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Acitretin
At least 0.4mg/kg/day
| Adverse event | Brief description of minimum grade of toxicity | National Institutes of Health common toxicity criteria grade |
|---|---|---|
| Bilirubin | > 1.5 x ULN | 2 (or higher) |
| Transaminases | ALT and/or AST > 2.5 x ULN or ALT and/or AST > 1.5 x ULN on three occasions over a three month period | 2 (or higher) |
| Serum alkaline phosphatase | 2.5 x ULN | 2 (or higher) |
| Use contraindicated in those with pre-existing significant renal disease | Creatinine > 1.5 ULN | 2 (or higher) |
| Retinoic acid syndrome | Symptoms of a degree to indicate steroid use | 2 (or higher) |
| Pseudotumour cerebri | Headache, nausea and vomiting associated with raised intracranial pressure | |
| Nausea | Oral intake significantly decreased | 2 (or higher) |
| Skin peeling | Development of fissures on the palms and soles which cause sufficient discomfort and pain to prevent normal day-to-day duties, and which have not responded to regular and liberal applications of a moisturising agent | |
| Skin burning | Sufficient to disturb activities of daily living and to disturb the normal sleep pattern |
Cyclosporin
At least 2mg/kg/day
| Adverse event | Brief description of minimum grade of toxicity | National Institutes of Health common toxicity criteria grade |
|---|---|---|
| Blood/bone marrow | ||
| Anaemia | Haemoglobin < 80 g/L | 3 (or higher) |
| Leukopenia | Total WCC < 3 x 109/L | 2 (or higher) |
| Thrombocytopenia | Platelets < 50 x 109/L | 3 (or higher) |
| Neutropenia | Total neutrophils < 1.0 x 109/L | 3 (or higher) |
| Cardiovascular | ||
| Hypertension | Recurrent/persistent rise of > 20 mmHg diastolic BP or rise to > 150/90 on two occasions if BP previously normal | 2 (or higher) |
| Fluid retention | Symptomatic, limiting function, unresponsive to therapy or requiring drug discontinuation | 3 (or higher) |
| Dermatology/skin | ||
| Rash/desquamation | Scattered macular or papular eruption or erythema with pruritis or other associated symptoms covering < 50% of body surface or localised desquamation or other lesions covering < 50% of body | 2 (or higher) |
| Gastrointestinal | ||
| Diarrhoea | Increase of 4-6 stools/day over pre-treatment | 2 (or higher) |
| Nausea | Oral intake significantly decreased | 2 (or higher) |
| Pancreatitis | Abdominal pain with pancreatic enzyme elevation | 3 (or higher) |
| Vomiting | 2 or more episodes/24 hours over pre-treatment | 2 (or higher) |
| Weight gain/loss | 20% or more weight gain or loss | 3 (or higher) |
| Hepatic | ||
| Bilirubin | > 1.5 x ULN | 2 (or higher) |
| Transaminases | ALT and/or AST > 2.5 x ULN or ALT and/or AST > 1.5 x ULN on three occasions over a three month period | 2 (or higher) |
| g Serum alkaline phosphatase | 2.5 x ULN | 2 (or higher) |
| Musculoskeletal | ||
| Muscle weakness | Symptomatic and interfering with function | 2 (or higher) |
| Neurology/senses | ||
| Ataxia (incoordination) | Mild symptoms interfering with function but not interfering with activities of daily living | 2 (or higher) |
| Decreased level of consciousness | Somnolence or sedation interfering with function but not interfering with activities of daily living | 2 (or higher) |
| Headaches (severe) | Severe pain: pain or analgesics that severely interfere with activities of daily living | 3 (or higher) |
| Hearing | Tinnitus or hearing loss not requiring hearing aid or treatment | 2 (or higher) |
| Mood alteration | Moderate mood alteration interfering with function but not interfering with activities of daily living | 2 (or higher) |
| Neuropathy -sensory | Objective sensory loss or paraesthesia interfering with function but not interfering with activities of daily living | 2 (or higher) |
| Seizure(s) | Seizures in which consciousness is altered | 3 (or higher) |
| Vision | Symptomatic and interfering with function but not interfering with activities of daily living | 2 (or higher) |
