Version May 2024
Serious and potentially life-threatening infusion reactions occurred in 26% of patients treated with dinutuximab. Administer required prehydration and premedication, including antihistamines, prior to each dinutuximab infusion. Monitor patients closely for signs and symptoms of an infusion reaction during and for at least 4 hours following completion of each dinutuximab infusion. Immediately interrupt dinutuximab for severe infusion reactions and permanently discontinue dinutuximab for anaphylaxis.
Dinutuximab causes serious neurologic adverse reactions including severe neuropathic pain and peripheral neuropathy.
Severe neuropathic pain occurs in the majority of patients. Administer intravenous opioid prior to, during, and for 2 hours following completion of the dinutuximab infusion. In clinical studies of patients with high-risk neuroblastoma, grade 3 peripheral sensory neuropathy occurred in 2% to 9% of patients. In clinical studies of dinutuximab and related GD2-binding antibodies, severe motor neuropathy has occurred. Resolution of motor neuropathy did not occur in all cases. Discontinue dinutuximab for severe unresponsive pain, severe sensory neuropathy, and moderate to severe peripheral motor neuropathy.
Not indicated for use in adults.
(For additional information see "Dinutuximab: Pediatric drug information")
Dosage guidance:
Safety: Intravenous hydration and premedication with analgesics, antihistamines, and antipyretics are required prior to administration. Ensure adequate hematologic, respiratory, hepatic, and renal function prior to each cycle of therapy.
Clinical considerations: Dinutuximab may be associated with a moderate emetic potential based on adult sources; pediatric guidelines do not describe emetogenic potential guidance for dinutuximab (Ref); antiemetics could be considered to prevent nausea and vomiting.
Neuroblastoma, high-risk, post-consolidation: Infants, Children, and Adolescents: IV: 17.5 mg/m2/day for 4 consecutive days for a maximum of 5 cycles. Infuse on days 4, 5, 6, and 7 during cycles 1, 3, and 5 (cycles 1, 3, and 5 are 24 days in duration); infuse on days 8, 9, 10, and 11 during cycles 2 and 4 (cycles 2 and 4 are 32 days in duration). Use in combination with sargramostim, aldesleukin, and isotretinoin. Note: Although the manufacturer's labeling includes aldesleukin (IL-2) as part of the original protocol, aldesleukin is no longer recommended for standard of care use with isotretinoin, dinutuximab, and sargramostim due to increased adverse effects and no additional efficacy benefit (Ref).
Neuroblastoma, relapsed or refractory: Limited data available: Infants, Children, and Adolescents: IV: 17.5 mg/m2/day for 4 consecutive days for up to 17 cycles. Infuse on days 2, 3, 4, and 5 of 21-day cycle; use in combination with temozolomide and irinotecan (Ref).
Supportive therapy medications for dinutuximab administration:
IV hydration: NS: IV: 10 mL/kg; infuse over 1 hour just prior to each dinutuximab infusion.
Antihistamine: Diphenhydramine: IV: 0.5 to 1 mg/kg/dose; maximum dose: 50 mg/dose; administer over 10 to 15 minutes starting 20 minutes prior to dinutuximab infusion and every 4 to 6 hours as tolerated during the infusion.
Antiemetics: Dinutuximab may be associated with a moderate emetic potential based on adult sources; pediatric guidelines do not describe emetogenic potential guidance for dinutuximab (Ref); antiemetics could be considered to prevent nausea and vomiting.
Antipyretics:
Acetaminophen: Oral: 10 to 15 mg/kg/dose; maximum dose: 650 mg/dose; administer 20 minutes prior to each infusion and every 4 to 6 hours as needed for fever and pain.
Ibuprofen: Oral: 10 mg/kg/dose; maximum dose: 400 mg/dose; every 6 hours as needed for control of persistent fever or pain (Ref); Note: Consider if platelet count is greater than 50 × 103/mcL and no history of GI bleeding (Ref).
Analgesics: Morphine: IV: 50 mcg/kg; administer immediately prior to dinutuximab infusion initiation; continue as a morphine drip at a rate of 20 to 50 mcg/kg/hour during and for 2 hours following completion of dinutuximab infusion. May administer additional morphine doses of 25 to 50 mcg/kg IV as needed up to once every 2 hours followed by an increase in the drip rate in clinically stable patients. Consider conversion to fentanyl or hydromorphone if morphine is not tolerated; if pain is inadequately controlled with opioids, consider adjunct therapy with gabapentin or lidocaine (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Dosing adjustment for toxicity: Infants, Children, and Adolescents: IV:
Anaphylaxis, grade 3 or 4: Permanently discontinue therapy.
Capillary leak syndrome:
Moderate to severe, but not life-threatening: Immediately interrupt infusion; upon resolution, resume infusion at 50% of the previous rate.
Life-threatening: Discontinue infusion for the current cycle; in subsequent cycles, infuse at 50% of the previous rate. If life-threatening capillary leak syndrome recurs, permanently discontinue therapy.
Hemolytic uremic syndrome: Permanently discontinue therapy and administer supportive management.
Hyponatremia, grade 4 (despite appropriate fluid management): Permanently discontinue therapy.
Hypotension (symptomatic hypotension, systolic blood pressure [SBP] less than lower limit of normal for age, or SBP decreased by more than 15% compared to baseline): Interrupt infusion; upon resolution, resume infusion at 50% of the previous rate. If blood pressure remains stable for ≥2 hours, gradually increase infusion rate as tolerated up to a maximum rate of 1.75 mg/m2/hour.
Infection (systemic)/sepsis, severe: Discontinue therapy until infection resolves; may resume therapy with subsequent cycles.
Infusion-related reaction:
Mild to moderate reaction (eg, transient rash, fever, rigors, and localized urticaria that respond promptly to symptomatic treatment): Reduce infusion rate by 50%; monitor closely. Upon resolution, gradually increase infusion rate up to a maximum of 1.75 mg/m2/hour.
Severe or prolonged reaction (eg, mild bronchospasm without other symptoms, angioedema that does not affect the airway): Immediately interrupt infusion; if symptoms resolve rapidly, resume infusion at 50% of the previous rate and monitor closely. If reaction recurs, discontinue therapy until the following day. If symptoms resolve and further treatment is warranted, premedicate with IV hydrocortisone 1 mg/kg (maximum dose: 50 mg/dose) and infuse at a rate of 0.875 mg/m2/hour in an intensive care unit. If reaction recurs again, permanently discontinue therapy.
Life-threatening reaction: Permanently discontinue therapy and administer supportive management.
Neuropathy:
Grade 4 sensory neuropathy or grade 3 sensory neuropathy that interferes with daily activities for more than 2 weeks: Permanently discontinue therapy.
Grade 2 or higher peripheral motor neuropathy: Permanently discontinue therapy.
Ocular neurological disorders (eg, blurred vision, photophobia, mydriasis, fixed or unequal pupils, optic nerve disorder, eyelid ptosis, and/or papilledema): Discontinue infusion until symptom resolution; upon resolution, reduce dose by 50%. If reaction recurs, or if reaction is accompanied by visual impairment (eg, subtotal or total vision loss), permanently discontinue therapy.
Pain, severe (grade 3) unresponsive to maximum supportive measures: Permanently discontinue therapy.
Reversible posterior leukoencephalopathy syndrome: Permanently discontinue therapy.
Serum sickness, grade 3 or 4: Permanently discontinue therapy.
Transverse myelitis: Permanently discontinue therapy.
Urinary retention (persistent after opioid discontinuation): Permanently discontinue therapy.
Infants, Children, and Adolescents:
Altered kidney impairment: Mild to severe: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). Note: Full dose dinutuximab dosing was administered to patients with neuroblastoma with end-stage kidney disease receiving dialysis (intermittent hemodialysis [n=1], peritoneal dialysis [n=1]); doses were well tolerated without added toxicity (Ref).
Infants, Children, and Adolescents: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in combination with granulocyte-macrophage colony stimulating factor, interleukin-2, and 13-cis-retinoic acid.
