Drug Action
Everolimus is a protein kinase inhibitor.
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Individual generic drug information
Extracted information for Everolimus only.
Everolimus is a protein kinase inhibitor.
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Neuroendocrine tumours of pancreatic origin | Neuroendocrine tumours of gastro-intestinal origin ▶BY MOUTH ▶Adult: 10 mg once daily, for dose interruption or adjustments due to side effects—consult product literature AFINITOR ® Neuroendocrine tumours of pancreatic origin | Neuroendocrine tumours of lung origin | Neuroendocrine tumours of gastro-intestinal origin | Renal cell carcinoma | Hormone-receptor positive HER2-negative breast cancer [in combination with exemestane] ▶BY MOUTH ▶Adult: 10 mg once daily, for dose interruption or adjustments due to side-effects—consult product literature CERTICAN ® Liver transplantation ▶BY MOUTH ▶Adult: Initially 1 mg twice daily, to be started approximately 4 weeks after transplantation; maintenance, dose adjusted according to response and whole blood everolimus concentration; dose adjustments can be made every 4–5 days Renal transplantation | Heart transplantation ▶BY MOUTH ▶Adult: Initially 750 micrograms twice daily, to be started as soon as possible after transplantation; maintenance, dose adjusted according to response and whole blood everolimus concentration; dose adjustments can be made every 4–5 days VOTUBIA ® DISPERSIBLE TABLETS Subependymal giant cell astrocytoma associated with tuberous sclerosis complex ▶BY MOUTH USING DISPERSIBLE TABLETS ▶Adult: (consult product literature) Adjunctive treatment of refractory partial-onset seizures, with or without secondary generalisation, associated with tuberous sclerosis complex ▶BY MOUTH USING DISPERSIBLE TABLETS ▶Adult: (consult product literature) VOTUBIA ® TABLETS Subependymal giant cell astrocytoma associated with tuberous sclerosis complex ▶BY MOUTH USING TABLETS ▶Adult: (consult product literature) Renal angiomyolipoma associated with tuberous sclerosis complex ▶BY MOUTH USING TABLETS ▶Adult: (consult product literature)
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History of bleeding disorders. peri-surgical period (impaired wound healing)
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Votubia ® is available as both tablets and dispersible tablets. These formulations vary in their licensed indications and are not interchangeable—consult product literature for information on switching between formulations.
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NICE decisions ▶Everolimus with exemestane for treating advanced breast cancer after endocrine therapy (December 2016) NICE TA421 Everolimus, in combination with exemestane, is recommended within its marketing authorisation for treating advanced human epidermal growth factor receptor 2 (HER2)-negative, hormone-receptor-positive breast cancer in postmenopausal women without symptomatic visceral disease that has recurred or progressed following treatment with a non-steroidal aromatase inhibitor. Everolimus is recommended only if the manufacturer provides it with the discount agreed in the patient access scheme. www.nice.org.uk/TA421 ▶Everolimus for advanced renal cell carcinoma after previous treatment (February 2017) NICE TA432 Everolimus is recommended within its marketing authorisation as an option for treating advanced renal cell carcinoma that has progressed during or after treatment with vascular endothelial growth factor targeted therapy. Everolimus is only recommended if the manufacturer provides it with the discount agreed in the patient access scheme. www.nice.org.uk/TA432 ▶Everolimus and sunitinib for treating unresectable or metastatic neuroendocrine tumours in people with progressive disease (June 2017) NICE TA449 Everolimus and sunitinib are recommended, within their marketing authorisations, as options for treating well- or moderately differentiated unresectable or metastatic neuroendocrine tumours (NETs) of pancreatic origin in adults with progressive disease. Everolimus is recommended, within its marketing authorisation, as an option for treating well-differentiated (grade 1 or grade 2) non-functional unresectable or metastatic NETs of gastrointestinal or lung origin in adults with progressive disease. Everolimus is recommended only when the company provides it with the discount agreed in the patient access scheme. www.nice.org.uk/TA449 VOTUBIA ® DISPERSIBLE TABLETS Scottish Medicines Consortium (SMC) decisions SMC No. 1331/18 The Scottish Medicines Consortium has advised (June 2018) that everolimus (Votubia ® dispersible tablets) are accepted for use within NHS Scotland for the adjunctive treatment of patients aged two years and older whose refractory partial-onset seizures, with or without secondary generalisation, are associated with tuberous sclerosis complex. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower. AFINITOR ® NICE decisions ▶Lenvatinib with everolimus for previously treated advanced renal cell carcinoma (January 2018) NICE TA498 Lenvatinib plus everolimus is recommended as an option for treating advanced renal cell carcinoma in adults who have had one previous vascular endothelial growth factor (VEGF)-targeted therapy, only if: . their Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1, and . the manufacturer provides lenvatinib with the discount agreed in the patient access scheme. Immune system and malignant disease Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta498 CERTICAN ® NICE decisions ▶Everolimus for preventing organ rejection in liver transplantation (July 2015) NICE TA348 Everolimus (Certican ®) is not recommended within its marketing authorisation for preventing organ rejection in patients who have undergone a liver transplant. Patients currently receiving everolimus for this indication should have the option to continue treatment until they and their clinician consider it appropriate to stop. www.nice.org.uk/guidance/TA348 ▶Immunosuppressive therapy for kidney transplant in adults (October 2017) NICE TA481 Everolimus is not recommended as an initial treatment to prevent organ rejection in adults having a kidney transplant. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/TA481
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Extracted information for Everolimus only.
RISKS OF INCORRECT DOSING OF ORAL ANTI-CANCER MEDICINES See Cytotoxic drugs p. 938.
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→Appendix 1: everolimus
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▶Common or very common Alopecia. anaemia. appetite decreased. arthralgia. asthenia. cough. decreased leucocytes. dehydration. diabetes mellitus. diarrhoea. dry mouth. dyslipidaemia. dysphagia. dyspnoea. electrolyte imbalance. eye inflammation. fever. gastrointestinal discomfort. haemorrhage. headache. hyperglycaemia. hypertension. increased risk of infection. insomnia. menstrual cycle irregularities. mucositis. nail disorders. nausea. neutropenia. oral disorders. peripheral oedema. proteinuria. renal impairment. respiratory disorders. skin reactions. taste altered. thrombocytopenia. vomiting. weight decreased ▶Uncommon Congestive heart failure. embolism and thrombosis. flushing. healing impaired. hepatitis B. musculoskeletal chest pain. pancytopenia. sepsis. urinary frequency increased ▶Rare or very rare Pure red cell aplasia ▶Frequency not known Hepatitis B reactivation SIDE-EFFECTS, FURTHER INFORMATION Reduce dose or discontinue if severe side-effects occur—consult product literature.
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Effective contraception must be used during and for up to 8 weeks after treatment.
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Manufacturer advises avoid (toxicity in animal studies). See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Manufacturer advises avoid.
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Consult product literature.
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▶For Votubia ® preparations: manufacturer advises everolimus blood concentration monitoring is required— consult product literature. ▶For Certican ®: manufacturer advises pre-dose (’trough’) whole blood everolimus concentration should be 3–8 nanograms/mL; monitoring should be performed every 4–5 days (using chromatographic assay) after initiation or dose adjustment until 2 consecutive stable concentrations; monitor patients with hepatic impairment taking concomitant strong CYP3A4 inducers and inhibitors when switching formulation, and/or if concomitant ciclosporin dose is reduced. ▶Manufacturer advises monitor blood-glucose concentration, complete blood count, serum-triglycerides and serum-cholesterol before treatment and periodically thereafter. ▶Manufacturer advises monitor renal function before treatment and periodically thereafter. ▶Manufacturer advises monitor for signs and symptoms of infection before and during treatment.
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Extracted information for Everolimus only.
