Naxitamab: Drug information

For additional information see "Naxitamab: Pediatric drug information" and "Naxitamab: Patient drug information"

For abbreviations, symbols, and age group definitions show table

ALERT: US Boxed Warning

Serious infusion-related reactions

Naxitamab can cause serious infusion reactions, including cardiac arrest, anaphylaxis, hypotension, bronchospasm, and stridor. Infusion reactions of any grade occurred in 94 to 100% of patients. Severe infusion reactions occurred in 32 to 68%, and serious infusion reactions occurred in 4 to 18% of patients in naxitamab clinical studies. Premedicate prior to each naxitamab infusion as recommended, and monitor patients for at least 2 hours following completion of each infusion. Reduce the rate, interrupt infusion, or permanently discontinue naxitamab based on severity.

Neurotoxicity

Naxitamab can cause severe neurotoxicity, including severe neuropathic pain, transverse myelitis, and reversible posterior leukoencephalopathy syndrome (RPLS). Pain of any grade occurred in 94 to 100% of patients in naxitamab clinical studies. Premedicate to treat neuropathic pain as recommended. Permanently discontinue naxitamab based on the adverse reaction and severity.

Brand Names: US

Danyelza

Pharmacologic Category

Antineoplastic Agent, Anti-GD2;
Antineoplastic Agent, Monoclonal Antibody

Dosing: Adult

Dosage guidance:

Safety: Administer premedications to reduce the risk of infusion-related reactions. Do not initiate naxitamab in patients with uncontrolled hypertension.

Clinical considerations : Naxitamab is associated with a moderate emetic potential; antiemetics are recommended to prevent nausea and vomiting (Ref). Administer pain management prior to and during infusion (Ref).

Neuroblastoma, high risk, relapsed or refractory

Neuroblastoma, high risk, relapsed or refractory:

IV: 3 mg/kg/day (maximum dose: 150 mg/day) on days 1, 3, and 5 of each 4-week treatment cycle (in combination with sargramostim [GM-CSF]); repeat cycle every 4 weeks until complete or partial response, followed by 5 additional cycles (every 4 weeks). Subsequent cycles may be repeated every 8 weeks. Discontinue (naxitamab and GM-CSF) with disease progression or unacceptable toxicity (Ref).

Premedication: Administer an antihistamine, an H₂ antagonist, acetaminophen, and an antiemetic 30 minutes prior to each naxitamab infusion. In addition, administer an IV corticosteroid such as methylprednisolone 2 mg/kg (maximum: 80 mg/dose) or equivalent corticosteroid 30 minutes to 2 hours prior to the first naxitamab infusion. The systemic corticosteroid may be administered for subsequent infusions if a severe infusion reaction occurred with the previous infusion (or during the previous cycle).

Pain management (prior to and during naxitamab infusion):

Day –4 through Day 7: Administer a 12-day course of a prophylactic medication for neuropathic pain (eg, gabapentin); initiate 5 days prior to the first naxitamab infusion in each cycle.

Prior to and during infusion: Administer oral opioids 45 to 60 minutes prior to initiation of each naxitamab infusion; additional IV opioids may be administered, as needed, for breakthrough pain during the infusion. If pain is not adequately controlled by opioids, may consider ketamine.

Missed dose: If a naxitamab dose is missed, administer the missed dose the following week (by day 10 of the cycle). Administer sargramostim (GM-CSF) on the first day of the naxitamab infusion, and on the day before and on the day of the second and third infusion, respectively (for a total of 5 days of the 500 mcg/m²/day sargramostim dose).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Obesity: Adult

American Society of Clinical Oncology guidelines for appropriate systemic therapy dosing in adults with cancer with a BMI ≥30 kg/m² : The dosing in the FDA-approved prescribing information should be followed in all patients, regardless of obesity status. If a patient with a BMI ≥30 kg/m²experiences high-grade toxicity from systemic anticancer therapy, the same dosage modification recommendations should be followed for all patients, regardless of obesity status. If dose reduction for toxicity is recommended in the prescribing information, the dose should be increased back to the initial or previously tolerated dose only if dose escalations are allowed in the prescribing information, if contributing underlying factors (eg, hepatic or kidney impairment) are sufficiently resolved, AND if performance status has markedly improved or is considered adequate (Ref). Note: According to the prescribing information, the maximum dose is 150 mg/day.

