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 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.
New Consumer Medicine Information (CMI)
New Product Information (PI)
Product information with an update to safety includes Agrylin, Ajovy, Amgevita, Apo-Clindamycin, Apo-Hydroxychloroquine, Beovu, Bortezomib Juno, Contrave, Coveram, Cresemba, Curam Duo & Curam Duo Forte Tablets, Curam Duo Suspension, Darzalex SC, DBL Diazepam, DBL Irinotecan, DBL Tobramycin, DBL Vinblastine, Diflucan, Emend IV, Enstilar, Epilim, Epilim IV, Estraderm MX, Forxiga, Fragmin, Gentamicin (Pfizer), Glyxambi, Heparinised Saline Injection (Pfizer), Hydrea, Iclusig, Ikervis, Jardiamet, Jardiance, Metronidazole Intravenous Infusion (Pfizer), Phenytoin Juno, Piax, Qtern, Reaptan, Renflexis, Ribomustin, Saxenda, Sertraline Sandoz, Setrona, Shingrix, Signifor LAR, Sodium Valproate Sandoz, Spravato, Talminex, Tecentriq, Telmisartan Sandoz, Telmisartan/HCT Sandoz, Tobramycin (Pfizer), Tobramycin PF (Pfizer), Uptravi, Valpro EC, Valproate Winthrop, Vaxzevria, Victoza, Voltaren Rapid 12.5, Voltaren Rapid 25, Voriconazole Sandoz, Xarelto, Xigduo XR, Zarontin, and Zolfend.
Product information with an update to indications includes Aspen Codeine, Byetta, Cefazolin-AFT, Comirnaty [Tris/Sucrose Presentation], Cosentyx, Keytruda, Ostelin Specialist Range Vitamin D, Rinvoq, and Tecartus.
Past Content Updates
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).
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.
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).
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.
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.
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.
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.
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.
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.
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.
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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