Xolair
XOLAIR
Omalizumab
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Xolair (Omalizumab)

What is Xolair (Omalizumab)?

Xolair is a subcutaneous (under the skin) injectable medication used for treating and managing moderate to severe allergic asthma in adults and children aged six and older, chronic idiopathic urticaria in adults and children aged twelve and older, and nasal polyps in adults who are eighteen years of age and older.

How does Xolair Work?

Xolair belongs to a drug class called Monoclonal antibodies, anti-asthmatics. Xolair works by inhibiting the binding of IgE-to-IgE receptors on mast cells and basophils. This prevents the release of histamine, which causes inflammation within the body. Histamine is also known to cause symptoms such as runny nose, watery eyes, tissue swelling, itchy skin, and hives.

Usage

Storage

Xolair should be stored in the refrigerator between 36?F to 46?F (2?C to 8?C).

How to Take

Xolair comes in a prefilled syringe that is injected subcutaneously (under the skin). Xolair should be refrigerated until the time of use. If Xolair is left at room temperature for longer than two days, it should be discarded. Depending on your doctor’s recommendation, Xolair is usually given every 2 or 4 weeks. Xolair should be injected into the stomach, thigh, or upper arm. The prefilled syringe contains a single dose of Xolair and should be discarded into a sharps container once injected.

Dosage

Xolair prefilled syringes are available in 75mg and 150mg doses.

Dosing for Adults and Children

 Asthma

The recommended dose of Xolair for treating moderate to severe asthma in adults and children aged six and older is 150-375mg every 2-4 weeks. Your total IgE level and body weight determine the dosage and frequency.

Chronic Idiopathic Urticaria

The recommended dose of Xolair for treating chronic idiopathic urticaria in adults and children aged 12 and older is 150-300mg every four weeks. The dosage is not dependent on IgE level or body weight but is determined by your doctor.

Nasal Polyps

The recommended dose of Xolair for the treatment of nasal polyps in adults aged 18 and older for the treatment of nasal polyps is 75-600mg every 2-4 weeks. The total IgE level and body weight determine the dosage and frequency.

Missed Dose

If you miss a dose of Xolair, call your doctor for further instructions and a new dosing schedule.

Overdose

Taking too much Xolair can lead to serious side effects. If you suspect an overdose, seek emergency medical attention or call the poison control helpline at 1-800-222-1222.

Side Effects

If you experience signs and symptoms of an allergic reaction, such as hives, rash, itching, difficulty breathing, or swelling of the face, mouth, or throat, seek medical attention immediately.

 The most common side effects of Xolair include:

  • Rash
  • Fever
  • Nosebleeds
  • Joint pain or bone fractures
  • Arm and leg pain
  • Nausea, vomiting, diarrhea, and stomach pain
  • Headache
  • Dizziness
  • Fatigue
  • Ear infection or ear pain
  • Pain, bruising or swelling at the injection site
  • Cold symptoms such as stuffy nose, sneezing, sinus pain, cough, and sore throat

Some serious side effects can also occur. Call your doctor or seek immediate medical attention if you experience any of the following symptoms:

  • Ongoing nausea, vomiting, severe or watery diarrhea
  • Difficulty breathing
  • Numbness or tingling in the arms and legs
  • Fever, muscle pain, and rash within a few days of injection
  • Fever, ear pain or full feeling, trouble hearing, or ear drainage (signs of an ear infection)
  • Chest pain or pressure, jaw or shoulder pain (signs of a heart attack)
  • Sudden numbness or weakness, problems with vision or speech, coughing up blood, swelling or redness in an arm or leg (signs of a blood clot)

Warnings and Precautions

Xolair is contraindicated in those who have a known allergy or sensitivity to Xolair or any of its ingredients.

Children

Xolair is approved for treating moderate to severe asthma in children aged six and older and treating chronic idiopathic urticaria in children aged twelve and older.

Pregnancy

It is not known if Xolair is safe during pregnancy as IgE crosses the placenta and there may be a potential harm to the fetus. Uncontrolled asthma in pregnancy is associated with preeclampsia, prematurity, and low birth weight. Xolair can be used in pregnancy under a doctor’s supervision if the benefit outweighs the risk.

Lactation

Xolair is approved for use in women who are breastfeeding. Studies have shown that there have been no adverse effects on breastfed infants.

