Details for: UNITUXIN
Company: UNITED THERAPEUTICS CORPORATION
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02483076 | UNITUXIN | DINUTUXIMAB | 3.5 MG / ML | SOLUTION | INTRAVENOUS |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication 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.
What it does
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.
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.
When it should not be used
Do not use Unituxin if:
- You or your child are allergic to dinutuximab.
What the medicinal ingredient is
dinutuximab
What the non-medicinal ingredients are
histidine, hydrochloric acid (to adjust pH), polysorbate 20, sodium chloride, and water for injection.
What dosage form it comes in
Single-use vials containing 17.5 mg/5 mL (3.5 mg/mL) of dinutuximab in solution.
Warnings and precautions
Serious Warnings and Precautions
Infusion Reactions
- Serious and potentially life-threatening infusion reactions and anaphylaxis have occurred in patients treated with Unituxin. 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.
- 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.
To help avoid side effects and ensure proper use, talk to your healthcare professional about any health conditions or problems you or your child may have before taking Unituxin, including if you or your child:
- 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
Interactions with this medication
The following may interact with Unituxin:
Prior to receiving Unituxin, tell your doctor or nurse if you or your child 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 your child 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 your child 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.
Proper use of this medication
How to take Unituxin:
Unituxin will be given to you or your child by a doctor or nurse while in the hospital. It is given
as an intravenous infusion.
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. M2 is a measurement of body surface area and your doctor will work out the dose based on this measurement of patient body size and weight.
Overdose
Missed Dose
It is very important for you or your child to keep all appointments to receive Unituxin. If you
miss an appointment, ask your doctor when to schedule the next dose.
What should I 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.
Side effects and what to do about them
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 your
child 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.
- 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.
- 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.
| 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 your child have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
Unituxin will be stored in the hospital or clinic where it is given to you or your child. 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.
Keep out of reach and sight of children.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
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 this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada.html); or by calling the customer service line at 1-877-864-8437.
Last Revised: November 2018
Copyright 2018 United Therapeutics Corp. All rights reserved.