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Rifampicin 300mg capsules shortage

Information for clinicians, pharmacies and health services.

Overview

The Department of Health has been notified of a critical shortage of rifampicin 300mg capsules. While an alternative S19a product has now been approved for use by the Therapeutic Goods Administration (TGA), there remain concerns that supplies will be insufficient to meet the current demand in Victoria. As such, there is a need to consider implementing measures to conserve rifampicin 300mg capsules where possible.

A Clinical Advisory Group including representatives from the Department of Health, Safer Care Victoria, and HealthShare Victoria, is coordinating the response to ensure safety and continuity of clinical care, including best practice in antimicrobial stewardship. This group is currently assessing the supply of rifampicin and reviewing clinical indications of rifampicin with a view to provide guidance on conservation.

This is an evolving situation and Safer Care Victoria alongside the Department of Health will continue to monitor and provide critical updates as they are available.

Situation

The TGA has advised of a shortage of rifampicin 300mg capsules due to global manufacturing issues and that this shortage will likely continue until 30 January 2026. While the TGA has approved an S19A alternative product from Sanofi, there remain concerns that this supply will not be able to meet current stock requirements in Victoria.

Actions

Health services are required to take the following actions. Advice will be updated when further information regarding supply becomes available.

Stock allocation and reporting

  • Patients receiving treatment for tuberculosis will be prioritised and health services should continue to place orders for this through the Royal Melbourne Hospital’s Victorian Tuberculosis Program. Rifampicin supplied through these allocations should only be used exclusively for the treatment of tuberculosis.
  • For non-tuberculosis indications where rifampicin is required, health services should place backorders through Symbion. Supply will be allocated by HealthShare Victoria as it becomes available.
  • Health services will be required to periodically report rifampicin stock on hand levels to HealthShare Victoria.

Conservation

Conserve rifampicin use where possible, prioritising indications where there is clinical evidence to support use of rifampicin, proven susceptibility, and no suitable alternative antibiotics. These include:

  • tuberculosis and other mycobacterial infections where rifampicin is a key component of the treatment regimen such as Mycobacterium ulcerans infection (Buruli ulcer), Mycobacterium kansasii, and leprosy
  • multidrug-resistant infections such as methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus epidermidis (MRSE) that are susceptible to rifampicin with no alternative oral antibiotic options
  • serious bone/joint or endovascular infections due to a rifampicin-susceptible organism involving prosthetic devices or implants where there is intent to cure

Review all patients currently prescribed rifampicin at their next scheduled appointment, and assess whether ongoing treatment is essential.

  • Limit supply to a maximum of 4 weeks at a time.
  • Refer to the clinical guidance to support consideration of alternative antimicrobial agents where initiation of rifampicin is required.

Clinical guidance

Clinical guidance is now available to support appropriate prioritisation of rifampicin use and identification of suitable antimicrobial alternatives.

Refer to the tables below for recommended approaches based on clinical indication. This guidance is being actively reviewed and updated as supply conditions evolve.

Table A: Indications where rifampicin use should be preserved or continued when commencing therapy

Indication for useAdditional information
Treatment of active tuberculosisNo alternatives – rifampicin to be used as part of a multi-drug regimen All tuberculosis (TB) medicines—including 4- and 2-drug fixed-dose combination tablets—should continue to be accessed through the Victorian TB Program at the Royal Melbourne Hospital, which may source supply via Section 19A or Special Access Scheme (SAS) as required.
Mycobacterium kansasii infectionNo alternatives – rifampicin to be used as part of a multi-drug regimen All tuberculosis (TB) medicines—including 4- and 2-drug fixed-dose combination tablets—should continue to be accessed through the Victorian TB Program at the Royal Melbourne Hospital, which may source supply via Section 19A or Special Access Scheme (SAS) as required.
Treatment of leprosyNo alternatives – rifampicin to be used as part of a multi-drug regimen All tuberculosis (TB) medicines—including 4- and 2-drug fixed-dose combination tablets—should continue to be accessed through the Victorian TB Program at the Royal Melbourne Hospital, which may source supply via Section 19A or Special Access Scheme (SAS) as required.
Treatment of latent tuberculosis infectionRifampicin should continue to be preserved or continued where already commenced. Consider deferral of commencing TB preventative therapy where there is low risk of progression. Where possible, other regimens should be used for TB preventive therapy. Isoniazid alone OR rifapentine plus isoniazid, as per Therapeutic Guidelines, may be considered when initiating therapy. Both rifapentine/isoniazid 300 mg/300 mg fixed-dose combination tablets and rifapentine 150 mg should be accessed through the Victorian TB Program at the Royal Melbourne Hospital.
Multidrug-resistant infections such as methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus epidermidis (MRSE) that are susceptible to rifampicin with no alternative oral antibiotic optionsConsider if other oral antibiotic options (e.g. linezolid) are available and appropriate for the indication. Susceptibility testing for additional antibiotic options can be requested through the Microbiological Diagnostic Unit Public Health Laboratory.
Mycobacterium ulcerans infection
(Buruli ulcer)
Rifampicin should continue to be preserved for this indication. Consider the use of moxifloxacin plus clarithromycin as an alternative regimen, where appropriate, with Infectious Diseases input and in accordance with Therapeutic Guidelines.
Serious bone/joint or endovascular infections due to a rifampicin-susceptible organism involving prosthetic devices or implants where there is intent to cureAdvised to only be used with Infectious Diseases input. Rifampicin use is in combination with other pathogen specific combinations as per susceptibility testing.

Table B: Indications where alternative agents should be utilised when commencing therapy

Indication for useRecommended alternative(s)
Amanita phalloides
mushroom poisoning

Silibinin or benzylpenicillin as per Therapeutic Guidelines.

Additional information

Silibinin is available via the TGA Special Access Scheme.

Bartonella endocarditisDoxycycline plus gentamicin as per Therapeutic Guidelines.
Brucellosis

Gentamicin plus trimethoprim+sulfamethoxazole (children 1 month to 8 years) or doxycycline (for adults and children 8 years or older) as per Therapeutic Guidelines.

Additional information

Rifampicin to only be considered as a second line option in combination with doxycycline or trimethoprim+sulfamethoxazole if gentamicin is contraindicated.

Cholestatic itch in palliative careSertraline as per Therapeutic Guidelines.
Haemophilus influenzae – clearance antibioticsCeftriaxone as per Therapeutic Guidelines.
Leprosy (Hansen’s disease) post-exposure prophylaxis

Rifapentine for patients 10 years and older as per NSW Health Leprosy control guideline.

Additional information

Rifampicin oral liquid should be used for patients 9 years and younger. Rifapentine is available via the TGA Special Access Scheme.

Meningococcal disease – clearance antibioticsCiprofloxacin or ceftriaxone as per Therapeutic Guidelines.
Pulmonary Mycobacterium avium complex (MAC) infection

Use three-drug regimen of azithromycin or clarithromycin plus ethambutol plus rifabutin as per Therapeutic Guidelines. For those who are already on guideline-based therapy, consider switching from rifampicin to rifabutin.

Additional information

Expert advice is recommended when initiating or modifying therapy in the context of the rifampicin shortage. Rifabutin is not suitable for use in an intermittent (3x weekly) regimen. For complex cases, refer to the national Nontuberculous mycobacteria (NTM) reference group.

Updated