Dosing: Adjustment for Toxicity: Adult

**Naxitamab Dosage Modifications for Adverse Reactions**
Adverse reaction	Grade	Dosage modification
^aNSAIDs = nonsteroidal anti-inflammatory drugs.
Cardiovascular toxicity: Myocarditis	Grade 2 or 3	Withhold naxitamab, reduce the dose, or permanently discontinue naxitamab based on the severity and duration.
Cardiovascular toxicity: Myocarditis	Grade 4	Permanently discontinue naxitamab.
Hypertension	Grade 3	Withhold naxitamab or interrupt infusion until recovery to ≤ grade 2, then resume infusion at 50% of prior infusion rate. If tolerated (no recurrence of symptoms), gradually increase infusion rate to rate prior to onset of symptoms. Permanently discontinue naxitamab if no response to medication intervention.
Hypertension	Grade 4	Permanently discontinue naxitamab.
Hypotension, orthostatic	All grades	Withhold naxitamab until recovery to ≤ grade 1. If resolved within 1 week: Restart naxitamab at 50% of the prior dose; if tolerated without recurrence of symptoms after completion of the next cycle, resume at the recommended dose for subsequent cycles. If NOT resolved within 1 week: Permanently discontinue naxitamab.
Infusion-related reactions	Grade 2: Therapy/infusion interruption indicated but responds promptly to symptomatic treatment (eg, antihistamines, NSAIDS^a, narcotics, IV fluids); prophylactic medications indicated for ≤24 hours	Reduce naxitamab infusion rate to 50% of previous rate. Monitor closely until improvement to ≤ grade 1, then increase infusion rate gradually as tolerated to rate prior to the event.
	Grade 3: Prolonged reaction (eg, not rapidly responsive to symptomatic therapy and/or brief infusion interruption); recurrence of symptoms following initial improvement; hospitalization indicated for clinical sequelae	Immediately interrupt naxitamab infusion. Monitor closely until recovery to ≤ grade 2, then resume infusion at 50% of the previous rate and increase infusion rate gradually as tolerated to rate prior to the event. Permanently discontinue naxitamab if no response to medical intervention.
	Grade 4: Life-threatening consequences; urgent intervention indicated or grade 3 or 4 anaphylaxis	Permanently discontinue naxitamab.
Ocular (neurologic disorders of the eye)	Grades 2 to 4 resulting in decreased visual acuity or limiting activities of daily living	Withhold naxitamab until resolution. If resolved, resume naxitamab at 50% of the prior dose; if tolerated (no recurrence of symptoms), gradually increase naxitamab dose to the dose prior to onset of symptoms. Permanently discontinue naxitamab if not resolved within 2 weeks, or if toxicity recurs.
Ocular (neurologic disorders of the eye)	Subtotal or total vision loss	Permanently discontinue naxitamab.
Pain	Grade 3 (unresponsive to maximum supportive measures)	Permanently discontinue naxitamab.
Peripheral neuropathy	≥ Grade 2 motor neuropathy	Permanently discontinue naxitamab.
Peripheral neuropathy	≥ Grade 3 sensory neuropathy	Permanently discontinue naxitamab.
Reversible posterior leukoencephalopathy syndrome (RPLS)	Any	Permanently discontinue naxitamab.
Transverse myelitis	Any	Permanently discontinue naxitamab.
Urinary retention, prolonged	Persistent despite opioid discontinuation	Permanently discontinue naxitamab.
Other adverse reaction	Grade 3	Withhold naxitamab until recovery to ≤ grade 2, then resume naxitamab at the same rate. Permanently discontinue naxitamab if not resolved to ≤ grade 2 within 2 weeks.
Other adverse reaction	Grade 4	Permanently discontinue naxitamab.

