Xolair

DRUG DESCRIPTION

Xolair (Omalizumab) is a recombinant DNA-derived humanized IgG1? monoclonal antibody that selectively binds to human immunoglobulin E (IgE). The antibody has a molecular weight of approximately 149 kilodaltons. Xolair (omalizumab) is produced by a Chinese hamster ovary cell suspension culture in a nutrient medium containing the antibiotic gentamicin. Gentamicin is not detectable in the final product.

Xolair (omalizumab) is a sterile, white, preservative-free, lyophilized powder contained in a single-use vial that is reconstituted with Sterile Water for Injection (SWFI), USP, and administered as a subcutaneous (SC) injection. A Xolair vial contains 202.5 mg of Omalizumab, 145.5 mg sucrose, 2.8 mg L-histidine hydrochloride monohydrate, 1.8 mg L-histidine, and 0.5 mg polysorbate 20, and is designed to deliver 150 mg of Omalizumab in 1.2 mL after reconstitution with 1.4 mL SWFI, USP.

What are the possible side effects of omalizumab (Xolair)?

Some people using omalizumab have had a severe, life-threatening allergic reaction to this medication, either right after the injection or hours later. Allergic reaction may occur even after using the medication regularly for a year or longer.

Get emergency medical help if you have any of these signs of an allergic reaction:

  • wheezing, tightness in your chest, trouble breathing;
  • hives or skin rash;
  • feeling anxious or light-headed, fainting;
  • warmth or tingling under your skin; or
  • ...

Read All Potential Side Effects and See Pictures of Xolair

What are the precautions when taking omalizumab (Xolair)?

Before using omalizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before...

Read All Potential Precautions of Xolair


Xolair Consumer (continued)

SIDE EFFECTS: See also Warning section.

Injection site itching, redness, stinging, or pain may occur. Leg, arm or ear pain may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: unusual lumps/growths/moles.

An allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of an allergic reaction include: rash, hives, itching/swelling (especially of the face/tongue/throat), dizziness, chest tightness, cough, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using omalizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Xolair Patient Information Including Side Effects

Brand Names: Xolair

Generic Name: omalizumab (Pronunciation: OH ma LIZ oo mab)

  • What is omalizumab (Xolair)?
  • What are the possible side effects of omalizumab (Xolair)?
  • What is the most important information I should know about omalizumab (Xolair)?
  • What should I discuss with my healthcare provider before using omalizumab (Xolair)?
  • How should I use omalizumab (Xolair)?
  • What happens if I miss a dose (Xolair)?
  • What happens if I overdose (Xolair)?
  • What should I avoid while using omalizumab (Xolair)?
  • What other drugs will affect omalizumab (Xolair)?
  • Where can I get more information?

What is omalizumab (Xolair)?

Omalizumab is an antibody that helps decrease allergic responses in the body.

Omalizumab is used to treat moderate to severe asthma that is caused by allergies in adults and children who are at least 12 years old.

Omalizumab is usually given after other asthma medications have been tried without successful treatment of symptoms.

Omalizumab may also be used for other purposes not listed in this medication guide.

What are the possible side effects of omalizumab (Xolair)?

Some people using omalizumab have had a severe, life-threatening allergic reaction to this medication, either right after the injection or hours later. Allergic reaction may occur even after using the medication regularly for a year or longer.

Get emergency medical help if you have any of these signs of an allergic reaction:

  • wheezing, tightness in your chest, trouble breathing;
  • hives or skin rash;
  • feeling anxious or light-headed, fainting;
  • warmth or tingling under your skin; or
  • swelling of your face, lips, tongue, or throat.

Other serious side effects include easy bruising or bleeding, numbness, or unusual weakness.

Less serious side effects may include:

  • pain;
  • headache, tired feeling;
  • joint or muscle pain;
  • dizziness;
  • ear pain;
  • hair loss;
  • mild itching or skin rash;
  • sore throat or cold symptoms; or
  • redness, bruising, warmth, burning, stinging, itching, pain, or swelling of your skin where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about omalizumab (Xolair)?

Some people using omalizumab have had a severe, life-threatening allergic reaction to this medication, either right after the injection or hours later. Allergic reaction may occur even after using the medication regularly for a year or longer.

Get emergency medical help if you have any of these signs of an allergic reaction: wheezing, tightness in your chest, trouble breathing; hives or skin rash; feeling anxious or light-headed, fainting; warmth or tingling under your skin; or swelling of your face, lips, tongue, or throat.

Asthma is often treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor.

If you also use a steroid medication, do not stop using the steroid suddenly. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing asthma attacks.

Your symptoms may not improve right away once you start receiving omalizumab. For best results, keep receiving the medication as directed. Talk with your doctor if your symptoms do not improve after a few weeks of treatment.

It is important to use omalizumab regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Using this medication may increase your risk of certain types of cancers of the breast, skin, prostate, or salivary gland. Talk to your doctor about your individual risk.

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