{"id":9119,"date":"2021-03-25T10:52:22","date_gmt":"2021-03-25T10:52:22","guid":{"rendered":"https:\/\/zeepedia.com\/?p=9119"},"modified":"2021-04-12T14:10:32","modified_gmt":"2021-04-12T14:10:32","slug":"fulvestrant-stada","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/fulvestrant-stada\/","title":{"rendered":"Fulvestrant STADA &#8211; Fulvestrant uses, dose and side effects"},"content":{"rendered":"\n<p>250 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 STADA is and what it is used for<\/h2>\n\n\n\n<p>Fulvestrant Stada contains the active substance fulvestrant, which belongs to the group of estrogen blockers.<\/p>\n\n\n\n<p>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 Stada 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&nbsp;.<\/li><\/ul>\n\n\n\n<p>When Fulvestrant Stada 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 Stada may also be approved for the treatment of other diseases not mentioned in this product information.&nbsp;Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">2. What you need to know before using Fulvestrant STADA<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Fulvestrant STADA<\/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 breastfeeding<\/li><li>if you have severe 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 Stada 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 previous problems with blood clots<\/li><li>problems with bone mineral loss (&nbsp;osteoporosis&nbsp;)<\/li><li>alcohol problem.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>Fulvestrant Stada 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 STADA<\/h2>\n\n\n\n<p>Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.<\/p>\n\n\n\n<p>It is especially important that you 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><strong>Pregnancy<\/strong><\/p>\n\n\n\n<p>You must not use Fulvestrant Stada if you are pregnant.&nbsp;If you could become pregnant, use an effective contraceptive when you are being treated with Fulvestrant Stada and for 2 years after your last&nbsp;dose&nbsp;.<br><\/p>\n\n\n\n<p><strong>Breast-feeding<\/strong><\/p>\n\n\n\n<p>You must not breast-feed while being treated with Fulvestrant Stada.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>Fulvestrant Stada is unlikely to affect your ability to drive or use machines, but if you feel tired after treatment, avoid driving or using 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;.&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 STADA contains ethanol, benzyl alcohol and benzyl benzoate<\/h2>\n\n\n\n<p><strong>Fulvestrant Stada contains benzyl alcohol<\/strong><\/p>\n\n\n\n<p>Fulvestrant Stada contains 1,000 mg of benzyl alcohol per 500 mg of fulvestrant.<\/p>\n\n\n\n<p>Benzyl alcohol can cause allergic reactions.<br><\/p>\n\n\n\n<p>If you have had liver or kidney problems, talk to your doctor or pharmacist before taking this medicine.&nbsp;Large amounts of benzyl alcohol can be stored in the body and cause&nbsp;side effects&nbsp;(metabolic&nbsp;acidosis&nbsp;).<br><\/p>\n\n\n\n<p><strong>Fulvestrant Stada contains benzyl benzoate<\/strong><\/p>\n\n\n\n<p>Fulvestrant Stada contains 1,500 mg of benzyl benzoate per 500 mg of fulvestrant.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">3. How to use Fulvestrant STADA<\/h2>\n\n\n\n<p>Always use this medicine exactly as your doctor or pharmacist has told you.&nbsp;Ask your doctor or pharmacist if you are unsure.<br><\/p>\n\n\n\n<p>The recommended&nbsp;dose&nbsp;is 500 mg fulvestrant (two 250 mg \/ 5 ml&nbsp;injection&nbsp;s) once per month, with an additional&nbsp;dose&nbsp;at 500 mg two weeks after the initial&nbsp;dose&nbsp;a&nbsp;<strong>.<\/strong><br><\/p>\n\n\n\n<p>Your doctor or nurse will give you Fulvestrant Stada as a slow&nbsp;intramuscular&nbsp;injection&nbsp;, 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&nbsp;, 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><br><\/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>Inflammation of the liver (&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>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 people)<\/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;).<\/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 cannot be assessed due to the underlying disease.