Xolair

• Overview
• Consumer Information
• Professional Information

 

Xolair Side Effects Center

What Is Xolair?

Xolair (omalizumab) is an antibody that helps decrease allergic responses in the body used to treat moderate to severe asthma that is caused by allergies in adults and children who are at least 12 years old. Xolair is usually given after other asthma medications have been tried without successful treatment of symptoms.

What Are Side Effects of Xolair?

Common side effects of Xolair include:

• headache,
• tired feeling,
• joint or muscle pain,
• dizziness,
• ear pain,
• hair loss,
• sore throat,
• cold symptoms,
• itching or skin rash,
• injection site reactions (itching, redness, stinging, pain, bruising, warmth, burning, or swelling), or
• leg or arm pain.

Tell your doctor if you have serious side effects of Xolair including unusual lumps/growths/moles.

Dosage for Xolair

Xolair in a dose of 150 to 375 mg is administered by injection every 2 or 4 weeks.

What Drugs, Substances, or Supplements Interact with Xolair?

Before using Xolair, tell your doctor if you are receiving allergy shots. There may be other drugs that can interact with Xolair. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Xolair During Pregnancy and Breastfeeding

Xolair should be used only when prescribed during pregnancy. It is not known whether this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Xolair (omalizumab) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Xolair Consumer Information

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

You will be watched closely for a short time after each injection, to make sure you do not have an allergic reaction to omalizumab.

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

• hives, itching;
• anxiety or fear, feeling like you might pass out;
• flushing (warmth, redness, or tingly feeling);
• chest tightness, wheezing, cough, feeling short of breath, difficult breathing;
• fast or weak heartbeats; or
• swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• ongoing nausea or vomiting, severe or watery diarrhea;
• trouble breathing;
• numbness or tingling in your arms or legs;
• fever, muscle pain, and rash within a few days after receiving an injection;
• signs of an ear infection--fever, ear pain or full feeling, trouble hearing, drainage from the ear, fussiness in a child;
• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder; or
• signs of a blood clot--sudden numbness or weakness, problems with vision or speech, coughing up blood, swelling or redness in an arm or leg.

Common side effects may include:

• rash;
• fever;
• nosebleeds;
• joint pain, bone fractures;
• arm or leg pain;
• nausea, vomiting, diarrhea, stomach pain;
• headache;
• dizziness, feeling tired;
• ear pain, ear infection;
• pain, bruising, swelling, or irritation where the medicine was injected; or
• cold symptoms such as stuffy nose, sneezing, sinus pain, cough, sore throat.

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.

Read the entire detailed patient monograph for Xolair (Omalizumab)

 

Xolair Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Anaphylaxis [see BOX WARNING and WARNINGS AND PRECAUTIONS]
• Malignancies [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Adverse Reactions From Clinical Studies In Adult And Adolescent Patients 12 Years Of Age And Older With Asthma

The data described below reflect XOLAIR exposure for 2076 adult and adolescent patients ages 12 and older, including 1687 patients exposed for six months and 555 exposed for one year or more, in either placebo-controlled or other controlled asthma studies. The mean age of patients receiving XOLAIR was 42 years, with 134 patients 65 years of age or older; 60% were women, and 85% Caucasian. Patients received XOLAIR 150 mg to 375 mg every 2 or 4 weeks or, for patients assigned to control groups, standard therapy with or without a placebo.

The adverse reactions most frequently resulting in clinical intervention (e.g., discontinuation of XOLAIR, or the need for concomitant medication to treat an adverse reaction) were injection site reaction (45%), viral infections (23%), upper respiratory tract infection (20%), sinusitis (16%), headache (15%), and pharyngitis (11%). These reactions were observed at similar rates in XOLAIR-treated patients and control patients.

Table 6 shows adverse reactions from four placebo-controlled asthma trials that occurred ≥1% and more frequently in adult and adolescent patients 12 years of age and older receiving XOLAIR than in those receiving placebo. Adverse reactions were classified using preferred terms from the International Medical Nomenclature (IMN) dictionary. Injection site reactions were recorded separately from the reporting of other adverse reactions.

Table 6. Adverse Reactions ≥1% More Frequent in XOLAIR-Treated Adult or Adolescent Patients 12 years of Age and Older in Four Placebo-controlled Asthma Trials

Adverse reaction	XOLAIR n=738	Placebo n=717
Body as a whole
Pain	7%	5%
Fatigue	3%	2%
Musculoskeletal system
Arthralgia	8%	6%
Fracture	2%	1%
Leg pain	4%	2%
Arm pain	2%	1%
Nervous system
Dizziness	3%	2%
Skin and appendages
Pruritus	2%	1%
Dermatitis	2%	1%
Special senses
Earache	2%	1%

There were no differences in the incidence of adverse reactions based on age (among patients under 65), gender or race.