>10%:
Cardiovascular: Capillary leak syndrome (40%), edema (17%), hypertension (14%), hypotension (60%), tachycardia (19%)
Dermatologic: Urticaria (37%)
Endocrine & metabolic: Hyperglycemia (18%), hypertriglyceridemia (16%), hypoalbuminemia (33%), hypocalcemia (27%), hypokalemia (43%), hypomagnesemia (12%), hyponatremia (58%), hypophosphatemia (20%)
Gastrointestinal: Decreased appetite (15%), diarrhea (43%), vomiting (46%)
Genitourinary: Proteinuria (16%)
Hematologic & oncologic: Anemia (51%; grades 3/4: 34%), hemorrhage (17%; grades 3/4: 6%), lymphocytopenia (62%; grades 3/4: 51%), neutropenia (39%; grades 3/4: 34%), thrombocytopenia (66%; grades 3/4: 39%)
Hepatic: Increased serum alanine aminotransferase (56%), increased serum aspartate aminotransferase (28%)
Immunologic: Antibody development (21%; neutralizing antibodies: 52%)
Infection: Bacteremia (grades 3/4: 13%), infection (device-related: 16%), sepsis (18%)
Nervous system: Pain (85%), peripheral neuropathy (13%; grades 3/4: 3%)
Renal: Increased serum creatinine (15%)
Respiratory: Hypoxia (24%)
Miscellaneous: Fever (72%), infusion related reaction (60%; severe infusion related reaction: 26%)
1% to 10%:
Endocrine & metabolic: Weight gain (10%)
Gastrointestinal: Nausea (10%)
Hematologic & oncologic: Febrile neutropenia (grades 3/4: 4%)
Hypersensitivity: Anaphylaxis (1%)
Nervous system: Peripheral motor neuropathy (grade 3: 1%), peripheral sensory neuropathy (9%; grade 3: 2% to 9%)
Ophthalmic: Blurred vision (2%)
<1%:
Hematologic & oncologic: Hemolytic-uremic syndrome
Ophthalmic: Diplopia, fixation of pupils, mydriasis
Frequency not defined:
Nervous system: Neuralgia
Ophthalmic: Blepharoptosis, optic nerve damage, papilledema, photophobia
Postmarketing:
Genitourinary: Urinary retention (prolonged)
Nervous system: Reversible posterior leukoencephalopathy syndrome, transverse myelitis
History of anaphylaxis to dinutuximab.
Concerns related to adverse effects:
• Bone marrow suppression: Severe (grade 3 or 4) anemia, neutropenia, thrombocytopenia, and neutropenic fever were observed in dinutuximab-treated patients.
• Capillary leak syndrome: Severe capillary leak syndrome was reported in close to one-fourth of patients receiving dinutuximab. Immediately interrupt infusion if capillary leak syndrome develops; infusion rate reduction and/or therapy discontinuation may be necessary. Initiate appropriate management in patients with symptomatic or severe capillary leak syndrome.
• Electrolyte abnormalities: Electrolyte abnormalities (such as hyponatremia, hypokalemia, and hypocalcemia) were reported in at least one-fourth of patients who received dinutuximab, including grade 3 or 4 events. In a study of a related anti-GD2 antibody, syndrome of inappropriate antidiuretic hormone secretion (SIADH) resulting in severe hyponatremia was reported.
• Hemolytic uremic syndrome: Hemolytic uremic syndrome (without documented infection) resulted in renal insufficiency, electrolyte abnormalities, anemia, and hypertension in a small number of patients. Atypical hemolytic uremic syndrome recurred in one patient upon rechallenge. Permanently discontinue if hemolytic uremic syndrome develops; manage supportively.
• Hypotension: Severe hypotension occurred more frequently in patients receiving dinutuximab. Intravenous hydration is required prior to each infusion; closely monitor blood pressure during infusion. May require therapy interruption or discontinuation; initiate appropriate medical management in patients with a systolic blood pressure (SBP) less than lower limit of normal for age, or SBP that is decreased by more than 15% compared to baseline.
• Infection: Severe (grade 3 or 4) bacteremia was reported more frequently in dinutuximab-treated patients, and required intravenous antibiotics or other urgent interventions. Sepsis was also observed in patients receiving dinutuximab. Monitor closely for signs/symptoms of systemic infection; may require therapy interruption until resolution of infection.
• Infusion reaction: Serious and potentially life-threatening infusion reactions occurred in approximately one-fourth of patients treated with dinutuximab. Prehydration and premedications are required prior to each dinutuximab infusion. Monitor closely for infusion reaction. Immediately interrupt dinutuximab for severe infusion reactions and permanently discontinue dinutuximab for anaphylaxis. Infusion reactions typically occurred during infusion or within 24 hours of completion and may include facial and upper airway edema, dyspnea, bronchospasm, stridor, urticaria, and hypotension. Infusion reactions may require blood pressure support, bronchodilator therapy, corticosteroids, infusion rate interruption and/or reduction, or permanent therapy discontinuation. Infusion should be in a facility with cardiopulmonary medication/equipment available.
