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Updates

What's New in AusDI – June 2024

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

 

New Product Summaries

 

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 Isotretinoin (Systemic) monograph has been updated to include information on sacroiliitis based on changes to a product information for isotretinoin. Sacroiliitis has been reported with isotretinoin therapy during post marketing evaluation. Cases of sacroiliitis have improved after appropriate treatment and discontinuation of isotretinoin. If clinical signs of sacroiliitis occur, further evaluation, including imaging modalities such as magnetic resonance imaging (MRI), may be required to differentiate sacroiliitis from other causes of back pain.

New Consumer Medicine Information (CMI)

 

 

 

New Product Information (PI)

Product information with an update to safety includes Apo-Levetiracetam Oral Solution, Azacitidine Sandoz, Beovu, Cardol 160mg, Cephalexin generichealth, Cholfen, Clustran, Comirnaty [Tris/Sucrose Presentation], Comirnaty Omicron XBB.1.5, Comirnaty Original/Omicron BA.4-5, DBL Cisplatin, DBL Diazoxide, Dovato, Durogesic, Efexor-XR, Epidyolex, Femara, Flamazine Cream, Iclusig, Inflectra, Jardiamet, Jorveza, Lanoxin, Lanzopran, Leflunomide Sandoz, Lenvima, Lyzalon, MenQuadfi, Metomax, OncoTICE, Roaccutane, Sigmaxin, Tivicay and Tivicay PD, Trajentamet, Tygacil, Vyvanse, Xeljanz and Xeljanz XR, and Zantac.

Product information with an update to indications includes Bimzelx.

 

Past Content Updates

May 2024

The Fluorouracil (Systemic) monograph has been updated to include precautions regarding thiamine based on changes to several product information for fluorouracil. Treatment with fluorouracil may interfere with thiamine metabolism, and decreases in thiamine concentrations have been reported in patients treated with fluorouracil. Decreases in thiamine concentrations may facilitate the onset of Wernicke's encephalopathy. Monitoring of thiamine concentrations and thiamine supplementation may be required.

April 2024

The Denosumab (Systemic) monograph has been updated to include more information about hypocalcaemia based on a recent FDA Drug Safety Communication. The FDA has found that the use of denosumab for osteoporosis ( Prolia brand) increases the risk of severe hypocalcaemia in patients with advanced chronic kidney disease (CKD), especially patients receiving dialysis. Severe hypocalcaemia appears to be more common in patients with CKD who also have chronic kidney disease mineral and bone disorder (CKD-MBD).

March 2024

The Influenza Virus Vaccine (Systemic) monograph has been updated with information for the Australian 2024 influenza season. The composition of the 2024 vaccine differs from the 2023 southern hemisphere and 2023/2024 northern hemisphere recommendations with the inclusion of two new strains for the A(H1N1)pdm09-like virus and A(H3N2)-like virus.

February 2024

The Pseudoephedrine (Systemic) monograph has been updated to include precautions to reduce the risk of posterior reversible encephalopathy syndrome and reversible cerebral vasoconstriction syndrome based on recommendations from the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC). PRAC has recommended that pseudoephedrine not be used in patients with severe or uncontrolled hypertension, or with severe acute or chronic kidney disease or failure. It is recommended that pseudoephedrine be immediately discontinued and appropriate treatment be sought if symptoms of posterior reversible encephalopathy syndrome or reversible cerebral vasoconstriction syndrome occur, such as confusion, feeling sick, seizures, severe headache with sudden onset, visual disturbances, and vomiting.

January 2024

The Ropinirole (Systemic) monograph has been updated to include information about mania based on recent changes to several product information. Mania has been reported in patients receiving ropinirole, and symptoms may occur with or without the symptoms of impulse control disorders. If symptoms of mania develop, it is recommended that dose reduction or tapered discontinuation of treatment be considered.

December 2023

The Linezolid (Systemic) monograph has been updated to include information about rhabdomyolysis based on a recent change to a product information. Rhabdomyolysis has been reported during postmarketing evaluation with the use of linezolid. If signs or symptoms of rhabdomyolysis occur, it is recommended that linezolid be discontinued and appropriate therapy initiated.

November 2023

The Pramipexole (Systemic) monograph has been updated to include information about augmentation in restless legs syndrome based on a recent change to a product information. Treatment of restless legs syndrome with dopaminergic medications, including pramipexole, has resulted in augmentation. Augmentation refers to the earlier onset of symptoms (in the afternoon or evening), increase in symptoms, and spread of symptoms to other extremities. Patients should be informed of possible augmentation with pramipexole treatment and be regularly monitored for its occurrence. If augmentation occurs, it is recommended that pramipexole treatment be reviewed and dosage adjustment or discontinuation be considered.

October 2023

The Azithromycin (Systemic) monograph has been updated with more information about pregnancy based on recent changes to several product information. Most observational studies do not suggest an association between azithromycin and adverse fetal effects, such as major congenital malformations or cardiovascular malformations. However, there is limited epidemiological evidence of an increased risk of miscarriage associated with azithromycin exposure during early pregnancy. Risk-benefit should be considered before use of azithromycin during pregnancy.

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.

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