| Renal | ||
| Haematuria | Macroscopic (or dipstick +++) confirmed on two separate occasions | 2 (or higher) |
| Proteinuria | > 1.0g/24 hours, elevated urine protein/creatinine ratios, (dipstick protein ++ or greater), confirmed on two separate occasions | 2 (or higher) |
| Renal impairment | Creatinine > 1.5 ULN or creatinine clearance < 30mL/min | 2 (or higher) |
| Other | ||
| Allergic reaction | Urticaria, drug fever > 38°C and/or bronchospasm | 2 (or higher) |
| Fatigue/malaise | Severe, loss of ability to perform some activities | 3 (or higher) |
| Fever (in the absence of neutropenia) | Body temp > 39°C (oral or tympanic) | 2 (or higher) |
| Hyperkalaemia | Potassium > 6 mmol/L | 3 (or higher) |
| Infection | Severe, systemic infection, requiring IV antimicrobial treatment or hospitalisation | 3 (or higher) |
| Secondary malignancy | Secondary malignancy present | 4 |
Methotrexate
At least 10mg weekly
| Adverse event | Brief description of minimum grade of toxicity | National Institutes of Health common toxicity criteria grade |
|---|---|---|
| Blood/bone marrow | ||
| Anaemia | Haemoglobin < 80 g/L | 3 (or higher) |
| Leukopenia | Total WCC < 3 x 109/L | 2 (or higher) |
| Thrombocytopenia | Platelets < 50 x 109/L | 3 (or higher) |
| Neutropenia | Total neutrophils < 1.0 x 109/L | 3 (or higher) |
| Cardiovascular | ||
| Pericardial effusion/pericarditis | Pericarditis (pericardial rub, ECG changes or chest pain) | 2 (or higher) |
| Thrombosis/embolism | Requiring anticoagulant therapy | 3 (or higher) |
| Dermatology/skin | ||
| Alopecia | Pronounced hair loss | 2 (or higher) |
| Rash/desquamation | Scattered macular or papular eruption or erythema with pruritis or other associated symptoms covering < 50% of body surface or localised desquamation or other lesions covering < 50% of body | 2 (or higher) |
| Gastrointestinal | ||
| Diarrhoea | Increase of 4-6 stools/day over pre-treatment | 2 (or higher) |
| Nausea | Oral intake significantly decreased, and symptoms do not improve with at least two of the following measures:
A minimum of three doses of methotrexate should have been trialled |
2 (or higher) |
| Pancreatitis | Abdominal pain with pancreatic enzyme elevation | 3 (or higher) |
| Stomatitis | Painful erythema, oedema or ulcers but able to eat or swallow | 2 (or higher) |
| Vomiting | 2 or more episodes/24 hours over pre-treatment | 2 (or higher) |
| Hepatic | ||
| Bilirubin | > 1.5 x ULN | 2 (or higher) |
| Transaminases | ALT and/or AST > 2.5 x ULN or ALT and/or AST > 1.5 x ULN on three occasions over a three month period | 2 (or higher) |
| g Serum alkaline phosphatase | 2.5 x ULN | 2 (or higher) |
| Musculoskeletal | ||
| Osteonecrosis | Symptomatic and interfering with function | 2 (or higher) (avascular necrosis) |
| Osteoporosis | Symptomatic and requiring treatment | 3 (or higher) |
| Neurology/senses | ||
| Decreased level of consciousness | Somnolence or sedation interfering with function but not interfering with activities of daily living | 2 (or higher) |
| Headaches (severe) | Severe pain: pain or analgesics that severely interfere with activities of daily living | 3 (or higher) |
| Hearing | Tinnitus or hearing loss not requiring hearing aid or treatment | 2 (or higher) |
| Mood alteration | Moderate mood alteration interfering with function but not interfering with activities of daily living | 2 (or higher) |
| Seizure(s) | Seizures in which consciousness is altered | 3 (or higher) |
| Vision | Symptomatic and interfering with function but not interfering with activities of daily living | 2 (or higher) |
| Pulmonary | ||
| Cough (severe) | Severe cough or coughing spasm, poor control or unresponsive to treatment. Evidence of reversal on cessation of treatment | 3 (or higher) |
| Pneumonitis/pulmonary infiltrates | Radiographic changes, Respiratory Function Test abnormalities and requiring steroids or diuretics | 2 (or higher) |
