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Updates

What's New in AusDI – October, 2023

Browse the latest AusDI drug updates and medicines information – created and curated by trusted Australian editorial pharmacists, monthly.

New Product Summaries

Content Updates to Monographs

As part of our rigorous editorial updating process, the AusDI editorial team monitors safety information issued by the Australian Therapeutic Goods Administration (TGA), the U.S. Food & Drug Administration (FDA), the European Medicines Agency (EMA), the New Zealand Medicines and Medical Devices Safety Authority (Medsafe), and the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA). FDA-approved indications and dosing information in adults and children are also reviewed by our editorial team and included in selected monographs.

The Morphine (Systemic) monograph has been updated with more information regarding biliary tract disorders based on recent changes to several product information. Morphine may cause an increase in intrabiliary pressure and spasm, and sphincter of Oddi dysfunction has been reported with morphine. It is recommended that patients with biliary tract disorders be monitored for worsening symptoms during treatment with morphine.

New Consumer Medicine Information (CMI)

 

 

 

New Product Information (PI)

Product information with an update to safety includes Albalon, Albalon-A, Apo-Fentanyl, Apomine Solution for Infusion, Apo-Nebivolol, Apo-Olanzapine, Apo-Simvastatin, Apo-Topiramate, Azithromycin Sandoz, Biktarvy, Cipramil, Clonac, Cyclogyl, Cytarabine (Pfizer), DBL Fluorouracil, Edurant, E-Mycin, Epidyolex, Estraderm MX, Gentamicin (Pfizer), Hypnovel, Lanvis, Lexapro, Mesasal, Monofer, Mozobil, Nubeqa, Olanzapine Sandoz, Omeprazole Sandoz Capsules, Omeprazole Sandoz Tablets, Ondansetron SZ, Otezla, Ovestin Cream, Ovestin Ovula, Ovestin Tablets, Penthrox, Pharmorubicin, Plaquenil, Pneumovax 23, Spikevax Bivalent Original/Omicron COVID-19 Vaccine, Sublimaze, Tecartus, Tramedo, Veltassa, Zaldiar, Zimstat, and Zydol SR.

Product information with an update to indications includes Dupixent, Flucelvax Quad, Otezla, and Spikevax Bivalent Original/Omicron BA.4-5 COVID-19 Vaccine.

 

Past Content Updates

September 2023

The Morphine (Systemic) monograph has been updated with more information regarding biliary tract disorders based on recent changes to several product information. Morphine may cause an increase in intrabiliary pressure and spasm, and sphincter of Oddi dysfunction has been reported with morphine. It is recommended that patients with biliary tract disorders be monitored for worsening symptoms during treatment with morphine.

August 2023

The monographs for Apixaban (Systemic)Dabigatran (Systemic)Rivaroxaban (Systemic), and Warfarin (Systemic) have been updated based on a recent TGA safety alert and updates to Product Information about the risk of kidney damage with oral anticoagulants. Anticoagulant-related nephropathy (ARN) has been reported following anticoagulant use and presents as acute kidney injury. It can lead to permanent kidney damage and death. Close monitoring, including renal function evaluation, is recommended in patients with excessive anticoagulation, previous kidney problems, or haematuria.

July 2023

The Topiramate (Systemic) monograph has been updated with new information regarding pregnancy based on recent changes to a product information. Prenatal exposure to topiramate has been associated with an increased risk of neurodevelopmental disorders (such as autism spectrum disorders and intellectual disability). Use of topiramate for the prophylaxis of migraine is not recommended during pregnancy or in women of child-bearing potential who are not using a highly effective method of contraception. When topiramate is used in the treatment of epilepsy, alternative therapies should be considered in women of child-bearing potential and in women planning a pregnancy.

June 2023

The Adrenaline (Epinephrine) (Systemic) monograph has been updated based on recent updates to several product information for adrenaline (epinephrine) auto-injectors used for the treatment of anaphylaxis. There is a risk of adrenaline (epinephrine) not reaching the muscle tissue when it is administered into the thigh via auto-injector in patients with a thick subcutaneous fat layer (i.e., more than 20 mm skin to muscle distance under maximum compression), which may result in a suboptimal response. An additional dose of adrenaline (epinephrine) may be required in these patients.

