Serious infusion-related reactions
DANYELZA® can cause serious infusion-related reactions that require immediate medical attention. Infusion-related reactions are common with DANYELZA.
Signs and symptoms of infusion-related reactions during or after DANYELZA treatment include:
- Swelling of the face, eyes, lips, mouth, or tongue
- Redness of the face
- Skin rash or hives
- Trouble breathing
- Coughing or wheezing
- Noisy, high-pitched breathing
- Feeling faint or dizzy
Nervous system problems
DANYELZA can also cause nervous system problems such as severe pain from nerves (neuropathic pain), including pain in the belly (abdomen), bone, neck, legs, or arms. Pain is common with DANYELZA and can be severe. Other nervous system problems include:
- Inflammation of the spinal cord
- Reversible Posterior Leukoencephalopathy Syndrome (RPLS – also known as Posterior Reversible Encephalopathy Syndrome - PRES), which is a condition of the brain
- Numbness, tingling, or burning sensation in the arms or legs
- Nervous system problems of the eye
- Problems urinating or emptying your bladder (prolonged urinary retention)
Talk to your child’s care team right away if you notice that your child has new or worsening symptoms of the above side effects
These are not all of the possible side effects of DANYELZA. Please see full Prescribing Information and Patient Information for DANYELZA including Boxed Warning on serious infusion-related reactions and nervous system problems.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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