| Pulmonary fibrosis | Respiratory Function Test abnormalities and requiring steroids or diuretics | 2 (or higher) |
| Pulmonary symptoms -new or worsening (probable drug-induced pneumonitis) | Development of syndrome consistent with drug-induced pneumonitis (e.g. cough, dyspnoea, fever, | |
| Renal | ||
| Haematuria | Macroscopic (or dipstick +++) confirmed on two separate occasions | 2 (or higher) |
| Renal impairment | Creatinine > 1.5 ULN or creatinine clearance < 30mL/min | 2 (or higher) |
| Other | ||
| Allergic reaction | Urticaria, drug fever > 38°C and/or bronchospasm | 2 (or higher) |
| Fatigue/malaise | Severe, loss of ability to perform some activities | 3 (or higher) |
| Fever (in the absence of neutropenia) | Body temp > 39°C (oral or tympanic) | 2 (or higher) |
| Infection | Severe, systemic infection, requiring IV antimicrobial treatment or hospitalisation | 3 (or higher) |
| Secondary malignancy | Secondary malignancy present | 4 |
Phototherapy toxicity
Required minimum dose of three treatments per week
| Adverse event | Brief description of minimum grade of toxicity | National Institutes of Health common toxicity criteria grade |
|---|---|---|
| Severe photosensitivity reaction | Erythema with desquamation | 3 (or higher) |
| Pruritis | Intense or widespread and interfering with activities of daily living (ADLs) | 3 (or higher) |
| Development of melanoma | ||
| Development of non melanoma skin cancer | ||
| Development of more than 10 actinic keratoses | ||
| Nausea (PUVA) | Oral intake significantly decreased. A minimum of three doses should be trialled | 2 (or higher) |
| More than 200 combined phototherapy treatments |
Apremilast
Required minimum dose of 30mg twice daily
| Adverse event | Brief description of minimum grade of toxicity | National Institutes of Health common toxicity criteria grade |
|---|---|---|
|
Gastrointestinal |
||
|
Diarrhoea |
Increase of 4-6 stools per day over baseline; moderate increase in ostomy output compared to baseline |
2 (or higher) |
|
Nausea |
Oral intake decreased without significant weight loss, dehydration or malnutrition |
2 (or higher) |
|
Vomiting |
3 - 5 episodes (separated by 5 minutes) in 24 hrs |
2 (or higher) |
|
Abdominal pain |
Moderate pain; limiting instrumental ADL |
2 (or higher) |
|
GORD |
Moderate symptoms; medical intervention indicated |
2 (or higher) |
|
General Disorders/administrative site |
||
|
Fatigue |
Fatigue not relieved by rest; limiting instrumental ADL |
2 (or higher) |
|
Weight decrease |
10 - <20% from baseline; nutritional support indicated |
2 (or higher) |
|
Immune System |
||
|
Hypersensitivity |
Intervention or interruption to treatment indicated; responds promptly to symptomatic treatment (e.g., antihistamines, NSAIDS, narcotics); prophylactic medications indicated for <=24 hrs |
2 (or higher) |
|
Infections/infestations |
||
|
Bronchitis |
Moderate symptoms; oral intervention indicated (e.g., antibiotic, antifungal, antiviral) |
2 (or higher) |
|
Upper respiratory tract infection |
Moderate symptoms; oral intervention indicated (e.g., antibiotic, antifungal, antiviral) |
2 (or higher) |
|
Decreased appetite |
Oral intake altered without significant weight loss or malnutrition; oral nutritional supplements indicated |
2 (or higher) |
|
Musculoskeletal/connective tissue |
||
|
Back pain |
Moderate back pain; prescription analgesics indicated; limiting instrumental ADL |
2 (or higher) |
|
Nervous system |
||
|
Migraine |
Moderate pain; limiting instrumental ADL |
2 (or higher) |
|
Tension headache |
Moderate pain; limiting instrumental ADL |
2 (or higher) |
|
Psychiatric |
||
|
Insomnia |
Moderate difficulty falling asleep, staying asleep or waking up early |
2 (or higher) |
|
Respiratory/thoracic/mediastinal |
||
|
Cough |
Moderate symptoms, medical intervention indicated; limiting instrumental ADL |
2 (or higher) |
|
Skin/subcutaneous tissue |
||
|
Rash |
Localized; local intervention indicated (e.g., topical antibiotic, antifungal, or antiviral) |
2 (or higher) |