Dosing: Pediatric

(For additional information see "Naxitamab: Pediatric drug information")

Note: Administer premedications to reduce the risk of infusion-related reactions and nausea/vomiting (naxitamab is associated with nausea and vomiting); administer pain management prior to and during infusion.

Neuroblastoma, relapsed or refractory

Neuroblastoma (high-risk), relapsed or refractory: Children and Adolescents: IV: 3 mg/kg/day (maximum dose: 150 mg/day) on days 1, 3, and 5 of each treatment cycle (in combination with sargramostim [GM-CSF]). Treatment cycles are repeated every 4 weeks until complete or partial response, followed by 5 additional cycles (every 4 weeks). Subsequent cycles may be repeated every 8 weeks. Discontinue for unacceptable toxicity or if patient experiences disease progression.

Premedication: Administer an H₁ antagonist antihistamine, an H₂ antagonist antihistamine, acetaminophen, and an antiemetic 30 minutes prior to each naxitamab infusion. In addition, administer an IV corticosteroid such as methylprednisolone 2 mg/kg (maximum: 80 mg/dose) or equivalent 30 minutes to 2 hours prior to the first naxitamab infusion. For subsequent infusions, administer systemic corticosteroid if a severe infusion reaction occurred with the previous infusion (or during the previous cycle).

Pain management (prior to and during naxitamab infusion):

Day −4 through Day 7: Administer a 12-day course of a prophylactic medication for neuropathic pain (eg, gabapentin); initiate 5 days (Day −4) prior to the first naxitamab infusion in each cycle.

Prior to and during infusion: Administer oral opioids 45 to 60 minutes prior to initiation of each naxitamab infusion; additional IV opioids may be administered as needed for breakthrough pain during the infusion. If pain is not adequately controlled by opioids, may consider ketamine.

Dosing adjustment for toxicity: Children and Adolescents:

**Naxitamab Dosage Modifications for Adverse Reactions**
Adverse reaction	Grade	Dosage modification
Hypertension	Grade 3	Withhold naxitamab or interrupt infusion until recovery to ≤ grade 2, then resume infusion at 50% of prior infusion rate. If tolerated (no recurrence of symptoms), gradually increase infusion rate to rate prior to onset of symptoms. Permanently discontinue naxitamab if no response to medical intervention.
Hypertension	Grade 4	Permanently discontinue naxitamab.
Infusion-related reactions	Grade 2	Reduce naxitamab infusion rate to 50% of previous rate. Monitor closely until improvement to ≤ grade 1, then increase infusion rate gradually as tolerated to rate prior to the event.
	Grade 3	Immediately interrupt naxitamab infusion. Monitor closely until recovery to ≤ grade 2, then resume infusion at 50% of the previous rate and increase infusion rate gradually as tolerated to rate prior to the event. Permanently discontinue naxitamab if no response to medical intervention.
	Grade 4: Life-threatening consequences; urgent intervention indicated or grade 3 or 4 anaphylaxis	Permanently discontinue naxitamab.
Ocular (neurologic disorders of the eye)	Grade 2 to 4 resulting in decreased visual acuity or limiting activities of daily living	Withhold naxitamab until resolution. If resolved, resume naxitamab at 50% of the prior dose; if tolerated (no recurrence of symptoms), gradually increase naxitamab dose to the dose prior to onset of symptoms. Permanently discontinue naxitamab if not resolved within 2 weeks, or if toxicity recurs.
Ocular (neurologic disorders of the eye)	Subtotal or total vision loss	Permanently discontinue naxitamab.
Pain	Grade 3 (unresponsive to maximum supportive measures)	Permanently discontinue naxitamab.
Peripheral neuropathy	Motor neuropathy ≥ Grade 2	Permanently discontinue naxitamab.
Peripheral neuropathy	Sensory neuropathy ≥ Grade 3	Permanently discontinue naxitamab.
Reversible posterior leukoencephalopathy syndrome (RPLS)	Any	Permanently discontinue naxitamab.
Transverse myelitis	Any	Permanently discontinue naxitamab.
Urinary retention, prolonged	Persistent despite opioid discontinuation	Permanently discontinue naxitamab.
Other adverse reaction	Grade 3	Withhold naxitamab until recovery to ≤ grade 2, then resume naxitamab at the same rate. Permanently discontinue naxitamab if not resolved to ≤ grade 2 within 2 weeks.
Other adverse reaction	Grade 4	Permanently discontinue naxitamab.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions (Significant): Considerations

