Patient Medication Information: uses, side effects, how to take - Unituxin
What UNITUXIN is used for:
- UNITUXIN is used to treat high-risk neuroblastoma in babies, children, and adolescents.
- Neuroblastomas are cancers that start in early nerve cells (called neuroblasts) in the body. Neuroblastoma is classified as ‘high risk’ if the cancer has spread to various parts of the body and contains certain types of cells. High-risk neuroblastomas are more likely to come back again after treatment than those of lower risk.
- To reduce the risk of the cancer coming back, UNITUXIN is given at the last stage of the treatment to eliminate small amounts of disease that may still be present after the cancer has responded to chemotherapy, surgery, and an autologous (self-donating) blood cell transplant.
- UNITUXIN has been shown to delay the progression or relapse of the disease and to increase survival.
How UNITUXIN works:
UNITUXIN is an antibody therapy, which means it acts similarly to the natural antibodies produced by the human body. Antibodies have the job of recognizing viruses, bacteria, and anything else that doesn’t belong in the body so that the immune system can fight them off.
As an antibody therapy, UNITUXIN can help the immune system recognize and fight the neuroblastoma cells.
Serious Warnings and Precautions
Infusion Reactions
- UNITUXIN can cause serious and potentially life-threatening infusion reactions and anaphylaxis. Immediately report any signs or symptoms, such as facial or lip swelling, urticaria, difficulty breathing, lightheadedness, or dizziness, that can occur during or within 24 hours following the infusion.
Neurologic Reactions
- UNITUXIN can cause severe pain, sensory and motor neuropathy, prolonged urinary retention, and transverse myelitis. Promptly report severe or worsening pain and signs and symptoms, such as numbness, tingling, burning, weakness, or inability to urinate.
UNITUXIN recognizes and attaches to a cell surface substance called ‘GD2’. GD2 is found on the surface of neuroblastoma and other GD2-expressing cells. When UNITUXIN attaches to the GD2 substance on the cancer cells, the patient’s immune system starts to attack these cells and kill them. UNITUXIN also binds to GD2 on nerve cells. This is why pain is the most common side effect of UNITUXIN.
The ingredients in UNITUXIN are:
Medicinal ingredient: dinutuximab
Non-medicinal ingredients: histidine, hydrochloric acid (to adjust pH), polysorbate 20, sodium chloride, and water for injection.
UNITUXIN comes in the following dosage form:
Single-use vials containing 17.5 mg/5 mL (3.5 mg/mL) of dinutuximab in solution.
Do not use UNITUXIN if:
- you or a person you are caring for are allergic to dinutuximab.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you or a person you are caring for take UNITUXIN. Talk about any health conditions or problems you or a person you are caring for may have, including if you or a person you are caring for:
- have ever had fits (convulsions)
- have liver problems
- have a low number of white blood cells or platelets in your blood – shown in tests
- have breathing problems such as shortness of breath when resting
- have kidney problems
- have any infections
- have had a serious allergic reaction to previous cancer therapies
- have had a serious allergic reaction to medications used to manage pain (narcotics or opioid medications)
- take steroids or other medications that lower immune response
Tell your healthcare professional about all the medicines you or a person you are caring for take, including any drugs, vitamins, minerals, natural supplements, or alternative medicines.
The following may interact with UNITUXIN:
Prior to receiving UNITUXIN, tell your doctor or nurse if you or a person you are caring for are taking, have recently taken, or might take during UNITUXIN therapy, any other medicines. This includes medicines obtained without a prescription and herbal medicines.
In particular, tell your doctor or nurse if you or a person you are caring for have recently received medication that may affect the immune system, such as:
- medicines called “corticosteroids” – such medications can alter the activity of your immune system, which is important for UNITUXIN to work.
- “intravenous immunoglobulin” – you or a person you are caring for should not have this type of medicine in the 2 weeks before UNITUXIN treatment and for at least 1 week after UNITUXIN treatment has finished.
How to take UNITUXIN:
- UNITUXIN will be given to you or a person you are caring for by a doctor or nurse while in the hospital. It is given as an intravenous infusion over 10 to 20 hours.
- UNITUXIN is given along with other medicines (IL-2, GM-CSF, and RA) as part of the treatment regimen.
Usual dose:
UNITUXIN will be given in 5 monthly cycles, and the UNITUXIN infusion is given for 4 days in a row each cycle. The usual dose of UNITUXIN is 17.5 mg/m2/day. Your doctor will determine the dose based on patient body size and weight.
