Plerixafor Msn

Package Leaflet: Information for the User

Plerixafor MSN, 20 mg/mL, Solution for Injection

Plerixafor

Read All of This Leaflet Carefully Before 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.
• 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 MSN and What Is It Used For
• 2. Before You Use Plerixafor MSN
• 3. How to Use Plerixafor MSN
• 4. Possible Side Effects
• 5. How to Store Plerixafor MSN
• 6. Contents of the Pack and Other Information

1. What Is Plerixafor MSN and What Is It Used For

Plerixafor MSN Contains the Active Substance Plerixafor, Which Blocks a Protein on the Surface of Haematopoietic Stem Cells. This Protein "Binds" Haematopoietic Stem Cells in the Bone Marrow. Plerixafor Facilitates the Release (Mobilization) of Haematopoietic Stem Cells into the Bloodstream. Haematopoietic Stem Cells Are Collected Using a Device That Separates Different Blood Components (Apheresis Device), Then Frozen and Stored Until Transplantation.

Plerixafor MSN Is Used in Cases of Insufficient Mobilization, to Facilitate the Collection of Haematopoietic Stem Cells (for Their Collection, Storage, and Transplantation),

• In Adult Patients with Lymphoma (White Blood Cell Cancer) or Multiple Myeloma (Cancer Affecting Plasma Cells in the Bone Marrow).
• In Children Aged 1 Year to Less Than 18 Years with Lymphoma or Solid Tumours.

2. Before You Use Plerixafor MSN

When Not to Use Plerixafor MSN

• If You Are Allergic to Plerixafor or Any of the Other Ingredients of This Medicine (Listed in Section 6).

Warnings and Precautions

Before Starting Treatment with Plerixafor MSN, Discuss It with Your Doctor.

Tell Your Doctor If:

• You Have Ever Had or Currently Have Heart Problems
• You Have Kidney Problems; Your Doctor May Need to Adjust the Dose
• You Have a High White Blood Cell Count
• You Have a Low Platelet Count
• You Have Ever Had or Currently Have Fainting or Dizziness When Standing Up or Sitting Down, or During or After Injections.

Your Doctor May Prescribe Regular Blood Teststo Monitor Your Blood Cell Count.

Plerixafor MSN Should Not Be Used to Mobilize Haematopoietic Stem Cells in Patients with Leukaemia (Blood or Bone Marrow Cancer).

Plerixafor MSN and Other Medicines

Tell Your Doctor or Pharmacist About All Medicines You Are Taking or Have Recently Taken, as Well as Any Medicines You Plan to Take.

Pregnancy and Breast-Feeding

Pregnant Women Should Not Use Plerixafor MSN, as There Is Limited Experience with the Use of This Medicine in Pregnancy. If You Are Pregnant, Think You May Be Pregnant, or Plan to Have a Baby, Ask Your Doctor for Advice Before Using This Medicine. Women of Childbearing Age Should Use Contraception.

Do Not Breast-Feed While Using Plerixafor MSN, as It Is Not Known Whether This Medicine Passes into Human Milk.

Driving and Using Machines

Plerixafor MSN May Cause Dizziness and Fatigue, So If You Feel Dizzy, Tired, or Unwell, Do Not Drive.

Plerixafor MSN Contains Sodium

This Medicine Contains Less Than 1 mmol (23 mg) of Sodium per Dose, Which Means It Is Essentially "Sodium-Free".

3. How to Use Plerixafor MSN

The Medicine Will Be Given to You by a Doctor or Nurse.

First, You Will Be Given G-CSF, Then Plerixafor MSN

The Stem Cell Mobilization Procedure Starts with the Administration of Another Medicine Called G-CSF (Granulocyte Colony-Stimulating Factor). G-CSF Helps Plerixafor MSN Work. If You Need More Information About G-CSF, Ask Your Doctor and Read the Relevant Package Leaflet.

What Is the Dose of Plerixafor MSN?

The Recommended Dose for Adults Is Either 20 mg (Fixed Dose) or 0.24 mg per Kilogram of Body Weight per Day.

The Recommended Dose for Children Aged 1 Year to Less Than 18 Years Is 0.24 mg per Kilogram of Body Weight per Day.

The Dose of Plerixafor MSN Is Determined Based on the Patient's Body Weight, So You Will Be Weighed in the Week Before the First Dose Is Given. If You Have Moderate or Severe Kidney Problems, Your Doctor Will Reduce the Dose.

How Is Plerixafor MSN Given?

