Naxitamab

Naxitamab is a prescription medication used 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. 

• Naxitamab is available under the following different brand names: Danyelza, naxitamab-gqgk

Common side effects of Naxitamab include:

• infusion-related reactions occurring on the day of infusion or the day following an infusion (low blood pressure, bronchospasm, flushing, wheezing, stridor, hives, shortness of breath, fever, swelling of the face/lips/tongue, respiratory tract edema, chills, low blood oxygen, itching, and rash)
• pain (abdominal pain, pain in extremities, bone pain, neck pain, back pain, and musculoskeletal pain)
• fast heart rate
• vomiting
• cough
• nausea
• diarrhea
• decreased appetite
• high blood pressure (hypertension)
• fatigue
• erythema multiforme
• numbness and tingling of extremities
• hives not occurring on the day of infusion or the day following an infusion
• fever not occurring on the day of infusion or the day following an infusion
• headache
• injection site reaction
• fluid retention (edema)
• anxiety
• localized swelling
• irritability
• decreased lymphocytes
• decreased neutrophils
• decreased hemoglobin
• decreased platelet count
• decreased potassium
• increased alanine aminotransferase
• decreased glucose
• decreased calcium
• decreased albumin
• decreased sodium
• decreased phosphate

Serious side effects of Naxitamab include:

• none

Rare side effects of Naxitamab include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injection, solution

• 40 mg/10 mL (4 mg/mL) single-dose vial

Neuroblastoma

Adult dosage

• 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 hour before administration
• Naxitamab 3 mg/kg/day (up to 150 mg/day) IV on Days 1, 3, and 5; repeat every 4 weeks until complete response or partial response, followed by 5 additional cycles every 4 weeks
• Then repeat every 8 weeks for subsequent cycles thereafter
• Discontinue naxitamab and GM-CSF for disease progression or unacceptable toxicity

Pediatric dosage

• Children aged younger than 1 year: Safety and efficacy not established
• Children aged 1 year and above:
  • 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 hour before administration
  • Naxitamab 3 mg/kg/day (up to 150 mg/day) IV on Days 1, 3, and 5; repeat every 4 weeks until complete response or partial response, followed by 5 additional cycles every 4 weeks
  • Then repeat every 8 weeks for subsequent cycles thereafter
  • Discontinue naxitamab and GM-CSF for disease progression or unacceptable toxicity

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Naxitamab has no noted severe interactions with other drugs
• Naxitamab has no noted serious interactions with other drugs
• Naxitamab has no noted moderate interactions with other drugs
• Naxitamab has no noted minor interactions with other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Severe hypersensitivity; including anaphylaxis to naxitamab

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Naxitamab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using 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 the 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 to 8 of each cycle
• Fetal harm may occur when administered to pregnant women

Pregnancy and Lactation

• Based on its mechanism of action, fetal harm may occur when administered to pregnant women
• No data are available on use in pregnant women 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 the third trimester
• Advise pregnant women of potential risk to the fetus
• Verify pregnancy status in women of reproductive potential before initiation
• Contraception
  • Women 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 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