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EVEROLIMUS MYLAN is a brand name for Everolimus. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Hormone receptor-positive advanced breast cancer Everolimus Mylan 5 mg tablets is indicated for the treatment of hormone receptor- positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a…
Verbatim from this product's MHRA label. Tap a section to expand.
Treatment with Everolimus Mylan 5 mg tablets should be initiated and supervised by a physician experienced in the use of anticancer therapies. 5 mg, 5 mg and 10 mg tablets. The recommended dose is 10 mg everolimus once daily. Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs.
If a dose is missed, the patient should not take an additional dose, but take the next prescribed dose as usual. Dose adjustment due to adverse reactions Management of severe and/or intolerable suspected adverse reactions may require dose reduction and/or temporary interruption of Everolimus Mylan 5 mg tablets therapy.
For adverse reactions of Grade 1, dose adjustment is usually not required. If dose reduction is required, the recommended dose is 5 mg daily and must not be lower than 5 mg daily. 4). Table 1 Everolimus Mylan 5 mg tablets dose adjustment recommendations Adverse reaction Severity1 Everolimus Mylan 5 mg tablets dose adjustment Grade 2 Consider interruption of therapy until symptoms improve to Grade ≤1.
Re-initiate treatment at 5 mg daily. Discontinue treatment if failure to recover within 4 weeks. Grade 3 Interrupt treatment until symptoms resolve to Grade ≤1. Consider re-initiating treatment at 5 mg daily. If toxicity recurs at Grade 3, consider discontinuation.
Non-infectious pneumonitis Grade 4 Discontinue treatment. Grade 2 Temporary dose interruption until recovery to Grade ≤1. Re-initiate treatment at same dose. If stomatitis recurs at Grade 2, interrupt dose until recovery to Grade ≤1. Re-initiate treatment at 5 mg daily.
Grade 3 Temporary dose interruption until recovery to Grade <1. Re- initiate treatment at 5 mg daily. Stomatitis Grade 4 Discontinue treatment. 2). 2). 5 mg daily. - Moderate hepatic impairment (Child-Pugh B) - the recommended dose is 5 mg daily.
Grade 2 If toxicity is tolerable, no dose adjustment required. If toxicity becomes intolerable, temporary dose interruption until recovery to Grade ≤1. Re-initiate treatment at same dose. If toxicity recurs at Grade 2, interrupt treatment until recovery to Grade ≤1.
Re-initiate treatment at 5 mg daily. Grade 3 Temporary dose interruption until recovery to Grade ≤1. Consider re-initiating treatment at 5 mg daily. If toxicity recurs at Grade 3, consider discontinuation. Other non-haematological toxicities (excluding metabolic events) Grade 4 Discontinue treatment.
Summary of the safety profile The safety profile is based on pooled data from 2,879 patients treated with everolimus in eleven clinical studies, consisting of five randomised, double-blind, placebocontrolled phase III studies and six open-label phase I and phase II studies, related to the approved indications.
The most common adverse reactions (incidence ≥1/10) from the pooled safety data were (in decreasing order): stomatitis, rash, fatigue, diarrhoea, infections, nausea, decreased appetite, anaemia, dysgeusia, pneumonitis, oedema peripheral, hyperglycaemia, asthenia, pruritus, weight decreased, hypercholesterolaemia, epistaxis, cough and headache.
The most frequent Grade 3-4 adverse reactions (incidence ≥1/100 to <1/10) were stomatitis, anaemia, hyperglycaemia, infections, fatigue, diarrhoea, pneumonitis, asthenia, thrombocytopenia, neutropenia, dyspnoea, proteinuria, lymphopenia, haemorrhage, hypophosphataemia, rash, hypertension, pneumonia, alanine aminotransferase (ALT) increased, aspartate aminotransferase (AST) increased and diabetes mellitus.
03. Tabulated list of adverse reactions Table 3 presents the frequency category of adverse reactions reported in the pooled analysis considered for the safety pooling. Adverse reactions are listed according to MedDRA system organ class and frequency category.
Frequency categories are defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Table 1 Adverse reactions reported in clinical studies Infections and infestations Very common Infections a, * Blood and lymphatic system disorders Very common Anaemia Common Thrombocytopenia, neutropenia, leukopenia, lymphopenia, lymphoedema Uncommon Pancytopenia Rare Pure red cell aplasia Immune system disorders Uncommon Hypersensitivity Metabolism and nutrition disorders Very common Decreased appetite, hyperglycaemia, hypercholesterolaemia Common Hypertriglyceridaemia, hypophosphataemia, diabetes mellitus, hyperlipidaemia, hypokalaemia, dehydration, hypocalcaemia Psychiatric disorders Common Insomnia Nervous system disorders Very common Dysgeusia, headache Uncommon Ageusia Eye disorders Common Eyelid oedema Uncommon Conjunctivitis Cardiac disorders Uncommon Congestive cardiac failure Vascular disorders Common Haemorrhage b, hypertension Uncommon Flushing, deep vein thrombosis Respiratory, thoracic and mediastinal disorders Very common Pneumonitis c, epistaxis, cough Common Dyspnoea Uncommon Haemoptysis, pulmonary embolism Rare Acute respiratory distress syndrome Gastrointestinal disorders Very common Stomatitis d, diarrhoea, nausea Common Vomiting, dry mouth, abdominal pain, mucosal inflammation, oral pain, dyspepsia, dysphagia Hepatobiliary disorders Common Aspartate aminotransferase increased, alanine aminotransferase increased Description of selected adverse reactions In clinical studies and post-marketing spontaneous reports, everolimus has been associated with serious cases of hepatitis B reactivation, including fatal outcome.
Non-infectious pneumonitis Non-infectious pneumonitis is a class effect of rapamycin derivatives, including everolimus. 8). Some cases were severe and on rare occasions, a fatal outcome was observed. A diagnosis of non-infectious pneumonitis should be considered in patients presenting with non-specific respiratory signs and symptoms such as hypoxia, pleural effusion, cough or dyspnoea, and in whom infectious, neoplastic and other non-medicinal causes have been excluded by means of appropriate investigations.
Opportunistic infections such as pneumocystis jirovecii (carinii) pneumonia (PJP, PCP) should be ruled out in the differential diagnosis of non-infectious pneumonitis (see “Infections” below). Patients should be advised to report promptly any new or worsening respiratory symptoms.
Patients who develop radiological changes suggestive of non-infectious pneumonitis and have few or no symptoms may continue Everolimus Mylan 5 mg tablets therapy without dose adjustments. If symptoms are moderate (Grade 2) or severe (Grade 3) the use of corticosteroids may be indicated until clinical symptoms resolve.
For patients who require use of corticosteroids for treatment of non-infectious pneumonitis, prophylaxis for pneumocystis jirovecii (carinii) pneumonia (PJP, PCP) may be considered. 8). Localised and systemic infections, including pneumonia, other bacterial infections, invasive fungal infections such as aspergillosis, candidiasis or PJP/PCP and viral infections including reactivation of hepatitis B virus, have been described in patients taking everolimus.
g. leading to sepsis, respiratory or hepatic failure) and occasionally fatal. Physicians and patients should be aware of the increased risk of infection with Everolimus Mylan 5 mg tablets. Pre-existing infections should be treated appropriately and should have resolved fully before starting treatment with Everolimus Mylan 5 mg tablets.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Grade 2 No dose adjustment required. Grade 3 Temporary dose interruption. Re-initiate treatment at 5 mg daily. g. hyperglycaemia, dyslipidaemia) Grade 4 Discontinue treatment. Grade 2 (<75, ≥50x109/l) Temporary dose interruption until recovery to Grade ≤1 (≥75x109/l).
