Product Information safety updates - May 2026

Calquence Capsules

AstraZeneca Pty Ltd

4.1 - Therapeutic indications

Deleted the lapsed provisionally registered indication for MCL and updated to the following: CALQUENCE is indicated for the treatment of patients with chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL).

4.4 - Special warnings and precautions for use

Revised warning under the subheading 'Cardiac arrhythmias including atrial fibrillation and flutter'. Serious cardiac arrhythmias have occurred in patients treated with CALQUENCE. In the combined safety database of 1040 patients with haematologic malignancies treated with CALQUENCE monotherapy, Grade 3 atrial fibrillation and atrial flutter occurred in 1% of patients and Grade 1 or 2 in 3% of patients. Monitor for symptoms of cardiac arrhythmia, including atrial fibrillation and atrial flutter, (e.g. palpitations, dizziness, syncope, chest pain, dyspnoea) and obtain an ECG as appropriate. Added a new warning under the subheading 'Hepatotoxicity, including drug-induced liver injury'. Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of drug-induced liver injury (DILI), has occurred in patients treated with Bruton tyrosine kinase inhibitors, including CALQUENCE. Evaluate bilirubin and transaminases at baseline and throughout treatment with CALQUENCE. For patients who develop abnormal liver tests after CALQUENCE, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold CALQUENCE. Upon confirmation of DILI, discontinue CALQUENCE.

4.8 - Adverse effects (Undesirable effects), Post-marketing experience

Added new adverse effects 'cardiac arrhythmias', 'hepatotoxicity' and 'drug-induced liver injury'

Lemtrada

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Addition of vasculitis under Autoimmunity

APO-Allopurinol / Zyloprim

Arrotex Pharmaceuticals Pty Ltd

4.4 - Special warnings and precautions for use

• Inclusion of maculopapular exanthema
• Added specific contraindication against rechallenge for patients who have experienced Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Added lactose warning

4.5 - - Interactions with other medicines and other forms of interactions

Added:

• 6-mercaptopurine and azathioprine
• Ace inhibitors
• diuretics

4.8 - Adverse effects (undesirable effects)

Updates to:

• Generalised hypersensitivity: chills, nausea, vomiting, DRESS/DIHS (drug reaction with eosinophilia and systemic symptoms) and multi-organ hypersensitivity. Fever, rash, vasculitis, lymphadenopathy, pseudolymphoma, arthralgia, leukopenia, eosinophilia, hepatosplenomegaly, abnormal liver function tests, and vanishing bile duct syndrome.
• Gastrointestinal disorders: diarrhoea, stomatitis, changed bowel habit, intermittent abdominal pain
• General disorders: erectile dysfunction, fever, aseptic meningitis, angioedema
• Laboratory parameters: liver function test abnormal, increased blood thyroid stimulating hormone and rise in urea

Rybrevant

Janssen-Cilag Pty Ltd

4.2 - Dose and method of administration

• Added new advice to Table 6 Rybrevant dosage modifications for the adverse reaction 'Infusion-related reactions (IRR)'. Permanently discontinue for any Grade anaphylaxis / anaphylactic reactions.

4.4 - Special warnings and precautions for use

• Updated warning under subheading 'Infusion-related reactions'. IRRs including anaphylaxis may occur in patients treated with RYBREVANT. The most frequent signs and symptoms include chills, nausea, dyspnoea, flushing, chest discomfort, and vomiting. Give RYBREVANT infusions in a monitored setting with appropriate medical support for the treatment of IRRs, including cardiopulmonary resuscitation medication and equipment. Interrupt infusion if IRR is suspected and reduce infusion rate or permanently discontinue RYBREVANT based on severity. If an anaphylactic reaction occurs, permanently discontinue RYBREVANT.

4.8 - Adverse effects (undesirable effects)

• Added infusion-related reactions, including anaphylaxis/anaphylactic reactions

Erlyand

Janssen-Cilag Pty Ltd

4.5 - Interactions with other medicines and other forms of interactions

• Added digoxin test interference

Aprepitant ARX

Arrotex Pharmaceuticals Pty Ltd

4.4 - Special warnings and precautions for use

• Addition of warning for use in pregnant women and nursing women

4.5 - Interactions with other medicines and other forms of interactions

• Updated interaction with methylprednisolone
• Addition of interaction with immunosuppressants
• Addition of interaction with substrates eliminated by CYP2C9, CYP3A4 and glucuronidation

4.8 - Adverse effects (undesirable effects)

• Updates to Highly and Moderately emetogenic chemotherapy topics including the addition of multiple adverse effects.

