Pronunciation: DIN ue TUX i mab

Brand: Unituxin

What is the most important information I should know about dinutuximab?

Do not use dinutuximab if you are pregnant.

Call your doctor at once if you have severe or worsening pain, numbness, tingling, weakness, or burning in your hands or feet, or if you have problems with walking or daily activities.

Some side effects may occur during the injection or up to 24 hours afterward. Tell your caregiver right away if you feel dizzy or light-headed, or if you have a skin rash, chest tightness, wheezing, trouble breathing, or swelling in your face.

What is dinutuximab?

Dinutuximab is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Dinutuximab is used in combination with other medicines to treat neuroblastoma (a type of brain tumor) in children.

Dinutuximab is usually given after other treatments or medicines have been tried without success.

Dinutuximab may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving dinutuximab?

You should not receive dinutuximab if you are allergic to it.

To make sure dinutuximab is safe for you, tell your doctor if you have:

  • any type of bacterial, fungal, or viral infection;
  • an eye disorder or vision problems;
  • bone marrow suppression;
  • low blood pressure;
  • an electrolyte imbalance (such as low levels of potassium, sodium, or calcium in your blood);
  • liver or kidney disease; or
  • problems with urination.

Do not use dinutuximab if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 2 months after your treatment ends.

It is not known whether dinutuximab passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How is dinutuximab given?

Dinutuximab is injected into a vein through an IV. A healthcare provider will give you this injection. Dinutuximab must be given slowly and the IV infusion can take 10 to 20 hours to complete.

You may be given other medicines to help prevent certain side effects of dinutuximab.

Dinutuximab is given with other medicines in a 28-day treatment cycle, and you may only receive dinutuximab for 4 days per cycle. Your doctor will determine how long to treat you with dinutuximab.

You will be watched closely for at least 4 hours after receiving dinutuximab, to make sure you do not have a reaction to the medicine.

Dinutuximab can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

Your blood pressure, vision, kidney function, liver function, or nerve and muscle function may also need to be checked.

What happens if I miss a dose?

Because you will receive dinutuximab in a clinical setting, you are not likely to miss a dose.

What happens if I overdose?

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid after receiving dinutuximab?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of dinutuximab?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection or up to 24 hours afterward. Tell your caregiver right away if you feel dizzy or light-headed, or if you have a skin rash, chest tightness, wheezing, trouble breathing, or swelling in your face.

A rare but serious side effect of dinutuximab is called capillary leak syndrome. Call your doctor right away if you have signs of this condition, which may include: stuffy or runny nose followed by weakness or tired feeling, and sudden swelling in your arms, legs and other parts of the body.

Call your doctor at once if you have:

  • sudden vision loss or vision changes;
  • severe or worsening pain anywhere in your body (especially your chest, stomach, back, arms, legs, muscles, or joints);
  • numbness, tingling, weakness, or burning pain in your hands or feet;
  • problems with walking or daily activities;
  • a light-headed feeling, like you might pass out;
  • signs of a blood cell disorder --easy bruising or bleeding, pale skin, severe diarrhea, vomiting, blood in your urine or stools, swelling, rapid weight gain, feeling short of breath, little or no urinating;
  • signs of infection --fever, flu symptoms, mouth sores, swollen gums, pain when swallowing, skin sores, rapid heart rate, rapid and shallow breathing; or
  • symptoms of an electrolyte imbalance --headache, confusion, slurred speech, tingly feeling around your mouth, vomiting, muscle tightness or contraction, feeling unsteady, leg cramps, constipation, irregular heartbeats, extreme thirst, increased urination, overactive reflexes, muscle weakness or limp feeling.

Common side effects may include:

  • pain;
  • fever or other signs of infection;
  • blood cell disorders;
  • electrolyte problems;
  • rash or other allergic-type reactions;
  • vomiting, diarrhea; or
  • abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect dinutuximab?

Other drugs may interact with dinutuximab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about dinutuximab.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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