Nolvadex-D

Breast cancer.

Adult (including elderly) 20-40 mg daily, given either in divided doses bd or as single dose once daily.

May be taken with or without food.

Hypersensitivity. Pregnancy.

Suppressed menstruation in a proportion of premenopausal women receiving treatment. Increased incidence of endometrial changes including hyperplasia, polyps, cancer & uterine sarcoma. Promptly investigate patient w/ abnormal gynaecological symptoms especially vag bleeding or who presents w/ menstrual irregularities, vag discharge & symptoms (eg, pelvic pain or pressure). Patients w/ hereditary angioedema. 2nd primary tumours may occur at sites other than the endometrium & the opposite breast. Increased risk for VTE. May increase risk of microvascular flap complications in delayed microsurgical breast reconstruction. Girls aged 2-10 yr w/ McCune Albright syndrome. Avoid concomitant use w/ potent CYP2D6 inhibitors (eg, paroxetine, fluoxetine, quinidine, cinacalcet, bupropion). Possible fatigue; observe caution when driving or operating machinery. Advise women not to become pregnant during treatment & for 9 mth following the cessation of therapy; use barrier or other non-hormonal contraceptive methods. Carefully examine premenopausal patients before treatment to exclude pregnancy. Potential foetal risk. Not recommended during lactation. Not recommended in childn.

Hot flushes, vag bleeding & discharge, pruritus vulvae, tumour flare; GI intolerance, headache, light-headedness; fluid retention, alopecia. Skin rashes (including rare cases of erythema multiforme, SJS, TEN, cutaneous vasculitis, bullous pemphigoid) & hypersensitivity reactions including angioedema; retinopathy, cataracts; optic neuropathy & neuritis; sensory disturbances including paraesthesia & dysgeusia; uterine fibroids, endometriosis & other endometrial changes including hyperplasia & polyps; cystic ovarian swellings; leucopenia (possibly associated w/ anaemia &/or thrombocytopenia); ischaemic cerebrovascular & thromboembolic events including DVT, microvascular thrombosis, pulmonary embolism; leg cramps & myalgia; changes in liver enzyme levels; elevated serum triglyceride levels (in some cases w/ pancreatitis); depression; fatigue.

May significantly increase the anticoagulant effect of coumarin-type anticoagulants. Increased risk of thromboembolic events w/ cytotoxics. May reduce levels by CYP450 3A4 inducers (eg, rifampicin). Reduced plasma level of active tamoxifen metabolite 4-hydroxy-N-desmethyltamoxifen (endoxifen) by CYP2D6 inhibitors. Efficacy may be reduced by some SSRIs (eg, paroxetine). Avoid co-administration w/ potent CYP2D6 inhibitors (eg, paroxetine, fluoxetine, quinidine, cinacalcet or bupropion).

Cancer Hormone Therapy

L02BA01 - tamoxifen ; Belongs to the class of anti-estrogens. Used in treatment of neoplastic diseases.

POM