Dinutuximab beta parenteral
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Infusions containing dinutuximab beta.
High-risk neuroblastoma in patients aged 12 months and above, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with a history of relapsed or refractory neuroblastoma, with or without residual disease. Prior to the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilised by other measures.
Each treatment course of dinutuximab beta consists of 5 consecutive courses, each comprising of 35 days.
The total dose for a single course should be 100mg per metre squared.
Typical dosing schedule
10mg per metre squared daily, for the first 10 days of the each treatment course.
Alternative dosing schedule
20mg per metre squared daily for the first 5 days of each treatment course.
Additional Dosage Information
Any adverse reaction
Grade 1 or 2: Decrease infusion rate to 50%. Resume at original rate after symptoms resolve.
Grade 3 or higher: Interrupt infusion and initiate supportive measures. Resume at 50% infusion rate after symptoms resolve to grade 2 or lower. Resume at original infusion rate if symptoms resolve completely.
Recurrent grade 3 or higher: Discontinue dinutuximab beta. Resume infusion next day if adverse reactions resolve.
Grade 1 or 2: Interrupt infusion and initiate supportive measures. Resume infusion at original rate after symptoms resolve.
Grade 3 or higher: Interrupt infusion, initiate supportive measures and treat appropriately. Resume treatment for subsequent courses.
Dilated pupils with sluggish light reflex, with or without photophobia
Any grade: Interrupt infusion. Resume at 50% infusion rate after symptoms resolve.
Capillary leak syndrome
Interrupt infusion and initiate supportive measures. Resume at 50% infusion rate after symptoms resolve to grade 2 or lower.
Grade 3 or 4 anaphylaxis
Grade 3 or prolonged grade 2 peripheral neuropathy
Grade 3 vision toxicity
Grade 4 hyponatraemia
Recurrent or grade 4 capillary leak syndrome
For administration by intravenous infusion, peripherally or centrally. Dinutuximab beta may also be combined with interleukin-2 (IL-2) which is administered as a subcutaneous injection.
For the typical 10-day dosing schedule, administer the continuous infusion at a rate of 2ml per hour, totalling 48ml per day.
For the alternative 5-day dosing schedule, administer the infusion at a rate of approximately 13ml per hour for 8 hours.
Absolute neutrophil count below 0.5 x 10 to the power of 9 / L
Children under 1 year
Haemoglobin concentration below 8g / dL
Platelet count below 20 x 10 to the power of 9 / L
Abnormal liver function test
Acute grade 3 or 4, or extensive chronic graft-versus-host disease
Renal impairment - creatinine clearance below 60ml/minute
Precautions and Warnings
Females of childbearing potential
Avoid vaccines during and for 10 weeks after treatment
Advise patient not to drive or operate machinery until assessed
Avoid corticosteroids 2 weeks prior to, during and 1 week after treatment
Premedication with analgesic recommended
Premedication with antihistamine recommended
Treat and control infections prior to commencing therapy
Consult local policy on the safe use of anti-cancer drugs
Must be diluted before use
Reduce infusion rate by 50% if grade 1 or 2 infusion reaction
Resuscitation facilities must be immediately available
Staff: Not to be handled by pregnant staff
Treatment to be administered under the supervision of a specialist
Monitor cardio-respiratory function
Monitor for hypersensitivity reactions-particularly 1st and 2nd infusions
Monitor for symptoms of Capillary Leak Syndrome
Monitor hepatic function regularly
Monitor patient for infusion-associated reactions (IARs)
Monitor pulse oximetry
Monitor serum electrolytes
Advise patient to report any blurred vision or any other eye symptoms
Risk of peripheral neuropathy
Discontinue if grade 3 or greater adverse reaction that recurs/persists
Discontinue if grade 3 or higher neuropathy occurs
Discontinue if grade 3 vision toxicity occurs
Discontinue if grade 4 hyponatremia occurs despite fluid management
Discontinue if recurrent or grade 4 capillary leak syndrome
Discontinue if serious allergic or anaphylactic reaction occurs
Interrupt treatment and/or reduce dose for any grade 3 toxicity
Interrupt treatment if mild hypersensitivity reactions occur
Interrupt treatment if severe infusion reaction occurs
Suspend treatment if grade 2 or 3 neuropathy
Female: Contraception required during and for 6 months after treatment
Breastfeeding: Do not breastfeed during & for 6 months after treatment
Nonopioid analgesics should be used permanently throughout treatment.
Prior to starting each treatment course, the following clinical parameters must be evaluated. Delay treatment until these values are reached.
Pulse oximetry above 94% on room air.
Adequate bone marrow function, defined as platelet count equal to or above 20,000 per microlitre, absolute neutrophil count equal to or above 500 per microlitre and haemoglobin above 8g per decilitre.
Adequate liver function, defined as alanine aminotransferase and aspartate aminotransferase less than 5 times the upper limit of normal.
Adequate renal function, defined as creatinine clearance or glomerular filtration rate above 60ml per minute per 1.73 metre squared.
Pregnancy and Lactation
Dinutuximab beta is contraindicated during pregnancy.
The manufacturer contraindicates the use of dinutuximab beta in pregnancy. At the time of writing there is limited published information regarding the use of dinutuximab beta during pregnancy. Dinutuximab beta may theoretically have an effect on neuronal tissue during embryofoetal development.
Dinutuximab beta is contraindicated during breastfeeding.
The manufacturer states that breastfeeding should be discontinued during treatment, and for 6 months afterwards. At the time of writing it is not known if dinutuximab beta is excreted in human breast milk. LactMed suggests that the high molecular weight may limit the amount present in breast milk, and absorption by the infant may also be limited as dinutuximab beta is thought to be destroyed in the infant's gastrointestinal tract.
Altered liver function tests
Capillary leak syndrome
Cytokine release syndrome
Decrease in glomerular filtration rate
Increased partial thromboplastin time
Injection site reactions
Intravascular coagulation (disseminated)
Left ventricular failure
Posterior reversible encephalopathy syndrome (PRES)
Prothrombin time increased
Raised intracranial pressure
Serum bilirubin increased
Serum creatinine increased
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 ).
Last Full Review Date: October 2019
Summary of Product Characteristics: Qarziba 20mg per 4.5ml concentrate for solution for infusion. EUSA Pharma UK Ltd. Revised March 2019.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Dinutuximab. Last revised: 03 December 2018.
Last accessed: 15 October 2019
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