Plerixafor accord 20 mg/ml solucion inyectable efg

Package Leaflet: Information for the User

Plerixafor Accord 20 mg/ml Injectable Solution

plerixafor

Read 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Plerixafor Accord contains the active ingredient plerixafor that blocks a protein on the surface of hematopoietic stem cells. This protein "fixes" the stem cells in the bone marrow. Plerixafor improves the release of the stem cells into the circulatory system ( mobilization). The stem cells can be collected with a device that separates the blood components (apheresis machine), and then frozen and stored until transplantation.

If mobilization is scarce, Plerixafor Accord is administered to help collect stem cells from the patient's blood for collection, storage, and re-introduction (transplantation),

• In adult patients with lymphoma (a cancer of white blood cells) or multiple myeloma (a cancer affecting bone marrow plasma cells).
• In children 1 year of age and under 18 years with lymphoma or solid tumors.

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 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 number of white blood cells.
• if you have a low number of platelets.
• if you have a history of dizziness or fainting while standing or sitting, or if you have fainted after injections.

Your doctor may performblood tests periodicallyto control the number of blood cells.

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

Other medicines and Plerixafor Accord

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

Pregnancy and breastfeeding

You must not use Plerixafor Accord if you are pregnant, as there is no data on the effects of Plerixafor Accord in pregnant women. It is essential to inform your doctor if you are pregnant, think you may be pregnant or intend to become pregnant. It is recommended to use contraceptive methods if you are fertile.

You must not breastfeed if you are using Plerixafor Accord, as it is unknown whether Plerixafor Accord passes into breast milk.

Driving and operating 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”.

Your doctor or a nurse will administer your medication.

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

Mobilization will begin by administering another medication called G-CSF (granulocyte-colony stimulating factor) first. G-CSF will help Plerixafor Accord to function properly in your body. If you would like more information about G-CSF, ask your doctor and read the corresponding leaflet.

How much Plerixafor Accord is administered?

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

The recommended dose in children, from 1 to less than 18 years, is 0.24 mg/kg of 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 administered?

Plerixafor Accord is administered via subcutaneous injection (under the skin).

When is Plerixafor Accord administered for the first time?

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

How long will the administration of Plerixafor Accord last?

The treatment lasts from 2 to 4 consecutive days (in some cases up to 7 days), until sufficient stem cells have been collected for your transplant. In some cases, it is not possible to collect a sufficient number of stem cells, and the attempt to collect will be interrupted.

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

Inform your doctor immediately if

• you experience any of the following shortly after receiving plerixafor: skin rash, swelling around the eyes, difficulty breathing or 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 skin redness, 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
• altered dreams, nightmares

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

Myocardial infarction

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

Tickling and numbness

Tickling and numbness are common in patients receiving cancer treatment. Approximately one in five patients experience them. However, these effects do not appear to occur more frequently when using Plerixafor Accord.

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

Reporting side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label after CAD, The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

Medicines should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the containers and medicines you do not need. This will help protect the environment.

Composition of Plerixafor Accord

• The active ingredient is plerixafor. Each milliliter 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, concentrated hydrochloric acid, and sodium hydroxide, and water for injectable preparations (see section 2 “Plerixafor Accord contains sodium”).

Appearance of the product and contents of the packaging

Plerixafor Accord is a clear, colorless, or pale yellow injectable solution contained in a glass vial with a rubber stopper, an aluminum type removable seal, and a PP plastic cap in a matte blue color. Each vial contains 1.2 ml of solution.

Each package contains 1 vial.

Marketing Authorization Holder

Accord Healthcare S.L.U.

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

Edifici Est 6th floor,

08039 Barcelona

Spain

Responsible for Manufacturing

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 KordinIndustrial Park, Paola

PLA 3000, Malta

Last date of this leaflet revision: