1 What is Unituxin?

Brand: Unituxin

Generic: Dinutuximab

Unituxin injection is used in combination with granulocyte-macrophage-colony-stimulating factor (GM-CSF), interleukin-2 (IL-2) and 12-cis-retinoic acid (RA) to treat children with high-risk neuroblastoma (a type of cancer that usually occurs in young children).

This medication is a GD2-binding monoclonal antibody. This medication is only to be administered by or under the immediate care of your doctor. This medication is available in the following forms:

  • Solution

2 What to Know Before Using

Before using Unituxin, you must know all about the risks and complications associated with it. This is a decision that you and your doctor will make together.

For this medication, there are many things that need to be considered:

Allergies: Inform your doctor if you have ever had an allergic reaction to any other medications. It is also important to inform your doctor of any non-medicine allergies such as foods, dyes, preservatives or animals.

Pediatric: Up-to-date Pediatric Appropriate studies have not indicated any problems that would limit the use of this medication.

Geriatric: No appropriate studies have been performed on the relationship of age to the effects of this medication in elderly patients. Safety and efficacy have not been established.

Breastfeeding: There are no up-to-date studies in women for determining infant risk when using this medication while breastfeeding. Weigh the potential risks with the benefits before taking this medication while breastfeeding.

Drug Interactions: Certain medications should not be used together. However, in certain cases, two medications may be used together, even if an interaction might occur. In these cases, your doctor may want to change your dose or take other precautions. When taking this medication, it is important that you inform your doctor if you are taking any prescription or over the counter medications.

Other Interactions: Certain medications should not be used while eating, or while eating certain foods in case of negative interactions. Using alcohol or tobacco with certain medications may also cause negative interactions. Talk with your doctor about the use of your medication with food, alcohol or tobacco.

Other Medical Problems: Pre-existing medical problems may affect the use of this medication.

Be sure to tell your doctor if you have any other medical problems, especially:

  • Anemia
  • Electrolyte imbalance (i.e. hypocalcemia, hypokalemia, hyponatremia)
  • Eye problems
  • Hypotension (low blood pressure)
  • Neutropenia (low number of white blood cells)
  • Peripheral neuropathy (nerve problem)
  • Thrombocytopenia (low number of platelets) - Use with caution. May make these conditions worse.
  • Infection - May decreases your body's ability to fight infection.

3 Proper Usage

Proper usage of Unituxin requires strict adherence to your doctor’s orders. A nurse or other trained health professional will give you this medication.

This medication is given through a needle placed in one of your veins (intravenously). This medication must be given slowly, so the catheter will remain in place for about 10-20 hours for 4 consecutive days for up to 5 cycles.

You may also receive medication to help prevent any possible allergic reactions to the medication. Drink extra fluids so you will pass more urine while using this medication. This may help prevent kidney problems.

4 Precautions to Take

Before using Unituxin, there are some precautions you must take. It is very important that your doctor checks in with you often while you are receiving this medication to make sure that it is working properly.

Blood tests may be needed to check for unwanted effects. Do not take other prescription or over-the-counter medications without asking your doctor.

Using this medication while pregnant can harm your unborn child. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant, inform your doctor immediately.

This medication may cause a rare, but serious, type of allergic reaction called an infusion reaction. This can be life-threatening and requires immediately medical attention. Inform your doctor immediately if you start to have a cough, difficulty breathing, hives, itching, skin rash, lightheadedness, dizziness, fainting (syncope), tightness in the chest or swelling of the face or lips.

Inform your doctor immediately if you are having burning, numbness, tingling or painful sensations in the arms, hands, legs or feet. These could be symptoms of a condition called peripheral neuropathy.

Inform your doctor immediately if you have cloudy urine, changes in the amount of urine, fainting (syncope) or lightheadedness, nausea, stomach pain or swelling of the hands, ankles or feet after receiving this medication. These may be symptoms of a rare, but serious, condition called capillary leak syndrome.

This medication could drastically lower your blood pressure and cause you to feel dizzy or lightheaded. If you faint, stop using this medication until you talk to your doctor. Stand or sit up slowly if you are dizzy. Hypotension is more likely to happen when you begin this medication.

Inform your doctor immediately if you have blurry vision, difficulty reading or any other change in vision. Your doctor may want you to have your eyes checked by an ophthalmologist.

This medication may temporarily lower the number of white blood cells in your blood, increasing the chance of infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take to reduce the risk of infection or bleeding:

  • Take care to avoid people with infections. Call your doctor if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain or painful or difficult urination.
  • Inform your doctor immediately if you notice any unusual bleeding or bruising, black stool, blood in the urine or stool or red spots on your skin.
  • Take care when brushing or flossing your teeth. Your doctor or dentist may recommend other ways to clean your teeth and gums. Ask your doctor before having any dental work done.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands.
  • Take care when using sharp objects such as shaving razors or nail cutters and be sure not to cut yourself.
  • Avoid contact sports or other situations where bruising or injury may occur.

Inform your doctor immediately if you have a tarry stool, blood in the urine, fever, increased or decreased urination, red spots on the skin, stomach pain, swelling of the fingers, feet or lower legs, unusual bleeding, bruising or weakness or yellow eyes or skin (jaundice) after receiving this medication. These may be symptoms of the hemolytic uremic syndrome.

5 Potential Side Effects

Make sure you meet with your doctor in using Unituxin to avoid unwanted potential side effects. A medication may produce unwanted effects along with the intended effects. Although not all of these side-effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if you experience any of the following side-effects:

More common:

  • Black, tarry stools
  • Bleeding gums
  • Blood in the urine or stools
  • Blurred vision
  • Chills
  • Cloudy urine
  • Coma
  • Confusion
  • Convulsions
  • Cough or hoarseness
  • Decrease or increase in the amount of urine
  • Difficult or labored breathing
  • Dizziness
  • Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • Dry mouth
  • Fainting (syncope) or lightheadedness
  • Fast heartbeat (tachycardia)
  • Fever
  • Headache
  • Hives or welts, itching, or skin rash
  • Increased thirst (polydipsia)
  • Irregular heartbeat (arrhythmia)
  • Loss of appetite
  • Lower back or side pain
  • Muscle pain or cramps
  • Nausea or vomiting
  • Noisy breathing
  • Numbness or tingling in the hands, feet, or lips
  • Painful or difficult urination
  • Pale skin
  • Pinpoint red spots on the skin
  • Redness of the skin
  • Sore throat
  • Stomach pain
  • Sweating
  • Swelling of the face, hands, ankles, feet, or lower legs
  • Tightness in the chest
  • Troubled breathing with exertion
  • Ulcers, sores, or white spots in the mouth
  • Unusual bleeding or bruising
  • Unusual fatigue or weakness

Less common:

  • Back pain
  • Bigger, dilated or enlarged pupils (black part of the eye)
  • Burning, numbness, tingling, or painful sensations
  • Change in color vision
  • Change in the ability to see colors, especially blue or yellow
  • Chest pain
  • Difficulty seeing at night
  • Drooping upper eyelids
  • Increased sensitivity of the eyes to sunlight
  • Muscle or joint pain
  • Nerve pain
  • Pain in the arms or legs
  • Unsteadiness or awkwardness
  • Weakness in the arms, hands, legs, or feet

Some side effects that may occur do not normally need medical attention. These may leave as your body becomes accustomed to treatment. Ask your doctor about ways to prevent or reduce some of these side effects.

Talk to your doctor if any of the following side effects continue or are bothersome, or if you have questions:

More common:

Some patients may experience other side effects that are not listed. Check with your doctor if you notice any other side effects. Ask your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.