Ustekinumab Injection for IV 5 mg/mL (26 mL) (USTEKINUMAB - INJECTION)

Instructions

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

Always inspect the medicine before using.

Do not use the medicine if it is cloudy, contains flakes or large particles, or if it has changed color.

Store new medicine in the refrigerator until you are ready to use it. Do not allow them to freeze.

Keep the medicine in its original container.

Protect medicine from light.

Take the medicine out of the refrigerator about 30 minutes before use to warm to room temperature.

Injecting cold drug may be uncomfortable.

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

It may take several weeks for this medicine to fully work.

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.

Tell your doctor if symptoms do not get better or if they get worse.

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

Cautions

During pregnancy, this medicine should be used only when clearly needed. Talk to your doctor about the risks and benefits.

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

Your doctor should check you for tuberculosis (TB) before you start this medicine and while you are using it. Tell your doctor if you are being treated for TB or any other infection.

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.

This medicine passes into breast milk. Ask your doctor before breastfeeding.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

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.

• back pain
• unusual bruising or discoloration on skin
• lack of energy and tiredness
• headaches
• pain, redness, swelling near injection
• itching
• sore throat
• upper respiratory infection

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

• confusion
• cough that does not go away
• fever or chills
• severe or persistent headache
• muscle pain
• seizures
• shortness of breath
• skin changes - a darker area with uneven edges or coloring
• change in the size or color of a skin mole
• skin sores
• stomach pain
• unusual or unexplained tiredness or weakness
• unsteadiness while walking
• increased urinary frequency
• difficulty or discomfort urinating
• blurring or changes of vision
• severe or persistent vomiting
• weight loss

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.