VOTUBIA ® DISPERSIBLE TABLETS Manufacturer advises tablets must be dispersed in water before administration— consult product literature for details. VOTUBIA ® TABLETS Tablets may be dispersed in approximately 30 mL of water by gently stirring, immediately before drinking. After solution has been swallowed, any residue must be re-dispersed in the same volume of water and swallowed.
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There can be variation in the licensing of different medicines containing the same drug. Dispersible tablet CAUTIONARY AND ADVISORY LABELS 13 ▶Votubia (Novartis Pharmaceuticals UK Ltd) Everolimus 2 mg Votubia 2mg dispersible tablets sugar-free | 30 tablet P £960.00 Everolimus 3 mg Votubia 3mg dispersible tablets sugar-free | 30 tablet P £1,440.00 Everolimus 5 mg Votubia 5mg dispersible tablets sugar-free | 30 tablet P £2,250.00 Tablet CAUTIONARY AND ADVISORY LABELS 25 ▶Everolimus (Non-proprietary) Everolimus 2.5 mg Everolimus 2.5mg tablets | 30 tablet P £1,150.00 Everolimus 5 mg Everolimus 5mg tablets | 30 tablet P £2,200.00 Everolimus 10 mg Everolimus 10mg tablets | 30 tablet P £2,920.00 ▶Afinitor (Novartis Pharmaceuticals UK Ltd) Everolimus 2.5 mg Afinitor 2.5mg tablets | 30 tablet P £1,200.00 Everolimus 5 mg Afinitor 5mg tablets | 30 tablet P £2,250.00 Everolimus 10 mg Afinitor 10mg tablets | 30 tablet P £2,673.00 ▶Certican (Novartis Pharmaceuticals UK Ltd) Everolimus 250 microgram Certican 0.25mg tablets | 60 tablet P £148.50 Everolimus 750 microgram Certican 0.75mg tablets | 60 tablet P £445.50 ▶Votubia (Novartis Pharmaceuticals UK Ltd) Everolimus 2.5 mg Votubia 2.5mg tablets | 30 tablet P £1,200.00 Everolimus 5 mg Votubia 5mg tablets | 30 tablet P £2,250.00 Everolimus 10 mg Votubia 10mg tablets | 30 tablet P £2,970.00
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Extracted information for Everolimus only.
Pneumonitis Non-infectious pneumonitis reported. Manufacturer advises patients and their carers should be informed to seek urgent medical advice if new or worsening respiratory symptoms occur. Infections Manufacturer advises patients and their carers should be informed of the risk of infection. Immune system and malignant disease
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Filter the extracted dose blocks for this individual drug.
First line only; read the complete Indications and dose section above.
10 mg once daily, for dose interruption or
This is a first-line fragment. Read the full Indications and Dose section above.
Candidate age grouping · source page 1056
First line only; read the complete Indications and dose section above.
10 mg once daily, for dose interruption or
This is a first-line fragment. Read the full Indications and Dose section above.
Candidate age grouping · source page 1056
First line only; read the complete Indications and dose section above.
Initially 1 mg twice daily, to be started
This is a first-line fragment. Read the full Indications and Dose section above.
Candidate age grouping · source page 1056
First line only; read the complete Indications and dose section above.
Initially 750 micrograms twice daily, to be
This is a first-line fragment. Read the full Indications and Dose section above.
Candidate age grouping · source page 1056
First line only; read the complete Indications and dose section above.
(consult product literature)
This is a first-line fragment. Read the full Indications and Dose section above.
Candidate age grouping · source page 1056
First line only; read the complete Indications and dose section above.
(consult product literature)
This is a first-line fragment. Read the full Indications and Dose section above.
Candidate age grouping · source page 1056
First line only; read the complete Indications and dose section above.
(consult product literature)
This is a first-line fragment. Read the full Indications and Dose section above.
Candidate age grouping · source page 1056
First line only; read the complete Indications and dose section above.
(consult product literature)
This is a first-line fragment. Read the full Indications and Dose section above.
Candidate age grouping · source page 1056