PLERIXAFOR ACCORD 20 mg/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Plerixafor Accord 20 mg/ml Solution for Injection

plerixafor

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Plerixafor Accord and what is it used for

Plerixafor Accord contains the active substance plerixafor, which blocks a protein on the surface of hematopoietic stem cells. This protein "anchors" the stem cells to the bone marrow. Plerixafor improves the release of stem cells into the bloodstream (mobilization). The stem cells can then be collected using a machine that separates the components of the blood (apheresis machine), frozen, and stored until they are transplanted.

If mobilization is poor, Plerixafor Accord is given to help collect stem cells from the patient's blood for collection, storage, and re-infusion (transplant),

• In adult patients with lymphoma (a cancer of white blood cells) or multiple myeloma (a cancer that affects the plasma cells of the bone marrow).
• In children from 1 to less than 18 years with lymphoma or solid tumors.

2. What you need to know before you use Plerixafor Accord

Do not use Plerixafor Accord

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before you start using Plerixafor Accord.

Tell your doctor:

• if you have or have had any heart problems.
• if you have kidney problems. Your doctor may adjust your dose.
• if you have a high number of white blood cells.
• if you have a low number of platelets.
• if you have a history of feeling faint or dizzy while standing or sitting, or if you have fainted after injections.

Your doctor may perform blood tests periodicallyto check the number of blood cells.

Plerixafor Accord is not recommended for the mobilization of stem cells if you have leukemia (a cancer of the blood or bone marrow).

Other medicines and Plerixafor Accord

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

Pregnancy and breastfeeding

Do not use Plerixafor Accord if you are pregnant, as there are no data on the effects of Plerixafor Accord in pregnant women. It is important that you inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. The use of contraceptive methods is recommended if you are of childbearing age.

Do not breastfeed if you are using Plerixafor Accord, as it is not known whether Plerixafor Accord passes into breast milk.

Driving and using machines

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

Plerixafor Accord contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially "sodium-free".

3. How to use Plerixafor Accord

Your doctor or nurse will inject the medicine into you.

First, you will receive G-CSF, and then you will be given Plerixafor Accord

Mobilization will begin by giving you another medicine called G-CSF (granulocyte-colony stimulating factor). G-CSF will help Plerixafor Accord work properly in your body. If you want more information about G-CSF, ask your doctor and read the corresponding package leaflet.

How much Plerixafor Accord is given?

The recommended dose in adults is 20 mg (fixed dose) or 0.24 mg/kg body weight/day.

The recommended dose in children from 1 to less than 18 years is 0.24 mg/kg body weight/day.

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

How is Plerixafor Accord given?

Plerixafor Accord is given by subcutaneous injection (under the skin).

When is Plerixafor Accord given for the first time?

You will receive the first dose between 6 and 11 hours before apheresis (collection of stem cells from your blood).

How long will the administration of Plerixafor Accord last?

Treatment lasts from 2 to 4 consecutive days (in some cases up to 7 days), until enough stem cells have been collected for transplantation. In some cases, it is not possible to collect enough stem cells, so the collection attempt will be interrupted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately if

• after receiving plerixafor, you experience a skin rash, swelling around the eyes, difficulty breathing, or a lack of oxygen, feeling dizzy while standing or sitting, feeling faint, or fainting
• you feel pain in the upper left part of your abdomen (stomach) or in your left shoulder

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

• diarrhea, nausea, redness, or irritation at the injection site
• low red blood cell count in laboratory tests (anemia in children)

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

• 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, generalized redness of the skin, joint pain, muscle and bone pain

Uncommon side effects(may affect up to 1 in 100 people)

• allergic reactions such as skin rash, swelling around the eyes, difficulty breathing
• anaphylactic reactions, including anaphylactic shock
• disturbed dreams, nightmares

In rare cases, gastrointestinal side effects can be severe (diarrhea, vomiting, stomach pain, and nausea).

Myocardial infarction

In clinical trials, patients with risk factors for myocardial infarction rarely experienced a myocardial infarction after administration of Plerixafor Accord and G-CSF. Tell your doctor immediately if you experience chest discomfort.

Numbness and tingling

Numbness and tingling are common in patients receiving cancer treatment. About one in five patients experience them. However, these effects do not seem to occur more frequently when using Plerixafor Accord.

You may also have an increased number of white blood cells (leukocytes) in your blood tests.

Reporting of side effects

If you experience any side effects, talk to your doctor, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Plerixafor Accord

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 label after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Once the vial is opened, Plerixafor Accord must be used immediately.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Plerixafor Accord

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

Each vial contains 24 mg of plerixafor in 1.2 ml of solution.

• The other ingredients are sodium chloride, hydrochloric acid (concentrated), sodium hydroxide, and water for injections (see section 2 "Plerixafor Accord contains sodium").

Appearance and pack contents

Plerixafor Accord is a clear, colorless or pale yellow solution for injection in a glass vial with a rubber stopper, aluminum seal, and blue PP plastic cap. Each vial contains 1.2 ml of solution.

Each pack contains 1 vial.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n,

Edifici Est 6ª planta,

08039 Barcelona

Spain

Manufacturer

Accord Healthcare Polska Sp.z o.o.

ul. Lutomierska 50,

95-200 Pabianice, Poland

Or

Laboratori Fundació Dau

C/ C, 12-14 Pol. Ind.

Zona Franca, Barcelona, 08040,

Spain

Or

Accord Healthcare B.V.

Winthontlaan 200, 3526KV Utrecht

Netherlands

Or

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park, Paola

PLA 3000, Malta

Date of last revision of this leaflet: