Product Information safety updates - September 2025

Apx-Clopidogrel/Aspirin 75/100 / Clopidogrel Winthrop Plus Aspirin / Duocover / Duoplidogrel

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Addition of COX-2 inhibitors to cautionary statements regarding concomitant medication use

4.8 - Adverse effects (undesirable effects)

• Added intestinal diaphragm-like strictures

C-Flox

Alphapharm Pty Ltd

4.5 - Interactions with other medicines and other forms of interactions

• Added interaction under subheading 'Levothyroxine'. Oral ciprofloxacin may decrease the absorption of levothyroxine. An interval of 6 hours between the administration of the two medications is recommended.

Ciprofloxacin Sandoz

Sandoz Pty Ltd

4.5 - Interactions with other medicines and other forms of interactions

• Added interaction under subheading 'Levothyroxine'. Oral ciprofloxacin may decrease the absorption of levothyroxine. An interval of 6 hours between the administration of the two medications is recommended.

Ciprofloxacin-WGR

GM Pharma International Pty Ltd

4.5 - Interactions with other medicines and other forms of interactions 

• Added interaction under subheading 'Levothyroxine'. Oral ciprofloxacin may decrease the absorption of levothyroxine. An interval of 6 hours between the administration of the two medications is recommended.

Colgout / Lengout

Aspen Pharmacare Australia Pty Ltd

4.3 - Contraindications Rare hereditary problems

Added:

• Galactose intolerance
• Total lactase deficiency
• Glucose-galactose malabsorption

4.4 - Special warnings and precautions for use

• Added colchicine has a narrow therapeutic index

4.8 - Adverse effects (undesirable effects)

Added:

• Amenorrhoea  
• Dysmenorrhoea

Imfinzi

AstraZeneca Pty Ltd

4.2 - Dose and Method of Administration

• Added to table 2, polymyalgia rheumatica as a footnote for the adverse drug reaction 'Other immune-mediated ADR'.

4.4 - Special warnings and precautions for use

• Added polymyalgia rheumatica to the existing warning under subheading ‘Other immune mediated ADR'
• Added new warning under subheading ‘Patients with pre-existing autoimmune disease (AID)’. In patients with pre-existing AID, data from observational studies suggest that the risk of immune-mediated ADR following immune checkpoint inhibitor therapy may be increased as compared with the risk in patients without pre-existing AID. In addition, flares of the underlying AID were frequent, but the majority were mild and manageable.

4.8 - Adverse effects (undesirable effects)

• Added polymyalgia rheumatica with a frequency of rare, into Table 3 'Adverse drug reactions in patients treated with IMFINZI monotherapy'
• Added new adverse event under subheading 'IMFINZI in combination with chemotherapy'. Musculoskeletal and connective tissue disorders: Polymyalgia rheumatica with a frequency of rare, plus a footnote, not observed in the IMFINZI + chemotherapy pool, but observed in other AstraZeneca-sponsored clinical studies.
• Added new adverse events under subheading ' Immune checkpoint inhibitor class effects' There have been cases of the following ADR reported during treatment with other immune checkpoint inhibitors which might also occur during treatment with durvalumab: pancreatic exocrine insufficiency, haemophagocytic lymphohistiocytosis (HLH), aplastic anaemia. Adverse drug reactions in patients with IMFINZI: As monotherapy - coeliac disease, in combination with chemotherapy - coeliac disease and in combination with tremelimumab - coeliac disease. All had a frequency of rare.

Zoely

Theramex Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Expanded warning related to use with hepatitis C virus treatment regimes, expanded warning in relation to exogenous estrogens, added warning related to depression.

4.5 - Interactions with other medicines and other forms of interactions

• Expanded information relating to hepatitis C virus treatment regimes.

