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TAMOXIFEN is a brand name for Tamoxifen. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Tamoxifen tablets are indicated for: 1. The treatment of breast cancer. 2. The treatment of anovulatory infertility.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Breast Cancer Adults:
The recommended daily dose of tamoxifen is normally 20mg. 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 30-40mg per day is not available, although these doses have been used in some patients with advanced disease.
Elderly:
The same dosage regimens of tamoxifen have been used in elderly patients with breast cancer and in some of these patients it has been used as sole therapy. Anovulatory Infertility The possibility of pregnancy must be excluded before commencing any course of treatment whether initial or subsequent.
The initial course of treatment in women menstruating regularly but with anovular cycles, consists of 20mg of tamoxifen daily in the second, third, fourth and fifth days of the menstrual cycle. Should the initial course of treatment, as judged by unsatisfactory basal temperature records and poor pre-ovulatory cervical mucus, prove unsuccessful, further courses of treatment may be given during subsequent menstrual periods, increasing the dosage to 40mg and then 80mg daily.
In women with irregular menstrual cycle, the initial course of treatment may begin on any day. Should there be no sign of ovulation, then a subsequent course of treatment may begin 45 days later with dosage increased to 40mg and then 80mg daily.
If a patient responds with menstruation then the next course of treatment is commenced on the second day of the cycle. 2). Method of administration Tamoxifen tablets are for oral administration.
g. g. gastro-intestinal intolerance, headache, light-headedness and occasionally, fluid retention and alopecia. When side effects are severe, it may be possible to control them by a simple reduction of dosage (to less than 20mg/day) without loss of control of the disease.
If side effects do not respond to this measure, it may be necessary to stop the treatment. Skin rashes (including isolated reports of erythema multiforme, StevensJohnson syndrome, cutaneous vasculitis and bullous pemphigoid) and commonly hypersensitivity reactions including angiodema have been reported.
Uncommonly, a small number of patients with bony metastases have developed hypercalcaemia on initiation of therapy. Falls in platelet count, usually to 80,000 to 90,000 per cu mm but occasionally lower, have been reported in patients taking tamoxifen for breast cancer.
A number of cases of visual disturbance including rare reports of corneal changes and common reports of retinopathy have been described in patients receiving tamoxifen. An increased incidence of cataracts has been reported in association with the administration of tamoxifen.
Cases of optic neuropathy and optic neuritis have been reported in patients receiving tamoxifen and, in a small number of cases, blindness has occurred. There is evidence of an increased incidence of ischaemic cerebrovascular events.
Sensory disturbances (including paraesthesia and dysgeusia) have been reported commonly in patients receiving tamoxifen. Uterine fibroids, endometriosis and other endometrial changes including hyperplasia and polyps have been reported.
Cystic ovarian swellings have occasionally been observed in pre-menopausal women receiving tamoxifen. Leucopenia has been observed following the administration of tamoxifen, sometimes in association with anaemia and/or thrombocytopenia.
Menstruation is suppressed in a proportion of pre-menopausal women receiving Tamoxifen for the treatment of breast cancer. An increased incidence of endometrial changes including hyperplasia, polyps, cancer and uterine sarcoma (mostly malignant mixed Mullerian tumours), has been reported in association with Tamoxifen treatment.
The underlying mechanism is unknown, but may be related to the oestrogen-like effect of Tamoxifen. Any patient receiving or having previously received Tamoxifen who report abnormal gynaecological symptoms, especially vaginal bleeding, or who presents with menstrual irregularities, vaginal discharge and symptoms such as pelvic pain or pressure should be promptly investigated.
Studies in premenopausal women who were treated with tamoxifen for reduction of breast cancer risk or in the management of breast cancer have reported decreases in bone mineral density. Premenopausal women taking Tamoxifen should be advised regarding measures to maintain bone health, according to local clinical guidelines.
A number of second 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.
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 prothrombic risk, patients should be screened for thrombophillic factors.
Patients who test positive should be counselled regarding their thromobotic risk. The decision to use tamoxifen in these patients should be based on the overall risk to the patient. 5) • The risk of VTE is further increased by severe obesity, increasing age and all other factors for VTE.
