Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - plerixafor

Document Subject

Generated Narrative: MedicinalProductDefinition mpaefacad9a6795a89d3df82b1bc20e9aa

identifier: http://ema.europa.eu/identifier/EU/1/22/1701/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Plerixafor Accord 20 mg/ml solution for injection

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-aefacad9a6795a89d3df82b1bc20e9aa

identifier: http://ema.europa.eu/identifier/EU/1/22/1701/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - plerixafor

Attesters

What is in this leaflet:

1. What Plerixafor Accord is and what it is used for
2. What you need to know before you use 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

Plerixafor Accord contains the active substance plerixafor which blocks a protein on the surface of blood stem cells. This protein ties blood stem cells to the bone marrow. Plerixafor improves the release of stem cells into the blood stream (mobilisation). The stem cells can then be collected by a machine that separates blood constituents (apheresis machine), and subsequently frozen and stored until your transplant.

If mobilisation is poor, Plerixafor Accord is used to help collect blood stem cells from the patient, for collection, storage and reintroduction (transplantation),

In adults who have lymphoma (a cancer of the white blood cells) or multiple myeloma (a cancer that affects plasma cells in the bone marrow).

In children age 1 to less than 18 years of age with lymphoma or solid tumours.

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 Talk to your doctor or pharmacist or nurse before using Plerixafor Accord.

Tell your doctor:

• if you have or have had any heart problems.
• if you have kidney problems. Your doctor may adjust the dose.
• if you have high white blood cell counts.
• if you have low platelet counts.
• if you have a history of feeling faint or lightheaded on standing or sitting or have fainted before upon injections.

Your doctor may perform regular blood tests to monitor your blood cell count.

It is not recommended to use Plerixafor Accord for stem cell mobilisation if you have leukaemia (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 breast-feeding You should not use Plerixafor Accord if you are pregnant, since there is no experience with Plerixafor Accord in pregnant women. It is important to tell your doctor if you are, think you may be or are planning to become pregnant. It is recommended to use contraception if you are of child-bearing age.

You should not breast-feed if you are using Plerixafor Accord, since it is not known if Plerixafor Accord is excreted in human 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 sodium (23 mg) per dose, that is to say essentially sodium- free .

Your medicine will be injected by a doctor or a nurse.

You will first receive G-CSF, then you will be given Plerixafor Accord Mobilisation will be started by first giving you another medicine called G-CSF (granulocyte-colony stimulating factor). G-CSF will help Plerixafor Accord to work properly in your body. If you want to know more about G-CSF ask your doctor and read the corresponding package leaflet.

How much Plerixafor Accord is given? The recommended adult dose is either a 20 mg (fixed dose) or 0.24 mg/kg body weight/day. The recommended dose for children, 1 to less than 18 years of age is 0.24 mg/kg of 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 given by subcutaneous injection (under your skin).

When is Plerixafor Accord given for the first time? You will receive your first dose 6 to 11 hours before apheresis (collection of your blood stem cells).

How long will Plerixafor Accord be given? Treatment lasts 2 to 4 consecutive days (in some cases up to 7 days), until enough stem cells have been collected for your transplant. In a few cases, enough stem cells may not be collected, and the collection attempt will be stopped.

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

Please tell your doctor immediately if

• shortly after receiving plerixafor, you experience rash, swelling around the eyes, shortness of breath or lack of oxygen, feeling lightheaded on standing or sitting, feeling faint or fainting
• you have pain in the upper left abdomen (belly) or your left shoulder

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

• diarrhoea, nausea (feeling sick), injection site redness or irritation
• low red blood cell count by laboratory test (anaemia in children)

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

• headache
• dizziness, feeling tired or unwell
• difficulty in sleeping
• flatulence, constipation, indigestion, vomiting
• stomach symptoms such as pain, swelling or discomfort
• dry mouth, numbness around the mouth
• sweating, generalised redness of the skin, joint pains, pains in muscles and bones

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, gastrointestinal side effects may be severe (diarrhoea, vomiting, stomach pain and nausea).

Heart attacks In clinical trials, patients with risk factors for a heart attack uncommonly suffered heart attacks after being given Plerixafor Accord and G-CSF. Please inform your doctor immediately if you experience chest discomfort.

Pins and needles and numbness Pins and needles and numbness are common in patients being treated for cancers. About one in five patients suffered from these feelings. However, these effects do not seem to occur more frequently when you use Plerixafor Accord. You may also have an increase in white blood cells count (leucocytosis), in your blood tests.

Reporting of side effects If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 that month.

This medicine does not require any special storage conditions

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

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Plerixafor Accord contains

• The active substance is plerixafor. Each ml solution for injection contains 20 mg plerixafor. Each vial contains 24 mg plerixafor in 1.2 ml solution.
• The other ingredients are sodium chloride, hydrochloric acid (concentrated) and sodium hydroxide and water for injections (see section 2 Plerixafor Accord contains sodium ).

What Plerixafor Accord looks like and contents of the pack
Plerixafor Accord is supplied as a clear colourless or pale yellow solution for injection in a glass vial with a rubber stopper, aluminium flip-off seal and PP plastic blue mate top. Each vial contains 1.2 ml solution.

Each pack contains 1 vial.

Marketing Authorisation Holder

Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est 6 planta,
08039 Barcelona,
Spain

Manufacturer Accord Healthcare Polska Sp.z o.o. ul. Lutomierska 50, 95-200 Pabianice, Poland

Or Laboratori Fundaci 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

This leaflet was last revised in