Naxitamab Dosage

Medically reviewed by Drugs.com. Last updated on Jan 25, 2024.

Applies to the following strengths: gqgk 4 mg/mL

Usual Adult Dose for Neuroblastoma

3 mg/kg/day (up to 150 mg/day) IV on Days 1, 3, and 5 of each cycle in combination with GM-CSF subcutaneously
NOTE: For the first infusion (Cycle 1, Day 1), administer over 60 minutes; for subsequent infusions, administer over 30 to 60 minutes, as tolerated.

RECOMMENDED DOSE REGIMEN FOR EACH TREATMENT CYCLE:

DAYS -4 to 0: Administer GM-CSF 250 mcg/m2 subcutaneously daily beginning 5 days prior to naxitamab infusion
DAYS 1 to 5: Administer GM-CSF 500 mcg/m2 subcutaneously daily at least 1 hour prior to naxitamab on Days 1, 3, and 5
DAYS 1, 3, and 5: Administer naxitamab 3 mg/kg/day (up to 150 mg/day) IV

Duration of therapy: Cycles are repeated every 4 weeks until complete response or partial response, followed by 5 additional cycles every 4 weeks. Subsequent cycles may be repeated every 8 weeks. Discontinue this drug and GM-CSF for disease progression or unacceptable toxicity.

PREMEDICATIONS AND SUPPORTIVE MEDICATIONS PAIN MANAGEMENT PRIOR TO AND DURING INFUSION:

Five days prior to the first infusion of naxitamab in each cycle, initiate a 12-day course (Day -4 through Day 7) of prophylactic medication for neuropathic pain, such as gabapentin.
Administer oral opioids 45 to 60 minutes prior to initiation of each naxitamab

infusion and additional IV opioids as needed for breakthrough pain during the infusion.

Consider use of ketamine for pain that is not adequately controlled by opioids.

PREMEDICATION: REDUCE RISK OF INFUSION-RELATED REACTIONS AND NAUSEA/VOMITING:

Administer IV corticosteroids (e.g., methylprednisolone 2 mg/kg with maximum dose of 80 mg or equivalent corticosteroid dose) 30 minutes to 2 hours prior to the first infusion of naxitamab.
Administer corticosteroid premedication for subsequent infusions if a severe infusion reaction occurred with the previous infusion or during the previous cycle.
Administer an antihistamine, an H2 antagonist, acetaminophen and an antiemetic 30 minutes prior to each infusion.

Comments:

Refer to the GM-CSF Prescribing Information for recommended dosing information.
Administer pre-infusion medications and supportive treatment, if needed, during infusion.

Use: In combination with granulocyte-macrophage colony-stimulating factor (GMCSF) for relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy

Usual Pediatric Dose for Neuroblastoma

1 year and older:
3 mg/kg/day (up to 150 mg/day) IV on Days 1, 3, and 5 of each cycle in combination with GM-CSF subcutaneously
NOTE: For the first infusion (Cycle 1, Day 1), administer over 60 minutes; for subsequent infusions, administer over 30 to 60 minutes, as tolerated.

RECOMMENDED DOSE REGIMEN FOR EACH TREATMENT CYCLE:

DAYS -4 to 0: Administer GM-CSF 250 mcg/m2 subcutaneously daily beginning 5 days prior to naxitamab infusion
DAYS 1 to 5: Administer GM-CSF 500 mcg/m2 subcutaneously daily at least 1 hour prior to naxitamab on Days 1, 3, and 5
DAYS 1, 3, and 5: Administer naxitamab 3 mg/kg/day (up to 150 mg/day) IV

Five days prior to the first infusion of naxitamab in each cycle, initiate a 12-day course (Day -4 through Day 7) of prophylactic medication for neuropathic pain, such as gabapentin.
Administer oral opioids 45 to 60 minutes prior to initiation of each naxitamab

infusion and additional IV opioids as needed for breakthrough pain during the infusion.

Consider use of ketamine for pain that is not adequately controlled by opioids.

PREMEDICATION: REDUCE RISK OF INFUSION-RELATED REACTIONS AND NAUSEA/VOMITING:

Administer IV corticosteroids (e.g., methylprednisolone 2 mg/kg with maximum dose of 80 mg or equivalent corticosteroid dose) 30 minutes to 2 hours prior to the first infusion of naxitamab.
Administer corticosteroid premedication for subsequent infusions if a severe infusion reaction occurred with the previous infusion or during the previous cycle.
Administer an antihistamine, an H2 antagonist, acetaminophen and an antiemetic 30 minutes prior to each infusion.

Comments:

Refer to the GM-CSF Prescribing Information for recommended dosing information.
Administer pre-infusion medications and supportive treatment, if needed, during infusion.

