Dosing & Uses
Dosage Forms & Strengths
injection, solution
- 40mg/10mL (4mg/mL) single-dose vial
Neuroblastoma
Indicated, in combination with granulocyte macrophage colony-stimulating factor (GM-CSF), for relapsed or refractory high-risk neuroblastoma in the bone or bone marrow in patients who have demonstrated a partial response, minor response, or stable disease with prior therapy
GM-CSF 250 mcg/m2/day SC on Days -4 to 0, beginning 5 days before infusion
GM-CSF 500 mcg/m2/day SC Days 1 to 5; administer 1 hr before administration
Naxitamab 3 mg/kg/day (up to 150 mg/day) IV on Days 1, 3, and 5; repeat q4Weeks until complete response or partial response, followed by 5 additional cycles q4Weeks
Then repeat q8Weeks for subsequent cycles thereafter
Discontinue naxitamab and GM-CSF for disease progression or unacceptable toxicity
Dosage Modifications
Infusion-related reactions
-
Grade 2
- Infusion interruption indicated, but responds promptly to symptomatic treatment (eg, antihistamines, NSAIDs, narcotics, IV fluids); prophylactic medications indicated for ≤24 hr
- Reduce to 50% of previous rate until recovery to Grade ≤1and monitor closely; gradually increase as tolerated to rate before the event
-
Grade 3
- Prolonged (eg, delayed response to symptomatic medication and/or interruption of infusion); recurrence of symptoms following initial improvement; hospitalization indicated for clinical sequelae
- Immediately interrupt infusion until recovery to Grade ≤2 and monitor closely
- Resume at 50% of the rate before the event; gradually increase as tolerated to rate before the event
- Permanently discontinue if nonresponsive to medical intervention
-
Grade 4
- Life-threatening consequences (eg, urgent intervention indicated) or Grade 3 or 4 anaphylaxis
- Permanently discontinue
Pain
- Grade 3 unresponsive to maximum supportive measures
- Permanently discontinue
Reversible posterior leukoencephalopathy syndrome (RPLS)
- All grades: Permanently discontinue
Transverse myelitis
- All grades: Permanently discontinue
Peripheral neuropathy
- Grade ≥2 motor neuropathy or Grade 3 or 4 sensory neuropathy
- Permanently discontinue
Neurological disorders of the eye
-
Grade 2-4
- Resulting in decreased visual acuity or limiting activities of daily living
- Withhold until resolution; resume at 50% of the prior dose once resolved
- If tolerated without recurrence of symptoms, gradually increase to dose prior to onset of symptoms
- Permanently discontinue if unresolved within 2 weeks or upon recurrence
-
Subtotal or total vision loss
- Permanently discontinue
Prolonged urinary retention
- Persisting following discontinuation of opioids: Permanently discontinue
Hypertension
-
Grade 3
- Withhold or pause infusion until recovery to Grade ≤2
- Resume at 50% of prior rate; if tolerated without recurrence of symptoms, gradually increase to rate prior to onset of symptoms
- Permanently discontinue if nonresponsive to medical intervention
-
Grade 4
- Permanently discontinue
Other adverse reactions
-
Grade 3
- Withhold until recovery to Grade ≤2, then resume at same rate
- Permanently discontinue if not resolved to Grade ≤2 within 2 weeks
-
Grade 4
- Permanently discontinue
Dosing Considerations
Verify pregnancy status in females of reproductive potential before initiation
Dosage Forms & Strengths
injection, solution
- 40mg/10mL (4mg/mL) single-dose vial
Neuroblastoma
Indicated, in combination with granulocyte macrophage colony-stimulating factor (GM-CSF), for patients aged >1 year with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease with prior therapy
<1 year: Safety and efficacy not established
≥1 year
- GM-CSF 250 mcg/m2/day SC on Days -4 to 0, beginning 5 days before infusion
- GM-CSF 500 mcg/m2/day SC Days 1 to 5; administer 1 hr before administration
- Naxitamab 3 mg/kg/day (up to 150 mg/day) IV on Days 1, 3, and 5; repeat q4Weeks until complete response or partial response, followed by 5 additional cycles q4Weeks
- Then repeat q8Weeks for subsequent cycles thereafter
- Discontinue naxitamab and GM-CSF for disease progression or unacceptable toxicity
Dosage Modifications
Infusion-related reactions
-
Grade 2
- Infusion interruption indicated, but responds promptly to symptomatic treatment (eg, antihistamines, NSAIDs, narcotics, IV fluids); prophylactic medications indicated for ≤24 hr
- Reduce to 50% of previous rate until recovery to Grade ≤1and monitor closely; gradually increase as tolerated to rate before the event
-
Grade 3
- Prolonged (eg, delayed response to symptomatic medication and/or interruption of infusion); recurrence of symptoms following initial improvement; hospitalization indicated for clinical sequelae
