The Australian Technical Advisory Group on Immunisation (ATAGI) has released its clinical advice for influenza vaccination in 2026. Annual vaccination continues to be recommended for all people six months of age and older. A notable change this year is the introduction of a needle-free option.
FluMist® is a live attenuated influenza vaccine (LAIV) that is administered intranasally. It is indicated for use in children and adolescents between 2 and 17 years of age. Each pre-filled nasal applicator delivers two sprays, with one spray administered to each nostril. Children up to 8 years of age who have not previously been vaccinated against seasonal influenza are recommended to receive an additional dose four weeks later.
While this is the first year that an intranasal influenza vaccine has been available in Australia, they have been safely used in other countries since 2003. A recent meta-analysis found intranasal influenza vaccines to be comparable to injectable influenza vaccines for both safety and effectiveness.
On-going surveillance has not identified any cases of intranasal LAIVs causing influenza in vaccine recipients. However, FluMist® is contraindicated in moderate and severe immunodeficiency and children receiving salicylate therapy (due to the association of Reye’s syndrome with salicylates and wild-type influenza infection). The National Centre for Immunisation Research and Surveillance (NCIRS) recommends against administration to children with a runny or blocked nose as absorption may be affected. In these cases, vaccination may be deferred or an age‑appropriate injectable influenza vaccine considered.
FluMist® is available by private prescription and is also state funded for specific age groups in Queensland, New South Wales, South Australia, and Western Australia.
The Pharmaceutical Benefits Scheme (PBS) listing for ravulizumab has been expanded to include generalised myasthenia gravis (gMG). Myasthenia gravis is a chronic autoimmune disorder that affects postsynaptic acetylcholine receptors (AChR). Neuromuscular transmission is disrupted, causing weakness in voluntary muscles. To be eligible for PBS-subsidised therapy, patients must have a positive serology for AChR binding autoantibodies. It is thought that at least 80% of people with gMG have antibodies to AChR.
Ravulizumab is a terminal complement inhibitor. It binds with high affinity to complement protein C5 and prevents its cleavage to C5a and C5b. By inhibiting downstream complement activation, ravulizumab prevents formation of the membrane attack complex (MAC), a key driver of damage at the neuromuscular junction.
Ravulizumab is administered by intravenous infusion, with maintenance dosing every eight weeks. Its safety and efficacy in gMG were demonstrated in the double-blind, randomised CHAMPION MG study. Compared with placebo, ravulizumab produced rapid and clinically meaningful improvements in patient‐ and physician‐reported outcomes. During the open-label extension period (up to four years), these benefits were maintained in patients who continued ravulizumab. Patients who switched from placebo to ravulizumab experienced rapid improvements in activities of daily living, muscle strength, fatigue, and quality of life.
Although early steps of complement activation are preserved, ravulizumab increases the risk of infection, particularly with Neisseria species and other encapsulated bacteria. Life-threatening meningococcal infections have occurred during ravulizumab therapy. Patients should receive meningococcal vaccination at least two weeks before starting ravulizumab.
The Pharmaceutical Benefits Scheme (PBS) listing for incobotulinumtoxinA (Xeomin®) has expanded to include chronic sialorrhea.
Eligible patient groups include:
- Adults with Parkinson’s disease, atypical Parkinson’s, traumatic brain injury, or chronic sialorrhea following an acute event; and
- Children (2-17 years) with cerebral palsy, traumatic brain injury, or a developmental disorder.
Sialorrhea is commonly associated with neurological conditions and can cause social issues, skin irritation, and aspiration risk. Management typically requires a multi-modal approach. While anticholinergic medications may be effective in reducing saliva production, their use is often limited by adverse effects and drug interactions.
IncobotulinumtoxinA offers a targeted treatment option. When injected directly into the salivary glands, it reduces saliva production by inhibiting acetylcholine release from peripheral nerve endings. The onset of effect typically occurs within one week, with peak response at around four weeks. Dosing intervals are determined by individual clinical need but should not be more frequent than every 16 weeks.
IncobotulinumtoxinA has demonstrated efficacy in reducing unstimulated salivary flow rate. It is often better tolerated than systemic anticholinergics, particularly for patients with dementia or Parkinson’s disease who are sensitive to their effects on the central nervous system. Common adverse effects associated with incobotulinumtoxinA therapy include paraesthesia, dry mouth, and dysphagia. Severe and persistent dry mouth has been reported and may contribute to complications such as dysphagia or dental issues.
