Naxitamab Side Effects

Medically reviewed by Drugs.com. Last updated on Oct 16, 2024.

Applies to naxitamab: intravenous solution.

Precautions

Your doctor will check your 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 are a woman who 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 a rare but serious type of an allergic reaction called an infusion reaction, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you or your child start to have cough, trouble breathing, hives, itching, skin rash, lightheadedness, dizziness, or fainting, tightness in the chest, 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 decreased in urine volume, decreased in frequency of urination, difficulty in passing urine, or painful urination.

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.

Serious side effects of naxitamab

Along with its needed effects, naxitamab 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 while taking naxitamab:

Other side effects of naxitamab

Some side effects of naxitamab 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:

For healthcare professionals

Applies to naxitamab: intravenous solution.

General adverse events

The most common adverse reactions were infusion-related reaction, pain, tachycardia, vomiting, cough, nausea, diarrhea, decreased appetite, hypertension, fatigue, erythema multiforme, peripheral neuropathy, urticaria, pyrexia, headache, injection site reaction, edema, anxiety, localized edema, and irritability. The most common Grade 3 or 4 laboratory abnormalities (5% or greater) were decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased platelet count, decreased potassium, increased alanine aminotransferase, decreased glucose, decreased calcium, decreased albumin, decreased sodium, and decreased phosphate.^[Ref]

Hypersensitivity

• Very common (10% or more): Anaphylactic reaction (12%)^[Ref]

Immunologic

• Very common (10% or more): Influenza (12%)^[Ref]

Local

• Very common (10% or more): Infusion related reactions (e.g., hypotension, bronchospasm, flushing, wheezing, stridor, urticaria, dyspnea, pyrexia, infusion-related reaction, face edema, edema mouth, tongue edema, lip edema, respiratory tract edema, chills, hypoxia, pruritus, rash) (all Grades: 100%; Grade 3 or 4: 68%)^[Ref]

Ocular

• Very common (10% or more): Neurological disorders of the eye (e.g., unequal pupils, blurred vision, mydriasis) (24%)^[Ref]

Metabolic

• Very common (10% or more): Anorexia (53%), weight loss (12%)^[Ref]

Psychiatric

• Very common (10% or more): Anxiety (26%), irritability (25%)^[Ref]

Respiratory

• Very common (10% or more): Cough (60%), cough (57%), rhinorrhea (24%), breath sounds abnormal (15%), rhinovirus infection (12%), enterovirus infection (13%), upper respiratory tract infection (12%)^[Ref]

Other

• Very common (10% or more): Pain (e.g., pain, abdominal pain, pain in extremity, bone pain, neck pain, back pain, musculoskeletal pain) (all Grades: 100%; Grade 3 or 4: 72%), fatigue/asthenia (28%), pyrexia not occurring on the day of infusion or the day following an infusion (28%), contusion (15%)^[Ref]

Hematologic

• Very common (10% or more): Lymphocytes decreased (74%), platelet count decreased (65%), neutrophils decreased (61%), hemoglobin decreased (48%)^[Ref]

Nervous system

• Very common (10% or more): Peripheral neuropathy (e.g., peripheral sensory neuropathy, paresthesia, neuralgia) (32%), headache (28%), depressed level of consciousness (24%), lethargy (14%)
• Postmarketing reports: Transverse myelitis^[Ref]

Cardiovascular

• Very common (10% or more): Tachycardia/sinus tachycardia (84%), hypertension (all Grades: 44%; Grade 3 or 4: 4%), localized edema (25%)
• Common (1% to 10%): Peripheral edema^[Ref]

Dermatologic

• Very common (10% or more): Erythema multiforme (33%), urticaria not occurring on the day of infusion or the day following an infusion (32%), hyperhidrosis (17%), erythema (11%)^[Ref]

Gastrointestinal

• Very common (10% or more): Vomiting (all Grades: 60%; Grade 3 or 4: 4%), diarrhea (all Grades: 56%; Grade 3 or 4: 8%), nausea (56%), constipation (15%), oropharyngeal pain (15%)^[Ref]

See also:

Further information

Naxitamab side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer