Pixuvri
pixantrone dimaleate
pixantrone
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor.
If you get any side effect, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.
What Pixuvri is and what it is used for
What you need to know before you use Pixuvri
How to use Pixuvri
Possible side effects
How to store Pixuvri
Content of the pack and other information
Pixuvri belongs to a pharmacotherapeutic group of medicines known as ‘antineoplastic agents’. These are used to treat cancer.
Pixuvri is used for the treatment of adult patients with multiply relapsed or refractory aggressive Non-Hodgkin Lymphomas. Pixuvri kills cancer cells by binding to DNA, resulting in cell death. It is used for patients whose cancer does not respond or has returned after they have received other chemotherapy treatments.
if you are allergic to pixantrone dimaleate or any of the other ingredients of this medicine (listed in section 6).
if you have recently received a vaccine.
if you have been told that you have persistent, long-term low numbers of red blood cells, white blood cells, and platelets.
if you have very severe liver problems.
Talk to your doctor before using Pixuvri:
if you have been told that your white blood cell count is very low.
if you have heart disease or uncontrolled high blood pressure, especially if you have ever been told you had heart failure or if you have had a heart attack within the last six months.
if you have an infection.
if you have ever been treated for cancer.
if you follow a specific sodium restricted diet.
if you are taking other medicines which could interact with Pixuvri (see ‘Taking other medicines’ below).
During treatment with pixantrone, you should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment). If you will be exposed to sunlight, you should wear sun- protective clothing and use sunscreen that strongly absorbs UV-A.
Do not give this medicine to children under the age of 18 years because there is no information about Pixuvri treatment in children and adolescents.
Tell your doctor if you are taking, have recently taken or might take any other medicines. This is extremely important as using more than one medicine at the same time can strengthen or weaken their effect. Pixuvri must not be used with other medicines unless your doctor has told you it is safe to do so.
In particular, make sure to tell your doctor if you are currently using, or have recently used, any of the following medicines:
Tell your doctor if you take medicines such as:
Warfarin to prevent blood clot formation
Theophylline to treat lung conditions like emphysema or asthma
Amitriptyline to treat depression
Olanzapine, Clozapine to treat schizophrenia or maniac depression
Haloperidol to treat anxiety and sleeplessness
Ondansetron to prevent nausea and vomiting during chemotherapy
Propranolol to treat high blood pressure
You do not have to change your diet after treatment with Pixuvri unless instructed by your doctor.
Pixuvri must not be given to pregnant women as it may cause harm to unborn babies. If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Adequate contraceptive precautions must be used when receiving Pixuvri and for up to 6 months after treatment. This applies to women who can become pregnant and men receiving Pixuvri who may be able to father a child.
Do not breast-feed while you are being treated with Pixuvri.
It is not known whether Pixuvri has an effect on your ability to drive a car or use machines.
Upon reconstitution and dilution, this medecine contains approximately 1g (43 mmol) sodium (main component of cooking salt) per dose. This is equivalent to 50% of the recommended maximum daily dietary intake of sodium for an adult.
The amounts (dose) of Pixuvri that will be given to you will depend on your body surface area in square meters (m2). This is determined by your height and weight. The results of blood tests and your medical condition will also be taken into account. The recommended dose is 50 mg/m2. If necessary, your doctor will adjust the dose during treatment.
Your doctor will carry out some tests before you are given Pixuvri.
Pixuvri is given on days 1, 8, and 15 of each 28-day cycle for up to 6 cycles.
Before the infusion is administered you may be given medicines to prevent or reduce possible reactions to Pixuvri, such as medicines to prevent sickness.
Pixuvri is given through a drip into a vein (by intravenous infusion). This will be done by a nurse or doctor.
This will take approximately one hour unless otherwise stated.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Pain/redness of the injection site may occur rarely during infusion of Pixuvri. Tell the person giving you the infusion immediately if you feel pain or if the injection site gets red. The infusion may need
to be slowed down or stopped. When these symptoms go away or improve, the infusion can be
continued.
Pixuvri has a deep blue colour and for several days after receiving Pixuvri, your skin and eyes may develop a bluish discolouration, and your urine may have a bluish discolouration. The skin discolouration generally disappears over a few days to weeks as the drug is cleared.
