Drug Action
Ospemifene is a selective oestrogen receptor modulator that has an oestrogen-like effect in the vagina, increasing the cellular maturation and mucification of the vaginal epithelium.
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Drug reference
Ospemifene is a selective oestrogen receptor modulator that has an oestrogen-like effect in the vagina, increasing the cellular maturation and mucification of the vaginal epithelium.
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Genito-urinary system Moderate to severe symptomatic vulvar and vaginal atrophy [in post-menopausal women who are not candidates for local vaginal oestrogen therapy] ▶BY MOUTH ▶Adult: 60 mg once daily
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Breast cancer (suspected or actively treated). endometrial hyperplasia. history of venous thromboembolism. sex-hormone dependent malignancy (suspected or active). unexplained vaginal bleeding
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Risk factors for stroke. risk factors for venous thromboembolism (discontinue if prolonged immobilisation)
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Scottish Medicines Consortium (SMC) decisions SMC No. SMC2170 The Scottish Medicines Consortium has advised (September 2019) that ospemifene (Senshio ®) is accepted for use within NHS Scotland for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy in post- menopausal women who are not candidates for local vaginal oestrogen therapy.
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→Appendix 1: ospemifene
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▶Common or very common Genital discharge. hot flush. increased risk of infection. muscle spasms. skin reactions. vaginal discharge ▶Uncommon Endometrial thickening. hypersensitivity. tongue swelling
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Manufacturer advises avoid—toxicity in animal studies.
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Manufacturer advises avoid in severe impairment—no information available.
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There can be variation in the licensing of different medicines containing the same drug. Tablet CAUTIONARY AND ADVISORY LABELS 21 ▶Senshio (Shionogi Ltd) A Ospemifene 60 mg Senshio 60mg tablets | 28 tablet P £39.50 DT = £39.50 Chapter 8 Immune system and malignant disease CONTENTS Immune system page 880 Immune system and malignant disease Immune system disorders and transplantation Multiple sclerosis 1.1 Malignant disease Antibody responsive malignancy Carcinoid syndrome Cytotoxic responsive malignancy Cytotoxic drug-induced side effects 3.1 Immune system Immune system disorders and transplantation Immune response Inflammatory bowel disease Azathioprine p. 881, ciclosporin p. 883, mercaptopurine p. 963, and methotrexate p. 963 have a role in the treatment of inflammatory bowel disease. Folic acid p. 1084 should be given to reduce the possibility of methotrexate toxicity [unlicensed indication]. Folic acid is usually given weekly on a different day to the methotrexate; alternative regimens may be used in some settings. Immunosuppressant therapy Immunosuppressants are used to suppress rejection in organ transplant recipients and to treat a variety of chronic inflammatory and autoimmune diseases. Solid organ transplant patients are maintained on drug regimens, which may include antiproliferative drugs (azathioprine or mycophenolate mofetil p. 891), calcineurin inhibitors (ciclosporin or tacrolimus p. 886), corticosteroids, or sirolimus p. 885. Choice is dependent on the type of organ, time after transplantation, and clinical condition of the patient. Specialist management is required and other immunomodulators may be used to initiate treatment or to treat rejection. Impaired immune responsiveness Modification of tissue reactions caused by corticosteroids and other immunosuppressants may result in the rapid spread of infection. Corticosteroids may suppress clinical signs of infection and allow diseases such as septicaemia or tuberculosis to reach an advanced stage before being recognised— important: normal immunoglobulin administration should be considered as soon as possible after measles exposure, and varicella–zoster immunoglobulin (VZIG) is recommended for individuals who have significant chickenpox (varicella) exposure. Specialist advice should be sought on the use of live vaccines for those being treated with immunosuppressive drugs. 3.1a Hyperuricaemia associated with page 993 cytotoxic drugs Hormone responsive malignancy Hormone responsive breast cancer 4.1 Immunotherapy responsive malignancy Photodynamic therapy responsive malignancy Targeted therapy responsive malignancy Antiproliferative immunosuppressants Azathioprine is widely used for transplant recipients and it is also used to treat a number of auto-immune conditions, usually when corticosteroid therapy alone provides inadequate control. It is metabolised to mercaptopurine, and doses should be reduced when allopurinol p. 1183 is given concurrently. Mycophenolate mofetil is metabolised to mycophenolic acid which has a more selective mode of action than azathioprine. There is evidence that compared with similar regimens incorporating azathioprine, mycophenolate mofetil reduces the risk of acute rejection episodes; the risk of opportunistic infections (particularly due to tissue-invasive cytomegalovirus) and the occurrence of blood disorders such as leucopenia may be higher. Cyclophosphamide p. 945 is less commonly prescribed as an immunosuppressant. Corticosteroids and other immunosuppressants Prednisolone p. 716 is widely used in oncology. It has a marked antitumour effect in acute lymphoblastic leukaemia, Hodgkin’s disease, and the non-Hodgkin lymphomas. It has a role in the palliation of symptomatic end-stage malignant disease when it may enhance appetite and produce a sense of well-being. The corticosteroids are also powerful immunosuppressants. They are used to prevent organ transplant rejection, and in high dose to treat rejection episodes. Ciclosporin a calcineurin inhibitor, is a potent immunosuppressant which is virtually non-myelotoxic but markedly nephrotoxic. It has an important role in organ and tissue transplantation, for prevention of graft rejection following bone marrow, kidney, liver, pancreas, heart, lung, and heart-lung transplantation, and for prophylaxis and treatment of graft-versus-host disease. Tacrolimus is also a calcineurin inhibitor. Although not chemically related to ciclosporin it has a similar mode of action and side-effects, but the incidence of neurotoxicity appears to be greater; cardiomyopathy has also been reported. Disturbance of glucose metabolism also appears to be significant. Sirolimus is a non-calcineurin inhibiting immunosuppressant licensed for renal transplantation. Basiliximab p. 889 is used for prophylaxis of acute rejection in allogeneic renal transplantation. It is given with ciclosporin and corticosteroid immunosuppression regimens; its use should be confined to specialist centres. Belatacept p. 892 is a fusion protein and co-stimulation blocker that prevents T-cell activation; it is licensed for prophylaxis of graft rejection in adults undergoing renal transplantation who are seropositive for the Epstein-Barr virus. It is used with interleukin-2 receptor antagonist induction, in combination with corticosteroids and a mycophenolic acid. Antithymocyte immunoglobulin (rabbit) below is licensed for the prophylaxis of organ rejection in renal and heart allograft recipients and for the treatment of corticosteroid- resistant allograft rejection in renal transplantation. Tolerability is increased by pretreatment with an intravenous corticosteroid and antihistamine; an antipyretic drug such as paracetamol may also be beneficial. Other drugs used for Immune system disorders and transplantation Anakinra, p. 1159. Chloroquine, p. 651. Everolimus, p. 1034. Hydroxychloroquine sulfate, p. 1156. Rituximab, p. 933 IMMUNE SERA AND IMMUNOGLOBULINS › IMMUNOGLOBULINS
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Manufacturer advises patients and their carers should be advised to seek immediate medical attention if they experience symptoms of thromboembolism (such as sudden chest pain, dyspnoea or swelling of a leg).
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60 mg once daily
First-line fragment. Read the complete Indications and Dose section above.
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