Veoza

Astellas Pharma Australia Pty Ltd

4.2 - Dose and Method of Administration

• Updated information under subheading 'Dosage'. Perform baseline hepatic laboratory tests to evaluate for hepatic function and injury [including serum alanine aminotransferase (ALT), serum aspartate aminotransferase (AST), serum alkaline phosphatase (ALP), and serum bilirubin (total and direct)] before initiating treatment with Veoza. Do not start Veoza if ALT or AST is ≥ 2 x ULN or if the total bilirubin is ≥ 2 x ULN for the evaluating laboratory. While using Veoza, perform follow-up hepatic laboratory tests monthly for the first 3 months at 6 months, and 9 months after initiation of therapy. Advise patients to discontinue Veoza immediately and seek medical attention including hepatic laboratory tests if they experience signs or symptoms that may suggest liver injury.

4.4 - Special warnings and precautions for use

• Updated warning under subheading 'Hepatotoxicity and liver function monitoring'. In the post-marketing setting, cases of serious but reversible hepatotoxicity have been reported within 40 days of treatment. Patients have experienced transaminase elevations (greater than 10 times the ULN) with concurrent elevations in bilirubin and/or alkaline phosphatase (ALP), sometimes associated with signs or symptoms such as fatigue, pruritus, jaundice, dark urine, or abdominal pain. Evaluate hepatic function (ALT, AST, ALP, and bilirubin) before initiating therapy. Do not initiate Veoza if ALT or AST is equal to or exceeds 2 times the ULN or if the total bilirubin is elevated (e.g., equal to or exceeds 2 times the ULN). Patients should discontinue Veoza immediately and seek medical attention, including hepatic laboratory tests, if they experience signs or symptoms that may suggest hepatotoxicity such as new onset fatigue, decreased appetite, nausea, vomiting, pruritus, jaundice, pale faeces, dark urine, or abdominal pain. Perform follow-up evaluation of hepatic function monthly for the first 3 months, at 6 months, and 9 months after initiating Veoza and thereafter periodically based on clinical judgement Discontinue Veoza if: transaminase elevations are greater than 5 times the ULN, transaminase elevations are greater than 3 times the ULN and the total bilirubin level is greater than 2 times the ULN. Monitoring of liver function tests should continue until they have normalised and the other causes of liver injury should be excluded.

4.8 - Adverse effects (undesirable effects)

• Added aspartate aminotransferase (AST) increased with a frequency of common.
• Added hepatotoxicity with a frequency of not known.
• Added new subheading 'Hepatotoxicity'. Serious cases of drug-induced hepatotoxicity occurred within 40 days of starting Veoza. Patients experienced elevated transaminases (up to 50 x ULN at peak elevation), elevated alkaline phosphatase (up to 4 x ULN at peak elevation), and bilirubin (up to 5 x ULN at peak elevation) coupled with symptoms of fatigue, nausea, pruritus, jaundice, pale faeces, and dark urine. After discontinuation of Veoza, these abnormalities gradually resolved.

Prohance

Bracco Pty Ltd

4.8 - Adverse effects (Undesirable effects)

• Added acute respiratory distress syndrome and pulmonary oedema.

Columvi

Roche Products Pty Ltd

4.2 - Dose and method of administration

• Added recommendation to consider prophylaxis for patients at increased risk of CMV, herpes, pneumocystis jirovecii pneumonia, and other opportunistic infections

4.4 - Special warnings and precautions for use

• Recommendation to administer prophylactic antimicrobials, as appropriate for serious infections

4.8 - Adverse effects (undesirable effects)

• Addition of information on CMV and pneumocystis jirovecii pneumonia infections and colitis

Isordil / Isordil Sublingual

Arrotex Pharmaceuticals Pty Ltd

4.3 - Contraindications

• Added hypertrophic obstructive cardiomyopathy (HOCM)

4.8 - Adverse effects (undesirable effects)

• Added heartburn

Kalydeco

Vertex Pharmaceuticals Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading 'Hypersensitivity Reactions, Including Anaphylaxis'. Hypersensitivity reactions including cases of anaphylaxis have been reported in the post-marketing setting. If signs or symptoms of serious hypersensitivity reactions develop during treatment discontinue Kalydeco and institute appropriate therapy. Consider the benefits and risks for the individual patient to determine whether to resume treatment with Kalydeco.

