Dinutuximab Injection (DINUTUXIMAB - INJECTION)

Instructions

This medicine is given as an IV injection into a vein.

This medicine is given gradually through the IV line.

The liquid should be clear and colorless.

Do not use the medicine if it contains any particles or if it has changed color.

This medicine should be given by a trained health care provider.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you miss a dose, contact your doctor for instructions.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Your doctor may prescribe other medications to reduce side effects. Follow instructions carefully.

You may need to cycle between periods of taking the medicine and taking breaks from the medicine to allow your body to recover. Follow your instructions carefully.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Some patients taking this medicine have experienced serious side effects. Please speak with your doctor to understand the risks and benefits associated with this medicine.

Tell your doctor or nurse right away if fever, chills, severe dizziness, skin rash, itching, swelling, or difficulty breathing develop while the medicine is being given. The medicine may need to be stopped or given at a slower rate.

This medicine may cause dizziness or fainting. Do not stand or sit up quickly.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive or operate machinery until you know how this medicine will affect you.

Please check with your doctor before drinking alcohol while on this medicine.

This medicine may reduce your body's ability to fight infections. Avoid contact with people with colds, flu or other infections. Contact your doctor if you develop fever, cough, sore throat, or chills.

Speak with your health care provider before receiving any vaccinations.

Do not breastfeed while on this medicine.

This medicine can hurt a new baby in the womb. If you become pregnant while on this medicine, tell your doctor immediately. Your doctor may switch you to a different medicine.

Women must use reliable forms of birth control while taking this medicine and for 2 months after stopping to prevent pregnancy.

Always carry an ID card or wear a medical alert bracelet indicating your medical condition.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• diarrhea
• dizziness or lightheadedness
• nausea and vomiting

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• confusion
• coughing
• swelling of the legs, feet, and hands
• drooping or swollen eyelids
• lack of energy and tiredness
• fever or chills
• numbness or tingling in hands and feet
• severe or persistent headache
• signs of kidney damage (such as change in urine color or bubbly urine)
• joint or muscle pain
• seizures
• sensitivity to light
• sore throat
• stomach upset or abdominal pain
• difficulty or discomfort urinating
• blurring or changes of vision

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.