XOLAIR 150mg Solution for injection in pre-filled syringe Ref.[8001] Active ingredients: Omalizumab

Xolair treatment should be initiated by physicians experienced in the diagnosis and treatment of severe persistent asthma or chronic spontaneous urticaria.

Allergic asthma

Posology

The appropriate dose and frequency of Xolair is determined by baseline IgE (IU/ml), measured before the start of treatment, and body weight (kg). Prior to administration of the initial dose, patients should have their IgE level determined by any commercial serum total IgE assay for their dose assignment.

Based on these measurements, 75 to 600 mg of Xolair in 1 to 4 injections may be needed for each administration.

Patients with IgE lower than 76 IU/ml were less likely to experience benefit (see section 5.1). Prescribing physicians should ensure that adult and adolescent patients with IgE below 76 IU/ml and children (6 to < 12 years of age) with IgE below 200 IU/ml have unequivocal in vitro reactivity (RAST) to a perennial allergen before starting therapy.

See Table 1 for a conversion chart and Tables 2 and 3 for the dose determination charts in adults, adolescents and children (6 to <12 years of age).

Patients whose baseline IgE levels or body weight in kilograms are outside the limits of the dose table should not be given Xolair.

The maximum recommended dose is 600 mg omalizumab every two weeks.

Table 1. Conversion from dose to number of syringes, number of injections and total injection volume for each administration:

Table 2. ADMINISTRATION EVERY 4 WEEKS. Xolair doses (milligrams per dose) administered by subcutaneous injection every 4 weeks:

Table 3. ADMINSTRATION EVERY 2 WEEKS. Xolair doses (milligrams per dose) administered by subcutaneous injection every 2 weeks:

Treatment duration, monitoring and dose adjustments

Xolair is intended for long-term treatment. Clinical trials have demonstrated that it takes at least 12-16 weeks for Xolair treatment to show effectiveness. At 16 weeks after commencing Xolair therapy patients should be assessed by their physician for treatment effectiveness before further injections are administered. The decision to continue Xolair following the 16-week timepoint, or on subsequent occasions, should be based on whether a marked improvement in overall asthma control is seen (see section 5.1, Physician’s overall assessment of treatment effectiveness).

Discontinuation of Xolair treatment generally results in a return to elevated free IgE levels and associated symptoms. Total IgE levels are elevated during treatment and remain elevated for up to one year after the discontinuation of treatment. Therefore, re-testing of IgE levels during Xolair treatment cannot be used as a guide for dose determination. Dose determination after treatment interruptions lasting less than one year should be based on serum IgE levels obtained at the initial dose determination. Total serum IgE levels may be re-tested for dose determination if treatment with Xolair has been interrupted for one year or more.

Doses should be adjusted for significant changes in body weight (see Tables 2 and 3).

Chronic spontaneous urticaria (CSU)

Posology

The recommended dose is 300 mg by subcutaneous injection every four weeks.

Prescribers are advised to periodically reassess the need for continued therapy.

Clinical trial experience of long-term treatment beyond 6 months in this indication is limited.

Special populations

Elderly (65 years of age and older)

There are limited data available on the use of Xolair in patients older than 65 years but there is no evidence that elderly patients require a different dose from younger adult patients.

Renal or hepatic impairment

There have been no studies on the effect of impaired renal or hepatic function on the pharmacokinetics of omalizumab. Because omalizumab clearance at clinical doses is dominated by the reticular endothelial system (RES) it is unlikely to be altered by renal or hepatic impairment. While no particular dose adjustment is recommended for these patients, Xolair should be administered with caution (see section 4.4).

Paediatric population

In allergic asthma, the safety and efficacy of Xolair in paediatric patients below the age of 6 years have not been established. No data are available.

In CSU, the safety and efficacy of Xolair in paediatric patients below the age of 12 years have not been established.

Method of administration

For subcutaneous administration only. Xolair must not be administered by the intravenous or intramuscular route.

Doses of more than 150 mg (Table 1) should be divided across two or more injection sites.

Patients with no known history of anaphylaxis may self-inject Xolair or be injected by a caregiver from the 4^th dose onwards if a physician determines that this is appropriate (see section 4.4). The patient or the caregiver must have been trained in the correct injection technique and the recognition of the early signs and symptoms of serious allergic reactions.

Patients or caregivers should be instructed to inject the full amount of Xolair according to the instructions provided in the package leaflet.

Maximum tolerated dose of Xolair has not been determined. Single intravenous doses up to 4,000 mg have been administered to patients without evidence of dose-limiting toxicities. The highest cumulative dose administered to patients was 44,000 mg over a 20-week period and this dose did not result in any untoward acute effects.

If an overdose is suspected, the patient should be monitored for any abnormal signs or symptoms. Medical treatment should be sought and instituted appropriately.

15 months.

The shelf life includes potential temperature excursions. The product may be kept for a total of 4 hours at 25°C. If necessary, the product may be returned to the refrigerator for later use, but this must not be done more than once.

Store in a refrigerator (2°C-8°C).

Do not freeze.

Store in the original package in order to protect from light.

1 ml solution in a pre-filled syringe barrel (type I glass) with staked needle (stainless steel), (type I) plunger stopper and needle cap.

Pack containing 1 pre-filled syringe, and multipacks containing 4 (4 × 1); 6 (6 × 1) or 10 (10 × 1) pre- filled syringes.

Not all pack sizes may be marketed.

Xolair 150 mg solution for injection is supplied in a single-use pre-filled syringe for individual use. The syringe should be taken out of the refrigerator 20 minutes before injecting to allow it to reach room temperature.

Disposal instructions

Dispose of the used syringe immediately in a sharps container.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.