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Drug overview for UNITUXIN (dinutuximab):
Generic name: DINUTUXIMAB (DIN-ue-TUX-i-mab)
Drug class: Antineoplastic - Anti-GD2 Ganglioside Monoclonal Antibody
Therapeutic class: Antineoplastics
Dinutuximab, a chimeric human-murine anti-glycolipid disialoganglioside (anti-GD2) monoclonal antibody, is an antineoplastic agent.
No enhanced Uses information available for this drug.
Generic name: DINUTUXIMAB (DIN-ue-TUX-i-mab)
Drug class: Antineoplastic - Anti-GD2 Ganglioside Monoclonal Antibody
Therapeutic class: Antineoplastics
Dinutuximab, a chimeric human-murine anti-glycolipid disialoganglioside (anti-GD2) monoclonal antibody, is an antineoplastic agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for UNITUXIN (dinutuximab) have been approved by the FDA:
Indications:
High-risk neuroblastoma
Professional Synonyms:
None.
Indications:
High-risk neuroblastoma
Professional Synonyms:
None.
The following dosing information is available for UNITUXIN (dinutuximab):
If toxicity occurs, temporary or permanent discontinuance of dinutuximab may be required based on causality.
Dinutuximab should be permanently discontinued in patients experiencing grade 3 or 4 anaphylaxis, grade 3 or 4 serum sickness, grade 3 pain unresponsive to optimal pain management, grade 4 peripheral sensory neuropathy, grade 3 peripheral sensory neuropathy that interferes with daily activities for more than 2 weeks, grade 2 peripheral motor neuropathy, subtotal or total loss of vision, grade 4 hyponatremia despite appropriate fluid management, or hemolytic uremic syndrome. (See Cautions: Warnings/Precautions.)
Dinutuximab should be permanently discontinued in patients experiencing grade 3 or 4 anaphylaxis, grade 3 or 4 serum sickness, grade 3 pain unresponsive to optimal pain management, grade 4 peripheral sensory neuropathy, grade 3 peripheral sensory neuropathy that interferes with daily activities for more than 2 weeks, grade 2 peripheral motor neuropathy, subtotal or total loss of vision, grade 4 hyponatremia despite appropriate fluid management, or hemolytic uremic syndrome. (See Cautions: Warnings/Precautions.)
Dinutuximab is administered by IV infusion over 10-20 hours. The drug should not be administered by rapid IV injection, such as IV push or bolus. Dinutuximab should be infused at an initial rate of 0.875
mg/m2 per hour for 30 minutes. The rate of infusion may be gradually increased as tolerated to a maximum infusion rate of 1.75 mg/m2 per hour.
Dinutuximab injection concentrate must be diluted prior to administration. Prior to dilution, the injection concentrate should be inspected visually for particulate matter and discoloration. The solution should be clear to slightly opalescent and colorless; the solution should not be used if it is cloudy or discolored or if particulate matter is present.
The appropriate dose (17.5 mg/m2 per treatment day) of dinutuximab injection concentrate (containing 3.5 mg/mL) should be withdrawn and added to an infusion bag containing 100 mL of 0.9% sodium chloride injection. This diluted solution should be mixed by gentle inversion and should not be shaken.
Diluted solutions of the drug should be stored under refrigeration (2-8degreesC). Infusion of the drug should be initiated within 4 hours of dilution, and the drug should be discarded 24 hours after dilution. Any unused portion left in the vial should be discarded since dinutuximab injection concentrate contains no preservative.
mg/m2 per hour for 30 minutes. The rate of infusion may be gradually increased as tolerated to a maximum infusion rate of 1.75 mg/m2 per hour.
Dinutuximab injection concentrate must be diluted prior to administration. Prior to dilution, the injection concentrate should be inspected visually for particulate matter and discoloration. The solution should be clear to slightly opalescent and colorless; the solution should not be used if it is cloudy or discolored or if particulate matter is present.
The appropriate dose (17.5 mg/m2 per treatment day) of dinutuximab injection concentrate (containing 3.5 mg/mL) should be withdrawn and added to an infusion bag containing 100 mL of 0.9% sodium chloride injection. This diluted solution should be mixed by gentle inversion and should not be shaken.
Diluted solutions of the drug should be stored under refrigeration (2-8degreesC). Infusion of the drug should be initiated within 4 hours of dilution, and the drug should be discarded 24 hours after dilution. Any unused portion left in the vial should be discarded since dinutuximab injection concentrate contains no preservative.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for UNITUXIN (dinutuximab):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for UNITUXIN (dinutuximab):
Drug contraindication overview.
Dinutuximab is contraindicated in patients with a history of anaphylaxis to the drug.
Dinutuximab is contraindicated in patients with a history of anaphylaxis to the drug.
There are 3 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Lactation |
| Posterior reversible encephalopathy syndrome |
| Urinary retention |
There are 9 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Anemia |
| Hemolytic uremic syndrome |
| Hypotension |
| Neutropenic disorder |
| Peripheral neuropathy |
| Pregnancy |
| Severe infection |
| SIADH syndrome |
| Thrombocytopenic disorder |
There are 0 moderate contraindications.
The following adverse reaction information is available for UNITUXIN (dinutuximab):
Adverse reaction overview.