May 2023

The Terlipressin (Systemic) monograph has been updated based on recent recommendations from the EMA and MHRA for the use of terlipressin in patients with hepatorenal syndrome type 1. This follows from the results of a clinical trial which found that in patients with hepatorenal syndrome type 1, the frequency of serious or fatal respiratory failure with terlipressin is higher than previously known, and the risk of sepsis and septic shock is increased with terlipressin. Recommendations include assessing the individual benefits and risks for patients with hepatorenal syndrome type 1 before initiating terlipressin, especially in those with severe hepatic or renal function impairment, and close monitoring of all patients during terlipressin treatment.

April 2023

The Pregabalin (Systemic) monograph has been updated to include the change in the Australian pregnancy category from B3 to D based on recent updates to several Australian product information. An observational study of more than 2700 pregnancies exposed to pregabalin during the first trimester has shown an increased risk of major congenital malformations. Adverse effects reported during post-marketing evaluation have also been added to the monograph, including bullous dermatosis, exfoliative dermatitis, parkinsonism, and Stevens-Johnson syndrome.

March 2023

The Influenza Virus Vaccine (Systemic) monograph has been updated with information for the Australian 2023 influenza season. The composition of the 2023 vaccine differs from last year's southern hemisphere vaccine and the 2022/2023 northern hemisphere recommendations with the inclusion of one new strain for the A(H1N1)pdm09-like virus.

February 2023

The Aminoglycosides (Systemic) monograph has been updated to include information about mitochondrial DNA mutations based on product information for aminoglycosides including amikacin, gentamicin, and tobramycin. Patients who have mitochondrial DNA mutations, especially the m.1555A>G mutation in the 12S rRNA gene, may have an increased risk of ototoxicity with aminoglycoside treatment, even when aminoglycoside serum concentrations are within the recommended range. It is recommended that alternative treatments be considered in patients with a family history of aminoglycoside-induced deafness or known mitochondrial mutations in the 12S rRNA gene.

January 2023

The Thiazide Diuretics (Systemic) monograph has been updated to include acute respiratory toxicity based on product information for hydrochlorothiazide. Severe cases of acute respiratory toxicity, including acute respiratory distress syndrome, have been reported very rarely with hydrochlorothiazide treatment. Pulmonary oedema usually develops within minutes to hours following hydrochlorothiazide administration. If acute respiratory distress syndrome is suspected, it is recommended that hydrochlorothiazide be discontinued and appropriate treatment be initiated. In addition, patients should not be administered hydrochlorothiazide if they have previously experienced acute respiratory distress syndrome with hydrochlorothiazide treatment.

December 2022

The Liraglutide (Systemic) monograph has been updated to include cutaneous amyloidosis as an adverse effect based on recent updates to product information for liraglutide. It is recommended that injection sites be continuously rotated to reduce the risk of developing cutaneous amyloidosis. There is also the risk that injecting liraglutide into sites with cutaneous amyloidosis may change the absorption or effect of liraglutide.

November 2022

The Azacitidine (Systemic) monograph has been updated to include differentiation syndrome (also known as retinoic acid syndrome) based on a product information for azacitidine. Cases of differentiation syndrome have been reported in patients receiving parenteral azacitidine. Clinical findings and symptoms include fever, hypotension, pericardial effusions, peripheral oedema, pleural effusions, pulmonary infiltrates, pulmonary oedema, rapid weight gain, renal dysfunction, respiratory distress, and skin rash. Differentiation syndrome may be fatal. It is recommended that treatment with high-dose intravenous corticosteroids and haemodynamic monitoring be considered at the first signs or symptoms suggestive of differentiation syndrome. It is also recommended that temporary discontinuation of parenteral azacitidine be considered until symptoms resolve.

October 2022

Information for adrenaline (epinephrine) has been reviewed and included in a new monograph, the Adrenaline (Epinephrine) (Systemic) monograph. It includes information from the latest Product Information for adrenaline (epinephrine) and some guidelines for use in anaphylaxis from the Australasian Society of Clinical Immunology and Allergy (ASCIA).

September 2022

The Ondansetron (Systemic) monograph has been updated to include myocardial ischaemia as a side effect of unknown frequency following recent updates to some Australian and international product information for ondansetron. There have been reported cases of myocardial ischaemia occurring in patients treated with ondansetron. In some cases, symptoms appeared immediately after administration of ondansetron, especially intravenous ondansetron. It is recommended that patients be alerted to the signs and symptoms of myocardial ischaemia.