Nuvigil

Neuraxpharm Australia Pty Ltd

4.5 - Interactions with other medicines and other forms of interactions

• Addition of warning regarding interactions with ioflupane

Malarone Tablets / Malarone Junior

GlaxoSmithKline Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Addition of new adverse events: psychiatric disorders including abnormal dreams, depression, anxiety, panic attacks, crying, nightmares, psychotic disorders

Imuran

Aspen Pharmacare Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Expanded information on additional monitoring

4.5 - Interactions with other medicines and other forms of interactions

• Added interaction between azathioprine and allopurinol

4.6 - Fertility, pregnancy and lactation

• Added cholestasis of pregnancy

4.8 - Adverse effects (undesirable effects)

• Added tremor, sialoadenitis, non-cirrhotic portal hypertension, porto-sinusoidal vascular disease

Dymista

Viatris Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Updated to include unpleasant taste under common Nervous System disorder
• Updated to include statement on paediatric safety

Black Snake Antivenom

Seqirus Pty Ltd

4.4 - Special warnings and precautions for use

• Updated section to strengthen wording around horse and horse-dander allergies

Cabenuva

ViiV Healthcare Pty Ltd

4.8 - Adverse Effects (Undesirable Effects)

• Added new description of selected adverse reaction 'Injection site reaction (pain and discomfort, site nodule, induration) in table 9: Tabulated summary of adverse drug reactions. May rarely result in temporary gait disturbance.

Captopril - Reach

Reach Pharmaceuticals Pty Ltd

4.4 - Special warnings and precautions for use

• Addition of insulin autoimmune syndrome and angioedema

4.8 - Adverse effects (undesirable effects)

• Addition of Immune system disorders

Neoral / Sandimmun

Novartis Pharmaceuticals Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added interaction with St John’s wort

4.5 - Interactions with other medicines and other forms of interactions

• Added interaction with St John's wort – coadministration may lead to a decrease in ciclosporin blood levels

Cortate

Aspen Pharmacare Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added panniculitis as a post-marketing adverse effect with frequency 'not known'

Death Adder Antivenom

Seqirus Pty Ltd

4.4 - Special warnings and precautions for use

• Update to strengthen wording around horse and horse dander allergies

Qlaira

Bayer Australia Ltd

4.4 - Special warnings and precautions for use

Wording under subheading 'Tumours' relocated from 5.3 Preclinical safety data subheading 'Carcinogenicity', The most important risk factor for cervical cancer is persistent human papillomavirus (HPV) infection. Some epidemiological studies have indicated that long-term use of COCs may further contribute to this increased risk but there continues to be controversy about the extent to which this finding is attributable to confounding effects, e.g. cervical screening and sexual behaviour including use of barrier contraceptives. A meta-analysis from 54 epidemiological studies reported that there is a slightly increased relative risk (RR = 1.24) of having breast cancer diagnosed in women who are currently taking COCs. The excess risk gradually disappears during the course of the 10 years after cessation of COC use. Because breast cancer is rare in women under 40 years of age, the excess number of breast cancer diagnoses in current and recent COC users is small in relation to the overall risk of breast cancer. These studies do not provide evidence for causation. The observed pattern of increased risk may be due to an earlier diagnosis of breast cancer in COC users, the biological effects of COCs or a combination of both. The breast cancers diagnosed in ever-users tend to be less advanced clinically than the cancers diagnosed in never-users. In rare cases, benign liver tumours, and even more rarely, malignant liver tumours have been reported in users of COCs. In isolated cases, these tumours have led to life-threatening intra-abdominal haemorrhages. A liver tumour should be considered in the differential diagnosis when severe upper abdominal pain, liver enlargement or signs of intra-abdominal haemorrhage occur in women taking COCs. Malignancies may be life-threatening or may have a fatal outcome.

Tecfidera

Biogen Australian Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading 'Effects on liver function'. Drug-induced liver injury, including liver enzyme increase (≥ 3 x upper limit of normal (ULN)) and elevation of total bilirubin levels (≥ 2 x ULN) can result from treatment with dimethyl fumarate. The time to onset can be directly, several weeks or longer. Resolution of the adverse reactions has been observed after treatment was discontinued. Assessment of serum aminotransferases (e.g. alanine aminotransferase (ALT), aspartate aminotransferase (AST)) and total bilirubin levels are recommended prior to treatment initiation and during treatment as clinically indicated.

