dinutuximab 3.5 mg/mL intravenous solution

Generic name:
Dinutuximab - injection

Pronunciation
(DIN-ue-TUX-i-mab)

Brand name(s)
Unituxin

Serious infusion reactions (sometimes fatal) or nerve problems (such as nerve pain) may happen during the infusion of this drug and for some time afterward. Your doctor may prescribe other medications (such as acetaminophen, diphenhydramine, opioids) before each treatment to help prevent these side effects. Get medical help right away if you have any symptoms of infusion reactions such as fever, chills, severe dizziness, swelling of the face/tongue/throat, trouble breathing, itching, or rash. Also tell your doctor right away if you have any symptoms of nerve pain such as numbness, burning, tingling, or weakness, or if you have pain that is not relieved. Your doctor may give you other medications to help with these side effects or may slow down or stop your treatment for some time.

This medication is used to treat a certain type of cancer (high-risk neuroblastoma). Dinutuximab belongs to a class of drugs known as monoclonal antibodies. It works by slowing or stopping the growth of cancer cells.

See also Warning section.

This medication is given by slow injection (infusion) into a vein as directed by your doctor, usually over 10 to 20 hours, for 4 days in a row during each treatment cycle.

The dosage and treatment schedule are based on your medical condition, body size, and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

See also Warning section.

Nausea, vomiting, diarrhea, dizziness, or lightheadedness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including:

• mental/mood changes (such as confusion)
• muscle/joint pain
• stomach/abdominal pain
• difficulty urinating
• signs of kidney problems (such as blood in the urine, change in the amount of urine)

Get medical help right away if you have any very serious side effects, including:

• seizures
• severe headache

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).

This medication can rarely cause a serious condition (capillary leak syndrome), that can sometimes be fatal. Tell your doctor right away if you develop symptoms including swelling, severe dizziness, or tiredness.

Rarely, this medication may cause a nerve problem of the eye(s). Tell your doctor right away if you develop symptoms such as blurred vision, double vision, drooping upper eyelid, or sensitivity to light.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using dinutuximab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• blood/bleeding problems
• kidney problems

Dinutuximab can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using dinutuximab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using dinutuximab. Dinutuximab may harm an unborn baby. Ask about reliable forms of birth control while using this medication and for at least 2 months after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as blood pressure, complete blood count, blood minerals) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.