• Neurotoxicity: Dinutuximab causes serious neurologic adverse reactions including severe peripheral motor neuropathy and peripheral sensory neuropathy. In clinical studies of patients with high-risk neuroblastoma, grade 3 peripheral sensory neuropathy occurred in some patients. In clinical studies of dinutuximab and related GD2-binding antibodies, severe motor neuropathy has occurred. Resolution of motor neuropathy did not occur in all cases. Discontinue permanently for grade 2 or higher peripheral motor neuropathy, grade 3 sensory neuropathy that interferes with activities of daily living for more than 2 weeks, or grade 4 sensory neuropathy. In patients who experienced peripheral sensory neuropathy of any grade, the median duration was 9 days (range: 3 to 163 days).
• Ocular toxicity: Neurological ocular toxicity such as blurred vision, photophobia, mydriasis, fixed or unequal pupils, optic nerve disorder, eyelid ptosis, and papilledema were reported in clinical trials. In patients who experienced complete resolution of ocular toxicity, the median duration of toxicity was 4 days (range: 0 to 221 days). May require therapy interruption, dosage reduction, and/or treatment discontinuation.
• Pain: Most patients experienced pain; severe pain was observed in over 50% of patients treated with dinutuximab; pain may occur despite analgesic/opioid therapy. Pain typically occurred during infusion and included abdominal, generalized, extremity, or back pain, neuralgia, musculoskeletal chest pain, and arthralgia. Premedication with analgesics, including opioids, is required prior to each dose, during the infusion, and for 2 hours following the infusion. Severe pain may require reduction of the infusion rate or therapy discontinuation.
• Reversible posterior leukoencephalopathy syndrome: Reversible posterior leukoencephalopathy syndrome (RPLS) has been reported. Symptoms of RPLS include severe headache, hypertension, visual changes, seizures or lethargy. Begin appropriate management and discontinue dinutuximab in patients with RPLS signs/symptoms.
• Transverse myelitis: Transverse myelitis has occurred in patients receiving dinutuximab; signs/symptoms (weakness, paresthesia, sensory loss or incontinence) should be evaluated promptly. Discontinue permanently in patients who develop transverse myelitis.
• Urinary retention: Prolonged urinary retention that persists for weeks to months after opioid discontinuation has occurred in patients receiving dinutuximab; discontinue permanently if urinary retention does not resolve following opioid discontinuation.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous [preservative free]:
Unituxin: 17.5 mg/5 mL (5 mL)
No
Solution (Unituxin Intravenous)
17.5 mg/5 mL (per mL): $4,159.55
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Unituxin: 17.5 mg/5 mL (5 mL) [contains mouse (murine) and/or hamster protein]
Note: Dinutuximab may be associated with a moderate emetic potential based on adult sources; pediatric guidelines do not describe emetogenic potential guidance for dinutuximab (Ref); antiemetics could be considered to prevent nausea and vomiting.
IV: Must be diluted prior to administration. Administer as an IV infusion only; do not administer as an IV push or bolus. Prior to each dinutuximab infusion, administer NS 10 mL/kg IV over 1 hour. Premedicate with analgesics, an antihistamine, and an antipyretic prior to administration. Infuse in an environment equipped to monitor for and manage infusion reactions. Interrupt infusion for toxicity.
Initiate dinutuximab infusion at a rate of 0.875 mg/m2/hour for 30 minutes. Increase infusion rate gradually as tolerated to a maximum rate of 1.75 mg/m2/hour to infuse dose over 10 to 20 hours each day. Monitor patients closely for signs and symptoms of an infusion reaction during and for at least 4 hours following completion of each dinutuximab infusion.
Neuroblastoma: Treatment of high-risk neuroblastoma (in combination with granulocyte-macrophage colony-stimulating factor [GM-CSF; sargramostim], interleukin-2 [IL-2; aldesleukin] and 13-cis-retinoic acid [RA; isotretinoin]) in pediatric patients who achieve at least a partial response to prior first-line multiagent, multimodality therapy.
Dinutuximab may be confused with daratumumab, denosumab, dostarlimab, durvalumab, isatuximab, loncastuximab tesirine, margetuximab, obinutuzumab, rituximab.
