Class: Biological Therapy

Generic Name: Dinutuximab

Trade Name: Unituxin™

For which conditions is this drug approved? Unituxin is approved for the treatment of children with high-risk neuroblastoma, a type of cancer that starts in certain very early forms of nerve cells found in an embryo or fetus.

What is the mechanism of action? Unituxin is a monoclonal antibody, which is a type of immunotherapy drug. It works by helping the body’s own immune system find and destroy cancer cells. Unituxin is approved for use along with other treatments, including chemotherapy, surgery, and radiation for children who have responded to previous treatment.

How is Unituxin typically given (administered)? Unituxin is given by intravenous infusion over 10 to 20 hours for four consecutive days for up to five cycles.

How are patients typically monitored? During treatment with Unituxin, patients are monitored for a condition known as capillary leak syndrome, where massive amounts of plasma and other blood components leak from blood vessels into nearby body cavities and muscles. In addition, patients will be monitored for infection, eye disorders, bone marrow function, kidney function, and electrolyte levels.

What are the common (occur in 30% or more of patients) side effects of treatment with Unituxin?

• Pain
• Fever
• Thrombocytopenia (low blood platelet count)
• Lymphopenia (low levels of lymphocytes)
• Anemia (low red blood cell count)
• Neutropenia (low count of neutrophils, a type of white blood cell that helps fight off infections)
• Infusion Reactions
• Capillary leak syndrome
• Hyponatremia (abnormally low blood sodium)
• Hypokalemia (lower than normal potassium in your bloodstream)
• Hypoalbuminemia (abnormally low blood levels of albumin, a type of protein)
• Vomiting
• Diarrhea
• Hives

What are the less common (occur in 10% to 29% of patients) side effects of treatment with Unituxin?

• Edema
• Hemorrhage
• Hypertension (high blood pressure)
• Hypocalcemia (low blood calcium)
• Hypophosphatemia (low blood phosphate)
• Hyperglycemia (high blood sugar)
• Hypertriglyceridemia (high triglyceride levels)
• Decreased appetite
• Hypomagnesemia (low blood magnesium)
• Weight gain
• Nausea
• Hypoxia (inadequate oxygen supply)
• Tachycardia (abnormally rapid heart rate)
• Sepsis (blood poisoning)
• Device related infection
• Proteinuria (abnormal quantities of protein in the urine)
• Peripheral neuropathy (weakness, numbness and pain, usually in your hands and feet)

 This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

• Do not miss any of your scheduled doctors’ visits or tests to monitor your condition during treatment.

Are there any special precautions patients should be aware of before starting treatment?

• Unituxin may harm your unborn baby, so you should not become pregnant during treatment. If you become pregnant during treatment or think you may be pregnant, tell your healthcare provider right away.
• Women who are able to become pregnant should use effective birth control during treatment with Unituxin and for at least two months after completing therapy.
• Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Unituxin will pass into your breast milk. You and your healthcare provider should decide if you will take Unituxin or breastfeed—you should not do both.
• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Keep a list of the medicines you take and show them to your healthcare providers and pharmacist when you get a new medicine.

When should patients notify their physician? Contact your doctor right away if you experience:

• Signs of an infusion reaction. These include: facial or lip swelling, hives, difficulty breathing, lightheadedness or dizziness that occur during or within 24 hours of the infusion.
• Severe pain or signs of neuropathy. These include: numbness, tingling, burning, or weakness.
• Signs of capillary leak syndrome. These include: sudden swelling (edema) of the arms, legs, and other parts of the body; rapid drop in blood pressure; shock; lightheadedness; weakness; fatigue; and nausea.
• Signs of low blood pressure. These include: fatigue, lightheadedness, dizziness, nausea, clammy skin, depression, loss of consciousness, and blurry vision.
• Signs and symptoms of eye disorders. These include: blurred vision, unequal pupil size, and other vision disorders.
• Signs of bone marrow suppression (the decrease in production of cells responsible for providing immunity carrying oxygen, and/or those responsible for normal blood clotting). Symptoms include: anemia, thrombocytopenia, or infection.
• Signs of electrolyte abnormalities. These include: hypokalemia, hyponatremia, hypocalcemia, seizures, heart palpitations, and muscle cramping.
• Signs of typical hemolytic uremic syndrome, a condition characterized by progressive renal (kidney) failure, problems associated with red blood cell and platelet counts, and problems with the vascular system. These include: fatigue, dizziness, fainting, pallor, edema, and decreased urine output.

Last updated: 07/15

 

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.