will depend on your weight. In order to calculate the dose of Mozobil to be given to you, your weight must be measured. This should be done within a week of your first Mozobil dose.
- The usual dose of Mozobil is 240 microgram/kg body weight by subcutaneous injection (under your skin).
- Mozobil should be administered 6 to 11 hours before it is planned to start collecting blood stem cells by apheresis.
- If you have moderate or severe kidney problems, your doctor will reduce the dose.
When to use Mozobil
- It usually only needs to be given on two to four consecutive days, but occasionally has been given for up to 7 consecutive days.
How long to use Mozobil
- The treatment with Mozobil will last until enough stem cells have been collected by apheresis for you to be able to have a transplant. In a few cases, enough stem cells may not be collected, and the collection attempt will be stopped.
If you are given too much Mozobil
There have been no reported overdoses of Mozobil.
Based on data in a small number of patients, doses up to 480 microgram/kg body weight have shown to be safe.
If you think you have been given a bigger dose than recommended you should tell your doctor immediately.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
If too much Mozobil has been injected or it goes into a vein, you may have a serious allergic reaction.
Your treating physician is trained to work out the correct dose and to contact the Australian Poisons Information Centre (telephone 13 11 26) in case of an overdose.
5. What should I know while using Mozobil?
Things you should do
Keep appointments with your treating physician or clinic.
It is important to have the treatment with Mozobil at the appropriate times to make sure the medicine has the best chance of providing treatment for the condition.
Have any tests when your treating physician says to.
You may experience short-lived abnormal blood laboratory results such as a raised white blood cell count or low platelet levels. Your treating physician may recommend to perform blood tests to monitor your blood cell count.
Remind any doctor, nurse, dentist or pharmacist you visit that you are using Mozobil.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Mozobil affects you.
The effect of Mozobil on your ability to drive a car or operate machinery has not been studied. Make sure that you know how you react to Mozobil before you drive a car or operate machinery or do anything else that may be dangerous if you are dizzy, light-headed, tired or drowsy.
Storing Mozobil
- Your medicine will be stored at the hospital.
- It should not be stored above 25°C.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
Once a vial has been opened it must be used immediately or disposed of, because it does not contain any preservative.
The doctor or nurse will check that the product has not passed its expiry date. Mozobil should not be used if there are particles in it.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.
Less serious side effects
| Less serious side effects | What to do |
Gut related:
| Speak to your doctor if you have any of these less serious side effects and they worry you. |
Serious side effects
| Serious side effects | What to do |
Allergic reaction related:
| Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects. |
Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.
Other side effects not listed here may occur in some people.
Heart attacks
In studies, patients with risk factors for a heart attack uncommonly suffered heart attacks after being given Mozobil and G-CSF. It seems unlikely that Mozobil increases the risk of having a heart attack because only one of these heart attacks occurred close to the use of Mozobil, and most of these patients were known to have risk factors for having a heart attack.
Pins and needles and numbness
Pins and needles and numbness are common in patients being treated for cancers. In the clinical studies carried out with Mozobil and G-CSF compared to G-CSF alone for mobilising blood stem cells, there was no difference in the pins and needles and numbness experienced whether or not the patients were given Mozobil. About one in five patients suffered from these feelings.
Reporting side effects
After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Mozobil contains
| Active ingredient (main ingredient) | plerixafor |
| Other ingredients (inactive ingredients) | sodium chloride hydrochloric acid sodium hydroxide (if needed) water for injections |
Do not take this medicine if you are allergic to any of these ingredients.
What Mozobil looks like
Mozobil is supplied as a solution for injection in a 2.0 mL glass vial. Each vial contains 24mg plerixafor in 1.2 mL solution. Each pack contains one vial with clear colourless or pale yellow liquid (Aust R 158423).
Who distributes Mozobil
Distributed in Australia by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Freecall: 1800 818 806
Email: [email protected]
Mozobil® is a registered trademark of Genzyme Corporation, USA.
This leaflet was prepared in August 2023.
mozobil-ccdsv10-cmiv7-01aug23
Published by MIMS September 2023
Other adverse reactions that occurred in < 5% of patients but were reported as related to Mozobil during HSC mobilisation and apheresis included abdominal pain, injection site irritation, hyperhidrosis, injection site reaction, abdominal distention, dry mouth, erythema, stomach discomfort, malaise, hypoaesthesia oral, constipation, dyspepsia and injection site rash.
In pharmacodynamic studies of Mozobil in healthy volunteers, peak mobilisation of CD34+ cells was observed between 6 and 9 hours after administration. In pharmacodynamic studies of Mozobil in conjunction with granulocyte-colony stimulating factor (G-CSF) in healthy volunteers, a sustained elevation in the peripheral blood CD34+ count was observed from 4 to 18 hours after Mozobil administration with peak response between 10 and 14 hours.
The median number of days to reach the primary endpoint of ≥ 5 x 106 CD34+ cells/kg was 3 days for the Mozobil group and not evaluable for the placebo group. Table 4 presents the proportion of patients who achieved ≥ 5 x 106 CD34+ cells/kg by apheresis day.
In AMD3100-3102, 71.6% of MM patients who were mobilised with Mozobil and G-CSF achieved the primary endpoint of collection of ≥ 6 X 106 CD34+ cells/kg from the peripheral blood in two or fewer apheresis sessions, compared with 34.4% of patients who were mobilised with placebo and G-CSF (p < 0.001). Secondary CD34+ cell mobilisation outcomes were consistent with the primary endpoint (Table 5).
The median number of days to reach the primary endpoint of ≥ 6 x 106 CD34+ cells/kg was 1 day for the Mozobil group and 4 days for the placebo group. Table 6 presents the proportion of patients who achieved ≥ 6 x 106 CD34+ cells/kg by apheresis day.
For transplanted patients in the phase 3 studies, time to neutrophil and platelet engraftment and graft durability up to 12 months post-transplantation were similar across the treatment groups. The median time to neutrophil engraftment was 10 days in AMD3100-3101 and 11 days in AMD3100-3102 (p = 0.330 and 0.690, respectively) and to platelet engraftment was 20 days in AMD3100-3101 and 18 days in AMD3100-3102 (p = 0.630 and 0.180, respectively). No difference in graft durability was observed across treatment groups in AMD3100-3101 or AMD3100-3102.
Molecular Weight: 502.79 g/mol.