- Immediately interrupt infusion until recovery to Grade ≤2 and monitor closely
- Resume at 50% of the rate before the event; gradually increase as tolerated to rate before the event
- Permanently discontinue if nonresponsive to medical intervention
-
Grade 4
- Life-threatening consequences (eg, urgent intervention indicated) or Grade 3 or 4 anaphylaxis
- Permanently discontinue
Pain
- Grade 3 unresponsive to maximum supportive measures
- Permanently discontinue
Reversible posterior leukoencephalopathy syndrome (RPLS)
- All grades: Permanently discontinue
Transverse myelitis
- All grades: Permanently discontinue
Peripheral neuropathy
- Grade ≥2 motor neuropathy or Grade 3 or 4 sensory neuropathy
- Permanently discontinue
Neurological disorders of the eye
-
Grade 2-4
- Resulting in decreased visual acuity or limiting activities of daily living
- Withhold until resolution; resume at 50% of the prior dose once resolved
- If tolerated without recurrence of symptoms, gradually increase to dose prior to onset of symptoms
- Permanently discontinue if unresolved within 2 weeks or upon recurrence
-
Subtotal or total vision loss
- Permanently discontinue
Prolonged urinary retention
- Persisting following discontinuation of opioids: Permanently discontinue
Hypertension
-
Grade 3
- Withhold or pause infusion until recovery to Grade ≤2
- Resume at 50% of prior rate; if tolerated without recurrence of symptoms, gradually increase to rate prior to onset of symptoms
- Permanently discontinue if nonresponsive to medical intervention
-
Grade 4
- Permanently discontinue
Other adverse reactions
-
Grade 3
- Withhold until recovery to Grade ≤2, then resume at same rate
- Permanently discontinue if not resolved to Grade ≤2 within 2 weeks
-
Grade 4
- Permanently discontinue
Dosing Considerations
Verify pregnancy status in females of reproductive potential before initiation
Adverse Effects
>10% (naxitamab + GM-CSF)
All grades
- Pain (94-100%)
- Infusion-related reaction (94-100%)
- Tachycardia (44-84%)
- Decreased lymphocytes (74-79%)
- Decreased hemoglobin (48-76%)
- Increased glucose (74%)
- Decreased neutrophils (61-72%)
- Decreased platelets (65-71%)
- Decreased albumin (50-68%)
- Decreased calcium (64%)
- Decreased potassium (47-63%)
- Vomiting (60-63%)
- Cough (57-60%)
- Nausea (56-57%)
- Diarrhea (50-56%)
- Increased ALT (42-55%)
- Decreased magnesium (54%)
- Decreased appetite (16-53%)
- Increased AST (49%)
- Decreased phosphate (47%)
- Hypertension (28-44%)
- Fatigue (28-44%)
- Decreased sodium (29-38%)
- Erythema multiforme (33%)
- Urticaria (32%)
- Peripheral neuropathy (25-32%)
- Decreased glucose (29%)
- Injection site reaction (28%)
- Edema (2.8-28%)
- Pyrexia (11-28%)
- Headache (18-28%)
- Anxiety (12-26%)
- Localized edema (25%)
- Irritability (25%)
- Rhinorrhea (15-24%)
- Depressed level of consciousness (24%)
- Neurological disorders of the eye (19-24%)
- Hyperhidrosis (17%)
- Constipation (15%)
- Oropharyngeal pain (15%)
- Breath sounds abnormal (15%)
- Contusion (15%)
- Lethargy (14%)
- Rhinovirus infection (12-14%)
- Enterovirus infection (13%)
- Anaphylactic reaction (12%)
- Influenza (12%)
- Upper respiratory tract infection (12%)
- Weight decreased (12%)
- Erythema (11%)
Grades 3 or 4
- Pain (2.8-72%)
- Infusion-related reaction (32-68%)
- Decreased lymphocytes (30-56%)
- Decreased neutrophils (39-46%)
- Decreased hemoglobin (4-42%)
- Decreased platelets (17-40%)
- Decreased potassium (8-32%)
- Depressed level of consciousness (16%)
- Anaphylactic reaction (12%)
1-10% (naxitamab + GM-CSF)
All grades
- Peripheral edema (8.3%)
- Apnea (4.2%)
- Device-related infection (4.2%)
- Hypopnea (2.8%)
Grades 3 or 4
- Increased ALT (8-9%)
- Decreased glucose (8%)
- Diarrhea (4.2-8%)
- Headache (8%)
- Decreased calcium (8%)
- Decreased albumin (7%)
- Hypertension (4-7%)
- Decreased sodium (6%)
- Decreased phosphate (5%)
- Decreased appetite (4.2%)
- Vomiting (2.8-4%)
- Urticaria (4%)
- Tachycardia (1.4-4%)
- Increased AST (4%)
- Nausea (1.4%)
Postmarketing Reports
Neurological: Transverse myelitis
Warnings
Serious Infusion-Related Reactions
Serious infusion reactions can occur, including cardiac arrest, anaphylaxis, hypotension, bronchospasm, and stridor
Premedicate before each infusion as recommended and monitor for at least 2 hr following completion of each infusion
Reduce rate, interrupt infusion, or permanently discontinue based on severity
Neurotoxicity
Severe neurotoxicity reported, including severe neuropathic pain, transverse myelitis, and RPLS