4.8 - Adverse effects (undesirable effects), post-marketing experience:

• Added anaphylaxis

Orudis Sr / Oruvail Sr

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use

• COX-2 inhibitors added to cautionary statements regarding concomitant medication use

4.8 - Adverse effects (undesirable effects)

• Added intestinal diaphragm-like strictures to adverse effects with unknown frequency

Orkambi

Vertex Pharmaceuticals Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading 'Hypersensitivity Reactions, Including Anaphylaxis'. Hypersensitivity reactions including cases of anaphylaxis have been reported in the post-marketing setting. If signs or symptoms of serious hypersensitivity reactions develop during treatment discontinue Orkambi and institute appropriate therapy. Consider the benefits and risks for the individual patient to determine whether to resume treatment with Orkambi.

4.8 - Adverse effects (undesirable effects)

• Added anaphylaxis under 'post-marketing experience'

Physeptone Aspen Methadone Syrup

Aspen Pharmacare Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading ‘Sleep-related breathing disorders'. Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage.
• Added new warning under subheading ‘Neonatal Withdrawal Syndrome’. Chronic use of methadone by the mother at the end of pregnancy may result in a withdrawal syndrome (e.g. hypertonia, neonatal tremor, neonatal agitation, myoclonus, convulsions, apnoea or bradycardia) in the neonate. In many reported cases the withdrawal was serious and required treatment. The syndrome is generally delayed for several hours to several days after birth.
• Added new warning under subheading 'Hepatobiliary disorders'. Opioids may cause dysfunction and spasm of the sphincter of Oddi, thus raising intrabiliary pressure and increasing the risk of biliary tract symptoms and pancreatitis. Therefore, Physeptone has to be administered with caution in patients with pancreatitis and diseases of the biliary tract.
• Added new warning under subheading 'Gastrointestinal Toxicity'. Reports of significant oesophageal dysfunction have been observed via high-resolution manometry in patients taking opioid medicines on a long-term basis. Discontinuation or weaning of opioids should be considered in patients presenting with oesophageal complaints including but not limited to dysphagia, regurgitation, or non-cardiac chest pain.

4.8 - Adverse effects (undesirable effects)

• Added central sleep apnoea with a frequency of not known
• Added pancreatitis with a frequency of not known
• Added spasm of sphincter of Oddi with a frequency of not known
• Added adrenal insufficiency and androgen deficiency with a frequency of not known

4.9 - Overdose

• Added toxic leukoencephalopathy has been observed with opioid overdose

Kapanol

Mayne Pharma International Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading 'Adrenal insufficiency'. Adrenal insufficiency has been reported with opioid use, more often following long-term use. Symptoms may include nausea, vomiting, anorexia, fatigue, weakness, dizziness, or low blood pressure. If adrenal insufficiency is suspected, appropriate laboratory testing is recommended and discontinuation of treatment with Kapanol should be considered.
• Updated warning under subheading 'Hormonal Changes'. Androgen deficiency may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.
• Added new warning under subheading 'Gastrointestinal Toxicity'. Reports of significant oesophageal dysfunction have been observed via high-resolution manometry in patients taking opioid medicines on a long-term basis. Discontinuation or weaning of opioids should be considered in patients presenting with oesophageal complaints including but not limited to dysphagia, regurgitation, or non-cardiac chest pain.
• Updated warning under subheading 'Post-operatively'. Prolonged release opioids should not be used for acute post-operative pain owing to the increased risk of persistent post-operative opioid use (PPOU) and opioid-induced ventilatory impairment (OIVI).
• Added new warning under subheading 'Neonatal Withdrawal Syndrome'. Chronic use of morphine by the mother at the end of pregnancy may result in a withdrawal syndrome (e.g. hypertonia, neonatal tremor, neonatal agitation, myoclonus, convulsions, apnoea or bradycardia) in the neonate. In many reported cases the withdrawal was serious and required treatment. The syndrome is generally delayed for several hours to several days after birth.

4.8 - Adverse effects (undesirable effects)

• Added adrenal insufficiency with a frequency of not known

4.9 - Overdose

• Added toxic leukoencephalopathy has been observed with opioid overdose

Avelox

Bayer Australia Ltd

4.4 - Special warnings and precautions for use

• Updated subheading 'photosensitivity reactions'. Fluoroquinolones have been shown to cause photosensitivity reactions in patients. However, studies have shown that moxifloxacin has a lower risk to induce photosensitivity. Nevertheless, patients should be advised to avoid extensive exposure to either UV irradiation or sunlight during treatment with moxifloxacin.
• Added new subheading 'Severe cutaneous adverse reactions'. Severe cutaneous adverse reactions (SCARs) including toxic epidermal necrolysis (TEN: also known as Lyell’s syndrome), Stevens Johnson syndrome (SJS), Acute Generalised Exanthematous Pustulosis (AGEP) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), which could be life-threatening or fatal, have been reported with moxifloxacin. At the time of prescription, patients should be advised of the signs and symptoms of severe skin reactions and be closely monitored. If signs and symptoms suggestive of these reactions appear, moxifloxacin should be discontinued immediately, and an alternative treatment should be considered. If the patient has developed a serious reaction such as SJS, TEN, AGEP or DRESS with the use of moxifloxacin, treatment with moxifloxacin must not be restarted in this patient at any time.

4.8 - Adverse effects (undesirable effects)

• Added Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), Photosensitivity reactions, Fixed drug eruption with frequency not known

Endone / Oxycodone Viatris

Viatris Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading ‘Sleep-related breathing disorders'. Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage.
• Added new warning under subheading ‘Adrenal Insufficiency’. Adrenal insufficiency has been reported with opioid use, more often following long-term use. Symptoms may include nausea, vomiting, anorexia, fatigue, weakness, dizziness, or low blood pressure. If adrenal insufficiency is suspected, appropriate laboratory testing is recommended and discontinuation of treatment with Endone should be considered.
• Added new warning under subheading 'Endocrine Effects'. Opioids, such as Endone, may influence the hypothalamic-pituitary-adrenal or –gonadal axes. Hormonal disturbances that have been observed include an increase in serum prolactin and decreases in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes. Androgen deficiency may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.
• Added new warning under subheading ‘Neonatal Withdrawal Syndrome’. Chronic use of oxycodone by the mother at the end of pregnancy may result in a withdrawal syndrome (e.g. hypertonia, neonatal tremor, neonatal agitation, myoclonus, convulsions, apnoea or bradycardia) in the neonate. In many reported cases the withdrawal was serious and required treatment. The syndrome is generally delayed for several hours to several days after birth.
• Added new warning under subheading 'Gastrointestinal Toxicity'. Reports of significant oesophageal dysfunction have been observed via high-resolution manometry in patients taking opioid medicines on a long-term basis. Discontinuation or weaning of opioids should be considered in patients presenting with oesophageal complaints including but not limited to dysphagia, regurgitation, or non-cardiac chest pain.

4.6 - Fertility, Pregnancy and Lactation

• Updated information under subheading 'Use in Pregnancy'. Neonatal withdrawal syndrome has been reported in newborn infants with chronic maternal use of oxycodone during pregnancy.

4.8 - Adverse effects (undesirable effects)

• Added central sleep apnoea syndrome with a frequency of not known
• Added pancreatitis with a frequency of not known
• Added adrenal insufficiency and androgen deficiency with a frequency of not known

Yorvipath

Specialised Therapeutics Pharma Pty Ltd

4.4 - Special warnings and precautions for use

• Added hypersensitivity reactions including anaphylaxis

Dolased Forte

Aspen Pharmacare Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading 'High Anion Gap Metabolic Acidosis'. Cases of high anion gap metabolic acidosis (HAGMA) due to pyroglutamic acidosis have been reported in patients with severe illness such as severe renal impairment and sepsis, or patients with malnutrition and other sources of glutathione deficiency (e.g., chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin. If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.
• Added new warning under subheading ‘Sleep-related breathing disorders'. Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage.
• Added new warning under subheading 'Adrenal insufficiency'. Adrenal insufficiency has been reported with opioid use, more often following long-term use. Symptoms may include nausea, vomiting, anorexia, fatigue, weakness, dizziness, or low blood pressure. If adrenal insufficiency is suspected, appropriate laboratory testing is recommended and discontinuation of treatment with Dolased Forte should be considered.
• Added new warning under subheading 'Endocrine effects'. Opioids, such as Dolased Forte, may influence the hypothalamic-pituitary-adrenal or –gonadal axes. Hormonal disturbances that have been observed include an increase in serum prolactin and decreases in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes. Androgen deficiency may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.
• Added new warning under subheading ‘Neonatal Withdrawal Syndrome’. Chronic use of codeine by the mother at the end of pregnancy may result in a withdrawal syndrome (e.g. hypertonia, neonatal tremor, neonatal agitation, myoclonus, convulsions, apnoea or bradycardia) in the neonate. In many reported cases the withdrawal was serious and required treatment. The syndrome is generally delayed for several hours to several days after birth.
• Added new warning under subheading 'Hepatobiliary disorders'. Opioids may cause dysfunction and spasm of the sphincter of Oddi, thus raising intrabiliary pressure and increasing the risk of biliary tract symptoms and pancreatitis. Therefore, Dolased Forte has to be administered with caution in patients with pancreatitis and diseases of the biliary tract.
• Added new warning under subheading 'Gastrointestinal Toxicity'. Reports of significant oesophageal dysfunction have been observed via high-resolution manometry in patients taking opioid medicines on a long-term basis. Discontinuation or weaning of opioids should be considered in patients presenting with oesophageal complaints including but not limited to dysphagia, regurgitation, or non-cardiac chest pain.

4.5 - Interactions with other medicines and other forms of interactions

• Updated interaction under subheading 'Flucloxacillin'. Caution should be taken when paracetamol is used concomitantly with flucloxacillin as concurrent intake has been associated with high anion gap metabolic acidosis due to pyroglutamic acidosis, especially in patients with risk factors of glutathione depletion such as sepsis, malnutrition or chronic alcoholism.

4.8 - Adverse effects (undesirable effects)

• Added high anion gap metabolic acidosis with frequency not known. Cases of high anion gap metabolic acidosis due to pyroglutamic acidosis have been observed in patients with risk factors using paracetamol. Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients.
• Added central sleep apnoea with a frequency of not known
• Added pancreatitis with a frequency of not known
• Added spasm of sphincter of Oddi with a frequency of not known
• Added adrenal insufficiency and androgen deficiency with a frequency of not known

4.9 - Overdose

• Added under subheading 'Codeine', toxic leukoencephalopathy has been observed with opioid overdose

Dolased

Aspen Pharmacare Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading 'High Anion Gap Metabolic Acidosis'. Cases of high anion gap metabolic acidosis (HAGMA) due to pyroglutamic acidosis have been reported in patients with severe illness such as severe renal impairment and sepsis, or patients with malnutrition and other sources of glutathione deficiency (e.g., chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin. If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.
• Added new warning under subheading ‘Sleep-related breathing disorders'. Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage.
• Added new warning under subheading 'Adrenal insufficiency'. Adrenal insufficiency has been reported with opioid use, more often following long-term use. Symptoms may include nausea, vomiting, anorexia, fatigue, weakness, dizziness, or low blood pressure. If adrenal insufficiency is suspected, appropriate laboratory testing is recommended and discontinuation of treatment with Dolased should be considered.
• Added new warning under subheading 'Endocrine effects'. Opioids, such as Dolased, may influence the hypothalamic-pituitary-adrenal or –gonadal axes. Hormonal disturbances that have been observed include an increase in serum prolactin and decreases in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes. Androgen deficiency may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.
• Added new warning under subheading ‘Neonatal Withdrawal Syndrome’. Chronic use of codeine by the mother at the end of pregnancy may result in a withdrawal syndrome (e.g. hypertonia, neonatal tremor, neonatal agitation, myoclonus, convulsions, apnoea or bradycardia) in the neonate. In many reported cases the withdrawal was serious and required treatment. The syndrome is generally delayed for several hours to several days after birth.
• Added new warning under subheading 'Hepatobiliary disorders'. Opioids may cause dysfunction and spasm of the sphincter of Oddi, thus raising intrabiliary pressure and increasing the risk of biliary tract symptoms and pancreatitis. Therefore, Dolased has to be administered with caution in patients with pancreatitis and diseases of the biliary tract.
• Added new warning under subheading 'Gastrointestinal Toxicity'. Reports of significant oesophageal dysfunction have been observed via high-resolution manometry in patients taking opioid medicines on a long-term basis. Discontinuation or weaning of opioids should be considered in patients presenting with oesophageal complaints including but not limited to dysphagia, regurgitation, or non-cardiac chest pain.

