Pronunciation:

nax-IT-a-mab - gqgk

Brand Names:

• Danyelza

Dosage Forms:

• Solution

Warnings:

Warning: Serious Infusion-related Reactions and NeurotoxicitySerious Infusion-related Reactions: Naxitamab-gqgk can cause serious infusion reactions, including cardiac arrest, anaphylaxis, hypotension, bronchospasm, and stridor. Premedicate prior to each naxitamab-gqgk infusion as recommended. Reduce the rate, interrupt infusion, or permanently discontinue naxitamab-gqgk based on severity.Neurotoxicity: Naxitamab-gqgk can cause severe neurotoxicity, including severe neuropathic pain, transverse myelitis, and reversible posterior leukoencephalopathy syndrome (RPLS). Premedicate to treat neuropathic pain as recommended. Permanently discontinue naxitamab-gqgk based on the adverse reaction and severity .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Naxitamab

Uses of This Medicine:

Naxitamab-gqgk injection is used in combination 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 most often occurs in young children) in the bone or bone marrow in patients who have shown 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.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. 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 tell your health care 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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of naxitamab-gqgk injection in children younger than 1 year of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies have not been performed on the relationship of age to the effects of naxitamab-gqgk injection in the geriatric population. Safety and efficacy have not been established.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change 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.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

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

• Eye problems or
• Peripheral neuropathy (nerve problem) or
• Spinal cord problems (eg, transverse myelitis) or
• Urinary retention (problem urinating or emptying the bladder)—Use with caution. May make these conditions worse.

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

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

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

Naxitamab-gqgk must be given slowly, so the IV 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.

Your doctor will also give you other medicines (eg, allergy medicine, fever medicine, steroids) to help prevent infusion-related reactions, pain, and nausea and vomiting.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

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.

Precautions While Using This Medicine:

Your doctor will check your or your child's progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to receive it. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 2 months after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause serious infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you or your child start to have chest tightness, cough, trouble breathing, hives, itching, skin rash, lightheadedness, dizziness, or fainting, or swelling of the face, eyes, lips, mouth, or tongue.

Naxitamab-gqgk may cause nerve pain (eg, pain in the stomach, bone, neck, legs, or arms). Tell your doctor right away if the pain becomes severe.

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

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

This medicine may cause peripheral neuropathy. Check with your doctor right away if you or your child are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may cause bladder problems (eg, prolonged urinary retention). Check with your doctor right away if you or your child have a decrease in urine volume, decreased frequency of urination, difficulty in passing urine, or painful urination.

Check with your doctor right away if you or your child have chest pain or discomfort, fast heartbeat, fever and chills, or trouble breathing. These maybe symptoms of myocarditis (swelling of the heart).

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

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

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

Incidence not known

Chest pain or discomfort

chills

cold sweats

confusion

dizziness, faintness, or lightheadedness when getting up suddenly from lying or sitting position

fast heartbeat

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

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 occur 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.