Monograph

MAFOmalizumab (Xolair) Injection 150 mg

As an add-on therapy to H₁-antihistamines for treating severe chronic spontaneous urticaria (CSU) in patients aged 12 years and older, with a mean weekly Urticaria Activity Score (UAS7) of 28 and above, despite the use of, or who are intolerant to, four-times registered dose of second generation non-sedating H₁-antihistamines.

A maximum of six 300 mg doses of omalizumab should be administered for each treatment course. Re-treatment with omalizumab can be considered upon relapse for patients who achieve an adequate response during the previous treatment course. Adequate response to omalizumab is defined as a UAS7 score of six or below while on treatment.

Additional Clinical Criteria
Severe antihistamine-resistant chronic spontaneous urticaria (First application)
Application for first treatment, patient:
• is aged 12 years old and older; AND
• has severe CSU defined by a mean weekly Urticaria Activity Score (UAS7) of 28 and above; AND
• has failed to achieve an adequate response, or is intolerant, to 4-fold registered dose of a 2nd gen non-sedating H1-antihistamine; AND
• is being treated by a specialist physician (immunologist, allergist, or dermatologist) with experience in managing CSU

The above criteria is for up to 24 weeks’ supply of omalizumab subcutaneous injection.

Severe antihistamine-resistant chronic spontaneous urticaria (Application for retreatment)
Application for retreatment, patient:
• has achieved an adequate response to omalizumab during the immediate previous treatment course as defined by mean UAS7 score of 6 or below while on omalizumab treatment; AND
• has experienced relapse of severe CSU defined by a mean UAS7 score of 28 or more after stopping previous course of omalizumab treatment; AND
• has failed to achieve an adequate response, or is intolerant, to 4-fold registered dose of a 2nd gen non-sedating H1-antihistamine; AND
• is being treated by a specialist physician (immunologist, allergist, or dermatologist) with experience in managing CSU

The renewal criteria is for up to 24 weeks' supply of omalizumab subcutaneous injection.

MAFOmalizumab (Xolair) Prefilled Syringe 150 mg/mL

As an add-on therapy to H₁-antihistamines for treating severe chronic spontaneous urticaria (CSU) in patients aged 12 years and older, with a mean weekly Urticaria Activity Score (UAS7) of 28 and above, despite the use of, or who are intolerant to, four-times registered dose of second generation non-sedating H₁-antihistamines.

A maximum of six 300 mg doses of omalizumab should be administered for each treatment course. Re-treatment with omalizumab can be considered upon relapse for patients who achieve an adequate response during the previous treatment course. Adequate response to omalizumab is defined as a UAS7 score of six or below while on treatment.

Additional Clinical Criteria
Severe antihistamine-resistant chronic spontaneous urticaria (First application)
Application for first treatment, patient:
• is aged 12 years old and older; AND
• has severe CSU defined by a mean weekly Urticaria Activity Score (UAS7) of 28 and above; AND
• has failed to achieve an adequate response, or is intolerant, to 4-fold registered dose of a 2nd gen non-sedating H1-antihistamine; AND
• is being treated by a specialist physician (immunologist, allergist, or dermatologist) with experience in managing CSU

The above criteria is for up to 24 weeks’ supply of omalizumab subcutaneous injection.

Severe antihistamine-resistant chronic spontaneous urticaria (Application for retreatment)
Application for retreatment, patient:
• has achieved an adequate response to omalizumab during the immediate previous treatment course as defined by mean UAS7 score of 6 or below while on omalizumab treatment; AND
• has experienced relapse of severe CSU defined by a mean UAS7 score of 28 or more after stopping previous course of omalizumab treatment; AND
• has failed to achieve an adequate response, or is intolerant, to 4-fold registered dose of a 2nd gen non-sedating H1-antihistamine; AND
• is being treated by a specialist physician (immunologist, allergist, or dermatologist) with experience in managing CSU

The renewal criteria is for up to 24 weeks' supply of omalizumab subcutaneous injection.