{"id":9123,"date":"2021-03-25T10:55:56","date_gmt":"2021-03-25T10:55:56","guid":{"rendered":"https:\/\/zeepedia.com\/?p=9123"},"modified":"2021-04-12T14:07:45","modified_gmt":"2021-04-12T14:07:45","slug":"fulvestrant-teva","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/fulvestrant-teva\/","title":{"rendered":"Fulvestrant Teva &#8211; Fulvestrant uses, dose and side effects"},"content":{"rendered":"\n<p>\n\n250 mg&nbsp;solution for injection&nbsp;in a pre-filled&nbsp;syringe<br>fulvestrant<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">1. What Fulvestrant Teva is and what it is used for<\/h2>\n\n\n\n<p>Fulvestrant Teva contains the active substance fulvestrant, which belongs to the group of estrogen blockers.&nbsp;Estrogen&nbsp;er, a type of female sex hormone may in some cases be involved in the growth of breast cancer.<br><\/p>\n\n\n\n<p>Fulvestrant Teva is used either:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>alone to treat postmenopausal women with a type of breast cancer called estrogen receptor-positive breast cancer that is locally advanced or has spread to other parts of the body (metastatic), or<\/li><li>in combination with palbociclib for the treatment of women with a type of breast cancer called hormone receptor-positive,&nbsp;human&nbsp;epidermal&nbsp;growth&nbsp;factor&nbsp;receptor 2-negative breast cancer, which is locally advanced or has spread to other parts of the body (metastatic).&nbsp;Women who have not reached menopause will also be treated with a drug called a luteinizing hormone-releasing&nbsp;hormone&nbsp;(LHRH)&nbsp;agonist.<\/li><\/ul>\n\n\n\n<p>When fulvestrant is given in combination with palbociclib, it is important that you also read the palbociclib package leaflet.&nbsp;Ask your doctor if you have any questions about palbociclib.<br><\/p>\n\n\n\n<p>Fulvestrant contained in Fulvestrant Teva may also be approved for the treatment of other conditions not mentioned in this product information.&nbsp;Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before using Fulvestrant Teva<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">DO NOT use Fulvestrant Teva<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to fulvestrant or any of the other ingredients of this medicine (listed in section 6).<\/li><li>if you are pregnant or breast-feeding (see section \u201cPregnancy, breast-feeding and fertility\u201d)<\/li><li>if you have&nbsp;<strong>severe<\/strong>&nbsp;liver problems<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<p>Talk to your doctor, pharmacist, or nurse before using Fulvestrant Teva if any of the following apply to you:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>kidney or liver problems<\/li><li>low&nbsp;platelet count&nbsp;(contributes to blood clotting), bleeding disorder<\/li><li>previous problems with blood clots<\/li><li>problems with bone mineral loss (&nbsp;osteoporosis&nbsp;)<\/li><li>alcohol problems (see section \u201cFulvestrant Teva contains&nbsp;96%&nbsp;ethanol&nbsp;(alcohol)\u201d).<\/li><\/ul>\n\n\n\n<p>The efficacy and safety of fulvestrant (either as&nbsp;monotherapy&nbsp;or in combination with palbociclib) have not been studied in patients with critical internal disease.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>Fulvestrant Teva is NOT intended for children and adolescents under 18 years of age.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Fulvestrant Teva<\/h2>\n\n\n\n<p>Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n<p>You must tell your doctor if you are&nbsp;taking anticoagulants&nbsp;(medicines that prevent blood clots).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n<p>You MUST NOT use Fulvestrant Teva if you are pregnant.&nbsp;If you could become pregnant, use an effective contraceptive when you are being treated with Fulvestrant Teva.<br><\/p>\n\n\n\n<p>You must NOT breast-feed while being treated with Fulvestrant Teva.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>Fulvestrant Teva is unlikely to affect your ability to drive or use machines, but if you feel tired after treatment, DO NOT drive or use machines.<br><\/p>\n\n\n\n<p>You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention.&nbsp;One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or&nbsp;side effects.&nbsp;Descriptions of these effects and&nbsp;side effects&nbsp;can be found in other sections.