Infusion-related reactions

Naxitamab may cause infusion-related reactions, including severe reactions. Anaphylaxis, hypotension, bronchospasm, and stridor have been reported. In clinical trials, most patients required an infusion rate reduction and/or interruption for at least 1 infusion reaction; permanent discontinuation may also be required depending on reaction severity.

Onset: Rapid; usually within 24 hours of completion of infusion with most reactions occurring within 30 minutes of infusion initiation. Reactions were most frequent during the first infusion in each cycle.

Risk factors:

• Rapid infusion rate

• Preexisting cardiac disease (predisposes for severe hypotension)

Hypertension

Hypertension was observed, including grade 3 and 4 events. Depending on severity, hypertension may warrant withholding or interrupting the infusion, decreasing infusion rate, or permanent discontinuation.

Onset: Varied; most cases occurred on the day of infusion; up to 9 days following infusion has been reported.

Risk factors:

• Uncontrolled hypertension (do not initiate in these patients)

Myocarditis

Myocarditis has been reported in adolescents receiving naxitamab. Depending on severity, myocarditis may warrant withholding or interrupting the infusion, decreasing the infusion rate, or permanent discontinuation.

Onset: Rapid; within days following infusion.

Neurotoxicity

Naxitamab may cause severe neurotoxicity, including severe neuralgia (or neuropathic pain), transverse myelitis and reversible posterior leukoencephalopathy syndrome (RPLS). Peripheral neuropathy, which included peripheral sensory, motor neuropathy, paresthesia, and neuralgia, was also reported. Cases of peripheral neuropathy lasted a median of 5.5 days (range: 0 to 22 days). In addition, neurological eye disorders, including anisocoria, blurred vision, accommodation disturbance, mydriasis, visual impairment, and photophobia, were observed. Cases of neurological eye disorders lasted a median of 17 days (range: 0 to 84 days) in one study. Neurotoxicities may warrant infusion interruption or permanent discontinuation, depending on severity.

Onset: Varied; RPLS: Varied; reported cases in clinical trials occurred 2 and 7 days following completion of the first cycle. Peripheral neuropathy: Rapid; most cases began on the day of infusion.

Orthostatic hypotension

Orthostatic hypotension has been reported with naxitamab therapy, including severe cases and cases requiring hospitalization. Depending on severity, orthostatic hypotension may warrant withholding or interrupting the infusion, decreasing the infusion rate, or permanent discontinuation.

Onset: Varied; within hours to 6 days following infusion in any cycle.

Pain

Pain (of any grade), including abdominal, bone, neck, and extremity pain, may occur with naxitamab therapy. Many reported cases were severe pain (grade 3 and 4 events). Pain typically lasted a median of <1 day (range: <1 day to 62 days). Neuropathic pain may also occur with therapy.

Onset: Varied; pain (eg, abdominal, bone, neck, and extremity pain) usually began during the infusion.

Urinary retention

Urinary retention, including some cases persisting after discontinuation of opioids, have been observed. Events lasted between 0 to 24 days during clinical trials. Permanent discontinuation may be required for persistent urinary retention.

Onset: Rapid; day of infusion for all cases during clinical trials.

Adverse Reactions

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 (GM-CSF).