Anaphylaxis Case Control Study

A retrospective case-control study investigated risk factors for anaphylaxis to XOLAIR among patients treated with XOLAIR for asthma. Cases with an adjudicated history of anaphylaxis to XOLAIR were compared to controls with no such history. The study found that a self-reported history of anaphylaxis to foods, medications or other causes was more common among patients with XOLAIR anaphylaxis (57% of 30 cases) compared to controls (23% of 88 controls) [OR 8.1, 95% CI 2.7 to 24.3]. Because this is a case-control study, the study cannot provide the incidence of anaphylaxis among XOLAIR users. From other sources, anaphylaxis to XOLAIR was observed in 0.1% of patients in clinical trials and at least 0.2% of patients based upon postmarketing reports. Approximately 60% to 70% of cases were reported to occur within the first three doses of XOLAIR, with additional cases occurring sporadically beyond the third dose. The time to onset for anaphylaxis was reported to occur within 2 hours for the majority of cases (approximately 75%) -[see WARNINGS AND PRECAUTIONS, Postmarketing Experience].

Injection Site Reactions

In adults and adolescents, injection site reactions of any severity occurred at a rate of 45% in XOLAIR-treated patients compared with 43% in placebo-treated patients. The types of injection site reactions included: bruising, redness, warmth, burning, stinging, itching, hive formation, pain, indurations, mass, and inflammation.

Severe injection site reactions occurred more frequently in XOLAIR-treated patients compared with patients in the placebo group (12% versus 9%).

The majority of injection site reactions occurred within 1 hour post injection, lasted less than 8 days, and generally decreased in frequency at subsequent dosing visits.

Adverse Reactions From Clinical Studies In Pediatric Patients 6 To <12 Years Of Age With Asthma

The data described below reflect XOLAIR exposure for 926 patients 6 to <12 years of age, including 583 patients exposed for six months and 292 exposed for one year or more, in either placebo-controlled or other controlled asthma studies. The mean age of pediatric patients receiving XOLAIR was 8.8 years; 69% were male, and 64% were Caucasian. Pediatric patients received XOLAIR 75 mg to 375 mg every 2 or 4 weeks or, for patients assigned to control groups, standard therapy with or without a placebo. No cases of malignancy were reported in patients treated with XOLAIR in these trials.

The most common adverse reactions occurring at ≥3% in the pediatric patients receiving XOLAIR and more frequently than in patients treated with placebo were nasopharyngitis, headache, pyrexia, upper abdominal pain, pharyngitis streptococcal, otitis media, viral gastroenteritis, arthropod bite, and epistaxis.

The adverse reactions most frequently resulting in clinical intervention (e.g., discontinuation of XOLAIR, or the need for concomitant medication to treat an adverse event) were bronchitis (0.2%), headache (0.2%) and urticaria (0.2%). These reactions were observed at similar rates in XOLAIR-treated patients and control patients.

Adverse Reactions From Clinical Studies In Adult Patients With Nasal Polyps

The data described below reflect XOLAIR exposure for 135 patients ≥ 18 years of age, exposed for six months in two placebo-controlled studies. The mean age of patients receiving XOLAIR was 49.7 years; 64% were male, and 94% were Caucasian. Patients received XOLAIR or placebo SC every 2 or 4 weeks, with dosage and frequency according to Table 3. All patients received background nasal mometasone therapy throughout the study. Table 7 lists the adverse reactions occurring in ≥3% of XOLAIR-treated patients and more frequently than in patients treated with placebo in Nasal Polyps Trials 1 and 2; results were pooled.

Table 7. Adverse Reactions Occurring in ≥3% of XOLAIR-Treated Patients and More Frequently than in Patients Treated with Placebo in Nasal Polyps Trials 1 and 2

Adverse reaction	XOLAIR n=135	Placebo n=130
Gastrointestinal disorder
Upper abdominal pain	4 (3.0%)	1 (0.8%)
General disorders and administration site conditions
Injection site reactions*	7 (5.2%)	2 (1.5%)
Musculoskeletal system and connective tissue disorders
Arthralgia	4 (3.0%)	2 (1.5%)
Nervous system disorders
Headache	11 (8.1%)	7 (5.4%)
Dizziness	4 (3.0%)	1 (0.8%)
*Injection site reactions terms: ‘injection site reaction’, ‘injection related reaction’ and ‘injection site pain’. All of the injection site reactions were mild to moderate severity and none resulted in study discontinuation

Adverse Reactions From Clinical Studies In Patients With Chronic Idiopathic Urticaria (CIU)

