Package Insert: Information for the User

Plerixafor Glenmark 20 mg/ml Injectable Solution EFG

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor.
• If you experience any side effects, consult your doctor or nurse, even if they are not listed in this package insert. See section 4.

Table of Contents

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

Plerixafor Glenmark contains the active ingredient plerixafor, which 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 is administered to help collect stem cells from the patient's blood for collection, storage, and reintroduction (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 to less than 18 years with lymphoma or solid tumors.

Do not use Plerixafor Glenmark

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

Warnings and precautions

Consult your doctor before starting to use plerixafor.

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 lightheadedness when standing or sitting, or if you have fainted after injections.

Your doctor may performperiodic blood teststo monitor the number of blood cells.

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

Other medications and Plerixafor Glenmark

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication. Do not use plerixafor if you are pregnant, as there is no data on the effects of plerixafor on pregnant women. It is recommended to use contraceptive methods if you are of childbearing age.

Do not breastfeed while using plerixafor, as it is unknown whether plerixafor passes into breast milk.

Driving and operating machinery

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

Plerixafor Glenmark contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose; it is essentially “sodium-free”.

Your doctor or a nurse will administer your medication.

First, you will receive G-CSF, and then Plerixafor Glenmark will be administered.

Mobilization will begin by administering another medication called G-CSF (granulocyte-colony stimulating factor) first. G-CSF will help plerixafor 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 Glenmark 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 Glenmark administered?

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

When is Plerixafor Glenmark administered for the first time?

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

How long will the administration of Plerixafor Glenmark 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 may not be 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 skin rash, swelling around the eyes, difficulty breathing or lack of oxygen, feeling of dizziness while standing or sitting, feeling of fainting 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 of fatigue or discomfort
• 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

Rare 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, patients with risk factors for myocardial infarction experienced myocardial infarction with low frequency after administration of plerixafor 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 plerixafor is used.

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

Reporting side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on 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 packaging.

Store below 25 °C.

Once the vial is opened, this medication must be used immediately.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Plerixafor Glenmark

• 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, hydrochloric acid and sodium hydroxide for pH adjustment, water for injectable preparations.

Appearance of the product and contents of the packaging

Plerixafor Glenmark is a transparent, colorless to pale yellow injectable solution contained in a type I transparent glass vial with a rubber stopper and aluminum seal with a plastic flip-top cap. Each vial contains 1.2 ml of solution.

Each package contains 1 vial.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Responsible manufacturer:

Pharmadox Healthcare Ltd

KW20A Kordin Industrial Park

Paola, PLA3000

Malta

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viso Farmacéutica S.L.U.

c/ Retama 7, 7th floor

28045 Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:February 2023.

Other sources of information

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).