Omalizumab Subcutaneous

Name: Omalizumab Subcutaneous

Uses For omalizumab

Omalizumab injection is used to treat moderate to severe persistent allergic asthma. It is used when a patient's asthma has not been controlled sufficiently on other asthma medicines. omalizumab will not relieve an asthma attack that has already started.

Omalizumab injection is also used to treat chronic idiopathic urticaria (CIU) in patients who continue to have hives that are not controlled by an antihistamine.

Omalizumab is a medicine called an IgE blocker. IgE is short for immunoglobulin E. IgE is a substance that occurs naturally in the body in small amounts. This substance plays an important role in allergic asthma. When people with allergic asthma breathe in a year-round allergen, such as cat or dog dander, their bodies make more IgE. This may cause a series of reactions in your body that can lead to asthma attacks and symptoms. Omalizumab works by helping to block IgE.

omalizumab is to be given only by or under the direct supervision of your doctor.

Before Using omalizumab

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For omalizumab, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to omalizumab or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Use of omalizumab injection to treat asthma in children younger than 6 years of age and CIU in children younger than 12 years of age is not recommended. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of omalizumab injection in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of omalizumab. Make sure you tell your doctor if you have any other medical problems, especially:

  • Asthma attack or
  • Bronchospasm (breathing problem), acute or
  • Other allergic conditions (besides asthma)—Should not be used for patients with these conditions.
  • Cancer, or history of or
  • Parasite infection—Use with caution. May make these conditions worse.

Proper Use of omalizumab

A nurse or other trained health professional will give you or your child omalizumab. Omalizumab is given as a shot under your skin.

If you are receiving omalizumab for asthma, you will receive omalizumab once every 2 or 4 weeks. Your dose will be determined by your IgE level, which your doctor will measure with a simple blood test before treatment begins, and your body weight. Based on your dose, your doctor will also tell you if you will need 1, 2, or 3 injections per dose. If you need more than 1 injection, each will be given in a different place on your body.

Omalizumab is not a rescue medication and should not be used to treat sudden asthma attacks. It is not a substitute for the medicines you are already taking. Never suddenly stop taking, or change the dose of your inhaled steroids or any other asthma medicine you are taking unless your doctor tells you to do so.

If you are receiving omalizumab for chronic idiopathic urticaria, you will receive omalizumab every 4 weeks.

omalizumab should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

omalizumab Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Rare
  • Cough
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • hives, itching, or skin rash
  • malignant tumor
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • tightness in the chest
  • unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Bleeding
  • blistering
  • body aches or pain
  • burning
  • chills
  • cold or flu-like symptoms
  • coldness
  • congestion
  • discoloration of the skin
  • dryness or soreness of the throat
  • feeling of pressure
  • fever
  • headache
  • hoarseness
  • itching
  • leg pain
  • lumps
  • muscle or joint pain
  • numbness
  • pain
  • pain or tenderness around the eyes and cheekbones
  • redness
  • runny nose
  • scarring
  • sore throat
  • soreness
  • stinging
  • stuffy or runny nose
  • swelling
  • tender, swollen glands in the neck
  • tenderness
  • tingling
  • ulceration
  • voice changes
  • warmth
Less common
  • Arm pain
  • blistering, crusting, irritation, itching, or reddening of the skin
  • body produces substance that can bind to drug making it less effective or cause side effects
  • cracked, dry, or scaly skin
  • earache
  • itching skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Interactions

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.

Overdose

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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Lab and/or medical tests (such as lung function) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Avoid substances that can worsen breathing problems by causing irritation or allergic reaction, such as smoke, pollen, pet dander, dust, and mold.

Missed Dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule.

Storage

Not applicable. This medication is given in a clinic or doctor's office and will not be stored at home.Information last revised August 2017. Copyright(c) 2017 First Databank, Inc.

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