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Xolair

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Xolair

Xolair

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Anaphylaxis

Anaphylaxis has been reported to occur after administration of Xolair in premarketing clinical trials and in postmarketing spontaneous reports. Signs and symptoms in these reported cases have included bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue. Some of these events have been life-threatening. In premarketing clinical trials in allergic asthma, anaphylaxis was reported in 3 of 3507 (0.1%) patients in clinical trials. Anaphylaxis occurred with the first dose of Xolair in two patients and with the fourth dose in one patient. The time to onset of anaphylaxis was 90 minutes after administration in two patients and 2 hours after administration in one patient. In postmarketing spontaneous reports, the frequency of anaphylaxis attributed to Xolair use was estimated to be at least 0.2% of patients based on an estimated exposure of about 57,300 patients from June 2003 through December 2006. Anaphylaxis has occurred as early as after the first dose of Xolair, but also has occurred beyond one year after beginning regularly scheduled treatment.

Administer Xolair only in a healthcare setting by healthcare providers prepared to manage anaphylaxis that can be life-threatening. Observe patients closely for an appropriate period of time after administration of Xolair, taking into account the time to onset of anaphylaxis seen in premarketing clinical trials and postmarketing spontaneous reports [see ADVERSE REACTIONS]. Inform patients of the signs and symptoms of anaphylaxis, and instruct them to seek immediate medical care should signs or symptoms occur. Discontinue Xolair in patients who experience a severe hypersensitivity reaction [see CONTRAINDICATIONS]

Malignancy

Malignant neoplasms were observed in 20 of 4127 (0.5%) Xolair-treated patients compared with 5 of 2236 (0.2%) control patients in clinical studies of adults and adolescents ( ≥ 12 years of age) with asthma and other allergic disorders. The observed malignancies in Xolair-treated patients were a variety of types, with breast, non-melanoma skin, prostate, melanoma, and parotid occurring more than once, and five other types occurring once each. The majority of patients were observed for less than 1 year. The impact of longer exposure to Xolair or use in patients at higher risk for malignancy (e.g., elderly, current smokers) is not known [see ADVERSE REACTIONS].

Acute Asthma Symptoms

Xolair has not been shown to alleviate asthma exacerbations acutely. Do not use Xolair to treat acute bronchospasm or status asthmaticus.

Corticosteroid Reduction

Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of Xolair therapy for allergic asthma. Decrease corticosteroids gradually under the direct supervision of a physician. In CIU patients, the use of Xolair in combination with corticosteroids has not been evaluated.

Eosinophilic Conditions

In rare cases, patients with asthma on therapy with Xolair may present with serious systemic eosinophilia sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition which is often treated with systemic corticosteroid therapy. These events usually, but not always, have been associated with the reduction of oral corticosteroid therapy. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal association between Xolair and these underlying conditions has not been established.

Fever, Arthralgia, And Rash

In post-approval use, some patients have experienced a constellation of signs and symptoms including arthritis/arthralgia, rash, fever and lymphadenopathy with an onset 1 to 5 days after the first or subsequent injections of Xolair. These signs and symptoms have recurred after additional doses in some patients. Although circulating immune complexes or a skin biopsy consistent with a Type III reaction were not seen with these cases, these signs and symptoms are similar to those seen in patients with serum sickness. Physicians should stop Xolair if a patient develops this constellation of signs and symptoms [see ADVERSE REACTIONS]

Parasitic (Helminth) Infection

Monitor patients at high risk of geohelminth infection while on Xolair therapy. Insufficient data are available to determine the length of monitoring required for geohelminth infections after stopping Xolair treatment.

In a one-year clinical trial conducted in Brazil in patients at high risk for geohelminthic infections (roundworm, hookworm, whipworm, threadworm), 53% (36/68) of Xolairtreated patients experienced an infection, as diagnosed by standard stool examination, compared to 42% (29/69) of placebo controls. The point estimate of the odds ratio for infection was 1.96, with a 95% confidence interval (0.88, 4.36) indicating that in this study a patient who had an infection was anywhere from 0.88 to 4.36 times as likely to have received Xolair than a patient who did not have an infection. Response to appropriate antigeohelminth treatment of infection as measured by stool egg counts was not different between treatment groups.

Laboratory Tests

Serum total IgE levels increase following administration of Xolair due to formation of Xolair:IgE complexes [see CLINICAL PHARMACOLOGY]. Elevated serum total IgE levels may persist for up to 1 year following discontinuation of Xolair. Do not use serum total IgE levels obtained less than 1 year following discontinuation to reassess the dosing regimen for allergic asthma patients, because these levels may not reflect steady state free IgE levels.

Patient Counseling Information

See FDA-approved patient labeling (Medication Guide)

Information For Patients

Provide and instruct patients to read the accompanying Medication Guide before starting treatment and before each subsequent treatment. The complete text of the Medication Guide is reprinted at the end of this document.

  • Inform patients of the risk of life-threatening anaphylaxis with Xolair including the following points [see WARNINGS AND PRECAUTIONS] :
  • There have been reports of anaphylaxis occurring up to 4 days after administration of Xolair
  • Xolair should only be administered in a healthcare setting by healthcare providers
  • Patients should be closely observed following administration
  • Patients should be informed of the signs and symptoms of anaphylaxis
  • Patients should be instructed to seek immediate medical care should such signs or symptoms occur

Instruct patients receiving Xolair not to decrease the dose of, or stop taking any other asthma or CIU medications unless otherwise instructed by their physician. Inform patients that they may not see immediate improvement in their asthma or CIU symptoms after beginning Xolair therapy.