&nbsp;Read all the information in this leaflet for guidance.&nbsp;If you are not sure, talk to your doctor or pharmacist.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Fulvestrant Teva contains ethanol and benzyl alcohol<\/h2>\n\n\n\n<p><strong>Fulvestrant Teva contains 96%&nbsp;ethanol&nbsp;(alcohol)<\/strong>, equivalent to about 1,000 mg per&nbsp;dose, to be equated with 20 ml of beer or 8 ml of wine per&nbsp;dose.<\/p>\n\n\n\n<p>Harmful to people suffering from alcoholism.&nbsp;Attention should be paid to pregnant or lactating women, children, and high-risk groups such as patients with liver disease or&nbsp;epilepsy.<br><\/p>\n\n\n\n<p><strong>Fulvestrant Teva contains benzyl alcohol<\/strong>, the amount of benzyl alcohol per&nbsp;dose&nbsp;is 500 mg per 5 ml (100 mg per 1 ml), which may cause allergic reactions.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">3. How to use Fulvestrant Teva<\/h2>\n\n\n\n<p>Always take this medicine exactly as your doctor, pharmacist or nurse has told you.&nbsp;If you are not sure, talk to your doctor, pharmacist, or nurse.<br><\/p>\n\n\n\n<p>The recommended&nbsp;dose&nbsp;is 500 mg fulvestrant (two 250 mg \/ 5 ml&nbsp;injections&nbsp;) once a month, with an additional&nbsp;dose&nbsp;of 500 mg two weeks after the initial&nbsp;dose.<br><\/p>\n\n\n\n<p>Your doctor or nurse will give you Fulvestrant Teva as a slow&nbsp;intramuscular&nbsp;injection, one in each buttock.<br><\/p>\n\n\n\n<p>If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">4. Possible side effects<\/h2>\n\n\n\n<p>Like all medicines, this medicine can cause&nbsp;side effects, although not everybody gets them.<br><\/p>\n\n\n\n<p><strong>You may need immediate medical attention if you get any of the following side effects:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>allergic reactions (hypersensitivity), including swelling of the face, lips, tongue, and\/or throat which may be signs of anaphylactic reactions<\/li><li>thromboembolism (increased risk of blood clots) *<\/li><li>liver inflammation (&nbsp;hepatitis&nbsp;)<\/li><li>liver failure.<\/li><\/ul>\n\n\n\n<p><strong>Tell your doctor, pharmacist, or nurse if you get any of the following side effects:<\/strong><br><\/p>\n\n\n\n<p><strong>Side effects&nbsp;reported for people treated with Fulvestrant Teva as monotherapy:<\/strong><br><\/p>\n\n\n\n<p><strong>Very common:<\/strong>&nbsp;may affect more than 1 user in 10<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>injection site reactions, such as pain and\/or&nbsp;inflammation<\/li><li>changes in liver enzyme values \u200b\u200b(shown by blood tests) *<\/li><li>nausea<\/li><li>weakness, fatigue *<\/li><li>joint and musculoskeletal pain<\/li><li>hot flashes<\/li><li>rash<\/li><li>allergic (hypersensitivity) reaction, including swelling of the face, lips, tongue, and\/or throat.<\/li><\/ul>\n\n\n\n<p><strong>Other side effects:<\/strong><br><\/p>\n\n\n\n<p><strong>Common:<\/strong>&nbsp;may affect up to 1 in 10 users<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>headache<\/li><li>vomiting, diarrhea, or decreased appetite *<\/li><li>urinary tract infection<\/li><li>back pain *<\/li><li>increase in&nbsp;bilirubin&nbsp;(a bile pigment produced by the liver)<\/li><li>thromboembolism&nbsp;(increased risk of blood clots) *<\/li><li>decreased&nbsp;platelet count&nbsp;(&nbsp;thrombocytopenia&nbsp;)<\/li><li>vaginal&nbsp;bleeding<\/li><li>pain in the lower back that radiates to the leg on one side (sciatica)<\/li><li>sudden weakness, numbness, tingling, or loss of mobility in the leg, especially only on one side of the body, sudden difficulty walking or maintaining balance (&nbsp;peripheral&nbsp;neuropathy&nbsp;)<br><\/li><\/ul>\n\n\n\n<p><strong>Uncommon:<\/strong>&nbsp;may affect up to 1 in 100 people<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>thick, whitish&nbsp;vaginal discharge&nbsp;and fungal infection<\/li><li>bruising and bleeding at the injection site<\/li><li>increase in gamma-GT, a liver enzyme seen in a blood test<\/li><li>liver inflammation (&nbsp;hepatitis&nbsp;)<\/li><li>liver failure<\/li><li>numbness, tingling, and pain<\/li><li>anaphylactic reactions<\/li><\/ul>\n\n\n\n<p>* Includes&nbsp;side effects&nbsp;for which the exact effect of Fulvestrant Teva cannot be assessed due to the underlying disease.