4.5 - Interactions with other medicines and other forms of interactions

• Added new interaction. Caution should be taken when paracetamol is used concomitantly with flucloxacillin as concurrent intake has been associated with high anion gap metabolic acidosis due to pyroglutamic acidosis, especially in patients with risk factors of glutathione depletion such as sepsis, malnutrition or chronic alcoholism.

4.8 - Adverse effects (undesirable effects)

• Added high anion gap metabolic acidosis with frequency not known. Cases of high anion gap metabolic acidosis due to pyroglutamic acidosis have been observed in patients with risk factors using paracetamol. Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients.
• Added central sleep apnoea with a frequency of not known
• Added pancreatitis with a frequency of not known
• Added spasm of sphincter of Oddi with a frequency of not known
• Added adrenal insufficiency and androgen deficiency with a frequency of not known

4.9 - Overdose

• Added toxic leukoencephalopathy has been observed with opioid overdose.

Pegasys

Echo Therapeutics Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading ‘Pulmonary Arterial Hypertension’. Cases of pulmonary arterial hypertension (PAH) have been reported with interferon alfa products. PAH has occurred in patients treated with interferon alfa products in the absence of other contributory factors. Many of the reported cases required hospitalization, including one case with interferon alfa in which the patient underwent a lung transplant. PAH has developed at various time points after initiating therapy with interferon alfa products and may occur several years after starting treatment. Patients who develop unexplained symptoms (e.g., dyspnoea, new or increasing fatigue) should be assessed for PAH. If alternative aetiologies have been ruled out and a diagnosis of PAH is confirmed, discontinue treatment and manage as clinically indicated.

4.8 - Adverse effects (undesirable effects)

• Added under subheading 'Post-Marketing Experience'. As with other interferon containing products pulmonary arterial hypertension has been reported in a post marketing setting.

Alimta

Eli Lilly Australia Pty Ltd

4.5 - Interactions with other medicines and other forms of interactions

• Added concomitant administration of pemetrexed with OAT3 (organic anion transporter 3) inhibitors (e.g. probenecid, penicillin, proton pump inhibitors (PPIs)) results in delayed clearance of pemetrexed. Caution should be made when these drugs are combined with pemetrexed.

Natulan

Link Medical Products Pty Ltd T/A Link Pharmaceuticals

4.2 - Dose and method of administration

• Added the dose should be determined only by a physician experienced with paediatric patients

4.3 - Contraindications

• Added breastfeeding and hypersensitivity

4.4 - Special warnings and precautions for use

• Added testing, hepatic and renal function, immunosuppression, combination therapies, considerations for discontinuation

4.5 - Interactions with other medicines and other forms of interactions

• Added further information concerning interactions with other medicines

4.6 - Fertility, pregnancy and lactation

• Expanded contraception advice and use in pregnancy and breastfeeding.

4.7 - Effects on ability to drive and use machines

• Added dizziness and somnolence

4.8 - Adverse effects (undesirable effects)

• Added significant addition of adverse events

4.9 - Overdose

• Added treatment, including activated charcoal

Ryeqo

Gedeon Richter Australia Pty Ltd

4.4 - Special warnings and precautions for use:

• Updated wording within subheading 'Depression' to include gonadotropin-releasing hormone receptor antagonist, including RYEQO, have been associated with mood disorders (including depression) and suicidal ideation. Evaluate women with a history of suicidal ideation, depression and mood disorders prior to initiating treatment. Women must be advised to contact their physician in case of mood changes and depressive symptoms, including shortly after initiating the treatment. Discontinue Ryeqo if depression recurs to a serious degree. Advise patients to seek immediate medical attention for suicidal ideation and behaviour.

