PIXUVRI 29 мг Порошок для раствора для внутривенного введения

Содержание инструкции

1. Pixuvri 29 mg powder for concentrate for solution for infusion
   1. What is Pixuvri and what is it used for
   2. What you need to know before using Pixuvri
   3. How to use Pixuvri
   4. Possible side effects
   5. How to store Pixuvri
   6. Package contents and other information

Pixuvri 29 mg powder for concentrate for solution for infusion

pixantrone

Read this leaflet carefully before you use the medicine, as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• If any side effects occur, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet

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

1. What is Pixuvri and what is it used for

Pixuvri belongs to a pharmacotherapeutic category of medicines known as “antineoplastic agents”,
used in the treatment of tumors.
Pixuvri is used in the treatment of adult patients with aggressive, relapsed
non-Hodgkin lymphomas, or refractory to treatment. By binding to DNA, Pixuvri destroys tumor cells causing their death.
The medicine is used in patients in whom the tumor does not respond to treatment or has reappeared
after taking other chemotherapies.

2. What you need to know before using Pixuvri

Do not use Pixuvri:

• if you are allergic to pixantrone dimaleate or any of the other ingredients of this medicine (listed in section 6);
• if you have been vaccinated recently;
• if you know you have a low number of red blood cells, white blood cells and platelets, which persists for a long time;
• if you suffer from serious liver problems.

Warnings and precautions
Talk to your doctor before using Pixuvri:

• if you have been told you have a very low number of white blood cells;
• if you have heart problems or if your blood pressure is high, despite treatment, especially if you have previously suffered from heart failure or if you have had a heart attack in the last six months;
• if you have an ongoing infection;
• if you have never undergone cancer therapy before;
• if you are following a low-salt (sodium) diet;
• if you are taking other medicines that may interact with Pixuvri (see “Other medicines and Pixuvri”).

Skin sensitivity to sunlight
During therapy with pixantrone, exposure to natural or artificial sunlight (solariums or UVA/B treatments) must be minimized or avoided.
If you are exposed to sunlight, you must wear protective clothing and use sunscreens with strong UV-A absorption.

Children and adolescents
This medicine should not be given to children and adolescents under the age of 18, because there is no information available on the use of Pixuvri in children and adolescents.

Other medicines and Pixuvri
Tell your doctor if you are taking, have recently taken or might take any other medicines. This is extremely important, because the simultaneous use of multiple medicines can strengthen or weaken their effect. Pixuvri should not be used with other medicines, unless your doctor determines that it is safe to do so.
In particular, be sure to tell your doctor if you are using or have recently used any of the following medicines:
Tell your doctor if you are taking medicines such as:

• Warfarin, to prevent blood clots;
• Theophylline, for the treatment of lung conditions such as emphysema or asthma;
• Amitriptyline, used in the treatment of depression;
• Olanzapine, clozapine, for the treatment of schizophrenia or manic depression;
• Haloperidol, used in the treatment of anxiety and insomnia;
• Ondansetron, used for the prevention of nausea and vomiting during chemotherapy;
• Propranolol, to treat high blood pressure.

Pixuvri with food and drink
After therapy with Pixuvri, you do not need to change your diet, unless otherwise indicated by your doctor.

Pregnancy, breastfeeding and fertility
Pixuvri should not be given to pregnant women, as it may harm the fetus. If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding, ask your doctor for advice before taking this medicine.
During therapy with Pixuvri and for up to 6 months after the end of therapy, adequate contraceptive methods must be used. This applies to both fertile women and potentially fertile men treated with Pixuvri.
Women treated with Pixuvri should not breastfeed.

Driving and using machines
It is not known whether Pixuvri affects the ability to drive vehicles or use machines.

Pixuvri contains sodium
After reconstitution and dilution, this medicine contains approximately 1g per dose (43 mmol) of sodium (the main component of table salt). The amount is equivalent to 50% of the maximum daily sodium intake for an adult.