The safety of XOLAIR for the treatment of CIU was assessed in three placebo-controlled, multiple-dose clinical trials of 12 weeks’ (CIU Trial 2) and 24 weeks’ duration (CIU Trials 1 and 3). In CIU Trials 1 and 2, patients received XOLAIR 75 mg, 150 mg, or 300 mg or placebo every 4 weeks in addition to their baseline level of H1 antihistamine therapy throughout the treatment period. In CIU Trial 3 patients were randomized to XOLAIR 300 mg or placebo every 4 weeks in addition to their baseline level of H1 antihistamine therapy. The data described below reflect XOLAIR exposure for 733 patients enrolled and receiving at least one dose of XOLAIR in the three clinical trials, including 684 patients exposed for 12 weeks and 427 exposed for 24 weeks. The mean age of patients receiving XOLAIR 300 mg was 43 years, 75% were women, and 89% were white. The demographic profiles for patients receiving XOLAIR 150 mg and 75 mg were similar.

Table 8 shows adverse reactions that occurred in ≥2% of patients receiving XOLAIR (150 or 300 mg) and more frequently than those receiving placebo. Adverse reactions are pooled from Trial 2 and the first 12 weeks of Trials 1 and 3.

Table 8. Adverse Reactions Occurring in ≥2% in XOLAIR-Treated Patients and More Frequently than in Patients Treated with Placebo (Day 1 to Week 12) in CIU Trials

Adverse Reactions*	CIU Trials 1, 2 and 3 Pooled
	150mg (n=175)	300mg (n=412)	Placebo (n=242)
Gastrointestinal disorders
Nausea	2 (1.1%)	11 (2.7%)	6 (2.5%)
Infections and infestations
Nasopharyngitis	16 (9.1%)	27 (6.6%)	17 (7.0%)
Sinusitis	2 (1.1%)	20 (4.9%)	5 (2.1%)
Upper respiratory tract infection	2 (1.1%)	14 (3.4%)	5 (2.1%)
Viral upper respiratory tract infection	4 (2.3%)	2 (0.5%)	(0.0%)
Musculoskeletal and connective tissue disorders
Arthralgia	5 (2.9%)	12 (2.9%)	1 (0.4%)
Nervous system disorders
Headache	21 (12.0%)	25 (6.1%)	7 (2.9%)
Respiratory, thoracic, and mediastinal disorders
Cough	2 (1.1%)	9 (2.2%)	3 (1.2%)
* by MedDRA (15.1) System Organ Class and Preferred Term

Additional reactions reported during the 24-week treatment period in Trials 1 and 3 [≥2% of patients receiving XOLAIR (150 mg or 300 mg) and more frequently than those receiving placebo] included: toothache, fungal infection, urinary tract infection, myalgia, pain in extremity, musculoskeletal pain, peripheral edema, pyrexia, migraine, sinus headache, anxiety, oropharyngeal pain, asthma, urticaria, and alopecia.

Injection Site Reactions

Injection site reactions of any severity occurred during the studies in more XOLAIR-treated patients [11 patients (2.7%) at 300 mg, 1 patient (0.6%) at 150 mg] compared with 2 placebo-treated patients (0.8%). The types of injection site reactions included: swelling, erythema, pain, bruising, itching, bleeding and urticaria. None of the events resulted in study discontinuation or treatment interruption.

Cardiovascular And Cerebrovascular Events From Clinical Studies In Patients With Asthma

A 5-year observational cohort study was conducted in patients ≥12 years of age with moderate to severe persistent asthma and a positive skin test reaction to a perennial aeroallergen to evaluate the long -term safety of XOLAIR, including the risk of malignancy [see WARNINGS AND PRECAUTIONS]. A total of 5007 XOLAIR-treated and 2829 nonXOLAIR-treated patients enrolled in the study. Similar percentages of patients in both cohorts were current (5%) or former smokers (29%). Patients had a mean age of 45 years and were followed for a mean of 3.7 years. More XOLAIR-treated patients were diagnosed with severe asthma (50%) compared to the non-XOLAIR-treated patients (23%) and 44% of patients prematurely discontinued the study. Additionally, 88% of patients in the XOLAIR-treated cohort had been previously exposed to XOLAIR for a mean of 8 months.

A higher incidence rate (per 1000 patient-years) of overall cardiovascular and cerebrovascular serious adverse events (SAEs) was observed in XOLAIR-treated patients (13.4) compared to non-XOLAIR-treated patients (8.1). Increases in rates were observed for transient ischemic attack (0.7 versus 0.1), myocardial infarction (2.1 versus 0.8), pulmonary hypertension (0.5 versus 0), pulmonary embolism/venous thrombosis (3.2 versus 1.5), and unstable angina (2.2 versus 1.4), while the rates observed for ischemic stroke and cardiovascular death were similar among both study cohorts. The results suggest a potential increased risk of serious cardiovascular and cerebrovascular events in patients treated with XOLAIR. However, the observational study design, the inclusion of patients previously exposed to XOLAIR (88%), baseline imbalances in cardiovascular risk factors between the treatment groups, an inability to adjust for unmeasured risk factors, and the high study discontinuation rate limit the ability to quantify the magnitude of the risk.