Cancers

Patients taking Xolair exhibited a higher rate of cancer during observational studies. The cancers reported include breast cancer, non-melanoma skin, prostate, melanoma, and parotid gland. It is unknown if more prolonged exposure to Xolair results in a higher risk of cancer development. Speaking to your doctor about your cancer risk before starting Xolair is essential.

Acute Asthma

Xolair has not been shown to alleviate acute asthma exacerbations. Do not use Xolair for the treatment of acute attacks or acute bronchospasm.

Corticosteroid Use

Do not abruptly discontinue systemic or inhaled corticosteroids upon initiation of Xolair for asthma. Corticosteroids should be decreased gradually under the supervision of a doctor.

Eosinophilic Conditions

Some patients taking Xolair presented with severe systemic eosinophilia. Patients taking Xolair should be monitored for eosinophilia intermittently while receiving treatment.

Fever, Rash and Arthralgia

Some patients taking Xolair experienced arthritis/arthralgia, rash, fever, and lymphadenopathy. Patients exhibiting these symptoms should have Xolair discontinued.

Parasitic Infection

Patients at high risk of parasitic infection should be monitored throughout treatment with Xolair for active infection. Studies have shown an increased risk of parasitic infections while taking Xolair. Patients who develop symptoms of parasitic infection should be rested appropriately.

Laboratory Tests

Patients taking Xolair showed an elevated serum total IgE level after one year of use.

Drug Interactions

This is not a complete list of potential drug interactions. Before taking Xolair, tell your doctor if you take any medications, herbal supplements, or vitamins.

Efgartigimod alfa

Efgartigimod alfa, a medication used in the treatment of generalized myasthenia gravis, may reduce the blood levels and effects of Xolair.

Omacetaxine

Omacetaxine, a medication used in treating chronic myelogenous leukemia, may increase the risk of serious infections when used with Xolair.

Alternative Medications

Other drugs are available to treat asthma, chronic idiopathic urticaria, and nasal polyps. Speak to your doctor to discuss other medications.

Corticosteroids

Corticosteroids reduce inflammation, swelling, and mucous production in the airways of people with asthma. Available corticosteroids include prednisone and methylprednisone (Medrol)

Leukotriene Modifiers

Leukotriene modifiers work by blocking leukotrienes, reducing breathing problems in people with asthma. Available leukotriene modifiers include montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo)

Biologic Medications

Biologic medications work by inhibiting overactive signaling of IL-4 and IL-13. These proteins contribute to the inflammation that causes moderate-to-severe asthma. Available biologic medications include amepolizumab (Nucala), benralizumab (Fasenra), reslizumab (Cinqair), and dupilumab (Dupixent).

Frequently Asked Questions

It is unknown if Xolair harms an unborn baby. Speak to your doctor before taking Xolair while pregnant.

Breastfeeding is not recommended while taking Xolair.

Xolair is approved for the use of asthma in children aged six and older and chronic idiopathic urticaria in children aged twelve and older.

Xolair comes in a prefilled syringe that is injected subcutaneously (under the skin). Xolair should be injected into the stomach, thigh, or upper arm.

The most commonly reported side effects of Xolair to include rash, fever, nosebleeds, joint pain or bone fractures, arm and leg pain, nausea, vomiting, diarrhea, stomach pain, headache, dizziness, fatigue, ear infection or ear pain, pain, bruising, or swelling at the injection site and cold symptoms such as stuffy nose, sneezing, sinus pain, cough, and sore throat.

If you miss a dose of Xolair, call your doctor for further instructions.

If you suspect an overdose, seek emergency medical attention or call the poison control helpline at 1-800-222-1222.

Xolair is used to treat moderate to severe allergic asthma in adults and children aged six and older, chronic idiopathic urticaria in adults and children aged twelve and older, and nasal polyps in adults who are eighteen years of age and older.

Xolair should be stored in the refrigerator before use.

Xolair is given via subcutaneous injection every 2-4 weeks.

It is not recommended to drink alcohol while taking Xolair. Xolair can cause dizziness which may worsen the side effects of Xolair.

Xolair is not known to cause weight gain.

Some patients taking Xolair have shown an increase in serum IgE levels.

Xolair should be injected into the stomach, thigh, or upper arm under the skin.

Xolair is available in 75mg and 150mg prefilled syringes.