Premedicate to treat neuropathic pain as recommended
Permanently discontinue based on the adverse reaction and severity
Contraindications
Severe hypersensitivity; including anaphylaxis to naxitamab
Cautions
Serious infusion reactions may occur requiring urgent intervention, including fluid resuscitation, administration of bronchodilators and corticosteroids, intensive care unit admission, infusion rate reduction, or interruption of infusion
May cause severe neurotoxicity, including severe neuropathic pain, transverse myelitis, and RPLS
Hypertension reported; do not initiate in patients with uncontrolled hypertension; monitor blood pressure during infusion and at least daily on Days 1-8 of each cycle
Fetal harm may occur when administered to pregnant females
Pregnancy & Lactation
Pregnancy
Based on its mechanism of action, fetal harm may occur when administered to pregnant females
No data available on use in pregnant females and no animal reproduction studies have been conducted
IgG1 monoclonal antibodies are transported across the placenta in a linear fashion as pregnancy progresses, with the largest amount transferred during third trimester
Advise pregnant females of potential risk to fetus
Verify pregnancy status in females of reproductive potential before initiation
Contraception
- Females of reproductive potential: Use effective contraception during treatment and for 2 months after the final dose
Lactation
There are no data on drug presence in human milk or its effects on the breastfed children, or on milk production
However, human IgG is present in human milk
Advise women not to breastfeed during treatment and for 2 months after the final dose
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Humanized anti-GD2 3F8 monoclonal antibody; stimulates antibody-dependent cell-mediated cytotoxicity against GD2-expressing tumor cells
GD2, a disialoganglioside with expression in normal tissues restricted primarily to the cerebellum and peripheral nerves, is commonly expressed at high levels on tumors of neuroectodermal origins such as melanomas and neuroblastomas
Absorption
Peak plasma concentration: 57.4 mcg/mL
Metabolism
Expected to be metabolized into small peptides by catabolic pathways
Elimination
Half-life: 8.2 days
Administration
IV Preparation
Visually inspect vial for particulate matter and discoloration before use; solution should appear clear to slightly opalescent and colorless to slightly yellow; discard if solution is discolored, cloudy, or contains particulate matter
Add appropriate quantities of 5% albumin (human) and 0.9% NaCl injection into an empty, sterile IV infusion bag large enough to hold total infusion volume (refer to prescribing information)
Allow for 5-10 min of passive mixing
Withdraw required dose and inject into infusion bag containing the 5% albumin (human) and 0.9% NaCl; discard any unused drug left in vial
Premedication
Pain management
- Initiate prophylactic medication for neuropathic pain (eg, gabapentin) on Days -4 through 7
- Administer oral opioids 45-60 min before initiating each infusion and additional IV opioids PRN for breakthrough pain during infusion
- Consider ketamine if pain is not adequately controlled by opioids
Prevention of infusion-related reactions and nausea/vomiting
- Administer IV corticosteroids (eg, methylprednisolone 2 mg/kg [up to 80 mg] or equivalent corticosteroid dose) 30 min to 2 hr before first infusion
- For subsequent infusions, administer corticosteroids if severe infusion reaction occurred with previous infusion or during previous cycle
- Administer antihistamine, H2 antagonist, acetaminophen, and antiemetic 30 min before each infusion
IV Administration
Administer as diluted IV infusion as recommended; do not administer as IV push or bolus
First infusion (Cycle 1, Day 1): Infuse over 60 min
Subsequent infusion: Infuse over 30-60 min, as tolerated
Following each infusion: Observe patients for at least 2 hr
Missed dose
- Administer missed dose the following week by Day 10
- Administer GM-CSF 500 mcg/m2/day on the first day of infusion, the day before and the day of the second and third infusion (total of 5 days)
Storage
Unopened vials
- Refrigerate at 2-8ºC (36-46ºF) in original carton to protect from light until time of use
Diluted infusions
- If not used immediately, store at room temperature (15-25ºC [59-77ºF]) for up to 8 hr or refrigerate (2-8ºC [36- 46ºF]) for up to 24 hr
- Once removed from refrigeration, initiate infusion within 8 hr
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Formulary
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