Motilium

Johnson & Johnson Pacific Pty Ltd

4.4 - Special warnings and precautions for use Addition of warnings:

• Psychiatric events following discontinuation or dose reduction.
• Suitability for childhood gastrooesophageal reflux disease
• Suitability for chemotherapy-orradiotherapy or post-operative nausea and vomiting
• Additional information on prolongation of QT intervals with potent CYP3A4 inhibitors, and patients underlying cardiovascular disease.
• Additional information on electrolyte disturbance and risk of arrythmias

4.5 - Interactions with other medicines and other forms of interactions

• Addition of interaction with apomorphine.

4.7 - Effects on ability to drive and use machines 

• Addition of warning to use caution if driving or operating machinery

4.8 - Adverse effects (undesirable effects) Addition of:

• angiodema
• dizziness
• urinary retention
• blood prolactin increased

Avodart

GlaxoSmithKline Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added reports of mood alterations including depressed mood, depression and suicidal ideation in patients treated with another oral 5-alpha reductase inhibitor (5-ARI)

Femoston / Femoston-Conti

Arrotex Pharmaceuticals Pty Ltd

4.3 - Contraindications

• Added meningioma or history of meningioma as a contraindication.

4.4 - Special warnings and precautions for use

• Addition of Warning - Combined oestrogen-progestogen therapy, Oestrogen-only, Ischaemic stroke and Other Conditions
• Additional Information included under Warning - Venous Thromboembolism (VTE)
• Additional warning included – Meningioma, Endometrial hyperplasia and Carcinoma
• Additional warning included under ALT elevations

4.5 - Interactions with other medicines and other forms of interactions

• Additional information about Interaction Interactions with HCV combination drug regimen included

Entecavir APO

Arrotex Pharmaceuticals Pty Ltd

4.4 - Special warnings and precautions for use Addition of:

• HIV antibody testing to be recommended for all patients
• HIV/HBV co-infected patients receiving concomitant antiretroviral therapy
• Resistance and specific precaution for lamivudine-refractory patients

Update to:

• Lactic acidosis and severe hepatomegaly with steatosis
• Exacerbations of hepatitis
• Use in renal impairment
• Decompensated liver disease

4.6 - Fertility, pregnancy and lactation

Update to:

• Use in pregnancy - recommendation to women of childbearing potential to use effective contraception

4.7 - Effects on ability to drive and use machines

Addition of:

• Dizziness, fatigue and somnolence as common side effects that may impair ability to drive and use machines

4.8 - Adverse effects (undesirable effects)

Addition of side effects:

• Upper abdominal pain
• Pancreatitis
• Leukopenia
• Neutropenia
• Platelet count decreased
• Hypersensitivity and drug hypersensitivity

Entecavir WGR

GM Pharma International Pty Ltd

4.4 - Special warnings and precautions for use

Addition of:

• HIV antibody testing to be recommended for all patients
• HIV/HBV co-infected patients receiving concomitant antiretroviral therapy
• Resistance and specific precaution for lamivudine-refractory patients Update to:
• Lactic acidosis and severe hepatomegaly with steatosis
• Exacerbations of hepatitis
• Use in renal impairment
• Decompensated liver disease

4.6 - Fertility, pregnancy and lactation Update to: 

• Use in pregnancy - recommendation to women of childbearing potential to use effective contraception.

4.7 - Effects on ability to drive and use machines

Addition of:

• Dizziness, fatigue and somnolence as common side effects that may impair ability to drive and use machines

4.8 - Adverse effects (undesirable effects)

Addition of side effects:

• Upper abdominal pain
• Pancreatitis
• Leukopenia
• Neutropenia
• Platelet count decreased
• Hypersensitivity and drug hypersensitivity

Nextstellis

Mayne Pharma International Pty Ltd

4.4 - Special Warnings and Precautions for Use

Updated information under subheading 'Carcinoma of the Breast and Cervix': A meta-analysis from 54 epidemiological studies showed that there is a slightly increased relative risk (RR = 1.24) of having breast cancer diagnosed in women who are currently using COCs (with ethinylestradiol as the estrogen component), compared to never-users. The increased risk gradually disappears during the course of the 10 years after cessation of COC use. Because breast cancer is rare in women under 40 years of age, the excess number of breast cancer diagnoses in current and recent COC users is small in relation to the lifetime risk of breast cancer. These studies do not provide evidence for causation. The observed pattern of increased risk may be due to an earlier diagnosis of breast cancer in COC users (due to more regular clinical monitoring), the biological effects of COCs or a combination of both. Breast cancers diagnosed in ever-users tend to be less advanced clinically than the cancers diagnosed in never-users.