A pooled analysis of 25 randomized double-blind, placebo-controlled clinical trials of 8 to 52 weeks in duration was conducted to further evaluate the imbalance in cardiovascular and cerebrovascular SAEs noted in the above observational cohort study. A total of 3342 XOLAIR-treated patients and 2895 placebo-treated patients were included in the pooled analysis. The patients had a mean age of 38 years, and were followed for a mean duration of 6.8 months. No notable imbalances were observed in the rates of cardiovascular and cerebrovascular SAEs listed above. However, the results of the pooled analysis were based on a low number of events, slightly younger patients, and shorter duration of follow-up than the observational cohort study; therefore, the results are insufficient to confirm or reject the findings noted in the observational cohort study.

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to omalizumab in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.

Antibodies to XOLAIR were detected in approximately 1/1723 (<0.1%) of patients treated with XOLAIR in the clinical studies evaluated for asthma in patients 12 years of age and older. In three pediatric studies, antibodies to XOLAIR were detected in one patient out of 581 patients 6 to <12 years of age treated with XOLAIR and evaluated for antibodies. There were no detectable antibodies in the patients treated in the CIU clinical trials, but due to levels of XOLAIR at the time of anti-therapeutic antibody sampling and missing samples for some patients, antibodies to XOLAIR could only have been determined in 88% of the 733 patients treated in these clinical studies. The data reflect the percentage of patients whose test results were considered positive for antibodies to XOLAIR in ELISA assays and are highly dependent on the sensitivity and specificity of the assays.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of XOLAIR in adult and adolescent patients 12 years of age and older. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Anaphylaxis

Based on spontaneous reports and an estimated exposure of about 57,300 patients from June 2003 through December 2006, the frequency of anaphylaxis attributed to XOLAIR use was estimated to be at least 0.2% of patients. Diagnostic criteria of anaphylaxis were skin or mucosal tissue involvement, and, either airway compromise, and/or reduced blood pressure with or without associated symptoms, and a temporal relationship to XOLAIR administration with no other identifiable cause. Signs and symptoms in these reported cases included bronchospasm, hypotension, syncope, urticaria, angioedema of the throat or tongue, dyspnea, cough, chest tightness, and/or cutaneous angioedema. Pulmonary involvement was reported in 89% of the cases. Hypotension or syncope was reported in 14% of cases. Fifteen percent of the reported cases resulted in hospitalization. A previous history of anaphylaxis unrelated to XOLAIR was reported in 24% of the cases.

Of the reported cases of anaphylaxis attributed to XOLAIR, 39% occurred with the first dose, 19% occurred with the second dose, 10% occurred with the third dose, and the rest after subsequent doses. One case occurred after 39 doses (after 19 months of continuous therapy, anaphylaxis occurred when treatment was restarted following a 3-month gap). The time to onset of anaphylaxis in these cases was up to 30 minutes in 35%, greater than 30 and up to 60 minutes in 16%, greater than 60 and up to 90 minutes in 2%, greater than 90 and up to 120 minutes in 6%, greater than 2 hours and up to 6 hours in 5%, greater than 6 hours and up to 12 hours in 14%, greater than 12 hours and up to 24 hours in 8%, and greater than 24 hours and up to 4 days in 5%. In 9% of cases the times to onset were unknown.

Twenty-three patients who experienced anaphylaxis were rechallenged with XOLAIR and 18 patients had a recurrence of similar symptoms of anaphylaxis. In addition, anaphylaxis occurred upon rechallenge with XOLAIR in 4 patients who previously experienced urticaria only.

Eosinophilic Conditions

Eosinophilic conditions have been reported [see WARNINGS AND PRECAUTIONS].

Fever, Arthralgia, And Rash

A constellation of signs and symptoms including arthritis/arthralgia, rash (urticaria or other forms), fever and lymphadenopathy similar to serum sickness have been reported in post-approval use of XOLAIR [see WARNINGS AND PRECAUTIONS].

Hematologic

Severe thrombocytopenia has been reported.

Skin

Hair loss has been reported.

DRUG INTERACTIONS

No formal drug interaction studies have been performed with XOLAIR.

In patients with asthma and nasal polyps, the concomitant use of XOLAIR and allergen immunotherapy has not been evaluated.

In patients with CIU, the use of XOLAIR in combination with immunosuppressive therapies has not been studied.

Read the entire FDA prescribing information for Xolair (Omalizumab)

&Copy; Xolair Patient Information is supplied by Cerner Multum, Inc. and Xolair Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.