Information for patients following a low-salt (sodium) diet
After dilution, the medicine contains approximately 1,000 mg (43 mmol) of sodium per dose. This should be taken into consideration by patients following a low-sodium diet.

3. How to use Pixuvri

What dose to administer
The amount (dose) of Pixuvri that will be administered to you depends on your body surface area
expressed in square meters (m²). Body surface area is calculated based on height and weight. Account will also be
taken of the results of blood tests and your general health condition. The recommended dose is 50 mg/m². If necessary, the doctor will adjust the dose during treatment.
Before starting therapy with Pixuvri, your doctor will prescribe some tests.

How often to administer Pixuvri
Pixuvri is administered on days 1, 8 and 15 of each 28-day cycle for a maximum of 6 cycles.
Before the infusion, you may be given medications to prevent or reduce
any reactions to Pixuvri, such as anti-nausea drugs.

How to administer Pixuvri
Pixuvri is administered by intravenous infusion into a vein (intravenous infusion). Administration is
performed by a nurse or a doctor.

Duration of the infusion
The infusion will last approximately one hour, unless otherwise specified.

4. Possible side effects

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

Reactions due to infusion
In rare cases, pain/redness occurs at the injection site during the infusion of Pixuvri. If you experience pain or notice redness at the injection site, immediately inform the person administering the infusion. It may be necessary to slow down or
stop the infusion. If the symptoms disappear or improve, the infusion may continue.
Pixuvri is a dark blue solution; for a few days after the administration of Pixuvri, your skin or your eyes may take on a bluish tinge, as well as your urine. The change in
skin color generally resolves within a few days or weeks, with the elimination
of the drug.

Infections
Report any symptoms of infection (for example fever, chills, difficulty
breathing, cough, mouth ulcers, difficulty swallowing or severe diarrhea) to your doctor after therapy with
Pixuvri. After the administration of Pixuvri, it is easier to contract an infection.

Heart
There is a possibility that the heart's pumping function may weaken following treatment; it is
not excluded that a serious condition called “heart failure” may occur, especially if your
heart function was already compromised at the start of treatment with Pixuvri. The doctor will monitor the
heart function for signs or symptoms of heart involvement.

Tell your doctor if you think you are experiencing any of the following reactions
Very common side effects (may affect more than 1 in 10 people):

• nausea, vomiting;
• changes in skin color;
• thinning or loss of hair;
• abnormal urine color;
• physical weakness;
• decreased number of white blood cells, decreased number of red blood cells (anemia);
• decreased number of platelets in the blood (may require transfusion).

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

• infections such as lung infection, skin infections, infections with decreased number of white blood cells, thrush;
• fever;
• severe blood infection (sepsis);
• altered taste;
• altered skin sensitivity including numbness, tingling, prickling (paresthesia);
• headache;
• insomnia;
• fatigue;
• eye inflammation (conjunctivitis);
• diarrhea;
• abdominal pain;
• inflammation and/or ulceration of the throat and mouth;
• dry mouth, constipation, indigestion, loss of appetite;
• skin changes such as redness and itching, changes affecting the nails;
• heart damage, decreased ability of the heart to pump blood, blockage of electrical signals in the heart, irregular or fast heartbeat;
• low blood pressure;
• alteration of the color of the veins, skin pallor;
• shortness of breath, cough;
• presence of blood in the urine;
• excessive protein in the urine;
• swelling of the legs or ankles or in other parts of the body;
• bone pain;
• chest pain;
• low levels of phosphate in the blood;
• altered values of tests for liver or kidney function.