Use: In combination with granulocyte-macrophage colony-stimulating factor (GMCSF) for pediatric patients 1 year and older with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

MISSED DOSE:

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

DOSE MODIFICATIONS FOR ADVERSE REACTIONS:
INFUSION-RELATED REACTIONS:

GRADE 2 (therapy or infusion interruption indicated but responds promptly to symptomatic treatment [e.g., antihistamines, NSAIDS, narcotics, IV fluids]; prophylactic medications indicated for 24 hours or less): Reduce naxitamab infusion rate to 50% of previous rate and monitor closely until recovery to Grade 1 or less; increase infusion rate gradually to rate prior to the event as tolerated.
GRADE 3 (prolonged [e.g., not rapidly responsive to symptomatic medication and/or brief interruption of infusion]; recurrence of symptoms following initial improvement; hospitalization indicated for clinical sequelae): Immediately interrupt naxitamab infusion and monitor until recovery to Grade 2 or less; resume infusion at 50% of the rate prior to the event and increase infusion rate gradually to infusion rate prior to the event as tolerated; permanently discontinue therapy in patients not responding to medical intervention.
GRADE 4 (e.g., life-threatening consequences: urgent intervention indicated or Grade 3 or 4 anaphylaxis): Permanently discontinue therapy.

PAIN:

GRADE 3 (e.g., unresponsive to maximum supportive measures): Permanently discontinue therapy.

REVERSIBLE POSTERIOR LEUKOENCEPHALOPATHY SYNDROME (RPLS):

ALL GRADES: Permanently discontinue therapy.

TRANSVERSE MYELITIS:

ALL GRADES: Permanently discontinue therapy.

PERIPHERAL NEUROPATHY:

Motor neuropathy (GRADE 2 or greater OR sensory neuropathy (GRADE 3 or 4): Permanently discontinue therapy.

NEUROLOGICAL DISORDERS OF THE EYE:

GRADE 2 to 4 resulting in decreased visual acuity or limiting activities of daily living: Withhold therapy until resolution; if resolved resume therapy at 50% of the prior dose; if tolerated without recurrence of symptoms, gradually increase to dose prior to onset of symptoms; permanently discontinue naxitamab if not resolved within 2 weeks or upon recurrence.
Subtotal or total vision loss: Permanently discontinue therapy.

PROLONGED URINARY RETENTION:

Persisting following discontinuation of opioids: Permanently discontinue therapy.

HYPERTENSION:

GRADE 3: Withhold therapy or pause infusion until recovery to Grade 2 or less; resume infusion at 50% of prior rate; if tolerated without recurrence of symptoms, gradually increase to rate prior to onset of symptoms; permanently discontinue therapy in patients not responding to medical intervention.
GRADE 4: Permanently discontinue therapy.

OTHER ADVERSE REACTIONS:

GRADE 3: Withhold therapy or pause infusion until recovery to Grade 2 or less; If resolved to Grade 2 or less resume at same rate; permanently discontinue therapy if not resolved to Grade 2 or less within 2 weeks.
GRADE 4: Permanently discontinue therapy.

Precautions

US BOXED WARNINGS:
SERIOUS INFUSION-RELATED REACTIONS:

This drug can cause serious infusion reactions (e.g., cardiac arrest, anaphylaxis, hypotension, bronchospasm, 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.

Recommendations:

Premedicate prior to each infusion and monitor patients for at least 2 hours after the infusion.
Reduce the rate, interrupt infusion, or permanently discontinue therapy based on severity.

NEUROTOXICITY:

This drug can cause severe neurotoxicity (e.g., severe neuropathic pain, transverse myelitis, reversible posterior leukoencephalopathy syndrome [RPLS]).
Pain of any Grade occurred in 94% to 100% of patients.

Recommendations:

Premedicate to treat neuropathic pain.
Permanently discontinue therapy based on severity.

CONTRAINDICATIONS:

Hypersensitivity to the active component or any of the ingredients

Safety and efficacy have not been established in patients younger than 1 year.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

Administer this drug as a diluted IV infusion.
Do not administer as an IV push or bolus.
Observe patients for a minimum of 2 hours following each infusion.

Storage requirements:

Store the vial refrigerated at 2C to 8C (36F to 46F) in the outer carton to protect from light.

Reconstitution/preparation techniques:

Use aseptic technique.
Visually inspect vial for particulate matter and discoloration prior to administration; discard vial if solution is discolored, cloudy, or contains particulate matter.
Add appropriate quantities of 5% albumin (human) and 0.9% sodium chloride Injection to an empty, sterile IV infusion bag large enough to hold the volume needed for the dose.
Allow for 5 to 10 minutes of passive mixing.
Withdraw the required dose and inject into the infusion bag containing the 5% albumin and 0.9% sodium chloride; discard any unused portion in the vial.
The manufacturer product information should be consulted.