Current Medications & Treatments
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The information is from the medicare site and can be accessed by clicking on this link. The medicare site may be updated so please check the original link for the latest information - this page is current as at 23rd August 2008.
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
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Restriction details
LINK TO FULL TRANSCRIPT AND RESTRICTION DETAILS
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.
Sitaxentan sodium is available under the PBS as an authority required item for the treatment of:
- WHO functional Class III PPH
or - WHO functional Class III PAH secondary to connective tissue disease.
Important: 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.
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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.
| Starting dose—first four weeks | Maintenance dose—week five onwards | |
|---|---|---|
| Adult > 40 kg | 62.5 mg twice daily | 125 mg twice daily |
| Patients 18 years and under and > 40 kg | ||
| Adult < 40kg (over 12 years) | 62.5 mg twice daily | 62.5 mg twice daily |
| Patients 18 years and under with a body weight > 20 to 40 kg | 31.25 mg twice daily | 62.5 mg twice daily |
| Patients 18 years and under with a body weight 10 to 20 kg | 31.25 mg once daily | 31.25 mg twice daily |
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 (Flolan®) is available in the following pack sizes:
The quantity approved will be based on the dosage recommendations in the TGA approved product information.
Epoprostenol sodium
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.
Sitaxentan sodium
Sitaxentan sodium (Thelin®) is available in 100 mg tablets. No applications for increased maximum quantities will be authorised.
Caution: Sitaxentan sodium is a category X drug and must not be given to pregnant women. Pregnancy must be avoided during treatment.
The quantity approved will be based on the dosage recommendations in the TGA approved product information.