Naxitamab-gqgk (Intravenous)

Naxitamab-gqgk injection is used together with granulocyte-macrophage colony-stimulating factor (GM-CSF) to treat relapsed (has come back) or refractory (did not respond to previous treatment) high-risk neuroblastoma (a type of cancer that mostly occurs in young children) in the bone or bone marrow in patients who have had a partial response, a minor response, or have stable disease to previous treatment. This medicine is a GD2-binding monoclonal antibody.

This medicine is to be given only by or under the direct supervision of your doctor.

Your doctor will monitor your progress closely while you are receiving this medicine. This will help your doctor see if the medicine is working correctly and to decide if you or your child should continue treatment. Blood and urine tests may be necessary to check for side effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may perform tests to ensure you are not pregnant before starting treatment. Use an effective form of birth control to prevent pregnancy during treatment and for at least 2 months after the last dose of this medicine. If you think you might be pregnant while using the medicine, inform your doctor immediately.

This medicine may cause a rare but serious allergic reaction called an infusion reaction, which can be life-threatening and require immediate medical help. Inform your doctor right away if you or your child experience cough, trouble breathing, hives, itching, skin rash, lightheadedness, dizziness, fainting, tightness in the chest, or swelling of the face, eyes, lips, mouth, or tongue.

Naxitamab-gqgk may cause nerve pain (for example, pain in the stomach, bones, neck, legs, or arms). Inform your doctor immediately if the pain becomes severe.

This medicine may lead to transverse myelitis (swelling of the spinal cord). Contact your doctor right away if you or your child have back, leg, or stomach pain, muscle weakness in the arms or legs, or problems with the bladder and bowel.

This medicine may cause reversible posterior leukoencephalopathy syndrome (RPLS). Inform your doctor if you have a severe headache, changes in vision, a fast, pounding, or uneven heartbeat, seizures, unusual drowsiness, dullness, tiredness, weakness, or a feeling of sluggishness.

This medicine may lead to peripheral neuropathy. Contact your doctor immediately if you or your child experience burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet.

Contact your doctor right away if you experience blurred vision, difficulty reading, or any other change in vision during or after treatment. Your doctor may want you or your child to see an ophthalmologist (eye doctor).

This medicine may cause bladder problems (for example, prolonged urinary retention). Contact your doctor immediately if you or your child notice a decrease in urine volume, a decrease in the frequency of urination, difficulty passing urine, or painful urination.

This medicine may cause hypertension (high blood pressure). Contact your doctor right away if you or your child have blurred vision, dizziness, nervousness, headache, pounding in the ears, or a slow or fast heartbeat.

In deciding to use a medicine, you and your doctor must consider the risks of taking the medicine against the benefits it can provide. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how naxitamab-gqgk injection affects children younger than 1 year of age. Its safety and effectiveness have not been established for this age group.

Geriatric

There have not been appropriate studies on how naxitamab-gqgk injection affects older adults. Its safety and effectiveness have not been established for this population.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to adjust the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating or with certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

• Eye problems or
• Peripheral neuropathy (nerve problem) or
• Spinal cord problems (e.g., transverse myelitis) or
• Urinary retention (difficulty urinating or emptying the bladder)—Use with caution. It may worsen these conditions.

• Hypertension (high blood pressure), uncontrolled—Should not be used in patients with this condition.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor or nurse right away if any of the following side effects happen:

More common

• Back pain, sudden and severe
• bigger, dilated, or enlarged pupils (black part of eye)
• blurred vision
• bone pain
• burning, numbness, tingling, or painful sensations
• change in color vision
• chest tightness
• confusion
• decrease in frequency of urination
• decrease in urine volume
• difficulty in passing urine
• difficulty seeing at night
• dizziness
• drowsiness
• fever
• flushing
• headache
• increased sensitivity of the eyes to light
• muscle weakness, sudden and progressing
• nausea and vomiting
• nervousness
• painful urination
• pounding in the ears
• seizures
• slow or fast heartbeat
• stomach pain
• swelling
• trouble breathing
• unsteadiness or awkwardness
• unusual tiredness or weakness
• weakness in the arms, hands, legs, or feet

Less common

• Constipation
• diarrhea

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome, or if you have any questions about them:

More common

• Blistering, peeling, loosening of the skin
• chills
• cough
• decreased appetite
• fast heartbeat
• flushing, redness of the skin
• increased sweating
• itching
• joint or muscle pain
• red, irritated eyes
• runny nose
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• unusually warm skin

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Danyelza

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Naxitamab

Find detailed information on biosimilars for this medication.

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

Naxitamab-gqgk must be given slowly, so the needle will remain in place for 30 to 60 minutes. It is given on Days 1, 3, and 5 of each treatment cycle, which is usually repeated every 4 or 8 weeks. Your doctor will tell you how many treatment cycles you need. You may also receive medicines to help prevent possible allergic reactions, pain, nausea, or vomiting to the injection.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.