1. Tamoxifen must not be given during pregnancy. Pre-menopausal patients must be carefully examined before treatment for breast cancer or infertility to exclude the possibility of pregnancy. 5).
Treatment for infertility:
Patients with a personal or family history of confirmed idiopathic venous thromboembolic events or a known genetic defect.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Tamoxifen in United Kingdom.
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Neutropenia has been reported on rare occasions; this can sometimes be severe and very rarely cases of agranulocytosis have been reported. 5). When tamoxifen used in combination with cytotoxic agents, there is an increased risk of thrombo-embolic events.
Leg cramps and myalgia have been reported commonly in patients receiving tamoxifen. Uncommonly, cases of interstitial pneumonitis have been reported. Tamoxifen has been associated with changes in liver enzyme levels and with a spectrum of more severe liver abnormalities which in some cases were fatal, including fatty liver, cholestasis and hepatitis, liver failure, cirrhosis, and, hepatocellular injury (including hepatic necrosis).
Commonly, elevation of serum trigylceride levels, in some cases with pancreatitis, may be associated with the use of tamoxifen. Uncommonly incidence of endometrial cancer and rare instances of uterine sarcoma (mostly malignant mixed Mullerian tumours) has been reported in association with tamoxifen treatment.
Vaginal polyps have rarely been observed in women receiving tamoxifen Cutaneous lupus erythematosus has been observed very-rarely in patients receiving tamoxifen. Porphyria cutanea tarda has been observed very-rarely in patients receiving tamoxifen.
Fatigue has been reported very commonly in patients taking tamoxifen 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.
1% and <1%) Metabolism and nutrition Hypercalcaemia (in patients with bony metastases) Neoplasms benign, malignant and unspecified Endometrial cancer Respiratory, Interstitial thoracic and mediastinal disorders pneumonitis Hepatobiliary disorders Cirrhosis of the liver Blood and lymphatic system disorders Neutropeniaa Agranulocytosisa Eye disorders Corneal changes Optic neuropathya Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine Sarcoma (mostly malignant mixed Mullerian tumours)a Tumour Flarea Nervous system Optic neuritis Hepatobiliary disorders Hepatitis Cholestasisa Hepatic failurea […]
The risks and benefits should be carefully considered for all patients before treatment with tamoxifen. 5). 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 being treated for infertility, tamoxifen should be stopped at least 6 weeks before surgery or long-term immobility (when possible) and restarted only when the patient is fully mobile. 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 anti-coagulant treatment. • If any patient presents with VTE, tamoxifen should be stopped immediately and appropriate anti-thrombosis measures initiated.
In patients being treated for infertility, tamoxifen should not be re-started unless there is a compelling alternative explanation for their thrombotic event. 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. • All patients should be advised to contact their doctors immediately if they become aware of any symptoms of VTE.
• 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.
While this finding is in line with the pharmacodynamic properties of tamoxifen, a causal relationship has not been established. Tamoxifen at the recommended dose, may prolong the QTc interval on the electrocardiogram (ECG). ECG and electrolyte monitoring are recommended in patients with underlying risks of QT prolongation and cardiac comorbidities such as: • Long QT syndrome • Clinically significant or uncontrolled heart disease, such as congestive heart failure, recent myocardial infarction, and cardiac conduction and repolarisation abnormalities • Concomitant use of QT prolonging medicines • Electrolyte abnormalities ECG should be assessed before initiating treatment and follow-up ECG should be repeated once tamoxifen has reached steady state concentrations (at least 4 weeks).
e. g. palpitations, dizziness, syncope). Appropriate monitoring of serum electrolytes (including potassium, magnesium, calcium, phosphate) should be performed before initiating treatment and during treatment as clinically indicated. Any abnormalities should be corrected prior to initiating tamoxifen and during treatment.
2). Concomitant medications that inhibit (CYPD2D6 may lead to reduced concentrations of the active metabolite endoxifen. g. 2). Patients with rare […]