HealthSearch

Health Guide

Dinutuximab (Intravenous route)

Pronunciation:

din-ue-TUX-i-mab

Brand Names:

  • Unituxin

Dosage Forms:

  • Solution

Warnings:

Intravenous route(Solution)

Serious and possibly life-threatening infusion reactions have been reported in 26% of patients receiving treatment with dinutuximab. Administer prehydration and premedication prior to each infusion and monitor patients for signs and symptoms of infusion reactions during treatment and for at least 4 hours after the infusion is completed. If severe infusion reactions occur during treatment, immediately stop the infusion. Permanently discontinue use if anaphylaxis occurs. Dinutuximab causes severe neuropathic pain in most patients and may include peripheral sensory neuropathy or severe motor neuropathy. Not all cases of neuropathy were resolved during clinical trials. Administer IV opioids prior to, during, and for 2 hours after completion of treatment. Discontinue use if severe unresponsive pain, severe sensory neuropathy, or moderate to severe peripheral motor neuropathy occur .

Classifications:

Pharmacologic

Monoclonal Antibody

Uses of This Medicine:

Dinutuximab injection is used in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), to treat children with high-risk neuroblastoma (a type of cancer that most often occurs in young children). This medicine is a GD2-binding monoclonal antibody.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of dinutuximab injection in children.

Older adults

Appropriate studies have not been performed on the relationship of age to the effects of dinutuximab injection in the geriatric population. Safety and efficacy have not been established.

Breast-feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

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

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

Dinutuximab must be given slowly, so the needle will remain in place for 10 to 20 hours for 4 consecutive days for up to 5 cycles. You may also receive medicines to help prevent possible allergic reactions to the injection.

Drink extra fluids so you will pass more urine while you are using this medicine. This may help prevent kidney problems.

Precautions While Using This Medicine:

Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to receive it. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for 2 months after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause a rare but serious type of an allergic reaction called an infusion reaction. This can be life-threatening and require immediate medical attention. Tell your doctor right away if you or your child start to have cough, trouble breathing, hives, itching, or skin rash, lightheadedness, dizziness, or fainting, tightness in the chest, or swelling of the face or lips.

Check with your doctor right away if you or your child 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.

Tell your doctor right away if you or your child have a cloudy urine, change in the amount of urine, fainting or lightheadedness, nausea, stomach pain, or swelling of the hands, ankles, or feet after receiving this medicine. These may be symptoms of a rare but serious condition called capillary leak syndrome.

This medicine could lower your blood pressure too much and cause you to feel dizzy or lightheaded. If you faint, stop using this medicine until you have talked to your doctor. Stand or sit up slowly if you are dizzy. Low blood pressure is more likely to happen when you begin to use the medicine.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor).

Dinutuximab can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an 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, especially when your blood count is low, to reduce the risk of infection or bleeding:

  • If you can, avoid people with infections. Check with your doctor immediately if you or your child 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.
  • Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical 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 and have not touched anything else in the meantime.
  • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
  • Avoid contact sports or other situations where bruising or injury could occur.

Tell your doctor right away if you or your child have black, tarry stools, blood in the urine, fever, increased or decreased urination, pinpoint red spots on the skin, stomach pain, swelling of the face, fingers, feet, or lower legs, unusual bleeding, bruising, or weakness, or yellow eyes or skin after receiving this medicine. These may be symptoms of hemolytic uremic syndrome.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

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 or lightheadedness
fast or irregular heartbeat
fever
headache
hives or welts, itching, or skin rash
increased thirst
irregular heartbeat
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 tiredness 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
Incidence not known
Yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
Diarrhea

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 9/15/2016
The information provided herein should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. A licensed medical professional should be consulted for diagnosis and treatment of any and all medical conditions. Call 911 for all medical emergencies. Links to other sites are provided for information only -- they do not constitute endorsements of those other sites.

Truven Health Analytics. All rights reserved.

Thomson & A.D.A.M