Pixuvri 29 mg powder for concentrate for solution for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

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. Content of the pack and other information

• 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 medicine 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.

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 100people

• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

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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.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: