Omalizumab
==========

Injection 150 mg in 1 mL single dose pre-filled pen

SavePublic hospital

PBS item code15529HMaximum quantity2 units

Repeats5

More detailsProgramHB

AdministrationINJECTION

Benefit typeS

Brands

- Omlyclo

Dispensed price for maximum quantity (DPMQ)2 pricesOmlyclo · s90-cp-s100$456.10

Omlyclo · s94-public-s100$411.96

Restrictions &amp; indications
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Streamline authority code16905

Chronic Spontaneous Urticaria (Severe) - Continuing treatment

Show full PBS criteriaHide full PBS criteriaSevere chronic spontaneous urticaria

Continuing treatment

Must be treated by a clinical immunologist; or

Must be treated by an allergist; or

Must be treated by a dermatologist; or

Must be treated by a general physician with expertise in the management of chronic spontaneous urticaria (CSU); AND

Patient must have demonstrated a response to the most recent PBS-subsidised treatment with this drug for this condition; AND

Patient must not receive more than 24 weeks per authorised course of treatment under this restriction.

Notes (4)Cessation of therapy should be considered after the patient has demonstrated clinical benefit with omalizumab to re-evaluate the need for continued therapy. Any patient who ceases therapy and whose CSU relapses will need to re-initiate PBS-subsidised omalizumab as a new patient.

A proportion of patients respond to 150 mg 4-weekly so where a substantial improvement has been obtained with a 300 mg dose it is reasonable to back-titrate dose after initial treatment.

Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).

Pharmaceutical benefits that have the form omalizumab 150 mg/mL syringe and pharmaceutical benefits that have the form omalizumab 150 mg/mL pen device are equivalent for the purposes of substitution.

Prescribing notes (4)Cessation of therapy should be considered after the patient has demonstrated clinical benefit with omalizumab to re-evaluate the need for continued therapy. Any patient who ceases therapy and whose CSU relapses will need to re-initiate PBS-subsidised omalizumab as a new patient.

A proportion of patients respond to 150 mg 4-weekly so where a substantial improvement has been obtained with a 300 mg dose it is reasonable to back-titrate dose after initial treatment.

Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).

Pharmaceutical benefits that have the form omalizumab 150 mg/mL syringe and pharmaceutical benefits that have the form omalizumab 150 mg/mL pen device are equivalent for the purposes of substitution.

Other listings for Omalizumab Injection 150 mg in 1 mL single dose pre-filled pen
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[Public14929RMaximum 1 units · 0 repeats

- Asthma (Uncontrolled severe) - Balance of supply](/p/14929R)[Public14945NMaximum 2 units · 2 repeats

- Chronic Spontaneous Urticaria (Severe) - Initial treatment](/p/14945N)[Public14922JMaximum 1 units · 5 repeats

- Asthma (Uncontrolled severe) - Continuing treatment](/p/14922J)[Public14937EMaximum 2 units · 5 repeats

- Chronic Spontaneous Urticaria (Severe) - Continuing treatment](/p/14937E)[Public15534NMaximum 1 units · 5 repeats

- Asthma (Uncontrolled severe) - Continuing treatment](/p/15534N)[Public14884JMaximum 1 units · 7 repeats

- Asthma (Uncontrolled severe) - Initial treatment - Initial 1 (New patients; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy)
- Asthma (Uncontrolled severe) - Initial treatment - Initial 2 (Change of treatment)](/p/14884J)

Data source: [Australian Government PBS Schedule](https://www.pbs.gov.au/info/browse/download) · Record updated 30 September 2026. Verify current listing and prescribing requirements on the [official PBS website](https://www.pbs.gov.au/).