<br><\/p>\n\n\n\n<p><strong>Side effects&nbsp;reported for people treated with Fulvestrant Teva as&nbsp;combination therapy&nbsp;with palbociclib:<\/strong><br><\/p>\n\n\n\n<p><strong>Very common:<\/strong>&nbsp;may affect more than one in 10 users<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>reduction in&nbsp;neutrophils&nbsp;(&nbsp;neutropenia&nbsp;)<\/li><li>decrease in&nbsp;white blood cell count&nbsp;(&nbsp;leukopenia&nbsp;)<\/li><li>infection&nbsp;is<\/li><li>fatigue<\/li><li>nausea<\/li><li>reduction of&nbsp;red blood cells&nbsp;(&nbsp;anemia&nbsp;)<\/li><li>inflammation&nbsp;or sores in the mouth<\/li><li>diarrhea<\/li><li>decreased&nbsp;platelet count&nbsp;(&nbsp;thrombocytopenia&nbsp;)<\/li><li>vomiting<\/li><li>hair loss<\/li><li>rash<\/li><li>loss of appetite<\/li><li>fever<br><\/li><\/ul>\n\n\n\n<p><strong>Common:<\/strong>&nbsp;may affect up to 1 in 10 users<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>weakness<\/li><li>the increased amount of liver enzyme<\/li><li>loss of taste<\/li><li>nosebleeds<\/li><li>excessively wet eyes<\/li><li>dry skin<\/li><li>dimsyn<\/li><li>dry eyes<br><\/li><\/ul>\n\n\n\n<p><strong>Uncommon:<\/strong>&nbsp;may affect up to 1 in 100 people<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>fever with other signs of&nbsp;infection&nbsp;(febrile&nbsp;neutropenia&nbsp;)<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">5. How to store Fulvestrant Teva<\/h2>\n\n\n\n<p><strong>Keep this medicine out of the sight and reach of children.<\/strong><br><\/p>\n\n\n\n<p>Do not use this medicine after the expiry date which is stated on the carton or syringe label after \u201cEXP\u201d.&nbsp;The expiration date is the last day of the specified month.<br><\/p>\n\n\n\n<p>Do not use this medicine if you see particles or discoloration before&nbsp;administration.<br><\/p>\n\n\n\n<p>Store and transport cold (2 \u00b0 C-8 \u00b0 C).<br><\/p>\n\n\n\n<p>Deviations outside the temperature range 2 \u00b0 C-8 \u00b0 C must be limited.&nbsp;This includes avoiding storage at temperatures exceeding 25 \u00b0 C and not exceeding a period of 28 days where the average storage temperature of the product is below 25 \u00b0 C (but above 2 \u00b0 C-8 \u00b0 C).&nbsp;After temperature deviations, the product must be returned immediately to the recommended storage conditions (stored and transported cold, 2 \u00b0 C-8 \u00b0 C).&nbsp;Temperature deviations have a cumulative effect on product quality and the time period of 28 days must not be exceeded during the entire shelf life of 2 years for Fulvestrant Teva.&nbsp;Exposure to temperatures below 2 \u00b0 C does not damage the product, provided it is not stored below -20 \u00b0 C.<br><\/p>\n\n\n\n<p>Store the prefilled syringe in the original package.&nbsp;Sensitive to light.<br><\/p>\n\n\n\n<p>The healthcare staff is responsible for the correct storage, use, and disposal of Fulvestrant Teva.<br><\/p>\n\n\n\n<p>This medicine may pose a risk to the aquatic environment.&nbsp;Medicines should not be disposed of via wastewater or household waste.&nbsp;Ask your pharmacist how to dispose of medicines no longer required.&nbsp;These measures will help to protect the environment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">6. Contents of the packaging and other information<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Content declaration<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>The active substance is fulvestrant.&nbsp;Each pre-filled&nbsp;syringe&nbsp;contains 250 mg fulvestrant.&nbsp;Each ml of solution contains 50 mg of fulvestrant.<\/li><li>The other ingredients (excipients) are&nbsp;ethanol&nbsp;(96%), benzyl alcohol, benzyl benzoate, and castor oil, refined.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">What the medicine looks like and the contents of the pack<\/h2>\n\n\n\n<p>Fulvestrant Teva is a clear, colorless to yellow,&nbsp;viscous&nbsp;solution in a pre-filled&nbsp;syringe&nbsp;fitted with a Luer-Lock connector, containing 5 ml&nbsp;solution for injection.&nbsp;Two syringes must be administered to reach the recommended monthly&nbsp;dose of&nbsp;500 mg.<br><\/p>\n\n\n\n<p>Fulvestrant Teva is available in two pack sizes,<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>1 pack containing 1 pre-filled&nbsp;syringe&nbsp;and 1 protected needle to connect the syringe.