Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Afinitor 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 non-steroidal aromatase inhibitor.
Afinitor is indicated for the treatment of unresectable or metastatic, well- or moderately-differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease.
Afinitor is indicated for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease (see sections 4.4 and 5.1).
Afinitor is indicated for the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy.
Treatment with Afinitor should be initiated and supervised by a physician experienced in the use of anticancer therapies.
For the different dose regimens Afinitor is available as 2.5 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.
Management of severe and/or intolerable suspected adverse reactions may require dose reduction and/or temporary interruption of Afinitor 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.
Table 1 summarises the dose adjustment recommendations for specific adverse reactions (see also section 4.4).
Table 1. Afinitor dose adjustment recommendations:
| Adverse reaction | Severity1 | Afinitor dose adjustment |
|---|---|---|
| Non-infectious pneumonitis | 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. | |
| Grade 4 | Discontinue treatment. | |
| Stomatitis | 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. | |
| Grade 4 | Discontinue treatment. | |
| Other non-haematological toxicities (excluding metabolic events) | 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. | |
| Grade 4 | Discontinue treatment. | |
| Metabolic events (e.g. hyperglycaemia, dyslipidaemia) | Grade 2 | No dose adjustment required. |
| Grade 3 | Temporary dose interruption. Re-initiate treatment at 5 mg daily. | |
| Grade 4 | Discontinue treatment. | |
| Thrombocytopenia | Grade 2 (<75, ≥50x109/l) | Temporary dose interruption until recovery to Grade ≤1 (≥75x109/l). Re-initiate treatment at same dose. |
| Grade 3 & 4 (<50x109/l) | Temporary dose interruption until recovery to Grade ≤1 (≥75x109/l). Re-initiate treatment at 5 mg daily. | |
| Neutropenia | Grade 2 (≥1x109/l) | No dose adjustment required. |
| Grade 3 (<1, ≥0.5x109/l) | Temporary dose interruption until recovery to Grade ≤2 (≥1x109/l). Re-initiate treatment at same dose. | |
| Grade 4 (<0.5x109/l) | Temporary dose interruption until recovery to Grade ≤2 (≥1x109/l). Re-initiate treatment at 5 mg daily. | |
| Febrile neutropenia | Grade 3 | Temporary dose interruption until recovery to Grade ≤2 (≥1.25x109/l) and no fever. Re-initiate treatment at 5 mg daily. |
| Grade 4 | Discontinue treatment. |
1 Grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0
No dose adjustment is required (see section 5.2).
No dose adjustment is required (see section 5.2).
Dose adjustments should be made if a patient’s hepatic (Child-Pugh) status changes during treatment (see also sections 4.4 and 5.2).
The safety and efficacy of Afinitor in children aged 0 to 18 years have not been established. No data are available.
Afinitor should be administered orally once daily at the same time every day, consistently either with or without food (see section 5.2). Afinitor tablets should be swallowed whole with a glass of water. The tablets should not be chewed or crushed.
Reported experience with overdose in humans is very limited. Single doses of up to 70 mg have been given with acceptable acute tolerability. General supportive measures should be initiated in all cases of overdose.
3 years.
Do not store above 25°C.
Store in the original package in order to protect from light and moisture.
Aluminium/polyamide/aluminium/PVC blister containing 10 tablets.
Afinitor 2.5 mg tablets: Packs containing 30 or 90 tablets.
Afinitor 5 mg tablets: Packs containing 10, 30 or 90 tablets.
Afinitor 10 mg tablets: Packs containing 10, 30 or 90 tablets.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