August 2022

The Metformin (Systemic) monograph has been updated with more information about decreased vitamin B 12 concentrations based on a recent UK MHRA Drug Safety Update. Metformin can commonly decrease vitamin B 12 concentrations in patients, which may cause vitamin B 12 deficiency. The risk of low vitamin B 12 concentrations increases with a higher metformin dose, longer duration of treatment, and in patients with pre-existing risk factors. It is recommended that vitamin B 12 serum concentrations be checked in patients who have symptoms suggestive of vitamin B 12 deficiency (e.g., megaloblastic anaemia or new-onset neuropathy).

July 2022

The Lamotrigine (Systemic) monograph has been updated with more information about aseptic meningitis and photosensitivity based on recent updates to several Product Information for lamotrigine. There have been postmarketing reports of aseptic meningitis in adult and paediatric patients receiving lamotrigine. Aseptic meningitis was reversible on withdrawal of lamotrigine in most cases, but recurred upon re-exposure to lamotrigine in some cases. There have also been postmarketing reports of photosensitivity reactions with lamotrigine. Discontinuation of lamotrigine should be considered if associated photosensitivity occurs. If continued treatment with lamotrigine is required, the patient should be advised to avoid exposure to sunlight and artificial ultraviolet light, and to take other precautionary measures.

June 2022

The Pregabalin (Systemic) monograph has been updated based on a UK MHRA Drug Safety Update about the risks during pregnancy. An observational study of more than 2700 pregnancies exposed to pregabalin has shown a slightly increased risk of major congenital malformations associated with pregabalin use during the first trimester. It is recommended that women of child-bearing potential continue to use effective contraception during treatment with pregabalin. Pregabalin should not be used during pregnancy unless clearly necessary and if the anticipated benefits outweigh the potential risks. If pregabalin is used during pregnancy, it is recommended that the lowest effective dose be used.

May 2022

The Hydroxychloroquine (Systemic) monograph, Azithromycin (Systemic) monograph, and monographs for other systemic macrolide antibiotics have been updated based on a UK MHRA Drug Safety Update. An observational retrospective study in patients with rheumatoid arthritis has shown that the concurrent use of hydroxychloroquine with azithromycin is associated with an increased risk of cardiovascular events (including angina and heart failure) and cardiovascular mortality. Similar risks may be associated with the concurrent use of hydroxychloroquine and other systemic macrolide antibiotics. It is recommended that risk-benefit be carefully considered before initiating systemic macrolide antibiotics in patients being treated with hydroxychloroquine.

April 2022

The Donepezil (Systemic) monograph has been updated with precautions about the risk of cardiac problems based on a recent TGA safety alert and updates to Product Information. QT interval prolongation and torsades de pointes have been reported with donepezil. Caution is recommended in patients with pre-existing or family history of QT interval prolongation, certain cardiac disease (e.g., bradyarrhythmia, heart failure, or recent myocardial infarction), electrolyte disturbances (hypokalaemia or hypomagnesaemia), or taking other medications that prolong the QT interval. Clinical monitoring may be necessary.

March 2022

The Influenza Virus Vaccine (Systemic) monograph has been updated with information for the Australian 2022 influenza season. The composition of the 2022 vaccine differs from last year's southern hemisphere vaccine and the 2021/2022 northern hemisphere recommendations with the inclusion of two new strains for the A (H3N2)-like and B Victoria lineage viruses.

February 2022

The Mycophenolate (Systemic) monograph has been updated with a precaution for coronavirus disease 2019 (COVID-19) based on the Cellcept Product Information. Mycophenolate may increase the severity of COVID-19 because of its cytostatic effect on B- and T-lymphocytes. It is recommended that a dose reduction or discontinuation of mycophenolate be considered in patients with clinically significant COVID-19.

January 2022

The Clindamycin (Systemic) monograph has been updated with information about potential nephrotoxicity based on updates to some Product Information for clindamycin. There have been reports of acute kidney injury, including acute renal failure, associated with clindamycin use. Renal function monitoring should be considered during therapy in patients with pre-existing renal function impairment or taking concurrent nephrotoxic medications. Renal function monitoring should be performed during prolonged therapy.

December 2021

The Octreotide (Systemic) monograph has been updated with information about atrioventricular (AV) block based on a recent TGA Medicines Safety Update. AV blocks, including complete AV block, have been reported in Europe in patients receiving high doses of octreotide continuous intravenous infusion (100 micrograms per hour) and in patients receiving bolus octreotide intravenously (50 micrograms bolus followed by 50 micrograms per hour continuous infusion). In Australia, the TGA-approved indications for octreotide do not involve intravenous administration. However, some off-label uses do involve intravenous administration.

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