Mozobil 20 mg/ml solution for injection

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Mozobil is and what it is used for
2. What you need to know before you use Mozobil
3. How to use Mozobil
4. Possible side effects
5. How to store Mozobil
6. Contents of the pack and other information

• if you are allergic to plerixafor or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor before using Mozobil.

Tell your doctor:

• if you have or have had any heart problems.
• if you have kidney problems. Your doctor may adjust the dose.
• if you have high white blood cell counts.
• if you have low platelet counts.
• if you have a history of feeling faint or lightheaded on standing or sitting or have fainted before upon injections.

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

It is not recommended to use Mozobil for stem cell mobilisation if you have leukaemia (a cancer of the blood or bone marrow).

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

You should not use Mozobil if you are pregnant, since there is no experience with Mozobil in pregnant women. It is important to tell your doctor if you are, think you may be or are planning to become pregnant. It is recommended to use contraception if you are of child-bearing age.

You should not breast-feed if you are using Mozobil, since it is not known if Mozobil is excreted in human milk.

Mozobil may cause dizziness and fatigue. Therefore, you should avoid driving if you feel dizzy, tired or unwell.

This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.

Mobilisation will be started by first giving you another medicine called G-CSF (granulocyte-colony stimulating factor). G-CSF will help Mozobil to work properly in your body. If you want to know more about G-CSF ask your doctor and read the corresponding package leaflet.

The recommended adult dose is either a 20 mg (fixed dose) or 0.24 mg/kg body weight/day.

The recommended dose for children, 1 to less than 18 years of age is 0.24 mg/kg of body weight/day.

Your dose will depend on your body weight, which should be measured the week before you receive your first dose. If you have moderate or severe kidney problems, your doctor will reduce the dose.

Mozobil is given by subcutaneous injection (under your skin).

You will receive your first dose 6 to 11 hours before apheresis (collection of your blood stem cells).

Treatment lasts 2 to 4 consecutive days (in some cases up to 7 days), until enough stem cells have been collected for your transplant. In a few cases, enough stem cells may not be collected, and the collection attempt will be stopped.

• 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 your left shoulder

Very common side effects (may affect more than 1 in 10 people)

• diarrhoea, nausea (feeling sick), injection site redness or irritation
• low red blood cell count by laboratory test (anaemia in children)

Common side effects (may affect up to 1 in 10 people)

• headache
• dizziness, feeling tired or unwell
• difficulty in 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 muscles and bones

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

Rarely, gastrointestinal side effects may be severe (diarrhoea, vomiting, stomach pain and nausea).

In clinical trials, patients with risk factors for a heart attack uncommonly suffered heart attacks after being given Mozobil and G-CSF. Please inform your doctor immediately if you experience chest discomfort.

Pins and needles and numbness are common in patients being treated for cancers. About one in five patients suffered from these feelings. However, these effects do not seem to occur more frequently when you use Mozobil.

You may also have an increase in white blood cells count (leucocytosis), in your blood tests.

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is plerixafor. Each ml solution for injection contains 20 mg 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.

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

Each pack contains 1 vial.