Nexavar

Bayer Australia Ltd

4.8 - Adverse effects (undesirable effects)

• Added thrombotic microangiopathy (TMA) under 'Post-marketing experience'

Diacomit

Chiesi Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added pneumonia
• Added aspiration pneumonia

Lamisil

Novartis Pharmaceuticals Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added drug resistance in dermatophytes

Trikafta

Vertex Pharmaceuticals Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading 'Hypersensitivity Reactions, Including Anaphylaxis'. Hypersensitivity reactions including cases of angioedema and anaphylaxis have been reported in the post-marketing setting. If signs or symptoms of serious hypersensitivity reactions develop during treatment discontinue Trikafta and institute appropriate therapy. Consider the benefits and risks for the individual patient to determine whether to resume treatment with Trikafta.

4.8 - Adverse effects (undesirable effects)

• Added rash to Table 6 and 7 with updated frequency and new footnote 'includes rash, rash generalised, rash erythematous, rash macular, rash pruritic'
• Added new information under subheading 'rash events'. Studies in Trikafta-treated patients above 12 years of age showed an incidence of rash events (e.g., rash, rash pruritic) of 10.9% (study 445-102) compared to 6.5% in placebo-treated patients. The paediatric population showed a higher incidence rate. The incidence of rash events by patient sex was 5.8% in males and 16.3% in females in Trikafta-treated patients and 4.8% in males and 8.3% in females in placebo-treated patients. In patients treated with Trikafta, the incidence of rash events was 20.5% in females taking hormonal contraceptive and 13.6% in females not taking hormonal contraceptive. Overall, rash events typically occur during the first month of therapy. Most events were mild to moderate in severity, and in rare cases, rash was associated with additional symptoms such as fever or facial swelling. In the majority of cases, administration of  Trikafta was continued and the rash resolved without treatment.
• Added new information under subheading 'Paediatric Population Rash'. While studies in patients above 12 years of age showed an incidence rate of 10.9% (study 445-102), patients between 6 and 11 years of age had an incidence rate of 24.2% (study 445-106). During study 445-111 in patients aged 2 to less than 6 years, 15 (20.0%) subjects had at least 1 rash event, 4 (9.8%) females and 11 (32.4%) males.
• Added under subheading 'Post-marketing experience' anaphylaxis and hypersensitivity

Symdeko

Vertex Pharmaceuticals Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading 'Hypersensitivity Reactions, Including Anaphylaxis'. Hypersensitivity reactions including cases of anaphylaxis have been reported in the post-marketing setting. If signs or symptoms of serious hypersensitivity reactions develop during treatment discontinue Symdeko and institute appropriate therapy. Consider the benefits and risks for the individual patient to determine whether to resume treatment with Symdeko.

4.8 - Adverse effects (undesirable effects), post-marketing experience:

• Added anaphylaxis

Tevimbra

Beigene Aus Pty Ltd

4.4 - Special warnings and precautions for use

• Added warning under subheading ‘Patients with pre-existing autoimmune disease (AID)’. In patients with pre-existing AID, data from observational studies suggest that the risk of immune-mediated adverse reactions following immune checkpoint inhibitor therapy may be increased as compared with the risk in patients without pre-existing AID. In addition, flares of the underlying AID were frequent, but the majority were mild and manageable.
• Added warning under subheading ‘Haemophagocytic lymphohistiocytosis (HLH)’. HLH has been reported in patients receiving tislelizumab. HLH is a life-threatening syndrome characterised by fever, skin rash, lymphadenopathy, hepato- and/or splenomegaly and cytopenias. Patients should be monitored for clinical signs and symptoms of HLH. For suspected HLH, tislelizumab must be interrupted. If HLH is confirmed, administration of tislelizumab should be discontinued.

4.8 - Adverse effects (undesirable effects)

• Added haemophagocytic lymphohistiocytosis and Coeliac disease to Table 3 'Adverse drug reactions with tislelizumab as monotherapy (N = 2,390) and in combination with chemotherapy (N = 1,950)'
• Added subheading 'Immune checkpoint inhibitor class effects'. There have been cases of the following adverse reactions reported during treatment with other immune checkpoint inhibitors which might also occur during treatment with tislelizumab: pancreatic exocrine insufficiency, aplastic anaemia.

