The new listings wrap-up is designed to provide you with information about medicines that have been listed on the PBS for which full NPS RADAR reviews or brief items are not available.

August 2019 sees the listing of:1

  • benzathine benzylpenicillin for infections susceptible to benzylpenicillin (new strength)
  • flucloxacillin for staphylococcal infections (new brand)
  • testosterone for androgen deficiency (new strength)

See the PBS Schedule for complete details for each PBS listing described in this article.

 

Benzathine benzylpenicillin

A new strength of benzathine benzylpenicillin (Bicillin L-A) is now listed on the PBS General Schedule (Section 85).1

Benzathine benzylpenicillin 0.6 million units (517 mg)/1.17 mL injection has been listed as an unrestricted benefit.1

What is it?

Benzathine benzylpenicillin is an antibiotic that is active against penicillin-sensitive microorganisms.2

It works during bacterial multiplication, by inhibiting bacterial cell wall peptidoglycan synthesis and causing osmotic imbalance in the bacterial cell wall.2

Benzathine benzylpenicillin is intended for intramuscular use.2

Who is it for?

Benzathine benzylpenicillin (Bicillin L-A) intramuscular injection is indicated for the treatment of infections due to penicillin-sensitive microorganisms.2

The microorganisms should be susceptible to low and very prolonged serum concentrations of benzathine benzylpenicillin (common to this dosage form).2

According to the Australian-approved product information, streptococcal infections and venereal infections (such as syphilis) will usually respond to an adequate dose of intramuscular benzathine benzylpenicillin.2

Benzathine benzylpenicillin can also be used for prophylaxis of rheumatic fever, as well as rheumatic heart disease and acute glomerulonephritis.2

The Pharmaceutical Benefits Advisory Committee noted that this new strength contains half the active ingredient of existing PBS-listed benzathine benzylpenicillin (0.6 versus 1.2 million units).3

It allows accurate administration of paediatric doses because it is within the TGA-approved dose range for young children (0.3–0.6 million units).3

Safety issues

Benzathine benzylpenicillin (Bicillin L-A) is contraindicated in patients with hypersensitivity to other penicillins.2

It must be injected intramuscularly. Intravenous administration has been associated with cardiorespiratory arrest and death.2

The bactericidal effect of benzathine benzylpenicillin may be antagonised when administered with tetracyclines, so concurrent use should be avoided.2

Antibiotic-associated pseudomembranous colitis (inflammation of the colon associated with overgrowth of Clostridium difficile) is an infrequently reported side effect of penicillins,4 but it can potentially develop into a life-threatening condition.2,4

Patients with renal impairment may be at an increased risk of toxicity due to accumulation of benzathine benzylpenicillin.2,4

Practical advice on managing a wide range of infections can be found in the updated Antibiotic Therapeutic Guidelines (version 16).

 

Flucloxacillin

A new brand of flucloxacillin (Medsurge) in 250 mg and 500 mg capsules is now listed on the PBS General Schedule for the treatment of serious staphylococcal infections or osteomyelitis.1

What is it?

Flucloxacillin is a narrow-spectrum penicillin antibiotic that is active against common strains of gram-positive bacteria.5

Flucloxacillin binds to penicillin-binding proteins within bacteria, which interferes with bacterial cell wall peptidoglycan synthesis and results in cell lysis and death.6

Who is it for?

Flucloxacillin (Medsurge) 250 mg and 500 mg capsules are PBS listed as a Restricted Benefit for the treatment of patients with serious staphylococcal infections.1

The 500 mg capsule also has an Authority Required (Streamlined) listing for the treatment of patients with osteomyelitis.1

Staphylococcal skin infections listed in the Australian Medicines Handbook include folliculitis, boils, carbuncles, bullous impetigo, mastitis, crush injuries, stab wounds and infected scabies.6

Safety issues

Flucloxacillin is contraindicated in patients with hypersensitivity to beta-lactam antibiotics, or history of jaundice or hepatic dysfunction resulting from use of flucloxacillin.5

The PBS listing cautions that severe cholestatic hepatitis has been reported with flucloxacillin.1

Significant risk factors include age (particularly over 55 years) and duration of treatment with flucloxacillin extending beyond 14 days.1

There is also potential for drug interactions with oral contraceptives, paracetamol and probenecid.5

Antibiotic-associated pseudomembranous colitis may occur infrequently with penicillin use. It can be mild or severe.5

Practical advice on managing a wide range of infections can be found in the updated Antibiotic Therapeutic Guidelines (version 16).

 

Testosterone

A new strength of testosterone gel (2%, Testavan) is now listed on the PBS General Schedule for the treatment of androgen deficiency or related conditions.1,7

What is it?

Testosterone is an androgen hormone that binds to androgen receptors. It is responsible for the development and maintenance of male sex organs and secondary sex characteristics.8,9

Who is it for?

