Pronunciation:

din-ue-TUX-i-mab

Brand Names:

• Unituxin

Dosage Forms:

• Solution

Warnings:

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 serious neurologic adverse reactions including severe neuropathic pain in most patients, as well as peripheral neuropathy (eg, peripheral sensory neuropathy, 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:

Therapeutic—

Antineoplastic Agent

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
• Spinal cord problems (eg, transverse myelitis) or
• Thrombocytopenia (low number of platelets) or
• Urinary retention—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. Stand or sit up slowly if you are dizzy. Low blood pressure is more likely to happen when you begin to use the medicine.

This medicine may cause reversible posterior leukoencephalopathy syndrome (RPLS). Tell your doctor if you have severe headache, changes in vision, fast, pounding, or uneven heartbeat, seizures, unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness.

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.