Zaldiar

Aspen Pharmacare Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading 'High Anion Gap Metabolic Acidosis'. Cases of high anion gap metabolic acidosis (HAGMA) due to pyroglutamic acidosis have been reported in patients with severe illness such as severe renal impairment and sepsis, or patients with malnutrition and other sources of glutathione deficiency (e.g., chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin. If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.
• Added new warning under subheading 'Adrenal insufficiency'. Adrenal insufficiency has been reported with opioid use, more often following long-term use. Symptoms may include nausea, vomiting, anorexia, fatigue, weakness, dizziness, or low blood pressure. If adrenal insufficiency is suspected, appropriate laboratory testing is recommended and discontinuation of treatment with Zaldiar should be considered.
• Added new warning under subheading 'Endocrine effects'. Opioids, such as Zaldiar, may influence the hypothalamic-pituitary-adrenal or -gonadal axes. Hormonal disturbances that have been observed include an increase in serum prolactin and decreases in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes. Androgen deficiency may manifest as low libido, importance, erectile dysfunction, amenorrhea or infertility.
• Added new warning under subheading ‘Neonatal Withdrawal Syndrome’. Chronic use of tramadol by the mother at the end of pregnancy may result in a withdrawal syndrome (e.g. hypertonia, neonatal tremor, neonatal agitation, myoclonus, convulsions, apnoea or bradycardia) in the neonate. In many reported cases the withdrawal was serious and required treatment. The syndrome is generally delayed for several hours to several days after birth.
• Added new warning under subheading 'Hepatobiliary disorders'. Opioids may cause dysfunction and spasm of the sphincter of Oddi, thus raising intrabiliary pressure and increasing the risk of biliary tract symptoms and pancreatitis. Therefore, Zaldiar has to be administered with caution in patients with pancreatitis and diseases of the biliary tract.
• Added new warning under subheading 'Gastrointestinal Toxicity'. Reports of significant oesophageal dysfunction have been observed via high-resolution manometry in patients taking opioid medicines on a long-term basis. Discontinuation or weaning of opioids should be considered in patients presenting with oesophageal complaints including but not limited to dysphagia, regurgitation, or non-cardiac chest pain.

4.5 - Interactions with other medicines and other forms of interactions

• Updated isoxazolyl penicillins interaction to include that concurrent intake has been associated with high anion gap metabolic acidosis due to pyroglutamic acidosis especially in patients with risk factors and prolonged treatment

4.8 - Adverse effects (undesirable effects)

• Added pancreatitis with a frequency of not known
• Added spasm of sphincter of Oddi with a frequency of not known
• Added adrenal insufficiency and androgen deficiency with a frequency of not known
• Added under subheading 'Paracetamol', high anion gap metabolic acidosis due to pyroglutamic acidosis (PGA) where reported with frequency not known. PGA may occur as a consequence of low glutathione levels in these patients.

4.9 - Overdose

• Added toxic leukoencephalopathy under subheading 'Symptoms of overdose from tramadol'

Mekinist

Novartis Pharmaceuticals Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added under subheading 'Hepatic Events', increased transaminases, and hepatic failure as an expansion of existing precaution

Imjudo

AstraZeneca Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading 'Patients with pre-existing autoimmune disease (AID)'. In patients with pre-existing AID, data from observational studies suggest that the risk of immune-mediated adverse reactions following immune checkpoint inhibitor therapy 8 of 25 may be increased as compared with the risk in patients without pre-existing AID. In addition, flares of the underlying AID were frequent, but the majority were mild and manageable.

4.8 - Adverse effects (undesirable effects), post-marketing experience:

• Added coeliac disease
• Added new adverse effect under subheading 'Immune checkpoint inhibitor class effects'. There have been cases of the following adverse reactions reported during treatment with other immune checkpoint inhibitors which might also occur during treatment with STRIDE: Haemophagocytic lymphohistiocytosis (HLH), pancreatic exocrine insufficiency and aplastic anaemia.