Triasyn

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Additional warning statements pertaining to angioedema of the head, neck and extremities

Zactin / Zactin Tabs

Alphapharm Pty Ltd

4.3 - Contraindications

• Added new contraindication under subheading 'Metoprolol'. Fluoxetine is contraindicated in combination with metoprolol used in cardiac failure.

4.5 - Interactions with other medicines and other forms of interactions

• Added new interaction under subheading 'Metoprolol used in cardiac failure'. Risk of metoprolol adverse events including excessive bradycardia, may be increased because of an inhibition of its metabolism by fluoxetine.

Engerix-B / Engerix-B Paediatric Dose

GlaxoSmithKline Australia Pty Ltd

4.1 - Therapeutic indications

• Added new statement limited data are available for the use of ENGERIX-B in patients over 60 years of age

4.4 - Special warnings and precautions for use

• Updated warning under subheading 'Use in the elderly'. Clinical studies of ENGERIX-B did not include sufficient numbers of subjects aged 65 years and older to determine whether they responded differently from younger subjects. However, in a later study it has been shown that a diminished antibody response and seroprotective levels can be expected in persons older than 60 years.

Brufen Ibuprofen 400Mg Tablet Blister Pack

Viatris Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading 'Cardiovascular Thrombotic Events'. Cases of Kounis syndrome have been reported in patients treated with ibuprofen. Kounis syndrome has been defined as cardiovascular symptoms secondary to an allergic or hypersensitive reaction associated with constriction of coronary arteries and potentially leading to myocardial infarction.
• Added new warning under subheading 'Renal'. Renal tubular acidosis and hypokalaemia may occur following acute overdose and in patients taking ibuprofen products over long periods at high doses (typically greater than 4 weeks), including doses exceeding the recommended daily dose.

4.8 - Adverse effects (undesirable effects)

• Added Renal tubular acidosis with a frequency of not known.
• Added Kounis syndrome with a frequency of not known.
• Added Hypokalaemia with a frequency of not known.
• Added new description of selected adverse reaction under subheading 'Post Marketing Experience'. Renal tubular acidosis and hypokalaemia have been reported in the post-marketing setting typically following prolonged use of ibuprofen at higher than recommended doses.

4.9 - Overdose 

• Added prolonged use at higher than recommended doses may result in severe hypokalaemia and renal tubular acidosis. Symptoms may include reduced level of consciousness and generalised weakness.

Pedea

Recordati Rare Diseases Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading 'Renal'. Renal tubular acidosis and hypokalaemia may occur following acute overdose and in patients treated with ibuprofen over long periods at high doses (typically greater than 4 weeks), including doses exceeding the recommended daily dose.

4.8 - Adverse Effects (Undesirable effects)

• Added renal tubular acidosis with a frequency of not known
• Added hypokalaemia with a frequency of not known
• Added new description of selected adverse reaction under subheading 'Post Marketing Experience'. Renal tubular acidosis and hypokalaemia have been reported in the post-marketing setting typically following prolonged use of ibuprofen at higher than recommended doses.

4.9 - Overdose

• Added prolonged use at higher than recommended doses may result in severe hypokalaemia and renal tubular acidosis. Symptoms may include reduced level of consciousness and generalised weakness.

Havrix 1440 / Havrix Junior

GlaxoSmithKline Australia Pty Ltd

4.1 - Therapeutic indications

• Added new statement limited data are available for the use of HAVRIX 1440 in elderly patients

4.4 - Special warnings and precautions for use

• Updated warning under subheading 'Use in the elderly'. Clinical studies of HAVRIX did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects. Other reported clinical experience from Hepatitis A vaccines has not identified differences in overall safety between these subjects and younger adult subjects.

Takhzyro

Takeda Pharmaceuticals Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Addition of 'Injection site urticaria' as a postmarketing ADR with unknown frequency

Vyvanse

Takeda Pharmaceuticals Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

Addition of:

• Takotsubo cardiomyopathy (stress cardiomyopathy) 
• Obsessive-compulsive disorder (OCD) (including trichotillomania and dermatillomania)
• Dry eye

4.9 - Overdose Addition of:

• Takotsubo cardiomyopathy (stress cardiomyopathy)

Xigduo XR

AstraZeneca Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading 'Patients with known or suspected mitochondrial diseases, Metformin hydrochloride'. In patients with known mitochondrial diseases such as Mitochondrial Encephalomyopathy with Lactic Acidosis, and Stroke-like episodes (MELAS) syndrome and Maternally Inherited Diabetes and Deafness (MIDD), metformin is not recommended due to the risk of lactic acidosis exacerbation and neurologic complications which may lead to worsening of the disease. In case of signs and symptoms suggestive of MELAS syndrome or MIDD after the intake of metformin, treatment with metformin should be withdrawn immediately and prompt diagnostic evaluation should be performed. Updated warning under subheading 'Diabetic ketoacidosis'. Consider monitoring for ketoacidosis. This is recommended for all patients on empagliflozin, even if drug treatment has been interrupted or discontinued.
• Updated warning under subheading 'Surgery'. Treatment with XIGDUO XR should be ceased at least 48 hours prior to major surgery or procedures associated with prolonged fasting. An increase in other glucose lowering agents may be required during this time.
• Updated warning under subheading 'Ketoacidosis', Ketoacidosis and glucosuria may be prolonged after discontinuation of XIGDUO XR in some patients, i.e. it may last longer than expected based on the plasma half-lives of dapagliflozin. Consider monitoring for ketoacidosis and glucosuria in patients on dapagliflozin, even if drug treatment has been interrupted or discontinued.
• Added new warning under heading 'Effects on laboratory tests', subheading 'Increased Haematocrit'. Increased haematocrit has been observed with dapagliflozin treatment. Patients with pronounced elevations in haematocrit should be monitored and investigated for underlying haematological disease.

4.8 - Adverse effects (undesirable effects)

• Updated adverse event under subheading 'Genital infections'. Cases of phimosis/acquired phimosis have been reported with dapagliflozin concurrent with genital infections and in some cases, circumcision was required.
• Added new adverse event Increased haematocrit with a frequency of common
• Added new adverse event tubulointerstitial nephritis with frequency very rare

Modavigil

Neuraxpharm Australia Pty Ltd

4.5 - Interactions with other medicines and other forms of interactions

• Addition of warning regarding interactions with ioflupane

Inomax

Ikaria Australia Pty Ltd

4.4 - Special warnings and precautions for use:

• Added new warning under subheading 'Pulmonary veno-occlusive disease'. Cases of pulmonary oedema have been reported with vasodilators, including nitric oxide, when used in patients with pulmonary veno-occlusive disease. Consequently, if signs of pulmonary oedema occur when INOmax is administered in patients with pulmonary arterial hypertension, the possibility of pulmonary veno-occlusive disease should be considered. If confirmed, the treatment is to be discontinued.

Opdualag

Bristol-Myers Squibb Australia Pty Ltd

4.8 - Adverse effects (undesirable effects), Postmarketing Experience:

• Added Stevens-Johnson syndrome
• Added toxic epidermal necrolysis
• Added pleural effusion
• Added serositis.

Tagrisso

AstraZeneca Pty Ltd

4.8 - Adverse effects (Undesirable effects)

• Added new description to footnote relating to interstitial lung disease in Table 2 Adverse drug reactions reported in ADAURA, FLAURA, FLAURA2 (monotherapy arm) and AURA studies. Cases of eosinophilic pneumonia have additionally been reported in the post-marketing setting.
• Added myopathy-related events such as myositis and rhabdomyolysis

Ibrance

Pfizer Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading 'Venous thromboembolism'. Venous thromboembolic events were reported in patients treated with IBRANCE. Patients should be monitored for signs and symptoms of deep vein thrombosis and pulmonary embolism, and treated as medically appropriate.

4.8 - Adverse effects (undesirable effects)

• Added venous thromboembolism

Pelgraz

Accord Healthcare Pty Ltd

4.4 - Special warnings and precautions for use

• Addition of Capillary Leak Syndrome

4.8 - Adverse effects (undesirable effects) 

• Addition of Capillary Leak Syndrome in post-marketing experience

Baxter Potassium Chloride

Baxter Healthcare Pty Ltd

4.4 - Special warnings and precautions for use

• Addition of information under sub-heading 'Hyperkalaemia'. To avoid Hyperkalaemia, do not infuse Baxter Potassium Chloride and Sodium Chloride IV Infusion rapidly.

Panafcortelone / Predsolone

Aspen Pharmacare Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Addition of panniculitis as an Adverse effect with frequency 'unknown'

Panafcort / Predsone

Aspen Pharmacare Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Addition of warning on Thyrotoxic Periodic Paralysis (TPP) in patients with hyperthyroidism and with prednisone-induced hypokalaemia

4.8 - Adverse effects (undesirable effects)

• Addition of panniculitis as an AE with a frequency 'not known'

Tritace / Ramipril Sandoz / Ramipril Winthrop

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Additional warning statements regarding angioedema of the head, neck and extremities

Red Back Spider Antivenom

Seqirus Pty Ltd

4.4 - Special warnings and precautions for use

• Strengthened wording around horse and horse dander allergies

Rocumed / Rocuronium Bromide Medsurge

Medsurge Pharma Pty Ltd

4.4 - Special warnings and precautions for use

• Added hypertensive crisis in patients with phaeochromocytoma

4.8 - Adverse effects (undesirable effects)

• Hypersensitivity with rocuronium and rocuronium-sugammadex complex added in postmarketing

Ventolin Inhaler

GlaxoSmithKline Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Update to include warning statement related to increased blood sugar levels

Stonefish Antivenom

Seqirus Pty Ltd

4.4 - Special warnings and precautions for use

• Strengthened wording around horse and horse-dander allergies

Septrin

Arrotex Pharmaceuticals Pty Ltd

4.4 - Special warnings and precautions for use

• Updated life-threatening reactions, respiratory toxicity reactions, skin reactions including SJS, TEN, DRESS, use in renal and hepatic impairment
• Added immune thrombocytopenia
• Added circulatory shock

4.8 - Adverse effects (undesirable effects)

• Updated allergic, endocrine and metabolism, gastrointestinal, haemotologic, hepatic and neurologic adverse effects
• Added musculoskeletal, ophthalmologic, psychiatric, respiratory, skin and subcutaneous tissue disorders, vascular disorders adverse effects
• Added circulatory shock

APO-Temazepam / Normison / Temazepam-WGR / Temtabs

Aspen Pharmacare Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Concomitant use of temazepam and opioids may result in sedation
• Warning regarding lactose intolerance these products contains lactose

4.5 - Interactions with other medicines and other forms of interactions

• The concomitant use of temazepam with opioids increases the risk of sedation, respiratory depression, coma and death due to additive CNS depressant effect

APO-Teriflunomide / Teriflunomide Dr.Reddy's

Dr Reddys Laboratories Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading 'Use in Males'. Teriflunomide is detected in human semen. Animal studies to specifically evaluate the risk of male mediated foetal toxicity have not been conducted. To minimise any possible risk, men not wishing to father a child and their female partners should use reliable contraception. Men wishing to father a child should discontinue use of Teriflunomide and undergo an accelerated elimination procedure or wait 2 years after treatment cessation. In either case, plasma levels of the active metabolite must be verified to be less than 0.02 mg/L on two separate tests at an interval of at least 14 days apart. If the plasma concentration is less than 0.02mg/L on both tests, and after a waiting period of at least 3 months, the risk of male-mediated foetal toxicity is considered very low.

4.6 - Fertility, pregnancy and lactation

• Updated warning under subheading 'Use in Males'. Teriflunomide is detected in human semen. Animal studies to specifically evaluate the risk of male mediated foetal toxicity have not been conducted. To minimise any possible risk, men not wishing to father a child and their female partners should use reliable contraception. Men wishing to father a child should discontinue use of Teriflunomide and undergo an accelerated elimination procedure or wait 2 years after treatment cessation. In either case, plasma levels of the active metabolite must be verified to be less than 0.02 mg/L on two separate tests at an interval of at least 14 days apart. If the plasma concentration is less than 0.02mg/L on both tests, and after a waiting period of at least 3 months, the risk of male-mediated foetal toxicity is considered very low.

Teriflunomide Sandoz

Sandoz Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading 'Use in Males'. Teriflunomide is detected in human semen. Animal studies to specifically evaluate the risk of male mediated fetal toxicity have not been conducted. To minimise any possible risk, men not wishing to father a child and their female partners should use reliable contraception. Men wishing to father a child should discontinue use of teriflunomide and undergo an accelerated elimination procedure or wait 2 years after treatment cessation. In either case, plasma levels of the active metabolite must be verified to be less than 0. 02 mg/L on two separate tests at an interval of at least 14 days apart. If the plasma concentration is less than 0.02 mg/L on both tests, and after a waiting period of at least 3 months, the risk of male-mediated fetal toxicity is considered very low.

4.6 - Fertility, pregnancy and lactation

• Updated warning under subheading 'Use in Males'. Teriflunomide is detected in human semen. Animal studies to specifically evaluate the risk of male mediated fetal toxicity have not been conducted. To minimise any possible risk, men not wishing to father a child and their female partners should use reliable contraception. Men wishing to father a child should discontinue use of teriflunomide and undergo an accelerated elimination procedure or wait 2 years after treatment cessation. In either case, plasma levels of the active metabolite must be verified to be less than 0.02 mg/L on two separate tests at an interval of at least 14 days apart. If the plasma concentration is less than 0.02 mg/L on both tests, and after a waiting period of at least 3 months, the risk of male-mediated fetal toxicity is considered very low.

4.8 - Adverse effects (Undesirable effects)

• Added nail psoriasis

Jinarc / Samsca

Otsuka Australia Pharmaceutical Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Addition of Post-marketing adverse reaction - blood creatine phosphokinase increased

Cyklokapron

Pfizer Australia Pty Ltd

4.8 - Adverse effects (undesirable effects) 

• Addition of 'seizure' and 'renal cortical necrosis'

Tranexamic-AFT

AFT Pharmaceuticals Pty Ltd

4.2 - Dose and method of administration

Added new warning TRANEXAMIC ACID MUST NOT BE USED FOR INTRATHECAL OR EPIDURAL ADMINISTRATION

4.3 - Contraindications

Added new contraindication, intrathecal and epidural administration of tranexamic acid is contraindicated

4.4 - Special warnings and precautions for use

Added new warning, serious events including death and cardiac arrythmias were reported in patients erroneously treated with tranexamic acid via intrathecal or epidural injection

Vesanoid

Pharmaco Australia Ltd

Diphereline

Ipsen Pty Ltd

4.4 - Special warnings and precautions for use

• Addition of warning related to Severe cutaneous adverse reactions (SCARs)
• Updated pseudotumour cerebri (PTC) / idiopathic intracranial hypertension (IIH)

4.8 - Adverse effects (undesirable effects)

• Addition of severe cutaneous adverse reactions (SCARs) to Adverse Reactions tables for use in men and children

Vfend

Pfizer Australia Pty Ltd

4.5 - Interactions with other medicines and other forms of interactions

• Addition of mavacamten drug-drug interaction text, and inclusion of mavacamten in Table 4

Brukinsa

BeOne Medicines AUS Pty Ltd

4.4 - Special warnings and precautions for use

• Updated the existing warning under the subheading 'Cardiac Arrhythmias' Serious cardiac arrhythmias have occurred in patients treated with BRUKINSA. Atrial fibrillation and atrial flutter of any grade have occurred in 4.6% of patients with haematological malignancies treated with zanubrutinib monotherapy, particularly in patients with cardiac risk factors, hypertension, and acute infections. Grade 3 or higher events occurred in 1.9% of patients. Grade 3 or higher ventricular arrhythmias were reported in 0.2% of patients. Monitor signs and symptoms of cardiac arrhythmias (e.g., palpitations, dizziness, syncope, dyspnea, chest discomfort) and manage as appropriate.
• Added a new warning under the subheading 'Hepatotoxicity, including drug-induced liver injury' Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of drug-induced liver injury (DILI), has occurred in patients treated with Bruton tyrosine kinase inhibitors, including BRUKINSA. Evaluate bilirubin and transaminases at baseline and throughout treatment with BRUKINSA. For patients who develop abnormal liver tests after BRUKINSA, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold BRUKINSA. Upon confirmation of DILI, discontinue BRUKINSA.

4.8 - Adverse effects (Undesirable effects), Postmarketing experience Added the subheading 'Postmarketing experience' and adverse effects 'hepatoxicity and drug-induced liver injury'

Clopixol

Lundbeck Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Rhabdomyolysis in relation to neuroleptic malignant syndrome