>10%:

Cardiovascular: Edema, hypertension, hypotension, sinus tachycardia, tachycardia

Dermatologic: Erythema multiforme, erythema of skin, hyperhidrosis, urticaria

Endocrine & metabolic: Decreased serum albumin, decreased serum calcium, decreased serum glucose, decreased serum magnesium, decreased serum phosphate, decreased serum potassium, decreased serum sodium, increased serum glucose, weight loss

Gastrointestinal: Constipation, decreased appetite, diarrhea, nausea, viral gastrointestinal infection, vomiting

Hematologic & oncologic: Bruise, decreased hemoglobin, decreased neutrophils, decreased platelet count, lymphocytopenia

Hepatic: Increased serum alanine aminotransferase, increased serum aspartate aminotransferase

Hypersensitivity: Infusion-related reaction (may be severe)

Infection: Influenza

Local: Injection-site reaction, localized edema

Nervous system: Anxiety, fatigue, headache, impaired consciousness, irritability, lethargy, pain, peripheral neuropathy

Ophthalmic: Accommodation disturbance, anisocoria, blurred vision, mydriasis, photophobia, visual impairment

Respiratory: Abnormal breath sounds, cough, nasal infection (viral), oropharyngeal pain, rhinorrhea, upper respiratory tract infection

Miscellaneous: Fever

1% to 10%:

Cardiovascular: Peripheral edema

Nervous system: Reversible posterior leukoencephalopathy syndrome

Respiratory: Apnea, shallow respiration

Frequency not defined:

Cardiovascular: Myocarditis (adolescents), orthostatic hypotension (may be severe)

Genitourinary: Urinary retention

Hypersensitivity: Anaphylaxis

Immunologic: Antibody development

Nervous system: Neuralgia (severe), neurotoxicity (may be severe)

Respiratory: Bronchospasm, respiratory depression, stridor

Postmarketing: Nervous system: Transverse myelitis

Contraindications

History of severe hypersensitivity (including anaphylaxis) to naxitamab or any component of the formulation.

Warnings/Precautions

Disease-related concerns:

• Cardiac disease: Use naxitamab with caution in patients with preexisting cardiac disease (may exacerbate the risk of severe hypotension).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous [preservative free]:

Danyelza: Naxitamab-gqgk 4 mg/mL (10 mL)

Generic Equivalent Available: US

Pricing: US

Solution (Danyelza Intravenous)

40 mg/10 mL (per mL): $2,923.28

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Naxitamab is associated with a moderate emetic potential; antiemetics are recommended to prevent nausea and vomiting (Ref). Administer in a setting where cardiopulmonary resuscitation medication and equipment is available.

IV: Administer the first infusion (day 1, cycle 1) over 60 minutes. Administer over 30 to 60 minutes as tolerated for subsequent infusions. Do not administer as an IV push or bolus. Observe patients for a minimum of 2 hours following each infusion. Premedication and pain management prior to infusions are required.

Administration: Pediatric

Naxitamab may be associated with a moderate emetic potential; administer an antiemetic, prior to each infusion. Administer an H₁ antagonist antihistamine , an H₂ antagonist antihistamine, and acetaminophen 30 minutes prior to each naxitamab infusion. Administer oral opioids 45 to 60 minutes prior to initiation of each naxitamab infusion; additional IV opioids may be administered as needed for breakthrough pain during the infusion

Parenteral: IV: Infuse the first infusion (day 1, cycle 1) over 60 minutes. For subsequent infusions, administer over 30 to 60 minutes as tolerated. Do not administer as an IV push or bolus. Observe patients for a minimum of 2 hours following each infusion.

Use: Labeled Indications

Neuroblastoma, high risk, relapsed or refractory: Treatment of relapsed or refractory high-risk neuroblastoma in the bone or bone marrow (in combination with granulocyte-macrophage colony-stimulating factor [GM-CSF]), in pediatric patients ≥1 year of age and adults who have demonstrated a partial response, minor response, or stable disease to prior therapy.

Medication Safety Issues

Sound-alike/look-alike issues:

Naxitamab may be confused with amivantamab, glofitamab, dinutuximab, nivolumab.

High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (chemotherapeutic agent, parenteral and oral) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care, Community/Ambulatory Care, and Long-Term Care Settings).

Metabolism/Transport Effects

None known.

Drug Interactions

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 drug interactions program by clicking on the “Launch drug interactions program” link above.