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

• severe infections including septic shock, bronchitis, pneumonia, candidiasis, cellulitis, meningitis, gastroenteritis;
• viral infections such as shingles or reactivation of other viruses such as oral Herpes;
• nervousness, insomnia;
• loss of energy;
• dizziness, vertigo;
• dry eyes;
• sensation of numbness in the mouth;
• corneal infection;
• allergy to the medicine;
• reduction of calcium and sodium concentration in the blood; increase of uric acid concentration in the blood;
• inflammation or fluid accumulation around the lungs;
• runny nose;
• bleeding such as intestinal bleeding or red spots on the body, due to rupture of blood vessels;
• venous irritation;
• night sweats;
• irregular heartbeat;
• spontaneous erection;
• rash and/or ulceration of the skin;
• pain, swelling, weakness, stiffness of joints or muscles;
• reduction of the amount of urine emitted each time;
• weight loss;
• increased bilirubin in the blood or urine;
• inflammation of the esophagus;
• neck, back, limb pain;
• nail infection;
• progression of the neoplasm (tumor);
• development of new bone marrow or blood tumors, such as acute myeloid leukemia (AML)
• myelodysplastic syndrome (MDS)
• liver damage;
• bone marrow failure;
• increased eosinophils in the blood.

Reporting of side effects
If you get any side effects, talk to your doctor. You can also report side effects directly through the national reporting system listed in Annex V.
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Pixuvri

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 label of the vial and on the
pack after “Exp.”. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C).
Keep the vial in the outer packaging to protect the medicine from light.
Pixuvri does not contain any components able to prevent bacterial growth and therefore its
immediate use after reconstitution is recommended. If this is not possible, the storage times and
conditions before administration are the responsibility of the user and must not
exceed 24 hours at a temperature of 2°C – 8°C.
The reconstituted pixantrone solution is stable for 24 hours at room temperature (from 15°C to 25°C) if
stored in standard infusion bags.
Each vial of Pixuvri is for single use only. Unused medicine and waste
derived from this medicine, including materials used for reconstitution, dilution and
administration, must be disposed of in accordance with current local regulations.

6. Package contents and other information

What Pixuvri contains

• The active substance is pixantrone. Each vial contains 50 mg of pixantrone dimaleate (equivalent to 29 mg of pixantrone). The other components are lactose monohydrate, sodium hydroxide, hydrochloric acid and sodium chloride.

Description of the appearance of Pixuvri and package contents
Pixuvri is a powder for concentrate for solution for infusion. It is presented as a dark blue powder in vials containing 29 mg of pixantrone. Pack: 1 vial.

Marketing Authorisation Holder
Les Laboratoires Servier
50, rue Carnot
92284 Suresnes cedex
France

Manufacturer/s
Les Laboratoires Servier Industrie
905 route de Saran
45520 Gidy
France
For further information on this medicine, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
S.A. Servier Benelux N.V.
Tél/Tel: +32 (0)2 529 43 11