<br><\/p>\n\n\n\n<p><em>Reporting of side effects<\/em><\/p>\n\n\n\n<p>If you get any side effects, talk to your doctor, pharmacist or nurse.&nbsp;This also applies to any side effects not mentioned in this information.&nbsp;You can also report side effects directly to the Medical Products Agency,&nbsp;<a target=\"_blank\" href=\"http:\/\/www.lakemedelsverket.se\/\" rel=\"noreferrer noopener\">www.lakemedelsverket.se<\/a>.&nbsp;By reporting side effects, you can help increase drug safety information.<a href=\"javascript:void(0);\">&nbsp;Postal address<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">5. How to store Fulvestrant STADA<\/h2>\n\n\n\n<p>Keep this medicine out of the sight and reach of children.<br><\/p>\n\n\n\n<p>Store and transport in a refrigerator (2 \u00b0 C-8 \u00b0 C).<\/p>\n\n\n\n<p>Store the pre-filled syringe in the original package.&nbsp;Sensitive to light.<br><\/p>\n\n\n\n<p>Deviations outside the temperature range 2 \u00b0 C &#8211; 8 \u00b0 C must be limited.&nbsp;This includes avoiding storage at temperatures exceeding 30 \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 in a refrigerator, 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 4 years for Fulvestrant Stada.&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>Do not use this medicine after the expiry date which is stated on the carton and label after EXP.&nbsp;The expiration date is the last day of the specified month.<br><\/p>\n\n\n\n<p>The medical staff is responsible for the correct storage, use and disposal of Fulvestrant Stada.<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;(5 ml) contains 250 mg fulvestrant.&nbsp;Each ml of solution contains 50 mg of fulvestrant.<\/li><li>The other ingredients 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 contents of the pack<\/h2>\n\n\n\n<p>Fulvestrant Stada is a clear, colorless to yellow, practically free from visible particle, oily and&nbsp;viscous&nbsp;solution, in a pre-filled&nbsp;syringe&nbsp;of glass.&nbsp;Each&nbsp;syringe&nbsp;contains 5 ml&nbsp;solution for injection&nbsp;.<br><\/p>\n\n\n\n<p>Fulvestrant Stada is available in two pack sizes:<\/p>\n\n\n\n<p>&#8211; Carton with a blister with a pre-filled&nbsp;syringe&nbsp;, a protected,&nbsp;sterile&nbsp;needle (BD SafetyGlide) and a package leaflet.<\/p>\n\n\n\n<p>Or<\/p>\n\n\n\n<p>&#8211; Cardboard with two blisters, each with a pre-filled&nbsp;syringe&nbsp;, two protected sterile needles (BD SafetyGlide) and a package leaflet.<br><\/p>\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>STADA Arzneimittel AG<\/p>\n\n\n\n<p>Stadastrasse 2-18<\/p>\n\n\n\n<p>61118 Bad Vilbel<\/p>\n\n\n\n<p>Germany<br><\/p>\n\n\n\n<p><strong>Other manufacturers<\/strong><\/p>\n\n\n\n<p>STADA Arzneimittel GmbH<\/p>\n\n\n\n<p>Muthgasse 36\/2<\/p>\n\n\n\n<p>1190 Vienna<\/p>\n\n\n\n<p>Austria<br><\/p>\n\n\n\n<p>STADAPHARM, GmbH<\/p>\n\n\n\n<p>Feodor-Lynen-Str.&nbsp;35<\/p>\n\n\n\n<p>30625 Hanover<\/p>\n\n\n\n<p>Germany<br><\/p>\n\n\n\n<p>SC Rompharm Company SRL<\/p>\n\n\n\n<p>St. Eroilor, no.&nbsp;1A<\/p>\n\n\n\n<p>075100 OTOPENI, ILFOV<\/p>\n\n\n\n<p>Romania<br><\/p>\n\n\n\n<p><strong>Local representative<\/strong><\/p>\n\n\n\n<p>STADA Nordic ApS<\/p>\n\n\n\n<p>Marielundvej 46A<\/p>\n\n\n\n<p>2730 Herlev<\/p>\n\n\n\n<p>Denmark<\/p>\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":[2385,2386,2260,2384,2261,2215,2216,2212,2213,2262],"class_list":["post-9119","post","type-post","status-publish","format-standard","hentry","category-f","category-medicines","tag-fulvestrant-doses","tag-fulvestrant-side-effects","tag-fulvestrant-stada","tag-fulvestrant-uses","tag-how-to-use-fulvestrant-stada","tag-injection","tag-injections","tag-medicine","tag-medicines","tag-side-effects-of-fulvestrant-stada"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/9119","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=9119"}],"version-history":[{"count":6,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/9119\/revisions"}],"predecessor-version":[{"id":9937,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/9119\/revisions\/9937"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=9119"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=9119"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=9119"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}