This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes which have a heightened risk of causing significant patient harm when used in error.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
5-Aminosalicylic Acid Derivatives: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When used at chemotherapy doses, hold blood pressure lowering medications for 24 hours before amifostine administration. If blood pressure lowering therapy cannot be held, do not administer amifostine. Use caution with radiotherapy doses of amifostine. Risk D: Consider therapy modification
Amisulpride (Oral): May enhance the hypotensive effect of Hypotension-Associated Agents. Risk C: Monitor therapy
Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy
Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]). Risk C: Monitor therapy
Antithymocyte Globulin (Equine): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy
Arginine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Barbiturates: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination
BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
BCG Products: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Benperidol: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Blood Pressure Lowering Agents: May enhance the hypotensive effect of Hypotension-Associated Agents. Risk C: Monitor therapy
Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy
Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Bromperidol: May diminish the hypotensive effect of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may enhance the hypotensive effect of Bromperidol. Risk X: Avoid combination
Chikungunya Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination
Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy
Chloramphenicol (Systemic): Myelosuppressive Agents may enhance the myelosuppressive effect of Chloramphenicol (Systemic). Risk X: Avoid combination
Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk X: Avoid combination
Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination
CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor therapy
Coccidioides immitis Skin Test: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing these oncologic agents several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification
COVID-19 Vaccine (Adenovirus Vector): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters). Risk D: Consider therapy modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy
COVID-19 Vaccine (mRNA): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider therapy modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy
COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy
Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider therapy modification
Dengue Tetravalent Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
Denosumab: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider therapy modification
Desmopressin: Hyponatremia-Associated Agents may enhance the hyponatremic effect of Desmopressin. Risk C: Monitor therapy
Deucravacitinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Risk X: Avoid combination
DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Risk C: Monitor therapy
Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination
Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Herbal Products with Blood Pressure Lowering Effects: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Risk C: Monitor therapy
Inebilizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy
Influenza Virus Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification
Leflunomide: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider therapy modification
Levodopa-Foslevodopa: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa-Foslevodopa. Risk C: Monitor therapy
Lormetazepam: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Mumps- Rubella- or Varicella-Containing Live Vaccines: May enhance the adverse/toxic effect of Immunosuppressants (Miscellaneous Oncologic Agents). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination
Nadofaragene Firadenovec: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination
Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Natalizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination
Nicergoline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Risk C: Monitor therapy
Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Risk D: Consider therapy modification
Ocrelizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy
Ofatumumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy
Olaparib: Myelosuppressive Agents may enhance the myelosuppressive effect of Olaparib. Risk C: Monitor therapy
Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Pholcodine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Pholcodine. Risk C: Monitor therapy
Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Pidotimod: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy
Pimecrolimus: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Pneumococcal Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination
Polymethylmethacrylate: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the potential for allergic or hypersensitivity reactions to Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification
Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Rabies Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification
Ritlecitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination
Ropeginterferon Alfa-2b: Myelosuppressive Agents may enhance the myelosuppressive effect of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider therapy modification
Ruxolitinib (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination
Silodosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Sipuleucel-T: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider therapy modification
Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk C: Monitor therapy
Tacrolimus (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination
Talimogene Laherparepvec: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination
Tertomotide: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination
Tofacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Tofacitinib. Risk X: Avoid combination
Typhoid Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination
Ublituximab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy
Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination
Vaccines (Inactivated/Non-Replicating): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 3 after therapy is complete. Risk D: Consider therapy modification
Vaccines (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Yellow Fever Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
Patients who could become pregnant should use effective contraception during therapy and for 2 months after the last dose.
Dinutuximab is a monoclonal antibody (IgG1). Potential placental transfer of human IgG is dependent upon the IgG subclass and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009). Based on the mechanism of action, dinutuximab may cause fetal harm.
It is not known if dinutuximab is present in breast milk.
IgG molecules are excreted in breast milk. Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer.
CBC with differential (monitor closely during treatment), serum electrolytes (daily during treatment), renal function, blood pressure, oxygen saturation. Monitor for signs/symptoms of infusion reactions (during and for at least 4 hours after infusion), pain, peripheral neuropathy, capillary leak syndrome, infection/sepsis, hemolytic uremic syndrome, ocular toxicity, urinary retention, transverse myelitis, and/or reversible posterior leukoencephalopathy syndrome.
Dinutuximab binds to the disialoganglioside GD2, which is highly expressed in neuroblastoma, most melanomas, and other tumors, as well as on normal tissues such as neurons, skin melanocytes, and peripheral sensory nerve fibers (Yu 2010). By binding to cell surface GD2, dinutuximab induces cell lysis (of GD2-expressing cells) through antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).
Distribution: Pediatric patients (age: 3.9 ± 1.9 years): Vdss: 5.4 L
Half-life elimination, terminal: 10 days
Excretion: Clearance: Pediatric patients (age: 3.9 ± 1.9 years): 0.21 L/day; increased with body size
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