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TAMOXIFEN ROSEMONT is a brand name for Tamoxifen. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: The treatment of breast cancer - The primary prevention of breast cancer in women at moderate or high risk (see section 5.1). Women aged less than 30 years old were excluded from primary prevention trials so the efficacy and safety of tamoxifen treatment in these younger women is unknown.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Breast cancer Adults:
The recommended dose is 20mg, given either in divided doses twice daily or as a single dose once daily. The current recommended treatment duration is five years; however the optimum duration has not been established. No additional benefit, in terms of delayed recurrence or improved survival in patients, has been demonstrated with higher doses.
Substantive evidence supporting the use of treatment with 30-40 mg per day is not available, although these doses have been used in some patients with advanced disease. Elderly people Similar dosing regimens of tamoxifen have been used in the elderly with breast cancer and in some of these patients it has been used as sole therapy.
Primary prevention of breast cancer Tamoxifen treatment for the primary prevention of breast cancer should only be initiated by a medical practitioner experienced in prescribing for this indication, and as part of a shared care pathway arrangement, with appropriate patient identification, management and follow up.
The recommended dose is 20mg daily for 5 years for those women at moderate or high risk. There are insufficient data to support a higher dose or longer period of use. Before commencing treatment, an assessment of the potential benefits and risks is essential, including calculating a patient’s risk of developing breast cancer according to local guidelines and risk assessment tools.
Validated algorithms are available that calculate breast cancer risk based on features such as age, family history, genetic factors, reproductive factors and history of breast disease. The use of tamoxifen should be as part of a program including regular breast surveillance tailored to the individual woman, taking into account her risk of breast cancer.
Paediatric Population Children:
Not applicable. 2). Method of Administration For oral use.
Unless specified, the following frequency categories were calculated from the number of adverse events reported in a large phase III study conducted in 9366 postmenopausal women patients with operable breast cancer treated for 5 years and unless specified, no account was taken of the frequency within the comparative treatment group or whether the investigator considered it to be related to study medication.
The safety findings in the breast cancer prevention trials appeared consistent overall with the established safety profile of tamoxifen. The frequencies of adverse events are ranked according to the following: 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).
4) Nervous system disorders Common: Light-headedness, headache, cerebral ischaemic events, sensory disturbances (including paraesthesia and dysgeusia) Rare: Optic neuritis Eye disorders Common: Cataracts and /or retinopathy that are only partly reversible.
The risk for cataracts increases with the duration of tamoxifen treatment Uncommon: Visual disturbances Rare: Corneal changes. Optic neuropathya that is only partly reversible. In a small number of cases, blindness has occurred.
Vascular disorders Very common:
Hot flushes Common: Thromboembolic events, including deep vein thrombosis, microvascular thrombosis and pulmonary embolism. 5) Respiratory, thoracic and mediastinal disorders Uncommon: Interstitial pneumonitis Gastrointestinal disorders Very common: Nausea Common: Vomiting, diarrhoea and constipation Uncommon: Pancreatitis Hepatobiliary disorders Common: Changes in liver enzyme levels, fatty liver Uncommon: Cirrhosis of the liver Rare: Hepatitis and cholestasisa, hepatic failurea, hepatocellular injurya and hepatic necrosisa.
The warnings and precautions for use are different depending on the indication being treated. The specific warnings and precautions for the primary prevention of breast cancer can be found at the end of the section. Premenopausal patients must be carefully examined before treatment to exclude pregnancy.
Women should be informed of the potential risks to the foetus, should they become pregnant whilst taking tamoxifen; or within two months of cessation of therapy. A number of secondary primary tumours, occurring at sites other than the endometrium and the opposite breast, have been reported in clinical trials, following the treatment of breast cancer patients with tamoxifen.
No causal link has been established and the clinical significance of these observations remains unclear. Menstruation is suppressed in a proportion of premenopausal women receiving tamoxifen for the treatment of breast cancer. There are several factors that influence the risk of developing endometrial cancer, with the majority of risk factors affecting oestrogen levels.
Therefore, tamoxifen treatment may increase the incidence of endometrial cancer. In addition, other risk factors include obesity, nulliparity, diabetes mellitus, polycystic ovary syndrome and oestrogen-only HRT. There is also the general risk for endometrial cancer with increasing age.
Any patients who have received tamoxifen therapy and have reported abnormal vaginal bleeding or patients presenting with menstrual irregularities, vaginal discharge and pelvic pressure or pain should undergo prompt investigation due to the increased incidence of endometrial changes including hyperplasia, polyps, cancer and uterine sarcoma (mostly malignant mixed Mullerian tumours) which has been reported in association with tamoxifen treatment.
The underlying mechanism is unknown, but may be related to the oestrogenic-like effect of tamoxifen. Before initiating tamoxifen a complete personal history should be taken. Physical examination (including pelvic examination) should be guided by the patients past medical history and by the ‘contraindications’ and ‘special warnings and precautions for use’ warnings for use for tamoxifen.