Adverse effects reported in 25% or more of patients receiving dinutuximab in combination with sargramostim, aldesleukin, and isotretinoin include pain, pyrexia, thrombocytopenia, lymphopenia, infusion-related reactions, hypotension, hyponatremia, elevated aminotransferase (i.e., AST, ALT) concentration, anemia, vomiting, diarrhea, hypokalemia, capillary leak syndrome, neutropenia, urticaria, hypoalbuminemia, hypocalcemia, and infection.
Adverse effects reported in 25% or more of patients receiving dinutuximab in combination with sargramostim, aldesleukin, and isotretinoin include pain, pyrexia, thrombocytopenia, lymphopenia, infusion-related reactions, hypotension, hyponatremia, elevated aminotransferase (i.e., AST, ALT) concentration, anemia, vomiting, diarrhea, hypokalemia, capillary leak syndrome, neutropenia, urticaria, hypoalbuminemia, hypocalcemia, and infection.
There are 25 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Abnormal hepatic function tests Anemia Capillary leak syndrome Hypersensitivity drug reaction Hypokalemia Hyponatremia Hypotension Hypoxia Increased alanine transaminase Increased aspartate transaminase Neutropenic disorder Thrombocytopenic disorder |
Bacterial sepsis Hemorrhage Hypertension Infection Neuropathic pain Peripheral motor neuropathy Peripheral sensory neuropathy |
| Rare/Very Rare |
|---|
|
Anaphylaxis Blurred vision Hemolytic uremic syndrome Myelitis Optic neuropathy Posterior reversible encephalopathy syndrome |
There are 23 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Diarrhea Fever Hypoalbuminemia Hypocalcemia Lymphopenia Pain Urticaria Vomiting |
Anorexia Bone pain Hypomagnesemia Hypophosphatemia Injection site pain Nausea Neck pain Pain in oropharynx Tachycardia Weight gain |
| Rare/Very Rare |
|---|
|
Blepharoptosis Mydriasis Papilledema Photophobia Urinary retention |
The following precautions are available for UNITUXIN (dinutuximab):
Safety and efficacy of dinutuximab have not been established in infants younger than 11 months of age.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Dinutuximab may cause fetal harm if administered to pregnant women based on its mechanism of action. The effects of dinutuximab may be greater during the third trimester of pregnancy. (See Fetal/Neonatal Morbidity and Mortality under Warnings/Precautions: Other Warnings and Precautions, in Cautions.)
It is not known whether dinutuximab is distributed into human milk; however, human IgG is distributed into milk. Because of the potential for serious adverse reactions to dinutuximab in nursing infants, women should be advised to discontinue nursing during dinutuximab therapy. Women may begin nursing 6 months after discontinuance of therapy. The effects of the drug on nursing infants or on the production of human milk are unknown.
Contraindicated
Absolute contraindication. (Human data usually available to support recommendations.) This drug should not be given to breast feeding mothers.
Contraindicated
Absolute contraindication. (Human data usually available to support recommendations.) This drug should not be given to breast feeding mothers.
| Drug Name | Excretion Potential | Effect on Infant | Notes |
|---|---|---|---|
| Dinutuximab | Unknown. It is unknown whether the drug is excreted in human breast milk. | It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data) | Potential for serious adverse outcomes |
Safety and efficacy of dinutuximab have not been established in geriatric patients.
The following prioritized warning is available for UNITUXIN (dinutuximab):
WARNING: Serious infusion reactions (sometimes fatal) or nerve problems (such as nerve pain) may happen during the infusion of this drug and for some time afterward. Your doctor may prescribe other medications (such as acetaminophen, diphenhydramine, opioids) before each treatment to help prevent these side effects. Get medical help right away if you have any symptoms of infusion reactions such as fever, chills, severe dizziness, swelling of the face/tongue/throat, trouble breathing, itching, or rash.
Also tell your doctor right away if you have any symptoms of nerve pain such as numbness, burning, tingling, or weakness, or if you have pain that is not relieved. Your doctor may give you other medications to help with these side effects or may slow down or stop your treatment for some time.
WARNING: Serious infusion reactions (sometimes fatal) or nerve problems (such as nerve pain) may happen during the infusion of this drug and for some time afterward. Your doctor may prescribe other medications (such as acetaminophen, diphenhydramine, opioids) before each treatment to help prevent these side effects. Get medical help right away if you have any symptoms of infusion reactions such as fever, chills, severe dizziness, swelling of the face/tongue/throat, trouble breathing, itching, or rash.
Also tell your doctor right away if you have any symptoms of nerve pain such as numbness, burning, tingling, or weakness, or if you have pain that is not relieved. Your doctor may give you other medications to help with these side effects or may slow down or stop your treatment for some time.
The following icd codes are available for UNITUXIN (dinutuximab)'s list of indications:
| High-risk neuroblastoma | |
| C74.1 | Malignant neoplasm of medulla of adrenal gland |
| C74.10 | Malignant neoplasm of medulla of unspecified adrenal gland |
| C74.11 | Malignant neoplasm of medulla of right adrenal gland |
| C74.12 | Malignant neoplasm of medulla of left adrenal gland |
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