Omalizumab Prefilled Syringe (OMALIZUMAB - INJECTION)

Instructions

This medicine is used by injecting it into the skin. Please ask your doctor, nurse or pharmacist for the correct places on your body where this medicine can be injected.

Read and make sure you understand the instructions for measuring dose and using syringe. If you have any questions, talk to your doctor, nurse, or pharmacist.

The liquid should be clear or slightly milky and colorless to light yellow-brown.

Check the medicine before each use. If the liquid medicine has any particles in it, appears discolored, or if the vial appears damaged, do not use it.

Keep medicine in refrigerator. Do not freeze. If frozen, throw away.

Keep the medicine in its original container.

Protect medicine from light.

Take the medicine out of the refrigerator about 15 to 30 minutes before use to warm to room temperature.

Do not remove protective outer wrap until ready to use.

Discard unused medicine after 4 hours at room temperature.

Never use any medicine that has expired.

Please ask your doctor, nurse, or pharmacist how to discard unused medicines safely.

This medicine should only be used by a person who has been trained to recognize when and how it should be used.

The first dose will be given by health care provider who will monitor for a severe allergic reaction. Later doses may be given by a health care provider or at home.

Your dose is based on your weight. Tell you doctor if you have any big changes in weight during treatment with this medicine.

You or a family member can be trained to give this medicine at home.

If your dose is 2 syringes or injections, inject each in 2 different locations.

Change the location of the injection each time. Choose a location at least 1 inch from the last injection.

Tell your doctor if you have ever had an allergic reaction to latex.

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

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.

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

Talk to your doctor before taking other medicines, including aspirins and ibuprofen containing products. Speak to your doctor about which medicines are safe to use while you are on this medicine.

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.

This medicine may increase the risk of cancer. Ask your doctor about the benefits and risks.

This medicine is associated with an increased risk of serious heart problems, heart attack, and stroke. Please speak with your doctor about the risks and benefits of using this medicine. Contact your doctor immediately if you experience chest pain or difficulty breathing.

Tell the doctor or pharmacist if you are pregnant, planning to be pregnant, or breastfeeding.

Ask your pharmacist how to properly throw away used needles or syringes.

Do not share this medicine with anyone who has not been prescribed this medicine.

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.

• headaches
• pain, redness, swelling near injection

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

• severe allergic reaction
• chest or jaw pain
• confusion
• cough that does not go away
• dizziness
• swelling of the face, mouth, tongue or throat
• swelling of the legs, feet, and hands
• fainting
• fever or chills
• numbness or tingling in hands and feet
• itching
• joint or muscle pain
• unusual growth or lump on the neck
• red, burning, or itchy skin
• shortness of breath
• skin changes - a darker area with uneven edges or coloring
• change in the size or color of a skin mole
• difficulty speaking
• symptoms of stroke (such as one-sided weakness, slurred speech, confusion)
• sweating
• 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.