Omalizumab Injection

IMPORTANT WARNING:

Omalizumab injection may cause serious or life-threatening allergic reactions. These reactions may occur immediately after your injection or at any time during your treatment. Tell your doctor if you have or have ever had a serious or life-threatening allergic reaction (anaphylaxis).

You will receive omalizumab injection in a healthcare setting until your doctor feels that you are safe to receive omalizumab injection at home. A doctor or nurse will watch you closely after you receive the medication for any signs of an allergic reaction. Tell your doctor immediately if you experience any of the following symptoms at any time during your treatment: wheezing or difficulty breathing, shortness of breath, cough, chest tightness, dizziness, fainting, fast or weak heartbeat, anxiety, feeling that something bad is about to happen, flushing, itching, hives, feeling warm, swelling of the throat or tongue, throat tightness, hoarse voice, or difficulty swallowing.

Your doctor will give you the manufacturer's patient information sheet (Medication Guide) each time you receive an injection of omalizumab. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risks of receiving omalizumab injection.

IMPORTANT NOTICE:

Omalizumab injection is available as different products that are biologic medications (medications made from living organisms). These biologic products are considered to be "biosimilar" to omalizumab injection which means they work just as well and are just as safe to use as omalizumab injection. Omalizumab injection mentioned in the monograph below refers to any of these products.

WHY is this medicine prescribed?

Omalizumab injection is used to:

• treat asthma
• to treat chronic rhinosinusitis with nasal polyps (condition where inflammation of the nasal cavity and sinuses occur for 12 weeks or longer with soft, noncancerous growths)
• treat chronic spontaneous urticaria
• reduce allergic reaction after unplanned exposure to a food allergen

Omalizumab injection is in a class of medications called monoclonal antibodies. It works by blocking the action of a certain natural substance in the body that causes the symptoms of allergic asthma, nasal polyps, hives, and food allergy reactions.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Omalizumab injection comes as a solution (liquid) in a single-dose, prefilled syringe, prefilled autoinjector, or as a powder to be mixed with water and injected subcutaneously (under the skin).Inject once every 2 or 4 weeks. You may need more than one injection for a single dose. Your doctor will tell you how often you will receive this medication and how many injections you need for a dose based on your weight and condition. Your doctor will determine the length of your treatment based on your condition and how well you respond to the medication.

Use omalizumab injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

If you will be injecting omalizumab injection by yourself at home or having a friend or relative inject the medication for you, your doctor will show you or the person who will be injecting the medication how to inject it. Read the written instructions for use that come with the medication. Ask your doctor or pharmacist if you have any questions about how to inject the medication.

Remove the prefilled syringe or autoinjector from the refrigerator. Place on a flat surface away from direct sunlight. Allow it to warm to room temperature away from direct sunlight before you inject the medication. Do not try to warm the medication by heating it in a microwave, placing it in hot water, or through any other method. Ask your doctor or pharmacist if you have any questions about how long it will take to warm a syringe or autoinjector to room temperature.

Use each syringe or autoinjector only once and inject all the solution in the syringe or autoinjector. Dispose of used syringes and autoinjectors in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

Always look at omalizumab solution before injecting it. Check that the expiration date has not passed and the liquid is clear and colorless to pale brownish yellow. Do not use if it is cloudy or discolored or contains particles.

Do not remove the cap from the prefilled syringe or autoinjector until you are ready to inject omalizumab. Do not replace the cap after you remove it. Do not use the syringe or autoinjector if you drop it on the floor.

Inject omalizumab injection on the front of the thighs or anywhere on your stomach except your navel (belly button) and the area 2 inches around it. If another person is injecting your medication, the outer area of the upper arms also may be used. Do not inject the medication into skin that is tender, bruised, red, hard, or not intact, or that has scars, moles, or bruises. Choose a different spot each time you inject the medication, at least 1 inch away from a spot that you have used before. If more than one injection is needed for a single dose, the injection sites must be at least 1 inch away from each other but can be on the same part of the body or a different part of the body.

It may take some time before you feel the full benefit of omalizumab injection. Do not decrease your dose or stop taking any other medication for your condition unless your doctor tells you to do so. Your doctor may want to decrease the doses of your other medications gradually.

Omalizumab injection is not used to treat a sudden attack of asthma symptoms. Your doctor will prescribe a short-acting inhaler to use during attacks. Talk to your doctor about how to treat symptoms of a sudden asthma attack. If your asthma symptoms get worse or if you have asthma attacks more often, be sure to talk to your doctor.

What SPECIAL PRECAUTIONS should I follow?

Before receiving omalizumab injection,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while receiving omalizumab injection. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had sudden breathing problems; cancer; blood clots in your legs lungs, or brain; a stroke or mini-stroke; or a heart attack or any other heart problems. Also tell your doctor if you have received or are receiving allergy shots (a series of injections given regularly to prevent the body from developing allergic reactions to specific substances).

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using omalizumab injection, call your doctor.

• talk to your doctor about whether there is a risk that you will develop a hookworm, roundworm, whipworm, or threadworm infection (infection with worms that live inside the body). Tell your doctor if you have or have ever had any type of parasitic infection caused by worms. If you are at high risk of developing this type of infection, using omalizumab injection may increase the chance that you will actually become infected. Your doctor will monitor you carefully during and after your treatment.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

If you are using omalizumab injection to reduce allergic reactions to food, you should continue to avoid all foods that you are allergic to.

What should I do IF I FORGET to take a dose?

If you miss a dose of omalizumab injection, call your doctor as soon as possible.

What SIDE EFFECTS can this medicine cause?

Omalizumab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• pain, redness, swelling, warmth, burning, bruising, hardness, or itching in the place omalizumab was injected
• pain, especially in the joints, arms, or legs
• tiredness
• ear pain
• headache
• nausea
• dizziness
• runny or stuffy nose, sore throat, or cough
• stomach pain
• nose bleeds

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• fever, muscle aches, rash, and swollen glands within 1 to 5 days after receiving a dose of omalizumab injection
• shortness of breath, chest pain, coughing up blood, fast heartbeat, dizziness, or fainting
• sudden weakness or numbness of face, arm or leg on one side of the body, slowed or slurred speech, or vision problems
• rash; shortness of breath; chest pain; or numbness, and tingling in your hands and feet
• bone fracture

Omalizumab injection may increase the risk of developing certain types of cancer. Talk to your doctor about the risks of receiving omalizumab injection.

Omalizumab injection may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the package it came in, away from light, tightly closed, and out of reach of children. Store omalizumab injection in the refrigerator in the original carton. Do not freeze. Discard any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication. Make sure you understand how to store your medication properly.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body's response to omalizumab injection.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are receiving omalizumab injection or if you have received omalizumab injection within the past year.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.