Plerixafor Accord 20 mg/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Plerixafor Accord 20 mg/ml injection solution

plerixafor

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

If mobilization is poor, Plerixafor Accord is administered to help collect stem cells from the patient's blood for collection, storage, and reinfusion (transplantation):

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

2. What you need to know before using Plerixafor Accord

Do not use Plerixafor Accord

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Plerixafor Accord.

Inform 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 white blood cell count.
• if you have a low platelet count.
• if you have a history of fainting or dizziness while standing or sitting, or if you have previously fainted after injections.

Your doctor may carry out periodic blood tests to monitor your blood cell counts.

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

Other medicines and Plerixafor Accord

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

Pregnancy and breastfeeding

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

You must not breastfeed while using Plerixafor Accord, as it is unknown 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; essentially, "sodium-free".

3. How to use Plerixafor Accord

Your doctor or a nurse will inject your medicine.

You will first receive G-CSF and then be given Plerixafor Accord

Mobilization will begin with administration of another medicine called G-CSF (granulocyte colony-stimulating factor). G-CSF will help Plerixafor Accord work properly in your body. If you would like more information about G-CSF, please ask your doctor and read the relevant patient information 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 of age is 0.24 mg/kg 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.

How is Plerixafor Accord given?

Plerixafor Accord is administered 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 Plerixafor Accord treatment last?

Treatment lasts for 2 to 4 consecutive days (in some cases up to 7 days), until enough stem cells have been collected for your transplant. In some cases, it may not be possible to collect a sufficient number of stem cells, in which case the collection attempt will be discontinued.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Tell your doctor immediately if

• shortly after receiving plerixafor, you develop a rash, swelling around the eyes, difficulty breathing or shortness of breath, dizziness while standing or sitting, feeling faint or fainting
• you feel pain in the upper left side of your abdomen (stomach) or in your left shoulder

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

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

Common adverse 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, bloating or discomfort
• dry mouth, numbness around the mouth
• sweating, generalized skin redness, joint pain, muscle and bone pain

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

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

In rare cases, gastrointestinal adverse effects may be severe (diarrhoea, 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. Inform your doctor immediately if you have chest discomfort.

Tingling and numbness

Tingling and numbness are common in patients receiving cancer treatment. Approximately one in five patients experiences these symptoms. However, these effects do not appear to occur more frequently with the use of Plerixafor Accord.

You may also have an increase in the number of white blood cells (leucocytes) in your blood tests.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 stated on the label after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

After opening the vial, Plerixafor Accord must be used immediately.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. 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 injectable solution contains 20 mg of plerixafor.

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

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

Nature of the product and pack contents

Plerixafor Accord is a colourless or pale yellow, clear injectable solution contained in a glass vial with a rubber stopper, an aluminium crimp seal, and a blue matte polypropylene cap. Each vial contains 1.2 ml of solution.

Each pack contains 1 vial.

Marketing Authorisation Holder

Accord Healthcare S.L.U.

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

Edifici Est, 6th floor,

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

The Netherlands

Or

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park, Paola

PLA 3000, Malta

Date of the most recent revision of this leaflet: