Dinutuximab beta
Generic name
Dinutuximab beta
Brand name
ATC Code
L01FX06
- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
No information is present at this moment.
dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
Available formulations
No information is present at this moment.
Dosages
| Neuroblastoma |
|---|
|
Renal impaiment in children > 3 months
No information available on dose adjustment in renal impairment.
The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here
Side effects in children
Very common (> 10%): fever (88%) and pain (77%) despite treatment with analgesics. Infection (including pneumonia, skin infection, herpes virus infection, myelitis, encephalomyelitis, device-related infection). Anemia (approx. 72%), leukopenia, neutropenia (approx. 52%), thrombocytopnia (approx. 50%). Hypersensitivity (approx. 74%), 'cytokine release syndrome'. Fluid retention. Headache. Mydriasis, pupillary lotonia, eye edema. Tachycardia. Hypotension (approx. 42%), capillary leak syndrome (approx. 40%). Hypoxia, coughing. Vomiting (approx. 57%), constipation, stomatitis, diarrhea (approx. 51%). Itching, rash, urticaria. Chills, peripheral edema, facial edema. Weight gain. Increase in ALT, AST, γ-GT, bilirubin and creatinine in the blood.
Common (1-10%): sepsis. Lymphopenia. Anaphylactic reaction. Decreased appetite, hypoalbuminemia, hyponatremia, hypokalemia, hypophosphatemia, hypomagnesemia, hypocalcemia, dehydration. Agitation, anxiety. Peripheral neuropathy, convulsion, paresthesia, dizziness, tremor. Ophthalmoplegia, papilledema, accommodation abnormality, blurred vision, photophobia. Heart failure, left ventricular dysfunction, pericardial effusion. Hypertension. Bronchospasm, dyspnea, respiratory failure, pulmonary infiltrate, pulmonary edema, pleural effusion, tachypnea, laryngospasm. Nausea, lip edema, dry lips, ascites, abdominal distension, ileus. (Exfoliative) dermatitis, erythema, dry skin, hyperhidrosis, petechiae, photosensitization. Muscle spasms. Oliguria, urinary retention, hyperphosphaturia, hematuria, proteinuria. Injection site reaction. Weight loss. Decrease in glomerular filtration rate. Hypertriglyceridaemia, activated partial thromboplastin time prolonged, prothrombin time prolonged, thrombin time prolonged.
Uncommon (0.1-1%): disseminated intravascular coagulation, eosinophilia. Serum sickness. Increased intracranial pressure, posterior reversible encephalopathy syndrome (PRES). Hypovolemic shock, veno-occlusive disease. Enterocolitis. Hepatocellular injury. Renal failure.
The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here
Contra-indications in children
Hypersensitivity and acute ‘graft versus host’ reactions (grade 3 or 4) or extensive ‘graft versus host’ reactions.
The treatment should be discontinued indefinitely in grade 3 or 4 anaphylaxis, long-term grade 2 peripheral motor neuropathy, grade 3 peripheral neuropathy, grade 3 eye toxicity, grade 4 hyponatraemia despite appropriate fluid policy, recurrent capillary leak syndrome and grade 4 capillary leak syndrome.
The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here
Warnings & precautions in children
This medicine has been authorized under exceptional circumstances; Due to the rarity of the disease and/or for ethical reasons, there is only limited data on efficacy and safety to date.
Neuropathic pain: usually occurs at the beginning of treatment; to prevent this, premedicate with analgesics, including IV, prior to each infusion. opioids. To combat pain, administer triple therapy with, among other things, a non-opioid analgesic, gabapentin and an opioid. An analgesic, such as paracetamol or an NSAID, should be used during treatment.
Serious infusion-related reactions may occur despite the use of premedication. Be alert for symptoms of cytokine release syndrome, such as fever, hypotension and urticaria within minutes to hours of the first infusion, or of an anaphylactic reaction, such as bronchospasm and urticaria within minutes of the first infusion. If a serious infusion-related reaction occurs, immediately discontinue treatment with dinutuximab β and initiate emergency treatment if necessary. Permanently discontinue treatment for grade 3 or 4 anaphylaxis.
Capillary Leak Syndrome (CLS): Carefully monitor circulatory and respiratory function due to the possible occurrence of CLS. CLS is characterized by a loss of vascular tone and extravasation of plasma proteins and fluid into the extravascular space. Clinical symptoms such as hypotension and tachycardia are usually reported after 2-12 hours. Permanently discontinue treatment in the event of recurrent CLS or CLS grade 4.
Neurological eye abnormalities: may occur because dinutuximab β binds to optic nerve cells. Refer immediately to an ophthalmologist. No dose adjustment is necessary for problems with accommodation if they can be corrected with glasses. Permanently discontinue treatment if grade 3 eye toxicity occurs.
Peripheral neuropathy: The occasional occurrence of neuropathy has been reported. Assess cases of motor or sensory neuropathy lasting more than 4 days and rule out non-inflammatory causes such as disease progression, infections, metabolic syndromes, and concomitant use of medications. In case of neuropathy grade 2 (motor with or without sensory), interrupt the treatment. Treatment can be resumed after neurological symptoms have resolved. Permanently discontinue treatment in case of prolonged weakness due to dinututximab β, or in case of motor peripheral neuropathy grade 2 or peripheral neuropathy grade 3.
Central neurotoxicity has been reported. If central neurotoxicity occurs, interrupt treatment with dinutuximab beta and exclude other triggering factors (e.g. active infection, metastatic neuroblastoma or concomitant use of neurotoxic medication). Permanently discontinue treatment in case of severe central neurotoxicity, including cases of grade 3 or 4 neurotoxicity with prolonged deficit for no apparent reason, recurrent grade 1-3 neurotoxicity, permanent neurological deficit or in posterior reversible encephalopathy syndrome and transverse myelitis.
Infection: There should be no evidence of systemic infection in the patient as he/she is likely to be immunocompromised due to previous treatments. Treat any established infection before initiating dinutuximab β.
Monitoring: Regular monitoring of liver function and electrolytes is recommended. Permanently discontinue treatment in case of hyponatremia grade 4 (< 120 mEq/l), despite adequate fluid administration.
Hematological toxicities: such as erytropenia, thrombocytopenia and neutropenia have been reported. For Grade 4 haematological toxicities that have improved to at least Grade 2 or to baseline values by the start of the next treatment course, no dose adjustment is required.
Research data: no data are available for reduced renal or hepatic function. Safety and efficacy in children < 12 months have not been established.
Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
CYTOTOXIC ANTIBIOTICS AND RELATED SUBSTANCES
This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.
| Anthracyclines and related substances | ||
|---|---|---|
| L01DB02 | ||
| L01DB01 | ||
| L01DB06 | ||
| L01DB07 | ||
| Other cytotoxic antibiotics | ||
|---|---|---|
| L01DC01 | ||
Reference
- EUSA Pharma (UK) Limited, SmPC Dinutuximab beta Apeiron (EU/1/17/1191/001) 01-08-2017, www.geneesmiddeleninformatiebank.nl
Changes
Therapeutic Drug Monitoring
Overdose
