XOLAIR 150 mg Solution for injection Ref.[8001] Active ingredients: Omalizumab

Treatment should be initiated by physicians experienced in the diagnosis and treatment of severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP) or chronic spontaneous urticaria.

Posology

Allergic asthma and chronic rhinosinusitis with nasal polyps (CRSwNP)

Dosing for allergic asthma and CRSwNP follows the same dosing principles. The appropriate dose and frequency of omalizumab for these conditions 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 omalizumab in 1 to 4 injections may be needed for each administration.

Allergic asthma patients with baseline 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.

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

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

Table 1. Conversion from dose to number of pre-filled syringes/pens*, number of injections** and total injection volume for each administration:

^* Xolair 300 mg pre-filled syringe and all dose strengths of Xolair pre-filled pen are not intended for use in patients <12 years of age.
^** This table represents the least number of injections for the patients, however there are other syringe/pen dosing combinations possible to achieve the desired dose.

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

^* Body weights below 30 kg were not studied in the pivotal trials for CRSwNP.

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

Treatment duration, monitoring and dose adjustments

Allergic asthma

Xolair is intended for long-term treatment. Clinical trials have demonstrated that it takes at least 12-16 weeks for the 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 treatment 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).

Chronic rhinosinusitis with nasal polyps (CRSwNP)

In clinical trials for CRSwNP, changes in nasal polyps score (NPS) and nasal congestion score (NCS) were observed at 4 weeks. The need for continued therapy should be periodically reassessed based upon the patient’s disease severity and level of symptom control.

Allergic asthma and chronic rhinosinusitis with nasal polyps (CRSwNP)

Discontinuation of 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 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 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)

The recommended dose is 300 mg by subcutaneous injection every four weeks. Each 300 mg dose is given as one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg.

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

Clinical trial experience of long-term treatment in this indication is described in section 5.1.

Special populations

Elderly (65 years of age and older)

There are limited data available on the use of omalizumab 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, omalizumab should be administered with caution (see section 4.4).

Paediatric population

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

In CRSwNP, the safety and efficacy of omalizumab in patients below the age of 18 years have not been established. No data are available.

In CSU, the safety and efficacy of omalizumab in patients below the age of 12 years have not been established. No data are available.

Method of administration

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

Xolair 300 mg pre-filled syringe and all dose strengths of Xolair pre-filled pen are not intended for use in children <12 years of age. Xolair 75 mg pre-filled syringe and Xolair 150 mg pre-filled syringe may be used in children 6 to 11 years of age with allergic asthma.

If more than one injection is needed to achieve the required dose, injections should be divided across two or more injection sites (Table 1).

Patients with no known history of anaphylaxis may self-inject Xolair or be injected by a caregiver from the 4th 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 for use 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.

18 months.

The product may be kept for a total of 48 hours at 25°C.

Store in a refrigerator (2°C-8°C).

Do not freeze.

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

Xolair 150 mg solution for injection in pre-filled syringe (26-gauge staked needle, purple syringe guard)

Xolair 150 mg solution for injection in pre-filled syringe is supplied as 1 ml solution in a pre-filled syringe barrel (type I glass) with 26-gauge staked needle (stainless steel), (type I) plunger stopper and needle cap.

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

Xolair 150 mg solution for injection in pre-filled syringe (27-gauge staked needle, purple plunger)

Xolair 150 mg solution for injection in pre-filled syringe is supplied as 1 ml solution in a pre-filled syringe barrel (type I glass) with 27-gauge staked needle (stainless steel), (type I) plunger stopper and needle cap.

Pack sizes: packs containing 1 pre-filled syringe, and multipacks containing 3 (3 × 1) or 6 (6 × 1) pre-filled syringes.

Xolair 300 mg solution for injection in pre-filled syringe

Xolair 300 mg solution for injection in pre-filled syringe is supplied as 2 ml solution in a pre-filled syringe barrel (type I glass) with 27-gauge staked needle (stainless steel), (type I) plunger stopper and needle cap.

Pack sizes: packs containing 1 pre-filled syringe, and multipacks containing 3 (3 × 1) or 6 (6 × 1) pre-filled syringes.

Xolair 150 mg solution for injection in pre-filled pen

Xolair 150 mg solution for injection in pre-filled pen is supplied as 1 ml solution in a pre-filled pen barrel (type I glass) with 27-gauge staked needle (stainless steel), (type I) plunger stopper and needle cap.

Pack sizes: packs containing 1 pre-filled pen, and multipacks containing 3 (3 × 1) or 6 (6 × 1) pre-filled pens.

Xolair 300 mg solution for injection in pre-filled pen

Xolair 300 mg solution for injection in pre-filled pen is supplied as 2 ml solution in a pre-filled pen barrel (type I glass) with 27-gauge staked needle (stainless steel), (type I) plunger stopper and needle cap.

Pack sizes: packs containing 1 pre-filled pen, and multipacks containing 3 (3 × 1) or 6 (6 × 1) pre-filled pens.

Not all pack sizes may be marketed.

Pre-filled syringe

The single-use pre-filled syringe is for individual use. It should be taken out of the refrigerator 30 minutes before injecting to allow it to reach room temperature.

Pre-filled pen

The single-use pre-filled pen is for individual use. It should be taken out of the refrigerator 30 minutes before injecting to allow it to reach room temperature.

Disposal instructions

Dispose of the used syringe or pen immediately in a sharps container.

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