Tell your doctor if you get any symptoms of an infection (for example, fever, chills, trouble breathing, cough, sores in your mouth, trouble swallowing, or severe diarrhoea) after Pixuvri
treatment. You might get infections more easily after you have been given Pixuvri.
There is a possibility that your heart pumping function could decrease as a result of the treatment or you might even develop a serious condition called heart failure, especially if your heart function was
already compromised at the beginning of the treatment with Pixuvri. Your doctor will monitor your
heart function if there is any sign or symptom of your heart being affected.
Very common: may affect more than 1 in 10 people
nausea, vomiting
skin discolouration
thinning or loss of hair
abnormal colouration of the urine
physical weakness
low number of white blood cells, low number of red blood cells (anaemia), and low number of platelets in the blood (may require transfusion).
Common: may affect up to 1 in 10 people
infection such as lung infection, skin infections, infections with low white blood cells, thrush
fever
severe blood infection (sepsis)
taste disturbances
abnormal sensations of the skin such as numbness, tingling, pricking (paraesthesia)
headache
sleepiness
tiredness
inflammation of the eyes (conjunctivitis)
diarrhoea
pain in the abdomen
inflammation and/or ulceration of the throat and the mouth
dry mouth, constipation, indigestion, loss of appetite
skin changes such as redness and itching of the skin, nail changes
damage to the heart, decrease in heart’s ability to pump blood, blockage of electrical signals in your heart, uneven or fast heartbeat.
low blood pressure
vein discolouration, pale skin
shortness of breath, cough
blood in urine
excess protein in urine
swelling of legs or ankles or other parts of the body
bone pain
chest pain
low levels of phosphate in the blood
abnormal blood test for liver or kidney function.
Uncommon: may affect up to 1 in 100 people
severe infections such as septic shock, bronchitis, pneumonia, candidiasis, cellulitis, meningitis, gastroenteritis
viral infections such as shingles or reactivation of other virus such as herpes in the mouth
nervousness, sleeplessness
loss of energy
dizziness, vertigo
dryness of the eye
numbness of the mouth
infection of the cornea
allergy to the medicine
decrease in blood calcium and sodium level; increase in blood uric acid level
inflammation or fluid accumulation around the lungs
runny nose
bleeding such as gut bleed, purple spots on body due to broken blood vessels
vein irritation
night sweats
irregular heartbeat
spontaneous erection
skin rash and/or ulceration
pain, swelling, weakness, stiffness in joints or muscles
decreased urinary output
loss of weight
increased bilirubin in blood or urine
inflammation of the gullet
pain in neck, back, extremities
nail infection
neoplasm (tumour) progression
new cancers of the bone marrow or blood, such as acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS)
liver damage
bone marrow failure
increased eosinophils in blood.
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 which is stated on the vial label and carton after “EXP”. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C to 8°C).
Keep the vial in the outer carton in order to protect from light.
Pixuvri does not contain anything to prevent the growth of bacteria and it is, therefore, recommended that it be used immediately after reconstitution. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2°C to 8°C.
Reconstituted pixantrone solution is stable for up to 24 hours at room temperature (15°C to 25°C) in standard infusion bags.
Pixuvri is for single use only. Any unused medicinal product or waste material, including materials used for reconstitution, dilution, and administration should be disposed of in accordance with local requirements.
The active substance is pixantrone. Each vial contains 50 mg pixantrone dimaleate (equivalent to 29 mg pixantrone). The other ingredients are lactose monohydrate, sodium hydroxide, hydrochloric acid, and sodium chloride.
Pixuvri is a powder for concentrate for solution for infusion. It appears as a dark blue powder which comes in vials containing 29 mg of pixantrone. Pack size: 1 vial.
Les Laboratoires Servier 50, rue Carnot
92284 Suresnes cedex France
Les Laboratoires Servier Industrie 905 Route de Saran
45520 Gidy France
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
S.A. Servier Benelux N.V. Tél/Tel: +32 (0)2 529 43 11
UAB “SERVIER PHARMA” Tel: +370 (5) 2 63 86 28
Сервие Медикал ЕООД Тел.: +359 2 921 57 00
S.A. Servier Benelux N.V. Tel: +32 (0)2 529 43 11
Servier s.r.o.