<\/li><li>1 pack containing 2 pre-filled syringes and 2 protected needles to connect to each&nbsp;syringe&nbsp;is also included.<\/li><\/ul>\n\n\n\n<p>Not all pack sizes may be marketed.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n<p><strong>Marketing Authorisation Holder<\/strong><\/p>\n\n\n\n<p>Teva AB<\/p>\n\n\n\n<p>Box 1070<\/p>\n\n\n\n<p>251 10 Helsingborg<\/p>\n\n\n\n<p><br><\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>PLIVA Hrvatska doo (PLIVA Croatia Ltd.)<\/p>\n\n\n\n<p>Prilaz baruna Filipovi\u0107a 25,<\/p>\n\n\n\n<p>Zagreb 10000<\/p>\n\n\n\n<p>Croatia<br><\/p>\n\n\n\n<p><strong>This medicinal product is authorized under the European Economic Area under the names: <\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td>Belgium:<\/td><td>Fulvestrant Teva 250 mg solution for injection \/ solution injectable \/ Injektionsl\u00f6sung<\/td><\/tr><tr><td>Bulgaria:<\/td><td>Fully Western Teva 250mg Coated Injection Mouthpieces<\/td><\/tr><tr><td>Denmark:<\/td><td>Fulvestrant Teva<\/td><\/tr><tr><td>Estonia:<\/td><td>Fulvestrant Teva<\/td><\/tr><tr><td>Finland:<\/td><td>Fulvestrant ratiopharm 250 mg injection, liuos, esit\u00e4ytetty ruisku<\/td><\/tr><tr><td>France:<\/td><td>Fulvestrant Teva 250 mg solution injectable in pre-sample Zeringue<\/td><\/tr><tr><td>Ireland:<\/td><td>Fulvestrant Teva 250 mg Solution for&nbsp;Injection&nbsp;in Pre-filled Syringe<\/td><\/tr><tr><td>Iceland:<\/td><td>Fulvestrant Teva 250 mg solution for injection in a pre-filled syringe<\/td><\/tr><tr><td>Italy:<\/td><td>Fulvestrant Teva<\/td><\/tr><tr><td>Croatia:<\/td><td>Fulvestrant Pliva 250 mg utopian for injection in nasal congestion&nbsp;<\/td><\/tr><tr><td>Latvia:<\/td><td>Fulvestrant Teva 250 mg weight loss pills<\/td><\/tr><tr><td>Lithuania:<\/td><td>Fulvestrant Teva 250mg Injection Tyroline Treatment<\/td><\/tr><tr><td>Luxembourg:<\/td><td>Fulvestrant Teva 250 mg solution for injection \/ solution injectable \/ Injektionsl\u00f6sung<\/td><\/tr><tr><td>Netherlands:<\/td><td>Fulvestrant Teva 250 mg, pre-filled syringe solution for injection<\/td><\/tr><tr><td>Poland:<\/td><td>Fulvestrant Teva<\/td><\/tr><tr><td>Portugal:<\/td><td>Fulvestrant Teva<\/td><\/tr><tr><td>Romania:<\/td><td>Fulvestrant Teva 250 mg injectable solution in premature ejaculation<\/td><\/tr><tr><td>Slovakia:<\/td><td>Fulvestrant Teva<\/td><\/tr><tr><td>Slovenia:<\/td><td>Fulvestrant Teva 250 mg injection for injection in Naples injection syringe<\/td><\/tr><tr><td>Spain:<\/td><td>Fulvestrant Teva 250mg injectable solution in EFG pre-loaded ring<\/td><\/tr><tr><td>UK:<\/td><td>Fulvestrant Teva 250mg solution for&nbsp;injection&nbsp;into the pre-filled syringe<\/td><\/tr><tr><td>Germany:<\/td><td>Fulvestrant Teva 250 mg solution for injection in a syringe<\/td><\/tr><tr><td>Hungary:<\/td><td>Fulvestrant Teva 250 mg \/ 5 ml oldatos injekci\u00f3 el\u0151ret\u00f6lt\u00f6tt fecskend\u0151ben<\/td><\/tr><tr><td>Austria:<\/td><td>Fulvestrant ratiopharm 250 mg solution for injection in a ready-made syringe<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"<p> 250 mg solution for injection in a pre-filled syringe<br \/>\nfulvestrant<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"cybocfi_hide_featured_image":"","footnotes":""},"categories":[2206,2200],"tags":[2383,2385,2386,2254,2388,2389,2387,2384,2255,2215,2216,2212,2213,2256],"class_list":["post-9123","post","type-post","status-publish","format-standard","hentry","category-f","category-medicines","tag-fulvestrant","tag-fulvestrant-doses","tag-fulvestrant-side-effects","tag-fulvestrant-teva","tag-fulvestrant-teva-doses","tag-fulvestrant-teva-side-effects","tag-fulvestrant-teva-uses","tag-fulvestrant-uses","tag-how-to-use-fulvestrant-teva","tag-injection","tag-injections","tag-medicine","tag-medicines","tag-side-effects-of-fulvestrant-teva"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/9123","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/comments?post=9123"}],"version-history":[{"count":6,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/9123\/revisions"}],"predecessor-version":[{"id":9930,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/9123\/revisions\/9930"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=9123"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=9123"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=9123"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}