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 Authority to prescribe bosentan monohydrate, epoprostenol sodium, iloprost trometamol, sildenafil citrate and sitaxentan sodium through the Pharmaceutical Benefits Scheme (PBS) under Section 100 of the National Health Act 1953.

Interchangeability between bosentan monohydrate, epoprostenol sodium, iloprost trometamol, sildenafil citrate and sitaxentan sodium (known as the PAH agents) to treat primary pulmonary hypertension or pulmonary arterial hypertension as defined in the Schedule of Pharmaceutical Benefits  LINK TO SCHEDULE

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Restriction details

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Ambrisentan is available under the PBS as an Authority required item for treatment of the following conditions:

• World Health Organization (WHO) functional Class III or IV PPH
• WHO functional Class III or IV PAH secondary to connective tissue disease

Bosentan monohydrate is available under the PBS as an authority required item for the treatment of the following conditions:

• World Health Organisation (WHO) functional Class III or IV Primary Pulmonary Hypertension (PPH)
  or
• WHO functional Class lll or lV Pulmonary Arterial Hypertension (PAH) secondary to scleroderma.
  or
• WHO functional Class III or IV PAH associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology).

Epoprostenol sodium is available under the PBS as an authority required item for the treatment of:

• WHO functional class III or IV PPH.

Iloprost trometamol is available under the PBS as an authority required item for the treatment of:

• WHO functional Class III or IV PPH
• WHO functional Class lll or lV PAH secondary to connective tissue disease
  or
• WHO functional Class III or IV drug induced PAH.

Sildenafil citrate is available under the PBS as an authority required item for the treatment of:

• WHO functional Class III PPH
  or
• WHO functional Class lll PAH secondary to connective tissue disease.

Important: Ambrisentan, bosentan monohydrate, epoprostenol sodium, iloprost trometamol, sildenafil citrate and sitaxentan sodium are not PBS subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with scleroderma, where the total lung capacity is less than 70 per cent of that predicted.

For more information please call 1800 700 270* and select option 1.

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Ambrisentan

Ambrisentan should be taken orally at a dose of 5mg once daily.  Additional benefit may be obtained by increasing the dose to 10mg. It is available in a pack size of 30m tablets.  

Caution: ambrisentan is a category X medicine and must not be given to pregnant women.  Pregnancy must be avoided during treatment and for at least 3 months following cessation of treatment with this medicine. 

Children

There is no data available on the use of ambrisentan in patients under 18 years of age, and therefore its use in this age group is not recommended.

Bosentan monohydrate

Bosentan monohydrate (Tracleer®) is available in 62.5 mg and 125 mg tablets. No applications for increased maximum quantities will be authorised.

Caution: Bosentan monohydrate is a category X drug and must not be given to pregnant women. Pregnancy must be avoided during treatment and for at least three months following cessation of treatment with this drug.

The quantity approved will be based on the dosage recommendations in the Therapeutic Goods Administration (TGA) approved product information.

Dose adjustment for patients with low body weight

In patients with a body weight below 40 kg but who are over 12 years of age the recommended initial and maintenance dose is 62.5 mg twice daily.

Dose adjustment in children

There is limited experience with the use of bosentan in children. On the basis of the available information, the recommended doses in children aged three years and over are listed in the table above.

Epoprostenol sodium

Epoprostenol sodium (Flolan®) is available in the following pack sizes:

• one vial containing equivalent to epoprostenol sodium 500 microgram, supplied with one 50 mL vial of buffer solution

 

• one vial containing equivalent to epoprostenol sodium 1.5 mg, supplied with two 50 mL vials of buffer solution.

 

The quantity approved will be based on the dosage recommendations in the TGA approved product information.

 Iloprost trometamol

Iloprost trometamol (Ventavis®) is available as a nebuliser solution, 27.2 microgram (equiv. iloprost 20 microgram)/2 mL.

The quantity approved will be based on the dosage recommendations in the TGA approved product information.

Each inhalation session should start with 2.5 micrograms iloprost (as delivered at the mouthpiece of the inhalation device). The dose can be increased to 5.0 micrograms iloprost according to the individual need and tolerability.

The dose per inhalation session should be administered six to nine times per day according to the individual need and tolerability.

Depending on the desired dose at the mouthpiece and on the nebuliser, the duration of an inhalation session is approximately five to 10 minutes.

Sildenafil citrate

Sildenafil citrate (Revatio®) is available in 20 mg tablets. No applications for increased maximum quantities will be authorised.

The quantity approved will be based on the dosage recommendations in the TGA approved product information.