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Pixantrone parenteral


Concentrate for infusions containing pixantrone (as dimaleate).

Drugs List

  • pixantrone 29mg powder for concentrate for solution for infusion
  • PIXUVRI 29mg powder for concentrate for solution for infusion
  • Therapeutic Indications


    Relapsed or refractory B-cell non-Hodgkin's lymphoma - monotherapy


    When using this agent, specialist literature, national guidelines, cancer networks protocols and Trust chemotherapy protocols should be consulted.


    The recommended dose is 50mg/metre squared of pixantrone on days 1, 8 and 15 of each 28-day cycle for up to 6 cycles.

    Dose should be adjusted based on nadir haematological counts and maximum toxicity from the previous cycle. Neutropenia usually reaches its nadir on days 15 to 22 and normally recovers by day 28.

    Additional Dosage Information

    Dose modifications for haematologic toxicities
    On day 1 of any cycle
    Platelet count less than 75 x 10 to the power 9/litre and/or absolute neutrophil count (ANC) less than 1.0 x 10 to the power 9/litre: Suspend treatment until platelet count greater than or equal to 75 x 10 to the power 9/litre and ANC greater than or equal to 1.0 x 10 to the power 9/litre.

    On days 8 and 15 of any cycle
    Platelet count between 25 and 50 x 10 to the power 9/litre and/or absolute neutrophil count (ANC) between 0.5 to 1.0 x 10 to the power 9/litre (Grade 3): Suspend treatment until platelet count greater than or equal to 50 x 10 to the power 9/litre and ANC greater than or equal to 1.0 x 10 to the power 9/litre.

    Platelet count less than 25 x 10 to the power 9/litre and ANC count less than 0.5 x 10 to the power 9/litre (Grade 4): Suspend treatment until platelet count greater than or equal to 50 x 10 to the power 9/litre and ANC greater than or equal to 1.0 x 10 to the power 9/litre. Reduce dose by 20%.

    Treatment modifications for non-haematologic toxicities
    Any grade 3 or 4 drug-related non cardiac toxicity other than nausea or vomiting:
    Suspend treatment until recovery to grade 1. Reduce the dose by 20%.

    Any grade 3 or 4 New York Heart Association cardiovascular toxicity or persistent Left Ventricular Ejection Fraction (LVEF) decline:
    Suspend treatment and monitor until recovery. Consider discontinuation for persistent decline in LVEF of greater than or equal to 15% of baseline value.


    For intravenous infusion only, over a minimum of 60 minutes.


    Children under 18 years
    Chronic infection
    History of recurrent infection
    Neutrophil count below 1.0 x 10 to the power of 9 / L
    Platelet count below 50 x 10 to the power of 9/L on day 8 or 15 of cycle
    Platelet count below 75 x 10 to the power of 9/L on day 1 of cycle
    Severe infection
    Severe hepatic impairment
    Severe myelosuppression

    Precautions and Warnings

    Females of childbearing potential
    History of mediastinal radiotherapy
    History of treatment with anthracyclines
    Left ventricular ejection fraction value of 45% or less
    Performance status of ECOG greater than 2
    Predisposition to infection
    Restricted sodium intake
    Risk factors for cardiovascular disorder
    Within 7 months of discontinuing trastuzumab
    Cardiac disorder
    Hepatic impairment
    New York Heart Association class III failure
    Renal impairment - serum creatinine above 1.5 times ULN
    Serious cardiac arrhythmias
    Uncontrolled hypertension
    Unstable angina
    Within 6 months of a myocardial infarction

    Administration of live vaccines is not recommended
    Sodium content of formulation may be significant
    Cardiotoxic -Avoid anthracyclines for up to 7 months after last trastuzumab
    Consider discontinuing if LVEF decreases by 15% or more and persists
    Consider premedication with hypouricaemic agent
    Evaluate left-ventricular ejection fraction before initiation
    Give pre-treatment counselling and consideration of sperm cryopreservation
    Maintain adequate hydration of patient prior / during treatment
    Treatment to be prescribed under the supervision of a specialist
    Consult local policy on the safe use of anti-cancer drugs
    If extravasation occurs follow local policy & seek expert help immediately
    Staff: Not to be handled by pregnant staff
    Monitor cardiac function before and regularly during treatment
    Monitor haematological parameters before and during treatment
    Monitor renal function prior to initiating treatment
    Monitor bilirubin levels before treatment
    Monitor patients for development of second primary malignancies
    Monitor patients for signs of tumour lysis syndrome
    Monitor serum biochemistry regularly
    Consider treatment with blood growth factors if severe cytopenias develop
    Interrupt therapy if neutrophil count <1.0x10 to the power 9/L
    Interrupt treatment and/or reduce dose for any grade 3 toxicity
    Interrupt treatment if platelet count <50 x 10 to the power of 9/L
    Male & female: Contraception required during & for 6 months after treatment
    Advise patient on appropriate sun protection methods

    Pregnancy and Lactation


    Pixantrone is contraindicated in pregnancy.

    At the time of writing there is limited data on the use of pixantrone in pregnant women. Studies in animals have shown reproductive toxicity.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Pixantrone is contraindicated in breastfeeding.

    At the time of writing it is unknown whether pixantrone is excreted in human milk, a risk to neonates cannot be excluded.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Alanine aminotransferase increased
    Aspartate aminotransferase increased
    Back pain
    Blood disorders
    Blood urea increased
    Bone marrow failure
    Bone pain
    Bundle branch block
    Cardiac disorders
    Chest pain
    Congestive cardiac failure
    Dry eyes
    Erectile disturbance
    Febrile neutropenia
    Gamma glutamyl transferase (GGT) increased
    Gastrointestinal disorder
    Hypersensitivity reactions
    Increase in alkaline phosphatase
    Mucosal inflammation
    Muscle weakness
    Nail disorders
    Neck pain
    Neutropenic sepsis
    Night sweats
    Painful extremities
    Pleural effusion
    Raised neutrophil count
    Rectal haemorrhage
    Second primary malignancies
    Sensation of warm and/or cold at injection site
    Septic shock
    Serum creatinine increased
    Skin discolouration
    Skin ulcer
    Sleep disturbances
    Taste disturbances
    Tumour lysis syndrome
    Vein discolouration
    Vein disorder
    Ventricular dysfunction
    Weight loss


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: November 2018

    Reference Sources

    Summary of Product Characteristics: Pixuvri 29mg powder for concentrate for solution for injection. CTI Life Sciences Ltd. Revised August 2018.

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.