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Xolair

Generic Name: omalizumab (OH ma LIZ oo mab)
Brand Names: Xolair
Xolair injection is used to treat moderate to severe asthma caused by allergies. Learn about side effects, interactions and indications.
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Drug Information:
Xolair (omalizumab) is an antibody that helps decrease allergic responses in the body. Xolair is used to treat moderate to severe asthma that is caused by allergies in adults and children who are at least 6 years old. Xolair is used when asthma symptoms are not controlled by asthma inhaled steroid medicine. It is not a rescue medicine for treating an asthma attack. Xolair is also used to treat chronic hives (idiopathic urticaria) in adults and children who are at least 12 years old, after antihistamines have been tried without success. Learn more

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Xolair Side Effects

Note: This document contains side effect information about omalizumab. Some of the dosage forms listed on this page may not apply to the brand name Xolair.

In Summary

More frequent side effects include: lower leg pain. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to omalizumab: subcutaneous powder for solution

Warning

Subcutaneous route (Powder for Solution)

Anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported with omalizumab administration. Anaphylaxis may occur at any time from the first dose to more than a year after omalizumab initiation. Closely monitor patients after omalizumab administration and prepare to manage any anaphylactic reactions.

Along with its needed effects, omalizumab (the active ingredient contained in Xolair) 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 while taking omalizumab:

Less common

  • 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

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

Incidence not known

  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • chest pain
  • chills
  • difficulty in moving
  • fever
  • muscle pain or stiffness
  • pain in the joints
  • painful or difficult urination
  • pinpoint red spots on the skin
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • unusual bleeding or bruising

Some side effects of omalizumab 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, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • body aches or pain
  • cold or flu-like symptoms
  • congestion
  • dryness or soreness of the throat
  • headache
  • hoarseness
  • leg pain
  • lumps
  • pain or tenderness around the eyes and cheekbones
  • stuffy or runny nose
  • voice changes

Less common

  • Arm pain
  • cracked, dry, or scaly skin
  • earache

Incidence not known

  • Hair loss

For Healthcare Professionals

Applies to omalizumab: subcutaneous powder for injection, subcutaneous solution

General

The more commonly reported side effects included injection site reactions, headache, and nasopharyngitis.

Local

In clinical trials, any injection site reaction occurred in 45% and 43% of patients given this drug and placebo, respectively; severe reactions occurred in 12% and 9%, respectively.

Very common (10% or more): Any injection site reaction, including pain, swelling, itching, redness, bruising, bleeding, induration, or mass (up to 45%), severe injection site reaction (up to 12%)

Uncommon (0.1% to 1%): Arm swelling

Immunologic

Very common (10% or more): Viral infection (up to 37%)

Uncommon (0.1% to 1%): Moniliasis, parasitic infection

Rare (0.01% to 0.1%): Anti-omalizumab (the active ingredient contained in Xolair) antibody development

Postmarketing reports: Serum sickness, allergic granulomatous angiitis (Churg-Strauss syndrome), lymphadenopathy

In clinical studies, viral infection occurred in 37% and 39% or patients given this drug or placebo, respectively. Increased parasitic infections, compared to placebo, were not statistically significant.

Nervous system

Very common (10% or more): Headache (up to 27%)

Common (1% to 10%): Dizziness

Uncommon (0.1% to 1%): Syncope, vasovagal syncope, somnolence, paresthesia

Frequency not reported: Migraine, sinus headache

In clinical trials, headache occurred in 37% of patients given either this drug (n=716) or placebo (n=694); headache occurred very commonly in patients 6 to 12 years old.

Musculoskeletal

Very common (10% or more): Back pain (up to 13%)

Common (1% to 10%): Arthralgia, myalgia, sprains, strains, extremity pain, fracture

Postmarketing reports: Joint swelling

Respiratory

In clinical trials with chronic idiopathic urticarial, patients reported nasopharyngitis 9.1%, 6.6%, and 7% in 150 mg, 300 mg, and placebo, respectively; sinusitis (1.1%, 4.9%, 2.1%), cough (1.1%, 2.2%,1.2%), and upper respiratory infection (11.1%, 3.4%, 2.1%) were also reported by patients, respectively.

Common (1% to 10%): Nasopharyngitis, sinusitis, viral upper respiratory infection (URI), URI

Uncommon (0.1% to 1%): Pharyngitis, cough, allergic bronchospasm

Rare (0.01% to 0.1%): Laryngoedema

Frequency not reported: Asthma, oropharyngeal pain

Dermatologic

Common (1% to 10%): Dermatitis, pruritus

Uncommon (0.1% to 1%): Skin rashes, flushing, photosensitivity

Postmarketing reports: Alopecia, hair loss

Other

Common (1% to 10%): Fever, earache

Uncommon (0.1% to 1%): Fatigue, post-injection phenomena

In clinical trials, fever occurred very commonly in patients 6 to 12 years old.

Gastrointestinal

In clinical trials, upper abdominal pain was very common in patients 6 to 12 years old. In clinical trials with chronic idiopathic urticarial, patients reported nausea 1.1%, 2.7%, and 2.5% of the time with 150 mg, 300 mg, and placebo, respectively.

Common (1% to 10%): Upper abdominal pain, nausea

Uncommon (0.1% to 1%): Diarrhea, dyspepsia, gastroenteritis

Frequency not reported: Toothache

Genitourinary

Common (1% to 10%): Urinary tract infection

Hypersensitivity

Uncommon (0.1% to 1%): Urticaria

Rare (0.01% to 0.1%): Anaphylactic reactions, angioedema

Postmarketing reports: Anaphylactoid reactions

Cardiovascular

Uncommon (0.1% to 1%): Postural hypotension

Frequency not reported: Peripheral edema, arterial thrombotic events (including transient ischemic attack, myocardial infarction, unstable angina, and cardiovascular death)

Postmarketing reports: Hypotension, chest tightness

Hematologic

Uncommon (0.1% to 1%): Asymptomatic platelet decreases

Postmarketing reports: Idiopathic severe thrombocytopenia, eosinophilic conditions

In clinical trials, 0.6% of patients developed decreased platelet counts below the normal laboratory range; these patients did not have associated bleeding episodes or decreased hemoglobin.

Metabolic

Uncommon (0.1% to 1%): Weight increases

Psychiatric

Frequency not reported: Anxiety

Editorial References and Review

Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.

Source: Drugs.com Xolair (www.drugs.com/xolair.html).