Overdose:
If you think you, or a person you are caring for, have received too much UNITUXIN, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed dose:
It is very important for you or a person you are caring for to attend all appointments to receive UNITUXIN. If you miss an appointment, ask your doctor when to schedule the next dose.
What you should expect on UNITUXIN treatment days:
The healthcare team will tell you exactly when to arrive at the hospital, if you are not already there. Expect to arrive a few hours earlier than the UNITUXIN infusion will begin in order to receive certain pre-treatment medications. These pre-treatments can help guard against possible side effects.
Each UNITUXIN dose will be given over 10 to 20 hours. Ask your healthcare team how long you should plan to stay in the hospital with each treatment cycle.
Possible side effects from using UNITUXIN:
Like all medications, this medicine can cause side effects. Your healthcare team will use various medications before, during, and after the UNITUXIN infusion to help prevent some of these side effects. Some side effects can be related to the rate of the UNITUXIN infusion, and your healthcare team will know how and when to adjust the UNITUXIN infusion rate. You or a person you are caring for may still experience side effects after you leave the hospital. If you have questions or concerns about side effects, contact your healthcare professional.
Side effects may include:
Very common:
- Pain including abdominal pain, back pain and pain in your legs or arms, fever
- Allergic reactions up to anaphylaxis, itching, hives, low oxygen in your blood, swelling in your face
- Loss of appetite, weight gain
- Dry skin
- Diarrhea
- Increased heart rate, low blood pressure that may make you feel dizzy or faint, or high blood pressure
- Abnormal tests, such as low platelets, low red or white blood cells, low level of albumin (this can cause swelling and make you feel weak and tired), abnormal liver function, low level of potassium, sodium, calcium, magnesium or phosphates, high level of glucose, creatinine or triglycerides, protein in your urine.
Common:
- Cough, difficulty breathing
- Chills, swelling in arms and legs, feeling tired
- Headache
- Constipation, blood in stool, vomiting
- Not being able to urinate, blood in your urine
- Higher risk of getting infections (especially from the devices used to give you the medicine), such as blood or gut infections
- Skin problems where the injection was given, such as a red rash with small bumps
- Abnormal blood tests, such as low levels of magnesium or glucose, or high levels of acids, calcium, or potassium.
Uncommon:
- Serum sickness – an illness similar to an allergy
- Abnormal heart rhythm
- Neuropathy – tingling, burning, or weakness in the arms or legs.
Below are listed serious side effects that may occur during or after treatment with UNITUXIN. When any of these side effects occur, in all cases, contact your healthcare professional and discuss the next course of action.
Serious side effects and what to do about them
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Very common | |||
Pain: Pain can occur in the stomach, throat, chest, face, hands, feet, legs or arms (such as numbness, tingling, or burning), back, neck, joint, bone, muscle, mouth, eye, genitals | ✓ | ||
Hypersensitivity/Anaphylactic reaction/Infusion reactions: Symptoms may include a skin rash, hives, swelling in the face or throat, dizziness, a rapid heartbeat or palpitations, being short of breath and difficulty breathing, fever, vomiting, aches and pains in your joints | ✓ | ||
| Common | |||
Neurological disorders of the eye: Blurred vision, being sensitive to light, the pupils of your eyes staying large (‘dilated’) | ✓ | ||
Capillary leak syndrome: Symptoms may include swelling of the arms, legs, and other parts of your body, rapid drop in blood pressure, light headedness and breathing difficulties, kidney failure | ✓ | ||
| Rare | |||
Transverse myelitis: Symptoms may include reduced sensation or weakness or the inability to control urine | ✓ | ||
Atypical hemolytic uremic syndrome (aHUS): This is an illness that affects the blood system and kidneys; symptoms may include flu-like symptoms that do not go away, confusion, lethargy, loss of appetite, or dark colored urine | ✓ | ||
Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Swelling in the back part of the brain; symptoms may include high blood pressure, headache, fits, change in vision or behavior, feeling drowsy or tired | ✓ | ||
If you or a person you are caring for have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
You may also contact United Therapeutics Corporation at 1-866-458-6479 to report suspected side effects/adverse events.
Storage:
UNITUXIN will be stored in the hospital or clinic where it is given to you or a person you are caring for. The vials are stored in a refrigerator (2°C to 8°C [36°F to 46°F]) until they need to be used. The vials must not be frozen or shaken. The vials are kept in their carton to protect from light.
If you want more information about UNITUXIN:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (Drug Product Database: Access the database); or by calling the customer service line at 1-844-864-8437.
Last Revised: February 10, 2026
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