Cancer Drug for Pediatric Neuroblastoma


What is Unituxin (dinutuximab), and how does it work?

Unituxin (dinutuximab) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2) and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior firstline multiagent, multimodality therapy.

What are the side effects of Unituxin?

The most common adverse drug reactions (≥ 25%) in the Unituxin/RA group were pain, pyrexia, thrombocytopenia, lymphopenia, infusion
reactions, hypotension, hyponatremia, increased alanine aminotransferase, anemia, vomiting, diarrhea, hypokalemia, capillary leak syndrome,
neutropenia, urticaria, hypoalbuminemia, increased aspartate aminotransferase, and hypocalcemia.

The most common serious adverse reactions (≥
5%) in the Unituxin/RA group were infections, infusion reactions, hypokalemia, hypotension, pain, fever, and capillary leak syndrome.

Serious Infusion Reactions

Inform patients and caregivers of the risk of serious infusion reactions and anaphylaxis and to immediately report any signs or symptoms, such
as facial or lip swelling, urticaria, difficulty breathing, lightheadedness or dizziness that occur during or within 24 hours following the infusion.

Pain, Peripheral Neuropathy, Prolonged Urinary Retention, And Transverse Myelitis

Inform patients and caregivers of the risk of severe pain, sensory and motor neuropathy, prolonged urinary retention, and transverse myelitis,
and to promptly report severe or worsening pain and signs and symptoms such as numbness, tingling, burning, weakness, or inability to urinate.

Neurological Disorders Of The Eye

Inform patients and caregivers of the risk of neurological disorders of the eye and to promptly report signs or symptoms such as blurred vision,
photophobia, ptosis, diplopia, or unequal pupil size.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS)

Inform patients and caregivers of the risk of RPLS and to immediately report signs or symptoms such as severe headache, hypertension, visual
changes, lethargy, or seizures.

Capillary Leak Syndrome

Inform patients and caregivers of the risk of capillary leak syndrome and to immediately report any signs or symptoms.

Hypotension

Inform patients and caregivers of the risk of hypotension during the infusion and to immediately report any signs or symptoms.

Infection

Inform patients and caregivers of the risk of infection following treatment and to immediately report any signs or symptoms.

Bone Marrow Suppression

Inform patients and caregivers of the risk of bone marrow suppression, and to promptly report signs or symptoms of anemia, thrombocytopenia,
or infection.

Electrolyte Abnormalities

Inform patients and caregivers of the risk of electrolyte abnormalities including hypokalemia, hyponatremia, and hypocalcemia, and to report
any signs or symptoms such as seizures, heart palpitations, and muscle cramping.

Atypical Hemolytic Uremic Syndrome

Inform patients and caregivers of the risk of hemolytic uremic syndrome and to report any signs or symptoms such as fatigue, dizziness,
fainting, pallor, edema, decreased urine output, or hematuria.



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