Tel: +420 222 118 111
Servier Danmark A/S Tlf: +45 36 44 22 60
V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 74
Servier Deutschland GmbH Tel: +49 (0)89 57095 01
Servier Nederland Farma B.V. Tel: + 31 (0)71 5246700
Servier Laboratories OÜ Tel:+ 372 664 5040
Servier Danmark A/S Tlf: +45 36 44 22 60
ΣΕΡΒΙΕ ΕΛΛΑΣ ΦΑΡΜΑΚΕΥΤΙΚΗ ΕΠΕ Τηλ: + 30 210 939 1000
Servier Austria GmbH Tel: +43 (1) 524 39 99
Laboratorios Servier S.L. Tel: + 34 91 748 96 30
Servier Polska Sp. z o.o. Tel: + 48 (0) 22 594 90 00
Les Laboratoires Servier Tél: + 33 (0)1 55 72 60 00
Servier Portugal, Lda Tel: + 351 21 312 20 00
Servier Pharma, d. o. o. Tel: + 385 (0)1 3016 222
Servier Pharma SRL Tel: + 4 021 528 52 80
Servier Laboratories (Ireland) Ltd. Tel: + 353 (0)1 663 8110
Servier Pharma d. o. o. Tel: + 386 (0)1 563 48 11
Servier Laboratories c/o Icepharma hf Sími: + 354 540 8000
Servier Italia S.p.A. Tel: + 39 (06) 669081
Servier Finland Oy
P. /Tel: +358 (0)9 279 80 80
CA Papaellinas Ltd.
Τηλ: + 357 22 741 741
Servier Sverige AB
Tel : +46 (0)8 522 508 00
SIA Servier Latvia Tel: + 371 67502039
Servier Laboratories (Ireland) Ltd Tel: +44 (0)1753 666409
This leaflet is available in all EU/EEA languages on the European Medicines Agency website.
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The following information is intended for healthcare professionals only:
Detailed instructions for users
Pixuvri is an anticancer medicinal product that is harmful to cells; caution should be exercised in handling. Avoid contact with eyes and skin. Use gloves, masks, and protective eyewear when
handling and during decontamination procedures. If Pixuvri (lyophilised powder or reconstituted
liquid solution) contacts the skin, wash the skin immediately and flush the membranes thoroughly with water.
Each single-use vial of Pixuvri contains pixantrone dimaleate equivalent to 29 mg pixantrone. After reconstitution with 5 ml sodium chloride 9 mg/ml (0.9%) solution for injection, each ml of
concentrate contains pixantrone dimaleate equivalent to 5.8 mg pixantrone.
Using sterile procedures, reconstitute each 29 mg vial with 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection. The powder should completely dissolve in 60 seconds with agitation. This yields a dark blue solution with a pixantrone concentration of 5.8 mg/ml.
Using sterile procedures, withdraw the volume needed for the required dose (based on 5.8 mg/ml concentration) and further dilute with sodium chloride 9 mg/ml (0.9%) solution for injection to a final volume of 250 ml.
Compatibility with other diluents has not been determined. After transferring, thoroughly mix the contents of the infusion bag. The mixture should be a dark blue solution.
Polyethersulfone 0.2 µm pore size in-line filters should be used during administration of the diluted Pixuvri solution.
Pixuvri does not contain anything to prevent the growth of bacteria and it is therefore recommended that it be used immediately after reconstitution. If not used immediately, in-use storage times and
conditions prior to use are the responsibility of the user and should not be longer than 24 hours at
2°C to 8°C.
The reconstituted and diluted solution is stable for up to 24 hours at room temperature (15°C to 25°C) and daylight exposure in standard polyethylene (PE) infusion bags.
Pixuvri is a cytotoxic agent. Any unused product or waste material should be disposed of in accordance with local requirements.
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% of available chlorine] for 0.58 mg of Pixuvri).
Equipment such as vials, needles and syringes used for Pixuvri administration should be handled as toxic waste.