Drugs List

Therapeutic Indications

Uses

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

Administration

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

Contraindications

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
Breastfeeding
Pregnancy
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
Obesity
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
Dehydration
Hepatic impairment
Myelosuppression
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

Pregnancy

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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

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 https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Alanine aminotransferase increased
Alopecia
Anaemia
Anorexia
Anxiety
Arrhythmias
Arthralgia
Arthritis
Aspartate aminotransferase increased
Asthenia
Back pain
Bilirubinuria
Blood disorders
Blood urea increased
Bone marrow failure
Bone pain
Bundle branch block
Cardiac disorders
Chest pain
Chills
Chromaturia
Congestive cardiac failure
Conjunctivitis
Cough
Dizziness
Dry eyes
Dyspnoea
Eosinophilia
Erectile disturbance
Erythema
Fatigue
Febrile neutropenia
Gamma glutamyl transferase (GGT) increased
Gastrointestinal disorder
Haematuria
Headache
Hepatotoxicity
Hyperbilirubinaemia
Hyperphosphataemia
Hypersensitivity reactions
Hyperuricaemia
Hypocalcaemia
Hyponatraemia
Hypophosphataemia
Hypotension
Increase in alkaline phosphatase
Infections
Insomnia
Keratitis
Lethargy
Leukopenia
Lymphopenia
Mucosal inflammation
Muscle weakness
Myelosuppression
Nail disorders
Neck pain
Neoplasms
Neutropenia
Neutropenic sepsis
Night sweats
Oedema
Oliguria
Painful extremities
Pallor
Paraesthesia
Petechiae
Photosensitivity
Pleural effusion
Pneumonitis
Proteinuria
Pruritus
Pyrexia
Raised neutrophil count
Rash
Rectal haemorrhage
Rhinorrhoea
Second primary malignancies
Sensation of warm and/or cold at injection site
Sepsis
Septic shock
Serum creatinine increased
Skin discolouration
Skin ulcer
Sleep disturbances
Somnolence
Stiffness
Tachycardia
Taste disturbances
Thrombocytopenia
Tumour lysis syndrome
Vein discolouration
Vein disorder
Ventricular dysfunction
Vertigo
Weight loss

Presentation

Concentrate for infusions containing pixantrone (as dimaleate).

Drugs List

Therapeutic Indications

Uses

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

Dosage

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

Adults

Additional Dosage Information

Administration

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

Contraindications

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
Breastfeeding
Pregnancy
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
Obesity
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
Dehydration
Hepatic impairment
Myelosuppression
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

Pregnancy

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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

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 https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Alanine aminotransferase increased
Alopecia
Anaemia
Anorexia
Anxiety
Arrhythmias
Arthralgia
Arthritis
Aspartate aminotransferase increased
Asthenia
Back pain
Bilirubinuria
Blood disorders
Blood urea increased
Bone marrow failure
Bone pain
Bundle branch block
Cardiac disorders
Chest pain
Chills
Chromaturia
Congestive cardiac failure
Conjunctivitis
Cough
Dizziness
Dry eyes
Dyspnoea
Eosinophilia
Erectile disturbance
Erythema
Fatigue
Febrile neutropenia
Gamma glutamyl transferase (GGT) increased
Gastrointestinal disorder
Haematuria
Headache
Hepatotoxicity
Hyperbilirubinaemia
Hyperphosphataemia
Hypersensitivity reactions
Hyperuricaemia
Hypocalcaemia
Hyponatraemia
Hypophosphataemia
Hypotension
Increase in alkaline phosphatase
Infections
Insomnia
Keratitis
Lethargy
Leukopenia
Lymphopenia
Mucosal inflammation
Muscle weakness
Myelosuppression
Nail disorders
Neck pain
Neoplasms
Neutropenia
Neutropenic sepsis
Night sweats
Oedema
Oliguria
Painful extremities
Pallor
Paraesthesia
Petechiae
Photosensitivity
Pleural effusion
Pneumonitis
Proteinuria
Pruritus
Pyrexia
Raised neutrophil count
Rash
Rectal haemorrhage
Rhinorrhoea
Second primary malignancies
Sensation of warm and/or cold at injection site
Sepsis
Septic shock
Serum creatinine increased
Skin discolouration
Skin ulcer
Sleep disturbances
Somnolence
Stiffness
Tachycardia
Taste disturbances
Thrombocytopenia
Tumour lysis syndrome
Vein discolouration
Vein disorder
Ventricular dysfunction
Vertigo
Weight loss

Overdosage

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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

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.