Plerixafor MSN Is Given by Subcutaneous Injection (Under the Skin).

When Is Plerixafor MSN First Given?

The First Dose of Plerixafor MSN Is Given 6-11 Hours Before the Start of Apheresis (Collection of Haematopoietic Stem Cells).

How Long Will Plerixafor MSN Be Given?

The Medicine Will Be Given for 2 to 4 Consecutive Days (Sometimes Up to 7 Days), Until a Sufficient Number of Stem Cells Have Been Collected for Transplantation. In Rare Cases, the Collection of Haematopoietic Stem Cells May Not Be Successful, and the Procedure May Need to Be Stopped.

4. Possible Side Effects

Like All Medicines, This Medicine Can Cause Side Effects, Although Not Everybody Gets Them.

Tell Your Doctor as Soon as Possible If:

• You Get a Rash, Swelling Around the Eyes, Shortness of Breath, or Difficulty Breathing, Dizziness When Sitting or Standing, or Fainting Soon After Receiving Plerixafor MSN
• You Get Pain in the Upper Left Part of the Abdomen or in the Left Shoulder Area

Very Common Side Effects(May Affect More Than 1 in 10 People)

• Diarrhoea, Nausea (Feeling Sick), Redness or Irritation at the Injection Site, Low Red Blood Cell Count in Laboratory Tests (Anaemia in Children)

Common Side Effects(May Affect Up to 1 in 10 People)

• Headache
• Dizziness, Feeling Tired or Unwell
• Difficulty Sleeping
• Bloating, Constipation, Indigestion, Vomiting
• Abdominal Symptoms, Such as Pain, Feeling Full, 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, Shortness of Breath
• Anaphylactic Reactions, Including Anaphylactic Shock
• Abnormal Dreams, Nightmares

Rarely, Severe Gastrointestinal Side Effects (Diarrhoea, Vomiting, Abdominal Pain, and Nausea) May Occur.

Heart Attacks

In Clinical Trials, After Receiving Plerixafor MSN and G-CSF, There Were Uncommon Cases of Heart Attacks in Patients with Risk Factors for Heart Attack. Tell Your Doctor as Soon as Possible If You Get Chest Discomfort.

Tingling and Numbness

Tingling and Numbness Often Occur in Patients Receiving Anti-Cancer Treatment. These Symptoms Were Reported in About 1 in 5 Patients, but It Does Not Appear That They Occur More Frequently with Plerixafor MSN.

In Blood Tests, You May Also Have an Increased White Blood Cell Count (Leukocytosis).

Reporting of Side Effects

If You Get Any Side Effects, Talk to Your Doctor or Pharmacist. This Includes Any Possible Side Effects Not Listed in This Leaflet.

You Can Also Report Side Effects Directly to the Regulatory Authority.

5. How to Store Plerixafor MSN

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 Carton and Label After EXP.

The Expiry Date Refers to the Last Day of That Month.

Store in a Refrigerator (2°C - 8°C).

Plerixafor MSN Should Be Used Immediately After Opening the Package.

Medicines Should Not Be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medicines No Longer Required. These Measures Will Help Protect the Environment.

6. Contents of the Pack and Other Information

What Plerixafor MSN Contains

• 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 (for pH Adjustment), Sodium Hydroxide (for pH Adjustment), and Water for Injections.

What Plerixafor MSN Looks Like and Contents of the Pack

Plerixafor MSN Is a Clear, Colourless to Pale Yellow Solution in a Glass Vial.

Each Pack Contains 1 Vial with 1.2 mL of Solution.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

MSN Labs Europe Limited

KW20A, Corradino Park

Paola, PLA 3000

Malta

Tel: (+48) 699 711 147

Manufacturer/Importer:

Pharmadox Healthcare Limited

KW20A, Kordin Industrial Park

Paola, PLA 3000

Malta

MSN Labs Europe Limited

KW20A, Corradino Park

Paola, PLA 3000

Malta

This Medicinal Product Is Authorised in the Member States of the European Economic Area Under the Following Names:

Germany:

Plerixafor Vivanta Generics 20 mg/mL Injektionslösung, ENR: 7006277

Czech Republic:

Plerixafor MSN

Hungary:

Plerixafor MSN 20 mg/mL oldatos injekció

Poland:

Plerixafor MSN

Romania:

Plerixafor MSN 20 mg/mL soluţie injectabilă

Slovakia:

Plerixafor MSN

Bulgaria:

Плериксафор MSN 20 mg/mL инжекционен разтвор

Date of Last Revision of the Leaflet: