Epipen/ Epipen Jr
Alphapharm Pty Ltd
4.4 - Special warnings and precautions for use
- Added biphasic anaphylaxis
- Updated high intraocular pressure
4.5 - Interactions with other medicines and other forms of interactions
Updated:
- Alpha-adrenergic blocking agents
- Beta-adrenergic blocking agents
Alustal House Dust Mites Extract
Stallergenes Australia Pty Ltd
4.2 - Dose and method of administration
Added:
- Concomitant treatment with more than one allergen
- Infection and atopic dermatitis
4.3 - Contraindications
Added:
- Hypersensitivity to excipients
- Auto-immune disorder
- Asthma
- Pregnancy
- Renal insufficiency
4.4 - Special warnings and precautions for use
Added:
- Previous systemic allergic reaction to allergen immunotherapy,
- Cardiovascular diseases
- Local allergic reactions
4.5 - Interactions with other medicines and other forms of interactions
- Added vaccines
4.6 - Fertility, pregnancy and lactation
- Added dose toxicity studies
4.8 - Adverse effects (undesirable effects)
Added:
- Rhinitis
- Conjunctivitis
- Headache
- Asthenia
Alustal Pollen Extract of Five Grasses
Stallergenes Australia Pty Ltd
4.2 - Dose and method of administration
Added:
- Concomitant treatment with more than one allergen
- Infection and atopic dermatitis
4.3 - Contraindications
Added:
- Hypersensitivity to excipients
- Auto-immune disorder
- Asthma
- Pregnancy
- Renal insufficiency
4.4 - Special warnings and precautions for use
Added:
- Previous systemic allergic reaction to allergen immunotherapy,
- Cardiovascular diseases
- Local allergic reactions
4.5 - Interactions with other medicines and other forms of interactions
- Added vaccines
4.6 - Fertility, pregnancy and lactation
- Added dose toxicity studies
4.8 - Adverse effects (undesirable effects)
Added:
- Rhinitis
- Conjunctivitis
- Headache
- Asthenia
Scemblix
Novartis Pharmaceuticals Australia Pty Ltd
4.5 - Interactions with other medicines and other forms of interactions
- Update to OATP1B substrates and strong CYP3A4 inducers
APO-atomoxetine
Arrotex Pharmaceuticals Pty Ltd
4.4 - Special warnings and precautions for use
- Added serotonin syndrome
- Added emotional lability
- Updated aggressive behaviour to include homicidal ideation
4.5 - Interactions with other medicines and other forms of interactions
- Added serotoninergic medications
4.8 - Adverse effects (undesirable effects)
- Added bruxism
4.9 - Overdose
- Added serotonin syndrome
Atomoxetine-WGR
GM Pharma International Pty Ltd
4.4 - Special warnings and precautions for use
- Added serotonin syndrome
- Added emotional lability
- Updated aggressive behaviour to include homicidal ideation
4.5 - Interactions with other medicines and other forms of interactions
- Added serotoninergic medications
4.8 - Adverse effects (undesirable effects)
- Added bruxism
4.9 - Overdose
- Added serotonin syndrome
Libtayo
Medison Pharma Australia 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 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 new adverse effect, aplastic anaemia, under subheading ‘immune checkpoint inhibitor class effects’.
Cotellic
Roche Products Pty Ltd
4.8 - Adverse effects (undesirable effects)
- Added stomatitis with a frequency of very common.
Veletri
Janssen-Cilag Pty Ltd
4.8 - Adverse effects (undesirable effects)
- Added urticaria
Yervoy
Bristol-Myers Squibb Australia Pty Ltd
4.2 - Dose and Method of Administration
- Added dosing modifications under subheading ‘recommended treatment modifications’. Added advice to permanently discontinue Yervoy as monotherapy with Grade 4 diabetes to Table 1 and advice to withhold dose of Yervoy as monotherapy with Grade 3 diabetes to Table 2.
4.4 - Special warnings and precautions for use
- Added new warning under subheading ‘immune-related endocrinopathy’, to include risk of type 1 diabetes mellitus and diabetic ketoacidosis with Yervoy. Also, for symptomatic diabetes, Yervoy should be withheld, and insulin replacement should be initiated as needed. Monitoring of blood sugar should continue to ensure appropriate insulin replacement is utilised. Yervoy must be permanently discontinued for life-threatening diabetes.
- Added new warning under subheading ‘other immune-mediated adverse reactions’. Cases of haemolytic anaemia and aplastic anaemia have been observed during treatment with immune checkpoint inhibitors. Patients should be monitored for signs and symptoms indicative of these immune-mediated adverse reactions.