Testosterone (Testavan) 2% (23 mg/actuation) gel is an Authority Required listing for the treatment of patients with established androgen deficiency, micropenis, pubertal induction or constitutional delay of growth and puberty.1,7

Depending on the condition, patients must be treated by (or in consultation with) a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist, or a Fellow of the Australasian Chapter of Sexual Health Medicine.7

To receive subsidised treatment for androgen deficiency, testosterone levels must be less than 6 nmol/L, or between 6 and 15 nmol/L with high levels of luteinising hormone.1

Patients with androgen deficiency must have an established pituitary or testicular disorder to receive subsidised treatment.1

Alternatively, if they do not have an established disorder, they must be over 40 years of age and the condition must not be due to age, obesity, cardiovascular diseases, infertility or drugs.1,7

For the treatment of micropenis, pubertal induction or constitutional delay of growth or puberty, patients must be under 18 years of age to receive subsidised treatment.1,7

Testavan 2% gel is indicated for use as testosterone replacement therapy for adult male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests.8

It is not indicated for use in children and has not been evaluated clinically in males under 18 years of age.8 However, the proposed PBS listings for patients under 18 were considered to be similar to existing testosterone replacement therapies.7

Testavan 2% gel may be preferred for paediatric patients due to ease of use, and a 2% testosterone gel may useful for patients preferring a shorter absorption time.7

Safety issues

Testosterone (Testavan) 2% gel is contraindicated in all women and male patients with known or suspected carcinoma of the breast or prostate.8

Testosterone should not be used by men planning to have children, patients with hypercalcaemia associated with cancer or conditions where haematocrit may be raised (such as respiratory disease, obstructive sleep apnoea or in smokers).8,9

There is potential for drug interactions with concurrent use of testosterone and anticoagulants, corticosteroids and insulin.8

Application site reactions with Testavan 2% are common. They can be mild or moderate in severity and include skin irritation, dryness, rash, erythema and pruritus.8

Patients should be advised on the proper use of Testavan 2% gel, including the risk of skin transfer to others.

Information about preventing testosterone transfer can be found in the Testavan product information.8

 

Other key items

Other items listed in August 2019 include:1

  • calcium for hyperphosphataemia (General Schedule, Item 11726E)10
  • methylprednisolone injection for indications where corticosteroids are appropriate, including (but not limited to) acute severe asthma and autoimmune or inflammatory diseases (General Schedule, Item 11739W)11
  • tocilizumab for severe active rheumatoid arthritis (General Schedule, Items 11720W, 11721X, 11722Y, 11725D, 11730J, 11734N, 11741Y, 11742B, 11743C, 11744D, 11748H, 11750K).12

See the PBS Summary of Changes for a complete list of all additions, deletions and alterations.

 

References

  1. Pharmaceutical Benefits Scheme. PBS Schedule: Summary of Changes (August 2019). Canberra: Australian Government Department of Health, 2019 (accessed 1 August 2019).
  2. Pfizer Australia Pty Ltd. Benzathine benzylpenicillin (Bicllin L-A) product information. West Ryde: Pfizer Australia Pty Ltd, 2019 (accessed 25 July 2019).
  3. Pharmaceutical Benefits Scheme. Public Summary Document: Benzathine benzylpenicillin (March 2019). Canberra: Australian Government Department of Health, 2019 (accessed 24 July 2019).
  4. Australian Medicines Handbook. Benzathine benzylpenicillin. Adelaide: AMH Pty Ltd, 2019 (accessed 25 July 2019).
  5. Alphapharm Pty Limited. Flucloxacillin (Staphylex) product information. Millers Point: Alphapharm Pty Limited, 2019 (accessed 25 July 2019).
  6. Australian Medicines Handbook. Flucloxacillin. Adelaide: AMH Pty Ltd, 2019 (accessed 25 July 2019).
  7. Pharmaceutical Benefits Scheme. Public Summary Document: Testosterone (November 2018). Canberra: Australian Government Department of Health, 2018 (accessed 25 July 2019).
  8. Ferring Pharmaceuticals Pty Ltd. Testosterone (Testavan) product information. Pymble: Ferring Pharmaceuticals Pty Ltd, 2019 (accessed 25 July 2019).
  9. Australian Medicines Handbook. Testosterone. Adelaide: AMH Pty Ltd, 2019 (accessed 25 July 2019).
  10. Pharmaceutical Benefits Scheme. PBS Schedule: Calcium carbonate (Cal-500). Canberra: Australian Government Department of Health, 2019 (accessed 25 July 2019).
  11. Australian Medicines Handbook. Methylprednisolone. Adelaide: AMH Pty Ltd, 2019 (accessed 25 July 2019).
  12. Pharmaceutical Benefits Scheme. PBS Schedule: Tocilizumab (Actemra). Canberra: Australian Government Department of Health, 2019 (accessed 25 July 2019).