Pregnancy Exposure Registry

Encourage pregnant women exposed to Xolair to enroll in the Xolair Pregnancy Exposure Registry [1-866-4XOLAIR (1-866-496-5247)\ or visit www.xolairpregnancyregistry.com.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

No long-term studies have been performed in animals to evaluate the carcinogenic potential of Xolair.

There were no effects on fertility and reproductive performance in male and female Cynomolgus monkeys that received Xolair at subcutaneous doses up to 75 mg/kg/week (approximately 10 times the maximum recommended human dose on a mg/kg basis).

Use In Specific Populations

Pregnancy

Pregnancy Category B

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Xolair during pregnancy. Encourage patients to call 1-866-4XOLAIR (1-866496- 5247) or visit www.xolairpregnancyregistry.com for information about the pregnancy exposure registry and the enrollment procedure.

Risk Summary

Adequate and well-controlled studies with Xolair have not been conducted in pregnant women. All pregnancies, regardless of drug exposure, have a background rate of 2 to 4% for major malformations, and 15 to 20% for pregnancy loss. In animal reproduction studies, no evidence of fetal harm was observed in Cynomolgus monkeys with subcutaneous doses of omalizumab up to 10 times the maximum recommended human dose (MRHD). Because animal reproduction studies are not always predictive of human response, Xolair should be used during pregnancy only if clearly needed.

Clinical Considerations

In general, monoclonal antibodies are transported across the placenta in a linear fashion as pregnancy progresses, with the largest amount transferred during the third trimester.

Data

Animal Data

Reproductive studies have been performed in Cynomolgus monkeys at subcutaneous doses of omalizumab up to 75 mg/kg (approximately 10 times the MRHD on a mg/kg basis). No evidence of maternal toxicity, embryotoxicity, or teratogenicity was observed when omalizumab was administered throughout organogenesis. Omalizumab did not elicit adverse effects on fetal or neonatal growth when administered throughout late gestation, delivery and nursing. Neonatal serum levels of omalizumab after in utero exposure and 28 days of nursing were between 11% and 94% of the maternal serum level. Levels of omalizumab in milk were 0.15% of maternal serum concentration.

Nursing Mothers

It is not known whether Xolair is present in human breast milk; however, IgG is present in human milk in small amounts. In Cynomolgus monkeys, milk levels of omalizumab were measured at 0.15% of the maternal serum concentration [see Use In Specific Populations]. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Xolair and any potential adverse effects on the breastfed child from Xolair or from the underlying maternal condition. Exercise caution when administering Xolair to a nursing woman.

Pediatric Use

Allergic Asthma

Safety and effectiveness of Xolair for allergic asthma were evaluated in 2 studies in 926 (Xolair 624; placebo 302) asthma patients 6 to < 12 years of age. One study was a pivotal study of similar design and conduct to that of adult and adolescent Asthma Studies 1 and 2 [see Clinical Trials] The other study was primarily a safety study and included evaluation of efficacy as a secondary outcome. In the pivotal study, Xolair-treated patients had a statistically significant reduction in the rate of exacerbations (exacerbation was defined as worsening of asthma that required treatment with systemic corticosteroids or a doubling of the baseline ICS dose), but other efficacy variables such as nocturnal symptom scores, beta-agonist use, and measures of airflow (FEV1) were not significantly different in Xolair-treated patients compared to placebo. Considering the risk of anaphylaxis and malignancy seen in Xolair-treated patients ≥ 12 years old and the modest efficacy of Xolair in the pivotal pediatric study, the risk-benefit assessment does not support the use of Xolair in patients 6 to < 12 years of age. Although patients treated with Xolair in these two studies did not develop anaphylaxis or malignancy, the studies are not adequate to address these concerns because patients with a history of anaphylaxis or malignancy were excluded, and the duration of exposure and sample size were not large enough to exclude these risks in patients 6 to < 12 years of age. Furthermore, there is no reason to expect that younger pediatric patients would not be at risk of anaphylaxis and malignancy seen in adult and adolescent patients with Xolair [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].

Studies in patients 0-5 years of age were not required because of the safety concerns of anaphylaxis and malignancy associated with the use of Xolair in adults and adolescents.

Chronic Idiopathic Urticaria

The safety and effectiveness of Xolair for adolescent patients with CIU were evaluated in 39 patients 12 to 17 years of age (Xolair 29, placebo 10) included in three randomized, placebo-controlled CIU studies. A numerical decrease in weekly itch score was observed, and adverse reactions were similar to those reported in patients 18 years and older.

Clinical studies with Xolair have not been conducted in CIU patients below the age of 12 years. Considering the risk of anaphylaxis and malignancy seen in Xolair-treated patients ≥ 12 years old, the risk-benefit assessment does not support the use of Xolair in patients < 12 years of age. Therefore, the use of Xolair in this patient population is not recommended.

Geriatric Use

In clinical studies 134 allergic asthma patients and 37 CIU phase 3 study patients 65 years of age or older were treated with Xolair. Although there were no apparent age-related differences observed in these studies, the number of patients aged 65 and over is not sufficient to determine whether they respond differently from younger patients.

Last reviewed on RxList: 4/10/2014
This monograph has been modified to include the generic and brand name in many instances.

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