Androgens: Hypertension-Associated Agents may enhance the hypertensive effect of Androgens. Risk C: Monitor therapy

Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Solriamfetol: May enhance the hypertensive effect of Hypertension-Associated Agents. Risk C: Monitor therapy

Reproductive Considerations

Evaluate pregnancy status prior to use in patients who could become pregnant.

Patients who could become pregnant should use effective contraception during therapy and for 2 months after the last naxitamab dose.

Pregnancy Considerations

Naxitamab is a humanized monoclonal antibody (IgG1). Placental transfer of human IgG is dependent upon the IgG subclass, maternal serum concentrations, newborn birth weight, 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, in utero exposure to naxitamab may cause fetal harm.

Breastfeeding Considerations

It is not known if naxitamab is present in breast milk. However, naxitamab is a humanized monoclonal antibody (IgG₁) and human IgG is present in breast milk.

Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during treatment and for 2 months after the last naxitamab dose.

Monitoring Parameters

Evaluate pregnancy status prior to use in patients who could become pregnant. Monitor closely for signs/symptoms of infusion reactions (during and for at least 2 hours after infusion completion). In patients with symptoms of orthostatic hypotension, monitor postural BP prior to treatment initiation and as clinically indicated with subsequent doses. Monitor BP during infusion and at least daily on days 1 to 8 of each cycle. Monitor for hypertensive and for orthostatic hypotension complications. Monitor for signs/symptoms of pain, transverse myelitis, reversible leukoencephalopathy syndrome, peripheral neuropathy, urinary retention, myocarditis, and ocular symptoms.

The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.

Mechanism of Action

Naxitamab binds to the glycolipid disialoganglioside (GD2), which is highly expressed in neuroblastoma, and other cells of neuroectodermal origin, including the central nervous system and peripheral nerves. By binding to cell surface GD2, naxitamab induces cell lysis (of GD2-expressing cells) through antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).

Pharmacokinetics (Adult Data Unless Noted)

Metabolism: Metabolized into small peptides by catabolic pathways.

Half-life elimination: 8.2 days.

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(PR) Puerto Rico: Danyelza

Danyelza (naxitamab) [prescribing information]. New York, NY: Y-mAbs Therapeutics Inc; March 2024.
Griggs JJ, Bohlke K, Balaban EP, et al. Appropriate systemic therapy dosing for obese adult patients with cancer: ASCO guideline update. J Clin Oncol. 2021;39(18):2037-2048. doi:10.1200/JCO.21.00471 [PubMed 33939491]
Herrstedt J, Clark-Snow R, Ruhlmann CH, et al; participants of the MASCC/ESMO Consensus Conference 2022. 2023 MASCC and ESMO guideline update for the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting. ESMO Open. 2024;9(2):102195. doi:10.1016/j.esmoop.2023.102195 [PubMed 38458657]
Hwang JP, Feld JJ, Hammond SP, et al. Hepatitis B virus screening and management for patients with cancer prior to therapy: ASCO provisional clinical opinion update. J Clin Oncol. 2020;38(31):3698-3715. doi:10.1200/JCO.20.01757 [PubMed 32716741]
Mora J, Chan GC, Morgenstern DA, et al. Outpatient administration of naxitamab in combination with granulocyte-macrophage colony-stimulating factor in patients with refractory and/or relapsed high-risk neuroblastoma: management of adverse events. Cancer Rep (Hoboken). 2023;6(1):e1627. doi:10.1002/cnr2.1627 [PubMed 35579862]
Palmeira P, Quinello C, Silveira-Lessa AL, Zago CA, Carneiro-Sampaio M. IgG placental transfer in healthy and pathological pregnancies. Clin Dev Immunol. 2012;2012:985646. doi:10.1155/2012/985646 [PubMed 22235228]
Pentsuk N, van der Laan JW. An interspecies comparison of placental antibody transfer: new insights into developmental toxicity testing of monoclonal antibodies. Birth Defects Res B Dev Reprod Toxicol. 2009;86(4):328-344. doi:10.1002/bdrb.20201 [PubMed 19626656]
Refer to manufacturer's labeling.

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Naxitamab: Drug information