An intranasal presentation of adrenaline (epinephrine) is now available for the emergency treatment of severe allergic reactions, including anaphylaxis. Neffy® is not currently listed on the Pharmaceutical Benefits Scheme (PBS), although an application has been made which is due for consideration in March.
Neffy® is formulated with dodecyl-beta-D-maltoside (DDM). This excipient functions as an absorption enhancer to promote systemic bioavailability. Studies demonstrate that Neffy® achieves adrenaline blood levels and cardiovascular effects (i.e. increased blood pressure and heart rate) within the range observed with approved adrenaline injection devices.
Real-world evidence from over 500 patients experiencing anaphylactic symptoms show a successful treatment rate of 89.2% with a single Neffy® dose. This is comparable to the rates reported in meta-analyses where around 90% of patients were successfully treated with a single intramuscular dose of adrenaline.
Practical guidance:
- Neffy® should be prescribed as part of an anaphylaxis action plan.
- There are two strengths available. The 1mg device is for patients from four years of age weighing between 15kg and 30kg; the 2mg device is for patients 30kg or more.
- Patients and carers must be instructed on how to use the device correctly. Placebo demonstrator devices can be obtained from Allergy & Anaphylaxis Australia.
- Each device is ready-to-use and contains only one dose. The nasal spray must not be primed before use.
- A second device may be used to deliver an additional dose if clinical improvement is absent or deterioration occurs after five minutes of the first dose.
- Patients should be encouraged to always carry two devices.
- Patients must seek emergency medical care after using the device.
Landiolol is a new ultra-short-acting beta-blocker for use in acute care settings. It is approved for the management of supraventricular tachycardia and for the rapid control of ventricular rate in atrial fibrillation or atrial flutter when short‑term rate control is required. It is also indicated for non‑compensatory sinus tachycardia when specific intervention is needed.
Landiolol is highly selective for β1 adrenoceptors with very low affinity for β2 receptors. This high degree of cardioselectivity minimises the impact on blood pressure and reduces the risk of bronchospasm compared with less selective beta-blockers. Landiolol has a very short half-life (~4 minutes) which supports precise dose titration and enables rapid recovery once the infusion is reduced or discontinued.
Hypotension is the most commonly observed adverse effect. This typically resolves quickly with fluid administration, dose reduction, or discontinuation. Continuous blood pressure and ECG monitoring are recommended for all patients receiving landiolol.
Vials contain 300mg landiolol hydrochloride (equivalent to 280mg landiolol). Dosing is based on the salt rather than the free base.
Ublituximab has recently been added to the Pharmaceutical Benefits Scheme (PBS) for the treatment of relapsing-remitting multiple sclerosis. Ublituximab is a monoclonal antibody that is administered as an intravenous infusion. The first two doses are given two weeks apart, with subsequent doses every 24 weeks.
The ULTIMATE I and II trials compared the efficacy of intravenous ublituximab (plus oral placebo) with oral teriflunomide (plus intravenous placebo). The primary end point was the annualised relapse rate (ARR). In the ULTIMATE I trial, ARR was 0.08 in the ublituximab group compared to 0.19 for the teriflunomide group. Similar results were seen in the ULTIMATE II trial, with an ARR of 0.09 in the ublituximab group and 0.18 in the teriflunomide group. However, no significant difference was observed in the risk of worsening of disability.
The most common adverse reactions are infections and infusion-related reactions (IRRs). Dosing is contraindicated in patients with severe active infection or severe immunocompromise. To minimise IRRs, a corticosteroid and antihistamine is administered prior to each infusion. An antipyretic may also be considered.
Although no cases of progressive multifocal leukoencephalopathy (PML) have been reported with ublituximab to date, its mechanism of action suggests a potential risk. Patients should be advised to immediately report any new or worsening neurological signs or symptoms to their doctor.
Odevixibat has recently been added to the Pharmaceutical Benefits Scheme (PBS) for the treatment of progressive familial intrahepatic cholestasis (PFIC). PFIC is a collection of rare genetic conditions of impaired bile formation and secretion. Signs and symptoms of cholestasis typically begin in infancy and can progress to liver failure.
Odevixibat acts locally in the distal ileum to inhibit the ileal bile acid transporter (IBAT). This reduces the reabsorption of bile acids, thereby increasing their clearance from the body.
The safety and efficacy of odevixibat was evaluated in a double-blind study of children with PFIC who had pruritus and elevated serum bile acids at baseline. Patients were randomly assigned to receive odevixibat (40 mcg/kg or 120 mcg/kg daily) or placebo for 24 weeks. Compared to placebo, odevixibat was associated with statistically significant improvements in pruritus. A serum bile acid response was observed in 33% of patients in the odevixibat group, while no patients met the response threshold in the placebo group. Data from the PEDFIC 2 extension study suggest these benefits are sustained with ongoing treatment.