5) Primary prevention of breast cancer Tamoxifen should not be used in: • Women with a history of deep vein thrombosis or pulmonary embolus. 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Some cases of more severe liver abnormalities have proved fatal Skin and subcutaneous tissue disorders Very common: Skin rash Common: Alopecia Rare: Angioedema, Stevens-Johnson-syndromea, cutaneous vasculitisa, bullous pemphigoida or erythema multiformea , toxic epidermal necrolysisa Very rare: Cutaneous lupus erythematosusb Not known: Exacerbation of hereditary angioedema Musculoskeletal and connective tissue disorders Common: Leg cramp, myalgia Not known: Decreased bone mineral density (premenopausal women) Reproductive system and breast disorders Very common: Vaginal discharge, vaginal bleeding Common: Pruritus vulvae, endometrial changes (including hyperplasia and polyps) Rare: Suppression of menstruation, cystic ovarian swellingsa, endometriosis and vaginal polyps Congenital, familial and genetic disorders Very rare: Porphyria cutanea tardab General disorders and administration site conditions Very common: Fatigue Common: Bone and tumour pain Investigations Common: Elevated triglycerides, in some cases with pancreatitis Rare: Electrocardiogram QT prolonged.
g. 3094). This is calculated as 3/3094 which equates to a frequency category of ‘rare’. b The event was not observed in other major clinical studies. The frequency has been calculated using the upper limit of the 95% confidence interval for the point estimate (based on 3/X, where X represents the total sample size of 13,357 patients in the major clinical studies).
This is calculated as 3/13,357 which equates to a frequency category of ‘very rare’. g. g. gastrointestinal intolerance, headache, light-headedness and occasionally, fluid retention and alopecia. When undesirable events are severe it may be possible to control them by a simple reduction of dosage (to not less than 20 mg/day) without loss of control of the disease.
If undesirable events do not respond to this measure, it may be necessary to cease treatment. Skin rashes (including rare reports of erythema multiforme, Stevens-Johnson syndrome, cutaneous vasculitis, and bullous pemphigoid) and commonly hypersensitivity reactions including angioedema have been reported.
Uncommonly, patients with bony metastases have developed hypercalcaemia on initiation of therapy. Cases of visual disturbances, including rare reports of corneal changes, and common reports of retinopathy have been described in patients receiving tamoxifen therapy.
Cataracts have been reported […]
During treatment periodic check-ups including gynaecological examination focussing on endometrial changes are recommended of a frequency and nature adapted to the individual woman and modified according to her clinical needs. When starting tamoxifen therapy the patient should undergo an ophthalmological examination.
If visual changes (cataracts and retinopathy) occur while on tamoxifen therapy it is urgent that an ophthalmological investigation be performed, because some of such changes may resolve after cessation of treatment if recognised at an early stage.
In cases of severe thrombocytopenia, leucocytopenia or hypercalcaemia, individual risk-benefit assessment and thorough medical supervision are necessary. 8). • In patients with breast cancer, prescribers should obtain careful histories with respect to the patient’s personal and family history of VTE.
If suggestive of a prothrombotic risk, patients should be screened for thrombophilic factors. Patients who test positive should be counselled regarding their thrombotic risk. The decision to use tamoxifen in these patients should be based on the overall risk to the patient.
5). 5). The risks and benefits should be carefully considered for all patients before treatment with tamoxifen. Long-term anti-coagulant prophylaxis may be justified for some patients with breast cancer who have multiple risk factors for VTE.
• Surgery and immobility: For patients with breast cancer tamoxifen treatment should only be stopped if the risk of tamoxifen-induced thrombosis clearly outweighs the risks associated with interrupting treatment. All patients should receive appropriate thrombosis prophylactic measures and should include graduated compression stockings for the period of hospitalisation, early ambulation, if possible, and anticoagulant treatment.
• All patients should be advised to seek immediate medical attention if they become aware of any symptoms of VTE; in such cases, tamoxifen therapy should be stopped and appropriate anti-thrombosis measures initiated. • In the above cases, the risks and benefits to the patient of tamoxifen therapy must be carefully considered.
In patients receiving tamoxifen for breast cancer, the decision to re-start tamoxifen should be made with respect to the overall risk for the patient. In selected patients with breast cancer, the continued use of tamoxifen with prophylactic anticoagulation may be justified.
In delayed microsurgical breast reconstruction tamoxifen may increase the risk of microvascular flap complications. In an uncontrolled trial in 28 girls aged 2–10 years with McCune Albright Syndrome (MAS), who received 20 mg once a day for up to 12 months duration, mean uterine volume increased after 6 months of treatment and doubled at the end of the one-year study.
1). The blood count including thrombocytes, liver function test and serum calcium should be controlled regularly. Assessment of triglycerides in serum may be advisable because in most published cases of severe hypertriglyceridemia dyslipoproteinemia was the underlying disorder.
2). Concomitant medications that […]