Lietuva
UAB “SERVIER PHARMA”
Tel: +370 (5) 2 63 86 28

България
Сервие Медикал ЕООД
Тел.: +359 2 921 57 00

Luxembourg/Luxemburg
S.A. Servier Benelux N.V.
Tel: +32 (0)2 529 43 11

Česká republika
Servier s.r.o.
Tel: +420 222 118 111

Magyarország
Servier Hungaria Kft.
Tel: +36 1 238 7799

Danmark
Servier Danmark A/S
Tlf: +45 36 44 22 60

Malta
V.J. Salomone Pharma Ltd
Tel: + 356 21 22 01 74

Deutschland
Servier Deutschland GmbH
Tel: +49 (0)89 57095 01

Nederland
Servier Nederland Farma B.V.
Tel: + 31 (0)71 5246700

Eesti
Servier Laboratories OÜ
Tel:+ 372 664 5040

Norge
Servier Danmark A/S
Tlf: +45 36 44 22 60

Eλλάδα
ΣΕΡΒΙΕ ΕΛΛΑΣ ΦΑΡΜΑΚΕΥΤΙΚΗ ΕΠΕ
Τηλ: + 30 210 939 1000

Österreich
Servier Austria GmbH
Tel: +43 (1) 524 39 99

España
Laboratorios Servier S.L.
Tel: + 34 91 748 96 30

Polska
Servier Polska Sp. z o.o.
Tel: + 48 (0) 22 594 90 00

France
Les Laboratoires Servier
Tél: + 33 (0)1 55 72 60 00

Portugal
Servier Portugal, Lda
Tel: + 351 21 312 20 00

Hrvatska
Servier Pharma, d. o. o.
Tel: + 385 (0)1 3016 222

România
Servier Pharma SRL
Tel: + 4 021 528 52 80

Ireland
Servier Laboratories (Ireland) Ltd.
Tel: + 353 (0)1 663 8110

Slovenija
Servier Pharma d. o. o.
Tel: + 386 (0)1 563 48 11

Ísland
Servier Laboratories
c/o Icepharma hf
Sími: + 354 540 8000

Slovenská republika
Servier Slovensko spol. s r.o.
Tel: + 421 2 5920 41 11

Italia
Servier Italia S.p.A.
Tel: + 39 (06) 669081

Suomi/Finland
Servier Finland Oy

• P. /Tel: +358 (0)9 279 80 80

Κύπρος
CA Papaellinas Ltd.
Τηλ: + 357 22 741 741

Sverige
Servier Sverige AB
Tel : +46 (0)8 522 508 00

Latvija
SIA Servier Latvia
Tel: + 371 67502039

United Kingdom
Servier Laboratories Ltd
Tel: +44 (0)1753 666409

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu
This leaflet is available in all languages of the European Union/European Economic Area on the
website of the European Medicines Agency.
__________________________________________________________________________________

• The following information is intended for healthcare professionals only:

Detailed instructions for users
BEFORE PROCEEDING WITH RECONSTITUTION, READ ALL
INSTRUCTIONS FOR PREPARATION CAREFULLY
Special precautions for use
Pixuvri is an antitumour medicine harmful to cells; caution is required during
handling. Avoid contact with eyes and skin. Wear gloves, masks and protective eyewear during handling and decontamination procedures. If Pixuvri
(lyophilised powder or reconstituted liquid solution) comes into contact with the skin, wash the skin immediately and
rinse membranes thoroughly with water.

Reconstitution/preparation for intravenous administration
Each single-dose vial of Pixuvri contains an amount of pixantrone dimaleate equivalent to 29
mg of pixantrone. After reconstitution with 5 ml of a sodium chloride 9
mg/ml (0.9%) injection solution, each ml of concentrate contains pixantrone dimaleate, equivalent to 5.8 mg of
pixantrone.
Reconstitute each 29 mg vial in aseptic conditions with 5 ml of sodium chloride
9 mg/ml (0.9%) solution. Shaking the vial should dissolve the powder completely within 60
seconds. This results in a dark blue solution with a pixantrone concentration of 5.8
mg/ml.
Following aseptic procedures, draw up the volume required for the required dose (based on a
concentration of 5.8 mg/ml) and then dilute with a sodium chloride 9 mg/ml
(0.9%) solution for infusion and make up to a volume of 250ml. Compatibility with other
diluents has not been established. After transfer, thoroughly mix the contents of the infusion bag.
The mixture should be a dark blue solution.
During the administration of the diluted solution of Pixuvri, the use of in-line filters with 0.2 µm pores in
polyethersulfone is recommended.

Storage conditions before administration
Pixuvri does not contain components capable of preventing bacterial growth and, therefore, it is
recommended to use it immediately after reconstitution. If not, the storage times and conditions before administration are the responsibility of the user and must not
exceed 24 hours at a temperature of 2°C – 8°C.
The reconstituted and diluted solution is stable for 24 hours at room temperature (from 15°C to 25°C) if
exposed to sunlight in standard polyethylene (PE) infusion bags.

Special precautions for disposal and handling
Pixuvri is a cytotoxic agent. Unused medicine and waste derived from this medicine
must be disposed of in accordance with local regulations.
Devices and surfaces accidentally contaminated with Pixuvri must be treated with a
solution of sodium hypochlorite (100 µl of water and 20 µl of sodium hypochlorite [7 ± 2% available chlorine
] per 0.58 mg of Pixuvri).
Instruments such as vials, needles and syringes used for the administration of Pixuvri must be
handled as toxic waste.