29 mg powder for concentrate for solution for infusion
pixantrone
What Pixuvri is and what it is used for
Pixuvri belongs to a group of pharmacotherapeutic agents called ‘antineoplastic agents’. These are used as a treatment for cancer.
Pixuvri is used to treat adult patients who have had multiple relapses or have refractory aggressive non-Hodgkin’s lymphoma. Pixuvri kills cancer cells by binding to DNA, leading to cell death. It is used for patients in cases where their cancer does not respond to or has recurred after other chemotherapy treatments.
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 recently been vaccinated,
- if you have been told that you have a persistent, persistently low number of red blood cells, white blood cells, and platelets,
- if you have very serious liver problems.
Warnings and cautions
Talk to your doctor before using Pixuvri
- if you have been told that you have a very low white blood cell count,
- if you suffer from heart disease or uncontrolled high blood pressure, especially if you have ever been told that you have had heart failure or if you have had a heart attack in the last six months,
- if you have an infection,
- if you have ever been treated for cancer,
- if you are on a special sodium-poor diet,
- if you are taking other medicines that may interact with Pixuvri (see “Other medicines and Pixuvri” below).
Sensitivity of the skin to sunlight
During your treatment with pixantrone, expose yourself as little as possible or completely avoid natural and artificial sunlight (tanning beds or UVA / B treatment). If you are exposed to sunlight, wear sunscreen and use sunscreen that is highly UV-A absorbent.
Children and young people
This medicine should not be given to children under the age of 18 as there is no information on the treatment of children and adolescents with Pixuvri.
Other medicines and Pixuvri
Tell your doctor if you are taking, have recently taken, or might take any other medicines. This is extremely important as concomitant use of more than one drug may enhance or weaken their effect. Pixuvri should not be used with other medicines unless your doctor tells you to. Be especially careful to tell your doctor if you are currently taking, or have recently taken, any of the following medicines:
Tell your doctor if you are taking any of the following medicines:
- Warfarin to prevent the formation of blood clots
- Theophylline for the treatment of lung diseases such as emphysema or asthma
- Amitriptyline for the treatment of depression
- Olanzapine, clozapine for the treatment of schizophrenia or manic depression
- Haloperidol for the treatment of anxiety and insomnia
- Ondansetron to prevent nausea and vomiting during chemotherapy
- Propranolol for the treatment of high blood pressure
Pixuvri with food and drink
You do not need to change your diet after treatment with Pixuvri unless your doctor tells you to.
Pregnancy, breastfeeding, and fertility
Pixuvri should not be given to pregnant women as it may harm the unborn baby. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Appropriate contraceptives must be used during treatment with Pixuvri and for a maximum of 6 months after treatment. This applies to women who may become pregnant and men who receive Pixuvri and can have children.
Do not breastfeed while you are being treated with Pixuvri.
Driving and using machines
It is not known if Pixuvri affects the ability to drive or use machines.
Pixuvri contains sodium
After reconstitution and dilution, this medicinal product contains approximately 1 g (43 mmol) of sodium (the main ingredient in table salt/table salt) per dose. This corresponds to 50% of the maximum recommended daily intake of sodium for adults.
How to use Pixuvri
How much Pixuvri will be given
The amount ( dose ) of Pixuvri you will receive depends on your body surface area in square meters (m 2 ). This is determined by your height and weight. Your blood test results and your state of health will also be taken into account.
The recommended dose is 50 mg / m 2 . If necessary, your doctor will adjust dose one during treatment.
Your doctor will perform some tests before you receive Pixuvri.
How often Pixuvri will be given
Pixuvri is given on days 1, 8, and 15 of each 28-day cycle for up to 6 cycles.
Before infusion, you may be given medicines to prevent or reduce any reactions to Pixuvri, such as medicines for nausea.
How Pixuvri will be given
Pixuvri will be given as a drip into a vein (by intravenous infusion ). This will be performed by a nurse or doctor.
How long an infusion one will take
It will take about an hour unless otherwise stated.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Infusion reactions
Pain/redness at the injection site may in rare cases occur during the infusion of Pixuvri. Tell the person giving you the infusion immediately if it hurts or if the injection site turns red. Infusion one may need to be slowed down or discontinued. When these symptoms disappear or improve, the infusion can be resumed.
Pixuvri has a deep blue color and for several days after receiving Pixuvri, your skin and eyes may get a bluish discoloration, just as your urine may discolor in blue. The discoloration of the skin usually disappears after a few days or weeks as the drug is eliminated.
Infection is
Tell your doctor if you get any symptoms of infection (such as fever, chills, difficulty breathing, cough, mouth ulcers, difficulty swallowing, or severe diarrhea) after treatment with Pixuvri. You may get an infection more easily after receiving Pixuvri.
Heart
There is a risk that your heart’s pumping function may be impaired as a result of treatment or that you may develop a serious condition called heart failure, especially if you already had impaired heart function at the start of Pixuvri treatment. Your doctor will monitor your heart function to see if there are any signs or symptoms that your heart may be affected.
Tell your doctor if you think you have any of the following reactions
Very common: may affect more than 1 in 10 people
- nausea, vomiting
- skin discoloration
- thinning or loss of hair
- abnormal staining of the urine
- physical weakness
- low white blood cell count, low red blood cell count ( anemia ), and low platelet count (may require transfusion ).