Re-initiate treatment at same dose. Thrombocytopenia Grade 3 & 4 (<50x109/l) Temporary dose interruption until recovery to Grade ≤1 (≥75x109/l). Re-initiate treatment at 5 mg daily. Grade 2 (≥1x109/l) No dose adjustment required. 5x109/l) Temporary dose interruption until recovery to Grade ≤2 (≥1x109/l).
Re-initiate treatment at same dose. 5x109/l) Temporary dose interruption until recovery to Grade ≤2 (≥1x109/l). Re-initiate treatment at 5 mg daily. 25x109/l) and no fever. Re-initiate treatment at 5 mg daily. 0 - Severe hepatic impairment (Child-Pugh C) - Everolimus Mylan 5 mg tablets is only recommended if the desired benefit outweighs the risk.
5 mg daily must not be exceeded. 2). Paediatric population The safety and efficacy of Everolimus Mylan 5 mg tablets in children aged 0 to 18 years have not been established. No data are available. 2). Everolimus Mylan 5 mg tablets should be swallowed whole with a glass of water.
The tablets should not be chewed or crushed.
Reactivation of infection is an expected event during periods of immunosuppression. In clinical studies and post-marketing spontaneous reports, everolimus has been associated with renal failure events (including fatal outcome) and proteinuria.
4). In clinical studies and post-marketing spontaneous reports, everolimus has been associated with cases of amenorrhoea (secondary amenorrhoea and other menstrual irregularities). 4). 4). g. 4)] and (rare) viral myocarditis b Includes different bleeding events from different sites not listed individually c Includes (very common) pneumonitis, (common) interstitial lung disease, lung infiltration and (rare) pulmonary alveolar haemorrhage, pulmonary toxicity, and alveolitis d Includes (very common) stomatitis, (common) aphthous stomatitis, mouth and tongue ulceration and (uncommon) glossodynia, glossitis e Frequency based upon number of women from 10 to 55 years of age in the pooled data f.
Adverse reaction identified in the post-marketing setting Elderly patients In the safety […]
While taking Everolimus Mylan 5 mg tablets, be vigilant for symptoms and signs of infection; if a diagnosis of infection is made, institute appropriate treatment promptly and consider interruption or discontinuation of Everolimus Mylan 5 mg tablets.
If a diagnosis of invasive systemic fungal infection is made, the Everolimus Mylan 5 mg tablets treatment should be promptly and permanently discontinued and the patient treated with appropriate antifungal therapy. Cases of pneumocystis jirovecii (carinii) pneumonia (PJP, PCP), some with fatal outcome, have been reported in patients who received everolimus.
PJP/PCP may be associated with concomitant use of corticosteroids or other immunosuppressive agents. Prophylaxis for PJP/PCP should be considered when concomitant use of corticosteroids or other immunosuppressive agents are required.
g. 3). g. g. 5). 8). Stomatitis mostly occurs within the first 8 weeks of treatment. 1). Management of stomatitis may therefore include prophylactic and/or therapeutic use of topical treatments such as an alcohol- free corticosteroid oral solution as a mouthwash.
However products containing alcohol, hydrogen peroxide, iodine and thyme derivatives should be avoided as they may exacerbate the condition. Monitoring for and treatment of fungal infection is recommended, especially in patients being treated with steroid-basedmedicinal product.
5). 8). Renal function should be monitored particularly where patients have additional risk factors that may further impair renal function. 8). Monitoring of renal function, including measurement of blood urea nitrogen (BUN), urinary protein or serum creatinine, is recommended prior to the start of Everolimus Mylan 5 mg tablets therapy and periodically thereafter.
8). Monitoring of fasting serum glucose is recommended prior to the start of Everolimus Mylan 5 mg tablets therapy and periodically thereafter. More frequent monitoring is recommended when Everolimus Mylan 5 mg tablets is co-administered with other medicinal products that may induce hyperglycaemia.
When possible optimal glycaemic control should be achieved before starting a patient on Everolimus Mylan 5 mg tablets. […]