Odevixibat is typically dosed once daily in the morning. The capsules may be swallowed whole, or the contents sprinkled on food. Odevixibat is minimally absorbed, and the most common adverse events are diarrhoea or frequent bowel movements.
The Therapeutic Goods Administration (TGA) has updated the product warnings for GLP-1 and dual GIP/GLP-1 receptor agonists due to a potential risk of suicidal thoughts. Glucagon-like peptide‑1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) are incretins that play important roles in glucose metabolism and energy homeostasis. Medications acting as agonists at GIP and GLP-1 receptors are used in the treatment of type 2 diabetes and weight management.
These medications include:
- Semaglutide;
- Liraglutide;
- Dulaglutide; and
- Tirzepatide.
A potential signal for self-harm and suicidality prompted investigations by the TGA and international regulatory agencies. As of September 2025, the TGA had received 85 such reports, including two reports of completed suicide. While there is insufficient evidence to support a causal link, the TGA notes the complex interaction between mental illness and the disorders for which these medicines are prescribed.
Use of GLP-1 agonists has increased significantly in recent years, particularly for weight loss. The TGA advises healthcare professionals to evaluate the benefits and risks of starting or continuing these medicines in patients with suicidal ideation or a history of suicide attempts. Patients should be monitored for any new or worsening mental health symptoms and encouraged to promptly report any concerning symptoms to their healthcare professional.
The subcutaneous formulation of ocrelizumab is now available on the Pharmaceutical Benefits Scheme (PBS) for relapsing-remitting multiple sclerosis (MS). While the intravenous infusion has been PBS listed since 2018, the subcutaneous option may improve the convenience and accessibility of therapy.
Ocrelizumab is a monoclonal antibody that targets CD20-expressing B cells. It reduces the number and function of these cells which are thought to play an important role in the initiation and progression of MS.
The pivotal OPERA I and OPERA II studies demonstrated the efficacy of ocrelizumab in relapsing MS. Patients were randomly assigned to receive intravenous ocrelizumab every 24 weeks or subcutaneous interferon beta-1a three times a week. The primary end point of annualised relapse rate was 46% and 47% lower for ocrelizumab in the respective studies. Pooled analyses showed a 40% risk reduction for confirmed disability progression at 12 weeks and 24 weeks, and a 33% relative increase in confirmed disability improvement at 12 weeks. The recently published OCARINA II study found subcutaneous ocrelizumab (920mg) to be non-inferior to intravenous ocrelizumab (600mg) for drug exposure, with comparable safety and efficacy.
The usual dose of subcutaneous ocrelizumab is 920mg/23mL injected in the abdomen over ten minutes. The subcutaneous formulation contains the permeation enhancer, vorhyaluronidase alfa. This enzyme hydrolyses hyaluronic acid in the subcutaneous tissue, temporarily increasing tissue permeability and allowing a larger volume to be injected.
Both the intravenous and subcutaneous formulations are administered every six months, although the first intravenous dose is split between two infusions. Premedication with a corticosteroid and an antihistamine reduces the risk of infusion-related reactions. An antipyretic, such as paracetamol, may also be considered.
The product information documents have been updated for denosumab medicines used in the treatment of osteoporosis. These revisions strengthen existing warnings regarding the risk of multiple vertebral fractures following treatment delay or discontinuation.
Bone metabolism is a dynamic process balancing activity between bone-forming osteoblasts and bone-resorbing osteoclasts. A key regulator of this process is the RANK/RANKL/OPG pathway. Denosumab binds to RANKL, preventing it from activating the RANK receptor. This inhibits osteoclast formation and activation, effectively reducing bone resorption.
However, accelerated bone turnover and rapid loss of bone mineral density can occur following discontinuation of denosumab. While the mechanism is not completely understood, denosumab may cause osteoclasts to fission into daughter cells, called osteomorphs. These cells accumulate during denosumab treatment and can quickly fuse to form functional osteoclasts once the inhibitory effect of denosumab is removed. This may explain the increased risk of multiple vertebral fractures, particularly in patients with a history of vertebral fracture.
Denosumab is administered subcutaneously every six months. Patients should be advised of the importance of adhering to the dosing schedule as dosing delays of just 30 days have been associated with a significant increase in fracture risk. If treatment must be stopped, Healthy Bones Australia recommends patients be started on a bisphosphonate within four weeks of the next scheduled denosumab dose.