Common: may affect up to 1 in 10 people
- infection such as lung infection, skin infections, infections is with low white blood cell count, cod
- fever
- blood poisoning ( sepsis )
- changed taste experience
- abnormal skin sensations such as numbness, and crawling or tingling ( paresthesia )
- headache
- somnolence
- fatigue
- inflammation of the eyes ( 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 of the skin, nail changes
- heart damage, decrease in the heart’s ability to pump blood, blocking of electrical signals in the heart, uneven or fast heart rate
- low blood pressure
- vascular discoloration, pale skin
- shortness of breath, cough
- blood in the urine
- excess protein is in the urine
- swollen legs or calves or other parts of the body
- pain in the skeleton
- chest pain
- low levels of phosphate in the blood
- an abnormal blood test of liver or kidney function.
Uncommon: may affect up to 1 in 100 people
- severe infections such as septic shock, inflammation of the lungs’ airways, pneumonia, fungal infection, inflammation of the skin ( cellulite ), meningitis, infection of the gastrointestinal tract
- viral infections such as shingles or reactivation of another virus such as oral herpes
- nervousness, insomnia
- reduced energy
- dizziness, fraud
- dry eyes
- numbness in the mouth
- corneal infection
- allergy to the drug
- decreased calcium and sodium levels in the blood, increased uric acid levels in the blood
- inflammation or accumulation of fluid around the lungs
- Suva
- bleeding such as bleeding in the intestine, purple spots on the body due to broken blood vessels
- vascular irritation
- night sweats
- irregular heartbeats
- spontaneous erection
- skin rash and/or ulceration
- pain, swelling, weakness, stiffness in joints or muscles
- reduced urine production
- weight loss
- elevated bilirubin in the blood or urine
- inflammation of the esophagus
- pain in the neck, back, extremities er
- nail infection
- development of a neoplasm ( tumor )
- new bone marrow or blood cancer, such as acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)
- liver damage
- bone marrow failure
- increased eosinophils in the blood
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 vial label and the carton after “EXP”. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C to 8 ° C).
Keep the vial in the outer carton. Sensitive to light.
Pixuvri contains nothing that prevents the growth of bacteria and should therefore be used immediately after reconstitution. If not used immediately, in-use storage times and conditions before use should not be allowed to exceed 24 hours from 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 product or waste material should be disposed of by local requirements.
Contents of the pack and other information
Content declaration
- The active substance is pixantrone. Each vial contains 50 mg of pixantron dimaleate (equivalent to 29 mg of pixantron). The other ingredients are lactose monohydrate, sodium hydroxide, hydrochloric acid, and sodium chloride.
What the medicine looks like and the contents of the pack
Pixuvri is a powder for concentrate for solution for infusion. It is a dark blue powder that is supplied in vials containing 29 mg pixantrone. Pack size: 1 vial.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Servier Laborierires Servier
50, rue Carnot
92284 Suresnes Cedex
France
Manufacturer
The Laboratory Servier Industrie
905 Route de Saran
45520 Judy
France
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienSA Servier Benelux NVTel: +32 (0) 2 529 43 11 | LithuaniaUAB “SERVIER PHARMA”Tel: +370 (5) 2 63 86 28 |
| BulgariaMedical LODG serviceTel: +359 2 921 57 00 | Luxembourg / LuxemburgSA Servier Benelux NVTel: +32 (0) 2 529 43 11 |
| Czech RepublicServier sroTel: +420 222 118 111 | HungaryServier Hungaria Kft.Tel: +36 1 238 7799 |
| DenmarkServier Danmark A / STel: +45 36 44 22 60 | MaltaVJ Salomone Pharma Ltd Tel: + 356 21 22 01 74 |
| GermanyServier Deutschland GmbHTel: +49 (0) 89 57095 01 | The NetherlandsServier Nederland Farma BVTel: + 31 (0) 71 5246700 |
| EestiServier Laboratories OÜTel: + 372 664 5040 | NorwayServier Danmark A / STel: +45 36 44 22 60 |
| E λλάδα ΕΠΕ ΕΛΛΑΣ ΦΑΡΜΑΚΕΥΤΙΚΗ ΕΠΕ :Ηλ: + 30 210 939 1000 | AustriaServier Austria GmbHTel: +43 (1) 524 39 99 |
| SpainServierios Servier SLTel: + 34 91 748 96 30 | PolandServier Polska Sp. z ooTel: + 48 (0) 22 594 90 00 |
| FranceServier Laborierires ServierTel: + 33 (0) 1 55 72 60 00 | PortugalServier Portugal, LdaTel: + 351 21 312 20 00 |
| CroatiaServier Pharma, dooTel: + 385 (0) 1 3016 222 | RomaniaServier Pharma SRLTel: + 4 021 528 52 80 |
| IrelandServier Laboratories (Ireland) Ltd.Tel: + 353 (0) 1 663 8110 | SloveniaServier Pharma dooTel: + 386 (0) 1 563 48 11 |
| IcelandServier Laboratoriesc / o Icepharma hfPhone: + 354 540 8000 | Slovak RepublicServier Slovensko spol. s roTel: + 421 2 5920 41 11 |
| ItalyServier Italia SpATel: + 39 (06) 669081 | Finland / FinlandServier Finland OyP. / Tel: +358 (0) 9 279 80 80 |
| .ΠροςCA Papaellinas Ltd.:Ηλ: + 357 22 741 741 | SwedenServier Sverige ABTel: +46 (0) 8 522 508 00 |
| LatviaSIA Servier LatviaTel: + 371 67502039 | United KingdomServier Laboratories LtdTel: +44 (0) 1753 666409 |