- Added new warning under subheading ‘patients with autoimmune disease’. Data from observational studies suggest that the risk of immune-mediated adverse reactions following immune checkpoint inhibitor therapy may be increased in patients with pre-existing autoimmune disease. In addition, flares of the underlying autoimmune disease were frequent, but the majority were mild and manageable.
4.8 - Adverse effects (undesirable effects)
- Added coeliac disease and pancreatic exocrine insufficiency with a frequency of rare for monotherapy ipilimumab.
- Added cytokine release syndrome to infusion related reactions. Added coeliac disease and pancreatic exocrine insufficiency with a frequency of rare for combination ipilimumab therapy with nivolumab.
- Added coeliac disease and pancreatic exocrine insufficiency with a frequency of rare for combination ipilimumab therapy with nivolumab and platinum-doublet chemotherapy.
Midazolam Injection
Pfizer Australia Pty Ltd
4.4 - Special warnings and precautions for use
- Addedlocal reactions and seizures with intraarterial injection (only intramuscularly or intravenously administration is recommended)
- Expanded warning for use in children
4.6 - Fertility, pregnancy and lactation
- Added advice to monitor neonates exposed to midazolam during pregnancy or labour
4.9 - Overdose
- Added additional signs of overdose
Contrave 8/90
iNova Pharmaceuticals (Australia) Pty Ltd
4.3 - Contraindications
- Added concomitant use of opioids contraindicated
4.4 - Special warnings and precautions for use
- Added concomitant use of opioids contraindicated
4.5 - Interactions with other medicines and other forms of interactions
- Added concomitant use of opioids contraindicated
4.8 - Adverse effects (undesirable effects)
- Updated ADR serotonin syndrome to include opioid interaction
Beyfortus
Sanofi Aventis Australia Pty Ltd
4.4 - Special warnings and precautions for use
- Added additional warning under subheading ‘Hypersensitivity including anaphylaxis’. Serious hypersensitivity reactions included urticaria, dyspnoea, cyanosis, and/or hypotonia.
Opdivo
Bristol-Myers Squibb Australia Pty Ltd
4.4 - Special warnings and precautions for use
- Added new warning under subheading ‘other immune-related adverse reactions’. Cases of haemolytic anaemia and aplastic anaemia have been observed during treatment with immune checkpoint inhibitors. Patients should be monitored for signs and symptoms indicative of these immune-mediated adverse reactions.
- 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 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 cytokine release syndrome to infusion related reactions. Added coeliac disease and pancreatic exocrine insufficiency with a frequency of rare for monotherapy nivolumab.
- Added including cytokine release syndrome to infusion related reactions. Added coeliac disease with a frequency of rare for combination nivolumab therapy with ipilimumab.
- Added cytokine release syndrome to infusion related reactions. Added coeliac disease with a frequency of not known for combination nivolumab therapy with ipilimumab and platinum-based chemotherapy.
- Added coeliac disease with a frequency of not known for combination nivolumab therapy with cabozantinib.
- Added cytokine release syndrome to infusion related reactions. Added coeliac disease with a frequency of not known for combination nivolumab therapy with chemotherapy.
- Added new post marketing adverse effect enterocolitis.
Opdualag
Bristol-Myers Squibb Australia 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 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 new adverse effects under the ‘Postmarketing experience’ heading: infusion related reaction (including cytokine release syndrome), coeliac disease, pancreatic insufficiency and enterocolitis.
Endone
Viatris Pty Ltd
4.4 - Special warnings and precautions for use
- Added hepatobiliary disorders
4.8 - Adverse effects (undesirable effects)
- Added sphincter of Oddi dysfunction
4.9 - Overdose
- Added hypoglycaemia
Actonel once a month /Actonel EC once a week /Actonel
Theramex Australia Pty Ltd
4.8 - Adverse effects (undesirable effects)
- Added orbital inflammation
Risperdal
Janssen-Cilag Pty Ltd
4.2 - Dose and Method of Administration
- Added new dosing instructions and figures for the oral solution under subheading ‘Directions for Opening the Bottle and using the Pipette for the Oral Solution’.
Mayzent
Novartis Pharmaceuticals Australia Pty Ltd
4.4 - Special warnings and precautions for use
- Added risk of Immune Reconstitution Inflammatory Syndrome (IRIS) in patients with PML
4.8 - Adverse effects (undesirable effects)
- Added malignant melanoma
- Updated infections
Revestive
Takeda Pharmaceuticals Australia Pty Ltd.
4.8 - Adverse effects (undesirable effects)
Added:
- Small intestinal polyps
- Injection site reactions
Zelboraf
Roche Products Pty Ltd
4.8 - Adverse effects (undesirable effects)
- Added stomatitis with a frequency of common.
